DDrare: Database of Drug Development for Rare Diseases

Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (+) erythromefloquine; (+) isomer of racemic mefloquine; (+) isomer or racemic mefloquine; (+)erythromefloquine; (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-; (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-beta-oxo-1-piperidinepropanenitrile,; (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-; (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,; (3R,4R)-4-metil-3-(metil-1H-pirrolo [2,3-d]pirimidin-4-ilamino)-beta-oxo-1-; (3R,4R)-4-metil-3-(metil-1H-pirrolo [2,3-d]pirimidin-4-ilamino)-ß-oxo-1-; (CDP6038; 0109-0012A 100 mg/ml; 0109-0012A 25 mg/ml; 0109-0012A 50 mg/ml; 0114-0006B; 0881; 1 ml 0.9 % NaCl; 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c; 100 mg LX3305 QD; 118-42-3; 13-valent pneumococcal conjugate vaccine; 15-O labeled water; 150 mg LX3305 QD; 18F-FDG; 18F-GE-180; 1H-Pyrazol; 2 million hMSC/kg; 2-{7-[1,1-dimethyl-3-(4-sulfobutyl)-benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl}-1,1-dimethyl-3-(sulfobutyl)-1H-benz[e]-indolium hydroxide,inner salt; 200 mg LX3305 QD; 23-Valent Pneumococcal Polysaccharide Vaccine; 23-valent pneumococcal polysaccharide vaccine; 250 mg LX3305 BID; 250 mg LX3305 QD; 2593; 300 mg LX3305 QD; 331731-18-1; 4 million hMSC/kg; 4-[5-(4-methylphenyl)-3-(trifluoromethyl)- 1H-pyrazol-1-yl] benzenesulfonamide; 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide; 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide; 40 mg MSB11022; 400 mg LX3305 QD; 42942019; 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin; 50 mg AP1189; 50 mg Etanercept; 50 mg LX3305 QD; 500 mg LX3305 QD; 6 million hMSC/kg; 6-(nitrooxy)hexyl(2Z)-4-(acetyloxy)-3-[4-(methylsulfonyl)phenyl]-2-phenylbut-2-enoate; 68Ga-BNOTA-PRGD2; 68Ga-FAPI; 68Ga-NEB; 7-valent Pneumococcal Conjugate vaccine; 70930.00.00; 8594739041288; 89Zr-DFO-CZP; 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline; 9512; 99mTc-3PRGD2; 99mTc-S-HYNIC Certolizumab pegol; 99mTc-rhAnnexin V-128; A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs; AB1010; ABA, open-label (OL); ABATACEPT; ABBV-105; ABBV-105, A-1519938.0; ABBV-257; ABBV-3373; ABP 501; ABP 710; ABP 710 - Biosimilar to infliximab; ABP 798; ABP 798 - Biosimilar to rituximab; ABP 798 Biosimilar to Rituximab; ABT 494; ABT 494 12mg; ABT 494 3mg; ABT-122; ABT-494; ABT-494 15mg; ABT-494 30mg; ABT-Humira; ABX464; ABX464 100mg; ABX464 50mg; AC430; ACTHAR; ACTHAR gel; ACZ885; ACZ885 (investigational); ACZ885 Drug Substance; AD 452; AD 452 18 mg tablet; AD 452 4.5 mg Tablet; AD 452 9 mg tablet; ADALIMUMAB; ADALIMUMAB HUMIRA; ADALIMUMAB-EU; ADL5859; AGM 719; AIN457; AIN457F; AK106-001616; ALD518; ALD518 monoclonal antibody (anti IL-6 mAb); ALENDRONIC ACID; ALLOGENEIC MESENCHYMAL PRECURSOR CELLS; ALX-0061; ALX-0061 Nanobody; AMG 108; AMG 162; AMG 357; AMG 570; AMG 592; AMG 714; AMG 719; AMG 827; AMG 827 140 mg; AMG 827 210 mg; AMG 827 70 mg; AMG592; AMOXICILLIN; AMP; AMP-110; AMT; AMT-101; ANAKINRA; ANIFROLUMAB; AP1189; APLA12; ARA290; ARAVA; ARAVA®; ARCOXIA; ARRY-371797, p38 inhibitor; ARRY-438162; ARRY-438162, MEK inhibitor; ART621; AS; ASK8007; ASP015K; ASP015K hydrobromide; ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide; ASP1707; ASP2408; ASP2409; ASP5094; ATACICEPT; ATI-450; ATN-103; ATN-103 10 mg q4wks; ATN-103 10 mg q8wks; ATN-103 30 mg q4wks; ATN-103 80 mg q4wks; ATN-103 80 mg q8wks; ATORVASTATIN; AVE9897; AZATHIOPRINE; AZD5672; AZD9056; AZD9056 hydrochloride; AZD9567; AZD9567 10 mg; AZD9567 125 mg; AZD9567 155 mg; AZD9567 20 mg; AZD9567 40 mg; AZD9567 80 mg; AZD9567 Monohydrat; AZD9567 monohydrate; Abatacept; Abatacept (ABA) + Methotrexate (MTX), double-blind (DB); Abatacept (BMS-188667); Abatacept (IV); Abatacept (SC); Abatacept + Methotrexate; Abatacept + Vaccines; Abatacept + csDMARD; Abatacept + vaccines; Abatacept Injection; Abatacept Placebo; Abatacept Prefilled Syringe; Abatacept, rituximab or tocilizumab; Acalabrutinib; Aceclofenac; Acellbia; Acetaminophen; Acetaminophen tablets; Acetate; Acetylsalicylic Acid; Acetylsalicylic acid; Acide folique; Actemra; Actemra(EU-licensed); Acthar; Acthar Gel; Acthar Injectable Product; Active comparator; Acycloguanosine; Adalimuab, Etanercept, Tocilizumab, or Abatacept; Adalimumab; Adalimumab (ADA); Adalimumab (HUMIRA®); Adalimumab (Humira); Adalimumab (Humira®); Adalimumab (up to 9 months exposure); Adalimumab - GP2017; Adalimumab - US licensed Humira; Adalimumab 40 mg; Adalimumab 40 mg subcutaneous (SC) every other week (EOW); Adalimumab 40mg q2w; Adalimumab 80 mg; Adalimumab Injection; Adalimumab PFS and Pen; Adalimumab with methotrexate; Adalimumab, Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe; Adalimumab, current formulation; Adalimumab, new formulation; Adalimumab, plus prednisone; Adalimumab-Pfizer; Adalimummab; Adefovir; Adenin; Administration of Cimzia®; Agrippal S1 (Influenza vaccination); Alemtuzumab; Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994; Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994); Alendronat Teva; Alendronate; Alendronate versus alfacalcidol (1-alpha OH vitamin D); Alendronic Acid; Alendronic acid; Alfacalcidol; Alkaline Phosphatase; Allogeneic Mesenchymal Precursor Cells; Allopurinol; Aluminium; Aluminium hydroxide; Aluminium phosphate; Amgevita; Aminopterin; Amoxapine; Amoxapine & dipyridamole; Amoxicilina; Amoxicillin; Anakinra; Anakinra (Kineret®); Anakinra (r-metHuIL-1ra); Anakinra and PEG sTNF-R1; Andecaliximab; Angiotensin; Angiotensin receptor blockers; Anifrolumab; Anifrolumab (MEDI-546); Anti IL 6 mAb; Anti IL-1beta antibody; Anti IL-1beta antibody, subclass IgG4; Anti IL-1ß antibody; Anti IL-1ß antibody, subclass IgG4; Anti LP40 antibody, subclass IgG4 LA294; Anti Lymphotoxin Alpha; Anti TNF + Meth; Anti human granulocyte-macrophage colo; Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) MONOCLONAL; Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal; Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody; Anti lymphotoxin alpha; Anti-C5aR; Anti-CD20 small modular immunopharmaceutical, WYE-400087; Anti-GM-CSF receptor alpha; Anti-IL-20; Anti-IL-20 (109-0012); Anti-IL-6 mAb; Anti-Interleukin-6 Monoclonal; Anti-Interleukin-6 Monoclonal Antibody; Anti-TNF; Anti-TNF Biologics Therapy; Anti-TNF biologics; Anti-TNF humanized antibody Fab fragment - PEG conjugate; Anti-TNF humanized antibody Fab' fragment - PEG conjugate; Anti-TNF suspended perioperatively; Anti-TNF therapy; Anti-TNF therapy (etanercept or adalimumab); Anti-TNF-alpha; Anti-TNFa continued perioperatively; Anti-Tumor Necrosing Factor (TNF) Therapy; Anti-inflammatory drugs; Anti-pandemic H1N1 influenza vaccine; Anti-thymocyte globulin; Anticuerpo monoclonal anti-humano recombinante humanizado, receptor de IL-6R.; Antihistamine; Apratastat; Apremilast; Apremilast 20 mg; Apremilast 30 mg; Arava; Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.); Arava 20 mg filmdrasjerte tabletter; Arcoxia; Arginine; Arm B: Rituxan®/Mabthera®; Arthroscopy & saline irrigation alone; Artilog; Ascal(r) / carbasalate calcium; Asendis; Asendis 50 mg; Aspirin; Aspirin 81mg tablet; Aspirin Tablets; Atacicept; Atacicept: with loading dose; Atorvastatin; Atorvastatin tablet 20 mg; Auto Injector; Autologous adipose derived stem cells; Autologous apoptotic cells injection; Autologous mesenchymal stem cells; Autologous stromal vascular fraction cells; Avelox- Moxifloxacin; Avelox®; Azathioprin; Azathioprine; B03BB01; BARICITINIB; BAT1806; BAT1806 injection; BCD-055; BCD-089; BCD-089, 162 mg, s/c, q2w; BCD-089, 162 mg, s/c, qw; BD; BDMARD; BDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept); BETAMETHASONE ACIBUTATE; BG00012; BG9924; BGX-0214; BI 655064; BI 655064 high dose; BI 655064 low dose; BI 655064 medium dose; BI 695500; BI 695501; BI 695501 Autoinjector; BI 695501 Prefilled syringe; BIAP; BIBR 796 BS; BIIB023; BIIB057; BIIL 284 BS high dose; BIIL 284 BS low dose; BIIL 284 BS medium dose; BIMEKIZUMAB; BIRB 796 BS, high dose; BIRB 796 BS, low dose; BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin); BMS-188667; BMS-582949; BMS-582949 and Methotrexate; BMS-817399; BMS-945429; BMS-986104; BMS-986142; BMS-986142 200mg; BMS-986142 350mg; BMS-986195; BMS-986251; BMS188667; BMS986142; BMS986195; BNP; BORTEZOMIB; BOW015; BR9001; BR900A; BREDININ; BRL-049653; BT061; BT061 (CD4 monoclonal antibody); BT971; BTK Inhibitor; BTT-1023; BUMEKIZUMAB; BUPIVACAINE HYDROCHLORIDE; Balance; Baminercept; Baminercept alfa; Baminercept alfa (BG9924); Baricitinib; Baricitinib, olumiant®; Behavioral: AbbVie Care 2.0; Behavioral: Balance exercise; Behavioral: Cannabis questionnaire; Behavioral: Dietary Counseling; Behavioral: Dietary guidance; Behavioral: Dietary recommendations; Behavioral: Instructional handouts; Behavioral: Marching in place; Behavioral: Physical therapist instruction and monitoring via teleconferencing; Behavioral: Posture training; Behavioral: Questionnaire; Behavioral: Resistance exercise; Behavioral: TIP / IMPACT Plus Care Coordination; Behavioral: Web-based instructional videos; Belatacept; Belimumab; Belimumab 1 mg/kg; Belimumab 10 mg/kg; Belimumab 4 mg/kg; Benepali; Benzimidazole; Benzimidazole,5-methoxy-2-[[(4-methoxy- 3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole; Benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole; Betamethasone; Bi 695500; Bicain spinal; Bimekizumab; Binyrebarkhormon; Binyrebsrkhormon; Biodmards; Biologic Agents; Biologic DMARD; Biologic TNFi; Biological agents; Biologics; Biosimilar; Biosimilar Infliximab; Biosimilar infliximab; Biosimilar product to adalimumab; Blood; Blood sample; Blood samples; Blood tests; Boostrix; Boostrix®; Borage seed oil; Bortezomib; Bovine intesastinal alkaline phosphatase (bIAP); Branebrutinib; Bredinin tablet 150mg; Bredinin tablet 50mg; Bucillamine; Bupivacaine; Bupivacaine hydrochloride; Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer); Buprenorphine; Buprenorphine Transdermal Patch; Buprenorphine transdermal patch; C. albicans; C10AA05; CAM-3001; CANNABIDIOL; CAPTURE; CBD; CC; CC-10004; CC-292; CCI-779; CCR1 Antagonist; CCX 354; CCX 354-C; CCX-354; CCX-354-C; CCX354; CCX354-C; CD; CDMARD; CDP; CDP 6038 SC; CDP6038; CDP870; CDP870 100mg; CDP870 200mg; CDP870 400mg; CDP870 Fab'-PEG; CE 224,535; CE-224,535; CELBESTA®; CELEBREX; CELEBREX 200MG 20CPS; CELEBREX®; CELECOXIB; CERTOLIZUMAB PEGOL; CERTOLUZIMAB PEGOL; CF101; CF101 1 mg; CF101 2 mg; CFZ533; CH-1504; CH-4051; CHS-0214; CICLOSPORIN; CIMZIA; CKD-374 5mg Tab.; CKD-506; CLAZAKIZUMAB; CLS; CMAB008; CNTO 136; CNTO 136 100 mg; CNTO 136 25 mg; CNTO 136 50 mg; CNTO 136 IgG; CNTO 148; CNTO 1959; CNTO 1959 + MTX (Group 4); CNTO 1959 + MTX (Group 5); CNTO 1959 IgG; CNTO 6785 100 mg; CNTO 6785 15 mg; CNTO 6785 200 mg; CNTO 6785 50 mg; CNTO1275; CNTO136; CNTO148; CNTO6785; COLECALCIFEROL; CP; CP 690,550; CP 690550 MR; CP-195,543; CP-690, 550 - 10; CP-690,55-10; CP-690,550; CP-690,550 (tasocitinib); CP-690,550 (tofacitinib); CP-690,550 + methotrexate; CP-690,550 – 10; CP-690,550-10; CP-690-550; CP690,550; CR 1; CR 2; CR 3; CR0686; CR6086; CR6086Z; CRX-139; CRx-102; CRx-102 (2.7/180); CRx-102 (2.7/360); CRx-139; CRx-150; CT- P10; CT-P10; CT-P13; CT-P17; CT-P17 SC; CT-P17 SC AI (adalimumab); CTLA4Ig; CZP; Caffeine; Calcitriol; Calcium; Calcium and cholecalciferol; Calcium carbonate; Calcium citrate; Canakinumab; Canakinumab (investigational); Canakinumab (proposed); Cannabidiol; Cannabidiol tablet 10 mg; Cannabis; Carbasalate calcium; Carbon; Carbonate; Celebra; Celebra (celecoxib); Celebrex; Celebrex 200 mg; Celebrex 200 mg Hartkapseln; Celebrex 200 mg capsule, hard; Celecoxib; Celecoxib 200mg capsule; Ceramic on Polyethylene articulation; Certolizumab; Certolizumab Pegol; Certolizumab Pegol (CZP); Certolizumab Pegol (CZP) 200 mg; Certolizumab Pegol (CZP) 400 mg; Certolizumab Pegol + Methotrexate (MTX); Certolizumab Pegol 200 MG/ML [Cimzia]; Certolizumab pegol; Certolizumab pegol (CDP870); Certolizumab pegol (CDP870, tradename Cimzia); Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg); Certolizumab pegol (CZP); Cetrorelix; Cevidoplenib; Chicken; Chicken type II collagen; Chimeric Human-Murine IgG1 <Monocolonal Antibody; Chimeric human/mouse anti-CD-20 monoclonal antibody; Chlor; Chloride; Chloroquine; Cholecalciferol; Chong Kun Dang Tofacitinib Tablet; Chromium; Ciclosporin; Cimzia; Cimzia 200 mg injeksjonsvæske, oppløsning; Cimzia 200 mg solution for injection; Cimzia®; Citalopram; Classic DMARDs treatment group; Clazakizumab; Clindamycin; Clobetasol; Clobetasol Propionate; Clobetasol propionate; Clofarabine; Co-medication: Synthetic DMARDs; Cobalt; Cobiprostone; Cod; Cod liver oil; Coenzyme Q10; Colchicine; Colecalciferol; Collect of 10 ml of peripheric blood for DNA extraction; Combination; Combination Product: Methotrexate; Combination Steroid; Combination fish oil and borage seed oil; Combination of Minocycline and MTX or MTX alone; Commercial Formulation Etanercept; Comparator: Diclofenac sodium; Comparator: diclofenac; Comparator: naproxen tablet 500 mg; Control; Control group; Control intervention (no dexamethasone); Conventional DMARD combination; Conventional DMARDs; Conventional Synthetic DMARD; Corn; Corn oil capsules; Corticosteroid and non-biological agents.; Corticosteroid or NSAID; Corticosteroids; Corticotrophin; Corticotrophin 80 units; Corticotropin; Creatine; Creatinine; CsDMARD(s); CsDMARDs; Cura-100; Curcumin; Curcumin (Longvida™); Cyclophosphamide; Cyclosporin; Cyclosporin A; Cyclosporine; Cyklokapron®; D2E7; D569 Tab.; DECORTIN (PREDNISONA) 5 MG COMPRIMIDOS; DELTACORTENE FORTE*10CPR 25MG; DEPALGOS*20+325MG 28CPR RP; DFO; DHA; DIBASE*IM OS 2F 1ML 300000UI/M; DIPHTHERIA TOXOID; DMARD; DMARD Therapy; DMARD cessation; DMARD maintenance; DMARDS; DMARDs; DMARDs (disease-modifying antirheumatic drugs); DMARDs (methotrexate; DMARDs or Biologics; DRL_RI; DRONABINOL; DWP422 25mg; Dacortin ®; Dalacin C; Dalacin C phosphate; Decortin; Decortin 5mg tablets; Decortin®; Decrease Tocilizumab, Abatacept; Defanyl 50 and 100 mg; Dekavil; Deltacortril; Deltacortril Enteric; Denosumab; Depemedrone; Depo Medrol; Depo medrol; Depo-Medrone; Device: AI-1000 G2; Device: AS Domelock System; Device: Abatacept combination product (ACP); Device: Active stimulation; Device: Adalimumab delivered in Physiolis autoinjector; Device: Adalimumab delivered in Physiolis syringe; Device: Adalimumab delivered in current autoinjector; Device: Adalimumab delivered in current syringe; Device: Auto-Injector Device (AID); Device: Autoinjector; Device: C-Stem™ AMT Femoral Component (standard and high off-set variants); Device: CLS Brevius stem with Kinectiv technology; Device: Carbon Modular Radial Head; Device: Carbon Modular Radial Head replacement; Device: Ceramic on Ceramic articulation; Device: Cobalt™ Bone Cement; Device: Doppler ultrasound.; Device: E1-Hip Bearing; Device: ESAOTE MyLab60; Device: Fluorescence Imaging; Device: High-resolution peripheral quantitative computed tomography (HR-pQCT); Device: Hyperbaric Oxygen; Device: Integra TITAN™ Total Shoulder Generation 1.0; Device: Integra Titan Modular Shoulder System 2.5; Device: Magnetic Resonance Imaging (MRI); Device: Metal Radial Head; Device: Metal Radial Head replacement; Device: Metal on Polyethylene articulation; Device: MultiSpectral Imaging System; Device: Pre-filled Syringe (PFS); Device: Primus FGTI (Flexible Great toe Implant); Device: Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001; Device: Scorpio NRG posterior stabilized (PS); Device: Sham stimulation; Device: Sham vagus nerve stimulation; Device: SimpleJectTM; Device: Simplex® Bone Cement; Device: Sofusa DoseConnect; Device: TC-A PS Total Knee Replacement System; Device: TC-PLUS Solution PS Total Knee Replacement System; Device: Technetium labelled glucosamine; Device: Total hip arthoplasty (THA); Device: Transcutaneous electrical vagus nerve stimulation; Device: VIBEX MTX; Device: Vanguard 360 TiNbN Femur with PS bearing; Device: Vanguard 360 TiNbN Femur with PSC bearing; Device: Vanguard DA 360; Device: Vanguard SSK 360 with PS Bearing; Device: Vanguard SSK 360 with PSC bearing; Device: conventional syringe - BD Ref 309604; Device: transthoracic echocardiographic; Dexamethason; Dexamethasone; Dexmedetomidine; Dextromethorphan; Dextromethorphan hydrobromide; Diacerein; Diagnostic Test: 11C-ER176; Diagnostic Test: 11C-MC1; Diagnostic Test: Adalimumab serum trough concentration; Diagnostic Test: Adalimumab trough concentration; Diagnostic Test: Biotherapy Prescription with SinnoTest® software; Diagnostic Test: CRQ; Diagnostic Test: Disease activity; Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system; Diagnostic Test: Serum Metal ion levels determined to monitor changes in chromium and cobalt levels; Diazepam; Diazepam, melatonin; Diclofenac; Diclofenac + Omeprazole; Diclofenac sodium; Dietary Fiber Supplementation; Dietary supplement omega3 fatty acids aand vitamins; Digoxin; Dihuang; Dimeythl Fumarate; Diphtheria toxoid; Dipotassium Salt; Diprofos Depot; Dipyridamole; Dipyridamole and Amoxapine; Disease modified antirheumatic drugs or biological agents; Disease-modifying anti-rheumatic drugs; Disease-modifying antirheumatic drug; Disease-modifying antirheumatic drugs (DMARDs); DnaJ peptide; Dolquine; Donepezil; Dose level 1; Dose level 2; Dose level 3; Dose level 4; Double-blind Abatacept; Double-blind adalimumab; Doxycycline; Doxycycline Tablets; Dr. Reddy’s Rituximab (DRL_RI) 100mg; Dr. Reddy’s Rituximab (DRL_RI) 500mg; Dronabinol; Dronabinol capsule 2.5. mg; Drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom; Drug treatment; Drug: Abatacept; Drug: Salirumab; Drug: Tocilizmab; Dummy Qing Re Huo Xue (QRHX); E-Device; E1; E6011; EC 3.1.3.1; EFALIZUMAB; EMEA/H/C000262; EN; ENBREL; ENBREL - 50 MG SOLUZIONE INIETTABILE IN SIRINGA (VETRO DA 1 ML) PRERIEMPITA - USO SOTTOCUTANEO 12 SIRINGHE PRERIEMPITE + 24 TAMPONI IMBEVUTI DI ALCOL; ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.; ENBREL 25MG PFS INJ.; ENBREL*SC 4FL 25MG+4SIR 1ML; ENBREL*SC 4FL 50MG+4SIR+4AGHI+; ENBREL*SC 4SIR 25MG 0,5ML+8TAM; ENBREL*SC 4SIR 50MG 1ML+8TAMP; ENBREL®; ENIA11; EPA; EPAX 6000 EE 1000mg (0.6 gr DHA+EPA); ERB-041; ERMM-1; ETANERCEPT; ETN; ETN Alone; ETN+MTX; ETORICOXIB; EU-Humira; EU-approved RoActemra; EU/1/99/126/017; EU/1/99/126/020; Ebetrexat; Edoxaban; Efalizumab; Efexor XL 75 mg; Efexor XL 75 mg (venlafaxine); Eldecalcitol; Enalapril; Enalapril Maleate; Enbrel; Enbrel (Etanercept); Enbrel (etanercept); Enbrel 25 mg; Enbrel 25 mg powder and solvent for solution for injection; Enbrel 25mg PFS; Enbrel 50 mg; Enbrel 50 mg powder and solvent for solution for injection; Enbrel 50 mg solution for injection in pre-filled syringe; Enbrel 50mg PFS; Enbrel 50mg pre-filled pen; Enbrel 50mg pre-filled syringe; Enbrel Auto Injector; Enbrel Pre-filled syringe; Enbrel liquid; Enbrel pre-filled pen; Enbrel pre-filled syringe; Enbrel, Benepali, Erelzi; Enbrel®; Enbrel® 50 mg Solution for Injection in Pre-filled Syringe; Engineered humanized monoclonal anti-human CD19 antibody.; Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml); Enoxaparin; Entanercept; Entecavir; Epaxal; Epinephrine; Epoetin alfa; Erbium citrate; Erelzi; Ergocalciferol; Ergocalciferol 1.25 mg tablet; Esbriet; Esomeprazole; Esomeprazole 20 mg; Estradiol; Eszopiclone; Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab; Etanercept; Etanercept (ETN); Etanercept (Enbrel); Etanercept (EnbrelTM); Etanercept + Methotrexate; Etanercept , Methotrexate; Etanercept / Autoinjector A; Etanercept 50 MG/ML; Etanercept 50mg; Etanercept Auto-Injector; Etanercept Liquid; Etanercept Optimal dosing; Etanercept Pre-filled syringe; Etanercept Treatment; Etanercept biosimilar; Etanercept or adalimumab; Etanercept pre-filled syringe sq injection; Etanercept via Autoinjector A; Etanercept via Autoinjector B; Etanercept, methotrexate and depomedrone; Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc; Ethinyl estradiol; Etodolac; Etoricoxib; Etoricoxib 60 mg; Etoricoxib 90 mg; Evobrutinib; Experimental: Arm A: DRL_RI; F8IL10; FANG(30); FB704A; FILGOTINIB; FKB327; FKB327 AI; FKB327 PFS; FPA008; FR104; FSME-IMMUN; FURESTEM-RA Inj; FURESTEM-RA Inj.; FX125L; Faecal sampling; Famotidine; Fang yi qing feng shi granule; Fendrix; Fendrix suspension for injection; Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).; Fentanyl; Fentanyl transdermal patch; Ferrograd; Ferrograd Folic Tablets; Filamentous haemagglutinin; Filamentous haemagglutinin adsorbed; Filgotinib; Filgrastim; Fish Oil; Fish oil; Fish oil supplement; Fish oil, gamma-linolenic acid; Fludarabine; Flurbiprofen; Focetria; Focetria (Monovalent MF59-Adjuvanted vaccine); Folate; FolateScan (Technetium Tc 99mEC20); Folic (or folinic) acid; Folic Acid; Folic acid; Folic acid or folate; Folic/folinic acid; Folimet; Folinic acid; Fontolizumab; FosD; Fosfamatinib Disodium; Fostamatinib; Fostamatinib 50 mg blue film-coated tablet; Fostamatinib Disodium; Fostamatinib Disodium (R935788); Fostamatinib disodium; Fostamatinib disodium (R935788); Fresenius-Kabi); G1567970; GB224 10mg; GB224 15mg; GB224 20mg; GB224 2mg; GB224 30mg; GB224 5mg; GB242; GCK 100 mg; GCK 200 mg; GCK 300 mg; GDC-0853; GDC-0853 RO7010939; GFI 38518168-AEK-B-007; GLPG0259; GLPG0259 (Part B); GLPG0259 oral capsule; GLPG0634; GLPG3970; GOL; GOLIMUMAB; GP2013; GP2013 - A Proposed biosimilar rituximab; GP2015; GP2017; GRC 4039; GS-5745; GS-6034; GS-9876; GSK 3196165; GSK1827771; GSK1841157; GSK2982772; GSK2982772 60 mg; GSK2982772A, where A denotes the free base; GSK3117391; GSK3152314A; GSK315234; GSK315234 Injection 100mg/mL; GSK3196165; GSK3196165 Dose 1; GSK3196165 Dose 2; GSK3196165 Dose 3; GSK706769; GW274150; GW274150 Tablets; GW406381; GW406381X; GW856553; Gadobutrol; Gadolinium; Gamma-Linolenic acid; Gerilimzumab; Ginger; Ginseng; Ginsenoside; GlucoCorticoid; Glucocorticoid Agent; Glucocorticoids (permitted,not necessary); Glucophage (metformin); Glucosamine; Gold; Golimumab; Golimumab 100 mg; Golimumab 100 mg injections; Golimumab 2 mg/kg IV; Golimumab 50 mg; Golimumab 50 mg SC; Golimumab 50 mg injections; Golimumab Final Vialed Product (FVP); Golimumab Intravenous; Golimumab Intravenous (IV); Golimumab Liquid in Vial; Golimumab Liquid in prefilled syringe; Golimumab Pre-Filled Syringe; Golimumab liquid in prefilled pen; Golimumab liquid in prefilled pen or Prefilled Syringe; Golimumab liquid in prefilled pen or prefilled syringe; Golimumab pre-filled syringe; Golimumab prefilled pen; Golimumab prefilled pen or prefilled syringe; Grapefruit; Green Tea; Green tea group; Group 1 or Orencia treated group; Growth Hormone; Growth hormone; Gum Arabic; Gum arabic; Guna-Anti Interleukin 1; Guna-Antiinterleukin 1 alfa; Guna-Antiinterleukin 1 beta; Guna-Interleukin 10; Guna-Interleukin 4; H.P. Acthar Gel; H.P. Acthar gel; H02AB07; HA20 (IMMU-106); HA20 (Immu-106); HB-adMSCs; HBVAXPRO; HBVAXPRO 5 micrograms/0.5 ml; HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA); HBVAXPRO® 40 micrograms; HBvaxpro; HCQ; HD-TIV; HE3286; HEPATITIS B VACCINE (RDNA); HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN); HL237; HL237 tablet; HLX01; HM71224 Multiple ascending dose; HM71224 food effect; HM71224 single ascending dose; HMPL-523; HUC-MSC + DMARDs; HUC-MSC suspension; HUMIRA; HUMIRA 40 mg solución inyectable en jeringa precargada; HUMIRA*SC 2SIR+F 40MG 0,8ML+2T; HYDROXYCHLOROQUINE; HYDROXYCHLOROQUINE SULFATE; HZT-501; Havrix; Hbvaxpro; Hematopoietic Stem Cell Transplantation; Hepatitis A Vaccine; Hepatitis A vaccine; Hepatitis A vaccine ( HAVRIX or EPAXAL); Hepatitis A vaccine and tetanus vaccine; Hepatitis B Vaccine; Herpes Zoster Vaccine; High dose ORTD-1; High dose of BIIL 284 BS tablets; High dose vehicle control; HrIL-2 active; HuMax-CD20; HuMax-CD4; Huang qi gui zhi wu wu granule; Hulio; Human Anti-TNF IgG1 Monoclonal Antibody; Human Anti-TNFalfa; Human Recombinant IgG1, lambda; Human anti TNF-alpha monoclonal; Human anti TNF-alpha monoclonal antibody; Human anti-IL6 monoclonal antibody; Human anti-TNF-alpha monoclonal antibody; Human monoclonal antibody directed against CD20 on B-cells; Humanised anti-CD 20 antibody; Humanised anti-CD4 IgG1 monoclonal; Humanized TNFa monoclonal antibody; Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody; Humira; Humira (adalimumab); Humira (adalimumab) 40 mg in 0.4 ml s.c. injection; Humira (adalimumab) 40 mg s.c. injection; Humira (adalimumab) 40mg in 0.4 ml s.c. injection; Humira (adalimumab) 40mg in 0.4ml s.c.injection; Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte; Humira 40 mg solution for injection in pre-filled syringe; Humira 40 mg/0.8 ml solution for injection; Humira 40mg Injektionslösung; Humira 40mg solution for injection in pre-filled syringe; Humira 40mg solution for injection in pre-filled syringe (adalimumab); Humira 40mg/0.8 ml solution for injection for paediatric use; Humira 40mg/0.8ml solution for injection in pre-filled syringe; Humira SC; Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe; Humira, 40 mg solution for injection in pre-filled syringe; Humira, Hulio, Amgevita, Hyrimoz, Idacio, Imraldi; Humira®; Humira® (adalimumab); Humira® 40 mg Injektionslösung in Fertigspritze; Humira® 40 mg solution for injection in pre-filled syringe; Humira® 40 mg/ 0.8 ml solution for injection in pre-filled syringe; Hyaluronic acid; Hydrocortisone; Hydrocortisone 10mg; Hydroxide; Hydroxychloroquine; Hydroxychloroquine sulfate; Hydroxycholoquine; Hydroxycloroquina; Hylase; Hyrimoz; IB-MECA; ICG-Pulsion; ICP-022; IDEC-C2B8 (rituximab); IL-2; IL-6 receptor inhibitor, humanized monoclonal antibody; IL-6 receptor inhibitor, recombinant humanized monoclonal antibody; ILV-094; IMUREL; INCB018424; INCB028050; INCB028050 phosphate; INCB028050 phosphate salt; INCB047986; INDOCYANINE GREEN; INFLIXIMAB; INN - FILGOTINIB; INN not available; INTERLEUKIN 2; IPI 145; IPI-145; IR Prednisone; IRAK 4; ISIS 104838; ISIS CRP Rx; IV Abatacept; IV golimumab; Ianalumab; Ibandronate; Ibuprofen; Idacio; Iguratimod; Iguratimod (Careram); Imatinib; Immune ablation and hematopoietic stem cell transplant; Immunoscintigraphy with radiolabeled Cimzia®.; Immunosporin; Impact; Imraldi; Imurel; Inactivated hepatitis A virus; Indocyanine Green; Indocyanine green; Indocyanine green(ICG); Infliximab; Infliximab (INF) + MTX, DB; Infliximab (Remicade); Infliximab + methotrexate (MTX); Infliximab 10 mg/kg; Infliximab 3 mg/kg; Infliximab Control; Infliximab Increased Dose; Infliximab Increased Frequency; Infliximab [infliximab biosimilar 3]; Infliximab biosimilar; Infliximab group; Infliximab, etanercept; Infliximab, etanercept, adalimumab; Infliximab, methylprednisolone, methotrexate; Infliximab-EU; Infliximab-Pfizer; Influenza vaccine; Influvac; Infusion without ALD518'; Innovator infliximab; Insulin; Integrative Medicine; Interleukin 10; Interleukin 2; Interleukin 4; Intra-articular Compound Betamethasone; Intra-articular Tocilizumab; Intraarticular betamethasone; Intraarticular dexamethasone; Intraarticular injection; Intraarticular morphine; Intravenous (IV) Abatacept; Intravenous (IV) abatacept; Intravenous Dexamethasone 1 mg; Iodine; Itacitinib; JAK 3; JAK1 / JAK2 Inhibitor; JAK1 / JAK2 Inhibtor; JHL1101; JNJ 38518168; JNJ-16240159-AAC; JNJ-38518168; JNJ-38518168 (10 mg); JNJ-38518168 (3 mg); JNJ-38518168 (30 mg); JNJ-38518168 / MTX; JNJ-38518168 50-mg Over Encapsulated Tablet; JNJ-38518168-AEK - Over Encapsulated Tablet - 50 mg; JNJ-38518168-ZBQ; JNJ-38518168-ZBQ - film-coated tablet - 10 mg; JNJ-38518168-ZBQ - film-coated tablet - 10mg; JNJ-38518168-ZBQ - film-coated tablet - 3 mg; JNJ-38518168-ZBQ - film-coated tablet - 30 mg; JNJ-38518168-ZBQ - film-coated tablet - 30mg; JNJ-38518168-ZBQ - film-coated tablet - 3mg; JNJ-39758979; JNJ-39758979 (10 mg); JNJ-39758979 (100 mg); JNJ-39758979 (30 mg); JNJ-39758979 (300 mg); JNJ-39758979 / MTX; JNJ-39758979-AAC - enteric coated tablet - 10 mg; JNJ-39758979-AAC - enteric coated tablet - 100 mg; JNJ-39758979-AAC - enteric coated tablet - 30 mg; JNJ-40346527; JNJ-40346527-AAC - capsule - 50 mg; JTE-051; Juanbi pill; K-832; KB003; KC706; KEVZARA; KINERET*SC 7SIR 100MG 0,67ML; KN019, 10 mg/kg; KN019, 5mg/kg; KR002524; Kenacort; Kenalog; Ketoprofen; Kevzara; Keyhole limpet hemocyanin; Kineret; Kineret®; Kineret® (Anakinra); Kolbet; Kunxian Capsule; L-000124467; L-000124467 (freebase); L-000124467-009J (succinat; L-000883191; L-001069957; L-883191; L-arginine; L01BA01; L01X CO2; L01XC02; L04 AB04; L04041); L04AA11; L04AA24; L04AB01; L04AB04; L04AB05; L04AC07; LBAL; LBEC0101; LD-aminopterin; LEFLUNOMIDE; LNP1955; LO4AB04; LTS 0.25mg; LTS 0.5mg; LTS 1.0mg; LX3305; LX3305 Dihydrate; LX3305 high dose; LX3305 low dose; LX3305 mid dose; LY2127399; LY2127399 (Tabalumab); LY2189102; LY2439821; LY3009104; LY3090106 - IV; LY3090106 - SQ; LY3337641; LY3337641 20 mg; LY3337641 5 mg; LY3462817; Lacosamide; Lamivudine; Lantarel; Large protein molecule; Ledertrexate; Ledertrexato; Leflunomide; Leflunomide (permitted, not necessary); Leflunomide 10 milligram (MG); Leflunomide 20 mg Tablets (Geneva Pharmaceutical); Leflunomide 20Mg Tab; Leflunomide-Sulfasalazine-Hydroxychloroquine; Leflunomidum; Leucovorin; Levobupivacaine; Levofloxacin; Lidocaine; Lingzhi and Sen Miao San; Linolenic acid; Lipitor®; Lisinopril; Lodotra®; Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol); Long-chain n-3 PUFA; Long-circulating liposomal prednisolone; Loratadine; Losartan; Losec; Losec Capsules 20 mg; Lovastatin; Low dose ORTD-1; Low dose of BIIL 284 BS tablets; Low dose vehicle control; Loxoprofen; Lumiracoxib; Lymphoseek; M2591 25 mg QD; M2951; M2951 50 mg BID; M2951 75 mg QD; M923; MABTHERA; MABTHERA 500 mg concentrado para solución para perfusión; MABTHERA*EV 1FL 50ML 500MG; MBS2320; MC1; MDA; MDX-1100; MDX-1342; MEDI-522; MEDI5117; METFORMINE ARROW 500mg; METHOTREXAT Lederle - Tabletten; METHOTREXATE; METHOTREXATE 2.5 mg tablets; METHOTREXATE DISODIUM; METHOTREXATE HOSPIRA 2,5 mg tablety; METHOTREXATE HOSPIRA 2.5 mg tablety; METHOTREXATE SODIUM; METHOTREXATE Sodium; METHOTREXATE*100CPR 2,5MG; METHOTREXATE*10MG/1,33ML 4S; METHOTREXATE*15MG/2ML 4SIR; METHOTREXATE*2,5MG 25CPR; METHOTREXATE*20MG/2,66ML 4S; METHOTREXATE*25CPR 2,5MG; METHOTREXATE*7,5MG/ML 4SIR.; METHYLPREDNISOLONE; METHYLPREDNISOLONE SODIUM SUCCINATE; METOTREXATO; METOTREXATO SANDOZ - 2.5 MG COMPRESSE 50 COMPRESSE IN FLACONE PP; METOTREXATO SODICO; METOTREXATO SODIO; METOTREXATO-LEDERLE 2,5 MG COMPRIMIDOS; METRONIDAZOLE; MK-0663; MK-0873; MK-8457; MK-8457 (free acid); MK-8457 100 mg; MK-8808; MK0359; MK0663, etoricoxib; MK0812; MK0812 / Duration of Treatment: 12 Weeks; MK0966; MK8457; MLN3897; MLTA3698A; MM-093; MONITOR; MOR103; MORAb-022; MORPHINE SULFATE; MP-435(dose1) + Methotrexate; MR Prednisone; MR prednisone; MRA; MRA (Tocilizumab); MRA (tocilizumab); MRA(Tocilizumab); MRA, Actemra; MRA-SC; MRC375; MRC375 150mg; MSB11022; MSB11456; MT203; MTRX1011A; MTX; MTX Goldshield Tablets; MTX HEXAL 2,5 mg Tabletten; MTX HEXAL 2,5mg Tabletten; MTX HEXAL Tablets; MTX plus anti-TNF; MTX start; MTX therapy; MabThera; MabThera (rituximab); MabThera 100mg; MabThera 500 mg; MabThera 500 mg (10 mg/ml) concentrate for solution for infusion; MabThera 500 mg (10mg/ml); MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung; MabThera 500 mg concentrate for solution for infusion; MabThera 500mg; MabThera infusions; MabThera/Rituxan; MabThera®; MabThera® (rituximab); MabThera®, 100 mg Concentrado para solución para perfusión; MabThera®, 100 mg concentrate for solution for infusion; MabionCD20; Mabthera; Mabthera (rituximab); Mabthera 500 mg Concentrate for solution for infusion; Magnesium; Manufacturerd by Cambridge Therapeutic Antibody Centre, Burroughs Wellcome, Glaxo Wellcome); Maraviroc; Masitinib; Masitinib (AB1010); Masitinib 3 mg; Masitinib 6.0 mg; Masitinib mesylate; Mavrilimumab; Mavrilimumab 10 mg; Mavrilimumab 100 mg; Mavrilimumab 150 mg; Mavrilimumab 30 mg; Mavrilimumab 50 mg; Maxtrex; Medium THC/medium CBD; Medrol; Medrol 4 mg tablets; Medrol A 16 mg tablets; Medrone; Mefloquine; Melatonin; Meloxicam; Meloxicam 0.125 mg/kg; Meloxicam 0.25 mg/kg; Meloxicam ampoule; Meloxicam oral suspension; Meloxicam tablet; Meriva; Mesalazine; Mesenchymal cell transplantation; Metex; Metex 10 mg/ml Injektionslösung, Fertigspritze; Metex 10mg Tabletten; Metex 2,5mg; Metex 2,5mg Tabletten; Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte; Metex 7,5mg Tabletten; Metex Pen; Metex®; Metex® 50 mg/ml Injektionslösung, Fertigspritze; Metformin; Metformin treatment; Metformin/CP-690,550; Metformine; Methorexate; Methotrexat; Methotrexat 2,5 mg Tabletten medac; Methotrexat HEXAL® 2,5 mg Tabletten; Methotrexat Lederle 2.5mg tablets; Methotrexate; Methotrexate 'Lederle' 2,5mg tablets; Methotrexate 'Lederle' 2.5mg Tablets; Methotrexate 'Lederle' Tablets; Methotrexate (MTX); Methotrexate (Metoject® prefilled pen); Methotrexate (stable dose); Methotrexate (tapering dose); Methotrexate + Infliximab; Methotrexate + Methylprednisolone; Methotrexate + biologic administration; Methotrexate + salazopyrine + hydroxychloroquine administration; Methotrexate - Amneal; Methotrexate - DAVA; Methotrexate - Delay; Methotrexate - Immediate; Methotrexate - etanercept - prednisolone arm; Methotrexate 10 mg; Methotrexate 10 mg tablets; Methotrexate 2.5 mg Tablets; Methotrexate 2.5 mg tablets; Methotrexate 2.5mg Tablets; Methotrexate 2.5mg Tablets BP; Methotrexate 50mg/ml solution for injection, pre-filled syringe; Methotrexate Disodium; Methotrexate Ebewe; Methotrexate Lederle 2.5 mg Tablets; Methotrexate Pfizer 2,5 mg tabletter; Methotrexate Placebo; Methotrexate Sodium; Methotrexate Sodium 2.5mg Tablets; Methotrexate Sodium Tablets 2.5 mg; Methotrexate Sodium Tablets 2.5mg; Methotrexate Sodium tablets 2.5mg; Methotrexate ``Lederle`` 2.5mg tablets; Methotrexate as methotrexate disodium; Methotrexate capsules; Methotrexate disodium; Methotrexate plus ENBREL or ENBREL alone; Methotrexate plus ERB-041 for 12 weeks; Methotrexate plus sulfasalazine; Methotrexate pre-filled pen; Methotrexate prefilled pen; Methotrexate prefilled syringe; Methotrexate sodium; Methotrexate sodium 2.5mg tablets; Methotrexate sodium tablets 2.5 mg; Methotrexate sodium tablets 2.5mg; Methotrexate tablets 2.5 mg; Methotrexate treatment; Methotrexate ® 2.5mg Tablets; Methotrexate(MTX); Methotrexate(MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol; Methotrexate(MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol.; Methotrexate(necessary); Methotrexate, Leucovorin and BMS-986142; Methotrexate,Adalimumab; Methotrexate-Lachema; Methotrexate-Sulfasalazine-Hydroxychloroquine; Methotrexate® 2.5 mg tablets; Methotrextate; Methoxsalen; Methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-beta-Dribofuronamide; Methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide; Methylaminopterin; Methylprednisolone; Methylprednisolone Sodium Succinate; Methylprednisone; Metoject; Metotab®; Metotrexat Orion; Metotrexato; Metotrexato Sodico; Metronidazol; Metronidazole; Mextrex; Micellar Paclitaxel for Injection; Microgynon® 30 (Oral contraceptive); Midazolam; Milnacipran; Minocycline; Minodronate; Minodronic acid; Misoprostol; Mizoribine; Modal; Montelukast; Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142; Morphine; Morphine Hexal; Morphinsulfat; Moxifloxacin; Multigrain powder (S); Mushroom; Mushroom extract; Mussel oil capsules; N-3 LC-PUFA; N.A.; NAMILUMAB; NC-503 (Anti-amyloidotic (AA) Agent); ND; NI-0101; NI-071; NNC 0109-0000-0012; NNC 0141-0000-0100; NNC 0142-0000-0002; NNC 0151-0000-0000; NNC 142-0002; NNC0109-0012; NNC0114-0000-0005; NNC0114-0006; NNC0142-0002; NNC0151-0000-0000; NNC0215-0384; NNC109-0012; NNC151-0000; NSAIDs; NSAIDs (permitted,not necessary); Na; Namilumab; Namilumab (MT203); Nanocort; Nanoparticulated Rebamipide; Naprosyn 500 mg; Naproxen; Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.); Naproxen 10 mg/kg; Naproxen 500 mg tablets (PN 200 minus omeprazole); Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.); Naproxen oral suspension; Naproxen sodium 550mg tablet; Nasopharyngeal swabs; Natalizumab; Natriumklorid 9mg/ml; Nerve block; New Formulation Etanercept; New formulation adalimumab; Niclosamide; Nimesulide; Nitric Oxide; Nitroglycerine; NiuBangZi pill; Nivolumab; No; Non-Biologic DMARDs; Non-anti-TNF biologics; Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD); Non-biologic anti-rheumatic drugs; Non-biological DMARD's; Non-biological DMARDs; Non-steroidal anti-inflammatory drug; Non-steroidal anti-inflammatory drug (NSAID); Non-steroidal anti-inflammatory drugs; Nonbiologic DMARDs of investigator's choice; None; None as of yet; Norethindrone; Normal Saline; Norspan; Null; Nulojix; OM 89.; OMALIZUMAB; ORENCIA; ORENCIA 125 mg solution for injection; ORENCIA 125 mg solution for injection in pre-filled syringe; ORENCIA 125 mg, solution injectable en seringue préremplie; ORENCIA 250 mg polvo para concentrado para sol. para perfusión; ORENCIA 250mg powder for concentrate for solution for infusion; ORENCIA Subcutaneous Injection; ORENCIA*IV 2FL 250MG+2SIR; OTILIMAB; OTL38; OXICODONE DC.IT; Observational study; Ocrelizumab; Ocrelizumab / rhuMAb 2H7; Ocrelizumab 500mg; Ocrelizumabu 200mg; Ocrelizumabu 50mg; Ofatumumab; Olikizumab; Olokizumab; Olokizumab 120 mg; Olokizumab 240 mg; Olokizumab 60 mg; Olokizumab 64 mg SC q2w; Olokizumab 64 mg SC q4w; Olokizumab 64mg q2w; Olokizumab 64mg q4w; Olokizumab q2w; Olokizumab q4w; Olumiant; Omalizumab; Omega-3; Omega-3 and Vitamin E supplementation; Omega-3 fatty acid; Omega3; Omegaven (10% fish-oil emulsion; Omeprazole; Oncoxin + Viusid; Open-label Abatacept; Open-label Adalimumab; Open-labelAdalimumabRescue; Oral; Oral Corticosteroids; Oral SCIO-469 capsule; Oral bovine type II collagen; Oral corticosteroids; Oral methotrexate; Orencia; Orencia (abatacept); Orencia 125 mg; Orencia abatacept; Originator; Originator (legacy) drug; Originator rituximab - Rituxan ® or MabThera ®; Orncia; Ortho-Novum® 1/35; Ortho-novum; Otelixizumab; Other Biologics; Other DMARDs; Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac; Other biological agent; Other: 18F-FDG; Other: 18F-GE-180; Other: Adalimumab; Other: Avise PG - Diagnostic test; Other: Baseline serum vitamin D level at or above 50 nmol/l; Other: Baseline serum vitamin D level below 50 nmol/l; Other: Dead Sea Solar and Water Treatment; Other: Determination of calcium intake by a dietician interview; Other: Dose reduction to 2mg/L; Other: Dose reduction to 5mg/L; Other: Dummy Tripterygium wilfordii Hook F (TwHF); Other: Exercise followed cold water immersion; Other: Gadobutrol; Other: Group 2 (DMARDS treated group); Other: Hand training; Other: Harkány medicinal water; Other: Healthy volunteers; Other: Hydroxychloroquine/Chloroquine; Other: Lab Work; Other: Losartan; Other: Metformin; Other: Methotrexate therapy; Other: Numerical rating scale; Other: Outpatient rheumatology department; Other: Plant-based diet; Other: QALCIMUM questionnaire; Other: Real-time data capture app; Other: Reduction group 1; Other: Reduction group 2; Other: Refered to general practice; Other: Resistance Exercise Program; Other: Simvastatin; Other: Sulfur Pool & Medicinal Mud; Other: Usual care; Other: Vegan Diet; Other: current treatment; Other: general population; Other: prednisone; Other: saline; Other: sterile saline; Otilimab; Otilimab (GSK3196165); Overencapsulated Prednisolone Tablets; Oxiklorin; Oxycodone; Oxycodone by patient-controlled analgesia (PCA); Oxygen; Ozoralizumab; P38 (4) Map Kinase Inhibitor; P38 Inhibitor (4); P38 Inhibitor (4) 150mg; P38 Inhibitor (4) 25mg; P38 Inhibitor (4) 300mg; P38 Inhibitor (4) 50mg; P38 Inhibitor (4) 75mg; P38 Map Kinase Inhibitor; P38(4) Map Kinase Inhibitor; PARACETAMOL; PARACETAMOLO DC.IT FU; PARALEN 500; PCA; PD 0360324; PDA001; PEG; PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ADSORBED ON ALUMINIUM HYDROXIDE; PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE; PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE; PF-04171327; PF-04171327 10 mg; PF-04171327 25 mg; PF-05280586; PF-06410293; PF-06438179; PF-06650833; PF-06650833 100 mg; PF-06650833 20 mg; PF-06651600; PF-06835375; PG; PG-760564; PH-797804; PL 00095/5079R; PLA + MTX switched to ABA+ MTX, DB; PLA-695; PLX3397; PLX5622; PN 200 tablets (500 mg naproxen and 20 mg omeprazole); PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT); PNEUMOVAX® 23; PR-06410293; PRALIA 60 mg Subcutaneous Injection Syringe(denosumab); PRALIA 60mg Subcutaneous Injection Syringe(denosumab); PRD4862257; PREDNISOLONE; PREDNISONE; PRIMUS; PRO283698; PROPOFOL; PRTX-100; PRTX-100 at 1.5 mcg/kg; PRTX-100 at 12.0 mcg/kg; PRTX-100 at 240 mcg; PRTX-100 at 3.0 mcg/kg; PRTX-100 at 420 mcg; PRTX-100 at 6.0 mcg/kg; PS; Paclitaxel; Panax Quinquefolius; Pandemrix,; Paracetamol; Paracetamol (acetaminophen); Parecoxib; Paroxetine; Paroxetine & Prednisolone; Paroxetine Hydrochloride tablets 10 & 20 mg and Prednisolone 1 mg BP; Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP; Part A; Part B; Patient Current Care; Patient treated with DMARD; Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses; Peficitinib; Pegsunercept; Pegsunercept (PEG sTNF-RI); Pelubiprofen; Pelubiprofen 30 mg; Peri-neural Dexamethasone 1 mg; Permitted DMARDs; Persantin; Persantin 100 mg; Persantin 100 mg and; Pertactin; Pertactin adsorbed; Pertussis vaccine; Pharmacokinetics of certolizumab pegol; Phase 1: Conventiaonal DMARD; Phase 1: Etanercept; Phase 1: Methotrexate; Phase 2: Optional ETN, SSZ, HCQ, MTX; Phosphate; Piclidenoson; Pig whipworm eggs; Pioglitazone; Pirfenidone; Placebo; Plaebo; Plaquenil; Plaquenil 200 mg filmdrasjerte tabletter; Plasma analysis for bacterial translocation; Platelet Rich Plasma; Pneumo23 / Pneumovax; Pneumococcal conjugate vaccine; Pneumococcal polysaccharide serotype 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F; Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F; Pneumococcal polysaccharide vaccine; Pneumococcal serotypes; Pneumovax; Pneumovax 23; Potassium; Potassium supplement; Pravastatin; Pre-filled syringe; Pred; Pred + Meth; PredniHEXAL; PredniHEXAL® 10mg Tabletten; PredniHEXAL® 20mg Tabletten; PredniHEXAL® 5mg Tabletten; PredniHEXAL® 5mg Tabletten, PredniHEXAL® 10mg Tabletten; PredniHEXAL® 5mg Tabletten, PredniHEXAL® 20mg Tabletten; Predniso; Prednisolene tablets BP 1 mg; Prednisolon; Prednisolone; Prednisolone & dipyridamole; Prednisolone 20 mg; Prednisolone 40 mg; Prednisolone 5 mg; Prednisolone Labesfal; Prednisolone Tablets BP; Prednisolone Tablets BP 1 mg; Prednisolone Tablets USP 5 mg; Prednisolone-Dipyridamole; Prednison; Prednisona; Prednisone; Prednisone 1 mg; Prednisone 15 mg; Prednisone 2 mg; Prednisone 3 mg; Prednisone 4 mg; Prednisone 5 mg; Prednisone 7.5 mg; Prednisone Tablets USP, 1 mg; Prednisone Tablets USP, 5 mg; Pregabalin; Prevenar 13; Prevenar vaccination; Prevenar vaccine; Previously known as R935788; Probiotic capsules containing Lactobacillus rhamnosus GR-1 and L. reuteri RC-14; Procedure: Acupuncture; Procedure: Arthroscopic synovial tissue biopsy; Procedure: Autologous Peripheral Blood Stem Cell Transplantation; Procedure: Blood Collection for PK Testing (15 Mins Before Injection); Procedure: Blood Collection for PK Testing (15 minutes post injection); Procedure: Blood Collection for PK Testing (18-20 hours post injection); Procedure: Blood Collection for PK Testing (180 minutes post injection); Procedure: Blood Collection for PK Testing (60 minutes post injection); Procedure: Blood Collection for PK Testing (after injection); Procedure: Blood sampling from infant; Procedure: Blood sampling from mother; Procedure: Blood sampling from umbilical cord; Procedure: Breast milk sampling; Procedure: Computed Tomography; Procedure: DEXA scan; Procedure: Exhaled nitric oxide assessment; Procedure: Extracorporeal Photopheresis; Procedure: FMT+MTX; Procedure: General anesthesia with tourniquet; Procedure: General anesthesia without tourniquet; Procedure: High frequency ultrasonography; Procedure: Implant Procedure; Procedure: Land exercises; Procedure: Planar Image with both Hands in Field of View; Procedure: Positron Emission Tomography; Procedure: Power doppler ultrasonography; Procedure: Quantiferon-TB Gold assay; Procedure: SPECT Imaging (180 Minutes post-injection); Procedure: SPECT Imaging (60 Minutes post-injection); Procedure: Spinal anesthesia with tourniquet; Procedure: Spinal anesthesia without tourniquet; Procedure: Synovial biopsy; Procedure: Tuberculin skin test; Procedure: Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects.; Procedure: Water exercises; Procedure: Whole body Protein turnover; Procedure: Whole body planar SPECT imaging (15 Minutes post-injection); Procedure: Whole body planar SPECT imaging (18-20 Hours post-injection); Procedure: Whole body planar SPECT imaging (180 Minutes post-injection); Procedure: Whole body planar SPECT imaging (60 Minutes post-injection); Procedure: intra-articular injection of etanercept; Procedure: intra-articular injection of steroid; Progressive spacing of TNF-blocker injections; Propofol; Propolipid; Proposed INN - FILGOTINIB; Propsoed INN - FILGOTINIB; Protein; Puerarin; Puerarin injection 400 mg; Puerarin tablet 50 mg; QAL964; Qing Re Huo Xue (QRHX); Qingkailing injection 40 ml; Quensyl; R788; R788 Sodium, R788 Na, R788; R788 sodium hexahydrate, RIG2-01, RIG-G; R935788; RAYOS (delayed-release prednisone); RC18 160 mg plus MTX; RECOMBINANT FACTOR FC FUSION PROTEIN; REGN88; REMICADE; REMICADE 100 mg polvo para concentrado para solución para perfusión; REMICADE*EV F 100MG+F 2ML; REMICADE® (Infliximab); REMSIMA; REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO; RGB-03; RITUXIMAB; RO 001-9265/F02-01; RO 487-7533; RO 496-4913; RO 496-4913/F03; RO 551-6922; RO-496-4913; RO001-9265/F04; RO0029893; RO045-2294; RO04877533; RO04877533/F05/F04; RO0506997; RO4402257; RO452294/V02; RO487-7533/F01-F05; RO487-7533/F10-04; RO4877533; RO4877533 (TCZ); RO4877533/F01; RO4877533/F04-F05; RO496-4913; RO7010939; RO7123520; RO7123520/F03-01; ROACTEMRA; ROACTEMRA 20 mg/ml, concentrado para solución para perfusión; RTNV148B IgG; RWJ-445380 100 mg; RWJ-445380 200 mg; RWJ-445380 300 mg; RWJ-445380 Capsules 50 mg; RWJ-445380 capsule 100 mg; RWJ-445380 capsules 150 mg; RWJ-445380-002; RYR; Radiation: Fluorine F 18 Clofarabine; Radiation: Stress myocardial perfusion PET; Radiofrequency; Raloxifene; Raloxifene hydrochloride; Ramelteon; Ramipril; Rapamycin; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Rebamipide; Recombinant TNF-a receptor: IgG Fc fusion protein; Recombinant human Mab of IgG4 subtype; Recombinant human anti IL-22 monoclonal antibody IgG1; Recombinant human monoclonal antibody; Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class; Recombinant human monoclonal antibody to interleukin-1beta of the IgG1-Kappa-class; Recombinant humanised anti-human monoclonal antibody directed against the IL-6R; Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal; Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody; Recombinant humanized anti-human Interleukin-6; Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody; Recombinant humanized anti-human monoclonal antibody directed against the IL-6R; Reditux; Remicade; Remicade (infliximab); Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning.; Remicade®; Remsima; Remsima (infliximab); Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Repository corticotropin injection; Response to anakinra associated with methotrexate; Response to infliximab associated with methotrexate; Reumatocept (etanercept); Revamilast; Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs); RhuMAb 2H7; RhuTNFR:Fc; RhumAb to Il-17A (IgG1-k-class); Rhustoxicodendron 30; Ribazen; Riboflavin; Rifampicin; Rimacalib; Risedronate; Ritumax®; Rituxan; Rituxan (INN: Rituximab), brand name in the US; Rituxan (INN: Rituximab), brand name in the United States; Rituxan (US, Canada, Japan), MabThera (rest of the world); Rituxan®; Rituxan® (rituximab); Rituximab; Rituximab (EU); Rituximab (US); Rituximab - MabThera; Rituximab MabThera; Rituximab [MabThera/Rituxan]; Rituximab [MabThera]; Rituximab [Mabthera/Rituxan]; Rituximab, MTX, folic acid; Rituximab, observational study amon patients with active RA; Rituximab-EU+ Rituximab-Pfizer x 2 Courses; Rituximab-Pfizer; Rituximab-Pfizer (PF-05280586) x 3 courses; Rituximab-US + Rituximab-Pfizer x 2 Courses; Rivaroxaban; Rixathon; Ro 002-9893/F02; Ro 45-2294; Ro 48-77533; Ro 487-7533; Ro 487-7533/F01; Ro 487-7533/F10; Ro 487-7533/F10-02; Ro 487-7533/F10-04; Ro 496-4913; Ro Actemra; Ro-Actemra; Ro487-7533; RoACTEMRA; RoActemra; RoActemra (R); RoActemra 162 mg; RoActemra 162 mg solution injectable en seringue préremplie; RoActemra 20 mg/ml Concentrate for solution for infusion; RoActemra 20 mg/ml concentrado para solución para perfusión; RoActemra 20 mg/ml concentrate for solution for infusion.; RoActemra(R); RoActemra®; RoActemra®EV Product Code: PRD82321; RoActerma; RoActmera; Roactemra; Rob 803; Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali; Rob 803 (capsules 12.5 mg); Rob 803 (capsules 15 mg); Rob 803 (capsules 25 mg); Rob 803 (capsules 6.25 mg); Rob 803 12.5mg capsule; Rob 803 15mg capsule; Rob 803 25mg capsule; Rob 803 6.25mg capsule; Rob 803 6.5mg capsule; Rofecoxib; Romosozumab; Ropivacaine; Rosiglitazone; Rosiglitazone Extended Release Tablets; Rosiglitazone XR; Rosiglitazone maleate; Rosuvastatin; Roxithromycin; Rupatadine; S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide; S.c. injections of bovine intestinal Alkaline Phosphatase; S1; SAIT101; SAIT101 (proposed rituximab biosimilar); SAIT101 (rituximab biosimilar); SAN-300; SANDIMMUN NEORAL*30CPS 100MG; SANDIMMUN NEORAL*50CPS 25MG; SAR153191; SAR153191 (REGN88); SARILUMAB; SB 681323; SB-681323; SB-681323 Tablets; SB-681323 oral tablets; SB2; SB2 (infliximab biosimilar); SB2 (proposed biosimilar to infliximab); SB4; SB4 (etanercept biosimilar); SB4 (proposed biosimilar to etanercept); SB5; SB5 (proposed biosimilar to adalimumab); SBI-087; SC golimumab; SC12267; SC12267 (4SC-101); SCH 900259; SCH900259; SCIO-469; SD-QIV; SECUKINUMAB; SHR0302; SIMPONI; SIMPONI 50 mg solución inyectable en pluma precargada; SKI-O-703; SKI-O-703 capsule; SM03; SMP-114; SODIUM CHLORIDE; SSR150106; SSR150106XB; STA 5326 mesylate; STNF-R1; SULFASALAZINE; Salazopyrin; Salazopyrin EN; Salazopyrin EN 500 mg enterotabletter; Salazopyrin EN-Tabs; Salazopyrin En-Tabs; Salazopyrine; Salazosulfapyridine; Sar; Sarilumab; Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]; Sarilumab SAR153191 (REGN88); Seasonal Influenza vaccine; Seasonal influenza vaccine; Secukinmab; Secukinumab; Secukinumab (AIN457); See D.3.9.3 'Other descriptive name' below; Shingrix; Sildenafil; Simponi; Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.; Simponi®; Simvastatin; Simvastatin 20 mg; Sirolimus; Sirukuma; Sirukumab; Sirukumab 100 mg; Sirukumab 50 mg; Sodium aurothiomalate; Sodium aurothiomalate (intramuscular gold); Sodium chloride; Sodium-[o-[(2,6-dichlorophenyl)-amino]- phenyl]-acetate; Sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate; Solu-Medrone 125mg; Solu-Medrone 2 Gram; Solu-Medrone 2mg; Somatropin; Somatropin [rDNA origin] for injection; Stable weekly dose of methotrexate; Standard DMARDs (Disease Modifying Anti Rheumatic Drugs); Standard of Care; Statins; Stem Cell Transplantation; Steroids; Stool analysis; Stools; Subcutaneous (SC) Abatacept; Subcutaneous (SC) abatacept; Subcutaneous Abatacept; Subcutaneous tocilizumab; Subcutaneous(SC) Abatacept; Subcutanious administration; Sublingual nitroglycerine; Sulfasalazine; Sulfate; Sulphasalazine; Sulphasalazine + Hydroxychloroquine OR Prednisolone; Sunflower oil; Suspension IR; Synovial biopsy; Synthetic DMARD(s); Systemic non-biological treatments; T-614; T0001; TA-650 (Infliximab); TA-650 10 mg/kg; TA-650 3 mg/kg; TA-650 6 mg/kg; TAB08; TABALUMAB; TACI - FC5; TACI-Fc5; TAK-715; TAK-715 and methotrexate; TAK-783; TAK-783 and methotrexate; TAS5315 high dose; TAS5315 low dose; TBE-vaccine; TC99m-tilmanocept; TDMARDs; TETANUS TOXOID; THA; THC; TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED); TILMANOCEPT; TJ003234 injection; TL011; TL011, anti CD20, for the treatment of rheumatoid arthritis; TMI-005; TMI-005 (WAY-177005); TMI-005 WAY-177005; TNF Antagonist (enbrel, humire, remicade, cimzia, symponi); TNF Inhibitor; TNF alpha blockers; TNF alpha inhibitors; TNF antagonist; TNF blockers (infliximab, adalimumab, etanercept); TNF blockers monotherapy; TNF inhibitor/TCZ; TNF inhibitors; TNF kinoid; TNF start; TNF-K; TNF-Kinoid; TNF-a antagonists, non-TNFs, DMARD non-biologics; TNF-a inhibitor OR JAK inhibitor; TNF-alpha Inhibitor; TNF-alpha antagonist and other biotherapy; TNF-alpha antagonists; TNF-blockers suspension in patients with rheumatoid arthritis; TNFR:Fc; TNFa Kinoid; TNR-001; TOCILIZUMAB; TOCILIZUMAB SC; TOFACITINIB; TOFACITINIB CITRATE; TOFACITINIB CITRATE CP-690550; TRIAMCINOLONACETONID; TRIAMCINOLONACETONID EP; TRIAMCINOLONE ACETONIDE; TRU-015; TS-152; TSO; Tabalumab; Tabalumab Auto-Injector; Tabalumab Prefilled Syringe; Tacrolimus; Tacrolimus (Prograf®); Tacrolimus with Methotrexate; Tasocitinib; Tasocitinib (proposed INN); Tasocitinib citrate; Tasocitinib plus Methotrexate; Tc 99m tilmanocept; Tc99m-tilmanocept; Tea; Technetium Tc 99m; Technetium Tc 99m Tilmanocept; Technetium Tc 99m tilmanocept; Teriparatide; Tetanus + pnemococcal vaccines alone; Tetanus Toxoid Adsorbed Vaccine; Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed); Tetanus toxoid; Tetanus toxoid adsorbed; Tetanus toxoid adsorbed booster vaccine; Tetraccycline; Tetraccycline-hydrochloride; Tetracycline; Tetrandrine; The effectiveness of Xeljanz in rheumatoid arthritis patients; Therapy with disease-modifying anti rheumatic drugs (DMARD); Ticagrelor; Tilmanocept; Tirabrutinib; Titan; To be confirmed; Tocilizumab; Tocilizumab (Actemra or RoActemra); Tocilizumab (Actemra); Tocilizumab (Actemra®); Tocilizumab (TCZ); Tocilizumab + methotrexate(MTX); Tocilizumab 162 mg; Tocilizumab 162mg/0.9ml SC PFS SC; Tocilizumab 162mg/0.9ml jeringa SC; Tocilizumab 162mg/0.9ml syringe SC; Tocilizumab IV; Tocilizumab Prefilled Syringe; Tocilizumab Roche; Tocilizumab SC; Tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI); Tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS); Tocilizumab [RoActemra/Actemra]; Tocilizumab [RoActemra]; Tocilizumab plus methotrexate; Tocilizumab+Methotrexate(MTX); Tocilizumab, Abatacept; Tocilizumabum; Tofacitinb; Tofacitinib; Tofacitinib (Xeljanz); Tofacitinib (Xeljanz®); Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet; Tofacitinib 5 MG [Xeljanz]; Tofacitinib 5 mg; Tofacitinib 5mg po bid; Tofacitinib citate (Phase III formulation); Tofacitinib citrate; Tofacitinib citrate (Phase III formulation); Tofacitinib citrate (Proposed commercial formulation - debossed); Tofacitinib citrate (Proposed commercial formulation debossed); Tofacitinib citrate (Proposed commercial formulation – debossed); Tofacitinib citrate (Proposed commercial formulation- debossed); Tofacitinib citrate (clinical trial image); Tofacitinib citrate (commercial image); Tofacitinib citrate( Phase III formulation); Tofacitinib or Baricitinib; Tofacitinib with methotrexate; Tofacitinib without methotrexate; Tofacitinib/baricitinib; TolDC; Tolerogenic dendritic cells; Tolicizumab; Tolicizumab Roche; Topical compound tripterygium; Topical tripterygium gel; Traditional antirheumatic drugs; Tramadol; Tramadol hydrochloride + acetaminophen; Tranexamic acid; Tranilast; Treat to target; Treatment A; Treatment B; Treatment C; Treatment I; Treatment II; Treatment III; Treatment of MTX; Treatment of MTX and HCQ; Treatment of MTX and TwHF; Treatment of TCM; Treatment of TwHF; Tregalizumab; Trexan; Trexan+Salazopyrin+Oxiklorin+prednisolone; Trexan+Salazopyrin+Oxiklorin+prednisolone + infliximab; Triam 40 mg Lichtenstein; Triamcinolone; Triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip); Triamcinolone acetonide; Triamcinolone hexacetonid (Lederspan); Triamcinolone hexacetonide; Triamcinolone hexacetonide (Lederspan); Trichuris suis ova; Tripterygium; Tripterygium Wilfordii; Tripterygium wilfordii Hook F; Tripterygium wilfordii Hook F (TwHF); Trivalent inactivated influenza vaccine; Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab); Tumor Necrosis Factor Inhibitors; TwHF; UC-MSC+DMARDS; UC-MSCs; UCB4940; UK-427,857; US-licensed Humira®; UVADEX; UVEDOSE; Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs); Umbilical cord mesenchymal stem cells; Upadacitinib; Upadacitinib 12mg; Upadacitinib 15mg; Upadacitinib 30mg; Upadacitinib 3mg; Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level; Ustekinumab; Ustekinumab + MTX (Group 2); Ustekinumab + MTX (Group 3); Uvadex; VAY736; VIB4920; VX-509; VX-702; Vaccination against TBE; Valdecoxib; Vancomycin; Varicella Zoster Vaccine; Velcade; Velcade®; Veltuzumab; Veltuzumab solution 75mg/ml; Venlafaxine; Venlafaxine Hydrochloride; Venous blood sample; Vidofludimus; Vitamin D; Vitamin D in arm B; Vitamin D3; Vitamin E; Vitamin K; Voltarol; Voltarol SR; Voltarol SR (generics also available in the EU); Voltrarol SR; WAY-177005; Warfarin; Warfarin+ Vitamin K; Water; Whale blubber oil; Whey Protein&Prebiotic Supplement; XELJANZ; XELJANZ 5 mg film-coated tablets; XELJANZ 5Mg Tablet; XENP5871; XOMA 052; Xeljanz; Xeljanz 5mg; Xinfeng capsule; XmAb5871_0.3MG; XmAb5871_1.0MG; XmAb5871_10.0MG; XmAb5871_3.0MG; XmAb®5871; Xolair; YLB113; YRA-1909 high dose; YRA-1909 low dose; YRA-1909 mid dose; Yellow Fever Vaccine; Yellow Fever vaccine (17D); Yisaipu; Z102; Z102 (Prednisolone and Dipyridamole).; ZD 4522; ZOLEDRONIC ACID; Zoledronate; Zoledronic Acid; Zoledronic acid; Zolpidem; Zostavax; Zostavax (varicella zoster virus) vaccine; Zostavax vaccine; Zostavax®; [18F]PEG-Folate; [BMS-188667]; [NA]; [na]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04585711 (ClinicalTrials.gov)	September 2022	7/10/2020	Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis	Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis	Juvenile Idiopathic Arthritis;Rheumatoid Arthritis;Obesity	Drug: Etanercept Optimal dosing	Duke University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Not yet recruiting	2 Years	65 Years	All	30	Phase 1	NULL
2	NCT04117165 (ClinicalTrials.gov)	March 1, 2021	30/9/2019	Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis	Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA)	Arthritis, Rheumatoid;Biological Therapy	Diagnostic Test: Biotherapy Prescription with SinnoTest® software;Drug: Patient Current Care	University Hospital, Grenoble	NULL	Not yet recruiting	18 Years	70 Years	All	180	N/A	France
3	NCT04170426 (ClinicalTrials.gov)	January 10, 2021	18/11/2019	Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid Arthritis	Phase 1/2a Clinical Study for Subjects With Rheumatoid Arthritis (RA) Using Multiple Dose Intravenous Infusions of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)	Rheumatoid Arthritis	Biological: autologous adipose derived stem cells	Celltex Therapeutics Corporation	NULL	Not yet recruiting	18 Years	75 Years	All	54	Phase 1;Phase 2	NULL
4	NCT04535427 (ClinicalTrials.gov)	January 1, 2021	22/8/2020	Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis	Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: L-arginine;Drug: Placebo	RenJi Hospital	NULL	Not yet recruiting	18 Years	45 Years	All	144	Phase 2	China
5	JPRN-jRCTs071200007	01/01/2021	20/04/2020	Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments	Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments	Rheumatoid arthritis	Rheumatoid arthritis patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I period and persisted with clinical remission or low disease activity discontinue infliximab BS. If they have relapse after discontinuation of infliximab BS,infliximab BS will be re-administered.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	80	Phase 4	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	ChiCTR2000036094	2021-01-01	2020-08-21	A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage	A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage	Rheumatoid Arthritis	Experimental group:Duhuo Jisheng Tang, MTX as base treatment.;Control group:Duhuo Jisheng Tang placebo, MTX as base treatment.;	Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine	NULL	Pending	18	70	Both	Experimental group:60;Control group:60;		China
7	ChiCTR2000036164	2021-01-01	2020-08-21	Effects of dexmedetomidine on periarticular infiltration analgesia in total hip arthroplasty: a prospective, double-blind, randomized controlled trial	Effects of dexmedetomidine on periarticular infiltration analgesia in total hip arthroplasty: a prospective, double-blind, randomized controlled trial	knee osteoarthritis/ knee rheumatoid arthritis	A:Drug composition of local infiltration around the joint: Ropivacaine ;B:Drug composition of local infiltration around the joint is: Ropivacaine and dexmedetomidine ;	West China Hospital, Sichuan University	NULL	Pending	18	80	Both	A:40;B:40;		china
8	ChiCTR2000036316	2021-01-01	2020-08-22	Effects of dexmedetomidine on periarticular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial	Effects of dexmedetomidine on periarticular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial	knee osteoarthritis/ knee rheumatoid arthritis	A:Drug composition of local infiltration around the joint: Ropivacaine ;B:Drug composition of local infiltration around the joint is: Ropivacaine and dexmedetomidine;	West China Hospital, Sichuan University	NULL	Pending	18	80	Both	A:40;B:40;		China
9	NCT04349046 (ClinicalTrials.gov)	January 1, 2021	14/4/2020	Exception Cementless Hip Stem	Exception Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)	Osteoarthritis, Hip;Rheumatoid Arthritis;Inflammatory Arthritis;Congenital Hip Dysplasia;Avascular Necrosis of Hip;Femoral Neck Fractures	Device: Total hip arthoplasty (THA)	Zimmer Biomet	NULL	Not yet recruiting	18 Years	100 Years	All	332		Belgium;France
10	NCT04539964 (ClinicalTrials.gov)	January 2021	31/8/2020	Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid Arthritis	A Randomized, Sham-Controlled, Double-Blind Study of Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid Arthritis: The RESET-RA Study	Rheumatoid Arthritis	Procedure: Implant Procedure;Drug: Conventional Synthetic DMARD;Device: Active stimulation;Device: Sham stimulation	SetPoint Medical Corporation	NULL	Not yet recruiting	22 Years	75 Years	All	250	Phase 3	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2020-003955-14-DE (EUCTR)	21/12/2020	04/11/2020	A Placebo controlled trial in adult patients with active rheumatoid arthritis with inadequate (partial) response to anti-TNF therapy	A Randomized, Double-blind, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Adults with Active Rheumatoid Arthritis who have demonstrated an inadequate Response to anti-TNF therapy.	Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: AMT -101 Other descriptive name: AMT -101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Germany
12	NCT04569890 (ClinicalTrials.gov)	December 1, 2020	20/9/2020	Treatment of Pregnancy RA	Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China	Rheumatoid Arthritis;Pregnancy Related	Drug: Certolizumab Pegol 200 MG/ML [Cimzia];Drug: Hydroxychloroquine;Drug: Prednisone	RenJi Hospital	NULL	Not yet recruiting	20 Years	40 Years	Female	100	N/A	China
13	NCT04649697 (ClinicalTrials.gov)	December 1, 2020	26/10/2020	Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients	Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial	Rheumatoid Arthritis	Drug: Rebamipide;Drug: Nanoparticulated Rebamipide;Drug: Clobetasol Propionate	Cairo University	NULL	Not yet recruiting	20 Years	70 Years	All	39	Phase 3	NULL
14	NCT04634253 (ClinicalTrials.gov)	December 1, 2020	17/11/2020	A Study of LY3462817 in Participants With Rheumatoid Arthritis	A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Placebo;Drug: LY3462817	Eli Lilly and Company	NULL	Not yet recruiting	18 Years	N/A	All	80	Phase 2	United States;Czechia;Hungary;Mexico;Poland;Puerto Rico
15	NCT04559412 (ClinicalTrials.gov)	December 2020	3/9/2020	Study to Assess the Safety and Efficacy of Enbrel Administered by Sofusa DoseConnect for Rheumatoid Arthritis	Phase 1b Proof-of-concept, Open-label Study to Assess the Safety and Pilot Efficacy of Enbrel® Administered by the Sofusa® DoseConnect™ Delivery System for the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Device: Sofusa DoseConnect;Drug: Enbrel	Sorrento Therapeutics, Inc.	NULL	Not yet recruiting	18 Years	75 Years	All	10	Phase 1	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT03828344 (ClinicalTrials.gov)	December 2020	30/1/2019	Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid Arthritis	A Phase 1 Randomized, Placebo-Controlled, Double-Blind Study of the Safety and Tolerability of a Single Intravenous Infusion of BX-U001, a Human Umbilical Cord Tissue Derived Mesenchymal Stem Cell Product, for Refractory Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: hUC-MSC suspension;Biological: Placebo	Baylx Inc.	NULL	Not yet recruiting	18 Years	70 Years	All	16	Phase 1	NULL
17	NCT04292067 (ClinicalTrials.gov)	November 23, 2020	26/2/2020	Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis	Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis	Spondyloarthritis;Rheumatoid Arthritis	Biological: Faecal sampling	Assistance Publique - Hôpitaux de Paris	NULL	Recruiting	18 Years	N/A	All	400		France
18	EUCTR2019-000878-30-BE (EUCTR)	18/11/2020	21/09/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
19	JPRN-jRCTs071200054	18/11/2020	18/11/2020	Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Rheumatoid arthritis	Rheumatoid arthritis patients with moderate or high disease activity will be introduce for etanercept BS MA within 14 days of case enrollment. The etanercept BS MA is given as a weekly subcutaneous injection of 50 mg for 24 weeks.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	40	Phase 4	Japan
20	NCT04470453 (ClinicalTrials.gov)	November 2020	9/7/2020	Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug	Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug	Rheumatoid Arthritis	Biological: Blood sample;Diagnostic Test: CRQ	Centre Hospitalier Universitaire de Saint Etienne	NULL	Not yet recruiting	18 Years	N/A	All	60	Phase 4	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	NCT04286789 (ClinicalTrials.gov)	November 2020	25/2/2020	Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Study in RA Patients Managed With DMARDs	A Randomized, Double-blind, Parallel, Vehicle Controlled, Repeat Dose Comparative Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ORTD-1 in Rheumatoid Arthritis Patients With Mild Disease Managed With DMARDs	Rheumatoid Arthritis	Drug: Low dose ORTD-1;Drug: Low dose vehicle control;Drug: High dose ORTD-1;Drug: High dose vehicle control	Oryn Therapeutics, LLC	NULL	Recruiting	18 Years	N/A	All	16	Phase 1	United States
22	ChiCTR2000034924	2020-10-30	2020-07-24	Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese	Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese	Rheumatoid arthritis, Sjogren's syndrome	Group 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets;	The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	NULL	Pending			Both	Group 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose toler	Phase 1	China
23	EUCTR2020-000658-83-BG (EUCTR)	21/10/2020	07/10/2020	A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate	A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25	Phase 2	Poland;Ukraine;Georgia;Bulgaria
24	NCT04577781 (ClinicalTrials.gov)	October 12, 2020	30/9/2020	A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Arthritis, Rheumatoid	Drug: GLPG3970;Drug: Placebo	Galapagos NV	NULL	Recruiting	18 Years	64 Years	All	25	Phase 2	Georgia;Poland;Ukraine
25	JPRN-jRCTs041200048	02/10/2020	02/10/2020	Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state	Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study	Rheumatoid arthritis	1) MTX* - Continued group: Continued at a stable dose and interval throughout the cours of the study. Folic acid is continued if concomitantly used. - Withdrawn group: Week 0 to 12 Reduced after registration. The dose of MTX is reduced to half, regardless of the initial dose. Folic acid is continued if concomitantly used. Week 12 to 52 Discontinued if low disease activity was maintained. Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) CZP and csDMARDs other than MTX Continued at a stable dose and interval throughout the course of the study in both groups. 3) Glucocorticoids Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group. 4) Rescue treatment One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request. - Restoring, restarting, or increasing doses of MTX - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.	Kojima Toshihisa	NULL	Recruiting	>= 20age old	Not applicable	Both	114	N/A	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	ChiCTR2000037008	2020-10-01	2020-08-26	The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study	The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study	rheumatoid arthritis	experimental group:MTX 15mg qw po+Bushen Jiedu Tongluo Decoction Granule One dose a day, two times a day;control group:MTX 15mg qw po+placebo Granule One dose a day, two times a day;	Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine	NULL	Pending	18	80	Both	experimental group:53;control group:53;		China
27	ChiCTR2000036141	2020-10-01	2020-08-21	A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluation	A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluation	Rheumatoid arthritis	1:Guizhi Decoction;1:MTX;	Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	NULL	Recruiting	18	75	Both	1:80;1:80;		China
28	EUCTR2019-002205-22-FR (EUCTR)	01/10/2020	13/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
29	ChiCTR2000037675	2020-10-01	2020-08-30	Clinical study of Shenshi Qianghuo Dihuang Decoction in the treatment of Rheumatoid arthritis from the perspective of ''7+1''	Clinical study of Shenshi Qianghuo Dihuang Decoction in the treatment of Rheumatoid arthritis from the perspective of ''7+1''	Rheumatoid arthritis	control group:Methotrexate;experimental group:Qianghuo Dihuang Decoction + Methotrexate;	Shanghai Traditional Chinese Medicine Hospital	NULL	Recruiting			Both	control group:72;experimental group:72;		China
30	NCT04514614 (ClinicalTrials.gov)	October 1, 2020	7/8/2020	Characterizing Rheumatoid Arthritis With 68Ga-FAPI PET/CT	Characterizing Rheumatoid Arthritis With 68Ga-FAPI PET/CT	Arthritis	Drug: 68Ga-FAPI	Peking Union Medical College Hospital	NULL	Not yet recruiting	18 Years	90 Years	All	100	Early Phase 1	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	NCT04530305 (ClinicalTrials.gov)	October 2020	24/8/2020	Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor	Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor	Rheumatoid Arthritis	Drug: Tofacitinib 5 MG [Xeljanz]	University Hospital, Montpellier	NULL	Not yet recruiting	18 Years	N/A	All	60		NULL
32	NCT04509427 (ClinicalTrials.gov)	October 2020	29/6/2020	EXercise and PosturE in Individuals With Rheumatoid ArthriTIs and OStEoporosis	Comparison of Video-based and Paper Instructional Material to Promote EXercise and PosturE in Individuals With Rheumatoid ArthrTIs and OStEoporosis	Rheumatoid Arthritis;Osteoporosis	Behavioral: Instructional handouts;Behavioral: Physical therapist instruction and monitoring via teleconferencing;Behavioral: Web-based instructional videos;Behavioral: Posture training;Behavioral: Resistance exercise;Behavioral: Balance exercise;Behavioral: Marching in place	University of Alabama at Birmingham	NULL	Not yet recruiting	51 Years	N/A	Female	24	N/A	NULL
33	NCT04638426 (ClinicalTrials.gov)	September 10, 2020	13/11/2020	Phase 2a Clinical Trial of HL237 for Rheumatoid Arthritis	For 12 Weeks, the Multi Center, Randomized, Double Blinded, Placebo Controlled, Parallel, Dose-finding Clinical Study for the Therapeutic Exploration of Safety and Efficacy Assessment of HL237 Tablet in Patients With Rheumatoid Arthritis (Phase IIa)	Rheumatoid Arthritis	Drug: HL237 tablet;Drug: Placebo of HL237 tablet	Hanlim Pharm. Co., Ltd.	NULL	Enrolling by invitation	19 Years	N/A	All	196	Phase 2	Korea, Republic of
34	NCT04255134 (ClinicalTrials.gov)	September 7, 2020	14/11/2019	Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)	Comparison of Abatacept With Tumor Necrosis Factor Inhibitors in the Treatment of Rheumatoid Arthritis Pain: A Phase IV Trial	Rheumatoid Arthritis	Drug: Abatacept Injection;Drug: Adalimumab Injection	St George's, University of London	NULL	Recruiting	18 Years	75 Years	All	60	Phase 4	United Kingdom
35	EUCTR2020-002507-19-NL (EUCTR)	07/09/2020	03/09/2020	Research into administration of lower dosed rituximab with an injection	Comparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial - RTX-SC	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: rituximab Trade Name: Rixathon Product Name: rituximab	Sint Maartenskliniek	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	36	Phase 4	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2019-000878-30-BG (EUCTR)	04/09/2020	11/08/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
37	NCT04378621 (ClinicalTrials.gov)	September 1, 2020	8/4/2020	Effect of Antiinflammatory Treatment Versus Hand Training on Neuropsychiatric Comorbidity in RA-patients	Treatment of Inflammation Versus Hand Training to Prevent and Revert Neuropsychiatric Comorbidity in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Pain;Fatigue;Cognitive Decline;Depression;Brain Diseases;Hand Rheumatism	Drug: TNF-a inhibitor OR JAK inhibitor;Other: Hand training	Vastra Gotaland Region	NULL	Not yet recruiting	45 Years	75 Years	All	212	N/A	Sweden
38	EUCTR2019-004369-42-CZ (EUCTR)	01/09/2020	05/08/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra (R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of
39	NCT04347798 (ClinicalTrials.gov)	September 2020	13/4/2020	IMPACT: IMPact of Antimalarials on Covid-19 Infections in RAPPORT	IMPACT RAPPORT: IMPact of Antimalarials on Covid Infections: a Case Control sTudy of RAPPORT	Covid-19 Infection;Rheumatoid Arthritis;Psoriatic Arthritis;Hydroxychloroquine	Other: Hydroxychloroquine/Chloroquine	University of Alberta	NULL	Enrolling by invitation	18 Years	N/A	All	500		Canada
40	NCT04421313 (ClinicalTrials.gov)	September 2020	18/5/2020	Fibres Supplementation in Rheumatoid Arthritis	Supplementation of Rheumatoid Arthritis Patients With Dietary Fibre to Improve Their Gut Microbiota	Rheumatoid Arthritis	Drug: Dietary Fiber Supplementation	University Hospital, Montpellier	University of Sydney;Institut de Génétique Moléculaire de Montpellier	Not yet recruiting	18 Years	85 Years	All	87	N/A	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2019-002676-14-BG (EUCTR)	20/08/2020	27/05/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
42	EUCTR2019-002205-22-DE (EUCTR)	12/08/2020	07/07/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
43	NCT04457856 (ClinicalTrials.gov)	August 6, 2020	28/6/2020	A Study of TJ003234 in Rheumatoid Arthritis Patients	A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Biological: TJ003234 injection	I-Mab Biopharma Co. Ltd.	NULL	Recruiting	18 Years	70 Years	All	63	Phase 1	China
44	ChiCTR2000035146	2020-08-01	2020-08-02	The effect of the IPACK block on pain after primary TKA in different levels of knee flexion deformity patients: a prospective, cohort trial	The effect of the IPACK block on pain after primary TKA in different levels of knee flexion deformity patients: a prospective, cohort trial	knee osteoarthritis/ knee rheumatoid arthritis	The knee flexion deformities of different degrees were divided into different groups, and the patients without knee flexion deformity were the control group:Under the guidance of ultrasound, 20 ml 0.25% ropivacaine was injected between popliteal artery and knee joint capsule;	West China Hospital, Sichuan University	NULL	Pending	18	80	Both	The knee flexion deformities of different degrees were divided into different groups, and the patients without knee flexion deformity were the control group:80;	N/A	China
45	ChiCTR2000035179	2020-08-01	2020-08-02	The effect of the iPACK block on pain and knee function in knee flexion deformity patients after primary TKA: a double-blinded, prospective, randomized controlled triala	The effect of the iPACK block on pain in knee flexion deformity patients after primary TKA: a double-blinded, prospective, randomized controlled trial	knee osteoarthritis/ knee rheumatoid arthritis	IPACK group:infiltration of 20 ml ropivacaine 0.25% between the interspace between the popliteal artery and capsule of the knee;control group:infiltration of 20ml 0.9% salinebetween the interspace between the popliteal artery and capsule of the knee;	West China Hospital, Sichuan University	NULL	Pending	18	80	Both	IPACK group:40;control group:40;	N/A	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	NCT04333771 (ClinicalTrials.gov)	July 31, 2020	2/4/2020	A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.	Rheumatoid Arthritis	Drug: SHR0302;Drug: Placebo	Jiangsu HengRui Medicine Co., Ltd.	NULL	Recruiting	18 Years	75 Years	All	600	Phase 3	China
47	NCT04413617 (ClinicalTrials.gov)	July 29, 2020	19/5/2020	TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis	Drug: PF-06650833;Drug: PF-06651600;Drug: Tofacitinib	Pfizer	NULL	Recruiting	18 Years	70 Years	All	450	Phase 2	Bulgaria;Canada;Chile;Czechia;Georgia;Hungary;Poland;Slovakia;Spain;Ukraine
48	JPRN-jRCTs071190030	28/07/2020	11/10/2019	Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments	Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments	Rheumatoid arthritis	Rheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS from Remicade. The dose and infusion intervals of infliximab BS are kept unchanged from those of Remicade.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	80	Phase 4	Japan
49	NCT04512001 (ClinicalTrials.gov)	July 27, 2020	11/8/2020	MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union-approved RoActemra® in Patients With Moderately to Severely Active Rheumatoid Arthritis (APTURA I Study)	Rheumatoid Arthritis	Drug: MSB11456;Drug: EU-approved RoActemra	Fresenius Kabi SwissBioSim GmbH	NULL	Recruiting	18 Years	N/A	All	542	Phase 3	Bulgaria;Czechia;Georgia;Hungary;Moldova, Republic of;Poland;Russian Federation;Serbia;Slovakia
50	NCT04324892 (ClinicalTrials.gov)	July 12, 2020	25/3/2020	Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study	Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study	Rheumatoid Arthritis	Drug: Treat to target	Chinese University of Hong Kong	NULL	Not yet recruiting	18 Years	N/A	All	110		NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	EUCTR2019-002676-14-CZ (EUCTR)	07/07/2020	11/05/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
52	NCT04428424 (ClinicalTrials.gov)	July 5, 2020	10/6/2020	Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients	The Impact of RF, and Anti-CCP on RA Patients in Response to Etanercept	Arthritis, Rheumatoid	Drug: Enbrel	Pfizer	NULL	Completed	18 Years	N/A	All	1		Iraq
53	JPRN-UMIN000040094	2020/07/01	01/07/2020	Development of chronotherapeutics in rheumatoid arthritis	Development of chronotherapeutics in rheumatoid arthritis - Development of chronotherapeutics in rheumatoid arthritis	rheumatoid arthritis	baricitinib 4mg morning baricitinib 4mg evening baricitinib 2mg evening	Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo college of Medicine	NULL	Pending	18years-old	100years-old	Male and Female	90	Not applicable	Japan
54	JPRN-jRCTs071190046	29/06/2020	20/02/2020	Efficacy of Etanercept Biosimilar Switching from Etanercept Reference Product, using Ultrasound and Clinical Data in Outcomes of Real World Therapy (ESCORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Efficacy of Etanercept Biosimilar Switching from Etanercept Reference Product, using Ultrasound and Clinical Data in Outcomes of Real World Therapy (ESCORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial	Rheumatoid arthritis	Rheumatoid arthritis patients who have been treated with enbrel (Subcutaneous injection of 25 mg once weekly or 25 mg twice weekly or 50 mg once weekly or 50 mg once biweekly) over 24 weeks and persisted with LDA/remission are switched to the same dose of etanercept BS MA from enbrel. In addition, for patients receiving etanercept BS MA 50 mg weekly, the dose will be reduced from 24 weeks to etanercept BS MA 25 mg weekly to test whether LDA/remission persists until week 52.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	62	Phase 4	Japan
55	NCT04163016 (ClinicalTrials.gov)	June 19, 2020	24/10/2019	A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)	A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)	Rheumatoid Arthritis;Psoriatic Arthritis;Crohn's Disease;Axial Spondyloarthritis;Plaque Psoriasis	Drug: Pharmacokinetics of certolizumab pegol	UCB Biopharma S.P.R.L.	NULL	Recruiting	18 Years	N/A	Female	20	Phase 1	United States;Canada;Switzerland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	EUCTR2019-002676-14-HU (EUCTR)	18/06/2020	14/04/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
57	EUCTR2019-002810-37-PL (EUCTR)	16/06/2020	11/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	Bulgaria;United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Germany
58	EUCTR2019-002810-37-BG (EUCTR)	15/06/2020	28/04/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	United States;Czechia;Estonia;Hungary;Poland;Lithuania;Bulgaria;Germany
59	NCT04584541 (ClinicalTrials.gov)	June 11, 2020	10/6/2020	SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism	Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments	Spondyloarthritis;Rheumatoid Arthritis;Covid19	Biological: blood tests;Biological: Nasopharyngeal swabs;Biological: Stools	Assistance Publique - Hôpitaux de Paris	NULL	Recruiting	18 Years	N/A	All	150	N/A	France
60	EUCTR2019-002676-14-SE (EUCTR)	01/06/2020	14/04/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	ChiCTR2000033004	2020-06-01	2020-05-17	Clinical study of intravenous lidocaine infusion in patients with rheumatoid arthritis	Clinical study of intravenous lidocaine infusion in patients with rheumatoid arthritis	Rheumatoid arthritis	Group 1:glucocorticoid;Group 2:intravenous lidocaine infusion and glucocorticoid;Group 3:intravenous lidocaine infusion;Group 4:NSAIDS;	Department of Pain, Guizhou Provincial People's Hospita	NULL	Pending	18	65	Both	Group 1:30;Group 2:30;Group 3:30;Group 4:30;		China
62	NCT04269993 (ClinicalTrials.gov)	June 1, 2020	12/2/2020	Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis	Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis	Rheumatoid Arthritis;Psoriatic Arthritis	Drug: Cannabis: placebo and medium THC/medium CBD	Brown University	NULL	Not yet recruiting	18 Years	65 Years	All	76	Phase 2	NULL
63	ChiCTR2000033214	2020-06-01	2020-05-24	Evaluation of the benefits of early standard control in the treatment of rheumatoid arthritis	Evaluation of the benefits of early standard control in the treatment of rheumatoid arthritis	Rheumatoid Arthritis	Group 1:Tofacitinib;Group 2:cDMARDs;	Department of Rheumatology, Anqing Hospital Affiliated to Anhui Medical University	NULL	Pending	18		Both	Group 1:52;Group 2:52;	Phase 4	NULL
64	NCT04402554 (ClinicalTrials.gov)	June 2020	15/5/2020	Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis	Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis	Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis	Behavioral: Cannabis questionnaire	University Hospital, Clermont-Ferrand	NULL	Not yet recruiting	18 Years	N/A	All	500		France
65	EUCTR2019-001185-15-BG (EUCTR)	29/05/2020	15/05/2020	A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	EUCTR2018-003418-41-GB (EUCTR)	18/05/2020	22/11/2019	A comparison of a radioactive imaging method with an existing immunological (involving cells from the Immune System) based method that involves staining of tissues from a patient with a known rheumatoid arthritic joint.	A Comparison of Tc 99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA)	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]	Trade Name: Lymphoseek Product Name: technetium Tc 99m tilmanocept INN or Proposed INN: not applicable Other descriptive name: TILMANOCEPT	Navidea Biopharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 2	United States;European Union;United Kingdom
67	EUCTR2019-004369-42-SK (EUCTR)	12/05/2020	09/03/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	United States;Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of
68	EUCTR2019-004078-24-ES (EUCTR)	07/05/2020	21/02/2020	Effect of Sarilumab on atherosclerotic disease in Rheumatoid Arthritis	Effect of Sarilumab on atherosclerotic disease measured by PET/CT (Positron Emission Tomography/Computed Tomography) in Rheumatoid Arthritis - SARIPET	RHEUMATOID ARTHRITIS MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: KEVZARA INN or Proposed INN: SARILUMAB	IDIVAL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 4	Spain
69	EUCTR2019-004369-42-PL (EUCTR)	05/05/2020	23/03/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra (R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	United States;Serbia;Czechia;Czech Republic;Hungary;Slovakia;Spain;Poland;Bulgaria;Russian Federation;Georgia;Moldova, Republic of
70	EUCTR2019-002205-22-GB (EUCTR)	01/05/2020	07/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	NCT04078191 (ClinicalTrials.gov)	May 2020	21/8/2019	Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue of Subjects With Rheumatoid Arthritis (RA)	A Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: Tc 99m tilmanocept	Navidea Biopharmaceuticals	NULL	Not yet recruiting	18 Years	N/A	All	24	Phase 2	United Kingdom
72	NCT04350216 (ClinicalTrials.gov)	April 30, 2020	8/4/2020	Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET)	Effect of Sarilumab Therapy on Atherosclerotic Disease Assessed by Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Atherosclerosis	Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]	Instituto de Investigación Marqués de Valdecilla	NULL	Not yet recruiting	18 Years	100 Years	All	20	Phase 4	NULL
73	EUCTR2019-004369-42-HU (EUCTR)	27/04/2020	03/03/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra (R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of
74	EUCTR2019-002810-37-LT (EUCTR)	17/04/2020	03/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany
75	NCT04361513 (ClinicalTrials.gov)	April 15, 2020	22/4/2020	Genicular Nerve Block in Rheuamtoid Arthritis	Genicular Nerve Block in Rheumatoid Arthritis: a Prospective Randomized Clinical Trial	Pain;Joint Function Disorder;Inflammation	Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer);Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)	Sohag University	NULL	Completed	18 Years	N/A	All	64	Phase 4	Egypt
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	EUCTR2019-000867-26-DE (EUCTR)	08/04/2020	04/07/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1800	Phase 3	United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of
77	JPRN-UMIN000040054	2020/04/06	04/04/2020	The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block	The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block - The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block	knee osteoarthritis or knee rheumatoid arthritis	Popliteal Plexus Block with 0.25% levobupivacaine 10 mL Tibial Nerve Block(TNB) with 0.25% levobupivacaine 10 mL	Daiyukai General Hospital	NULL	Recruiting	20years-old	100years-old	Male and Female	120	Phase 3	Japan
78	EUCTR2019-002205-22-ES (EUCTR)	06/04/2020	23/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom
79	EUCTR2019-002205-22-PL (EUCTR)	29/03/2020	07/02/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom
80	EUCTR2019-000878-30-HU (EUCTR)	26/03/2020	28/02/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	Japan;Serbia;United States;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	NCT04434118 (ClinicalTrials.gov)	March 20, 2020	13/6/2020	Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients	Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study	Rheumatoid Arthritis;COVID	Drug: Traditional antirheumatic drugs	Sadat City University	NULL	Enrolling by invitation	18 Years	60 Years	All	600		Egypt
82	NCT04247815 (ClinicalTrials.gov)	March 16, 2020	16/1/2020	Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA	A Phase 2a, Randomized, Investigator and Patient-blind, Sponsor-unblinded, Parallel Group, Placebo-controlled Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: ATI-450;Drug: Placebo oral tablet;Drug: Methotrexate	Aclaris Therapeutics, Inc.	NULL	Active, not recruiting	18 Years	70 Years	All	19	Phase 2	United States
83	NCT04389320 (ClinicalTrials.gov)	March 15, 2020	11/5/2020	Antimalarial and Covid 19 in Rheumatoid Arthritis	Antimalarial and Covid 19 in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Hydroxychloroquine	Assiut University	NULL	Completed	20 Years	70 Years	All	60		Egypt
84	EUCTR2019-003700-12-FR (EUCTR)	13/03/2020	04/06/2020	Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients	Association between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug	rheumatoid arthritis MedDRA version: 21.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Methotrexate Product Code: MTX Other descriptive name: METHOTREXATE DISODIUM Product Code: bDMARD INN or Proposed INN: INFLIXIMAB INN or Proposed INN: ETANERCEPT INN or Proposed INN: ADALIMUMAB INN or Proposed INN: CERTOLIZUMAB PEGOL INN or Proposed INN: GOLIMUMAB	CHU Saint-Etienne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	France
85	EUCTR2019-000868-18-DE (EUCTR)	13/03/2020	08/07/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	JPRN-jRCT1041190127	10/03/2020	10/03/2020	Romosozumab Against GLucocorticoid-induced Osteoporosis in Rheumatoid arthritis despite bisphosphonate over a Year	Randomized controlled trial of romosozumab and denosumab for glucocorticoid-induced osteoporosis with inadequate response to bisphosphonate in rheumatoid arthritis patients	Rheumatoid arthritis, Glucocoluticoid-induced osteoporosis Rheumatoid arthritis, Glucocoluticoid-induced osteoporosis	arm Romosozumab-denosumab: romosozumab 210mg s.c. once monthly for 12months, after that, denosumab 60mg s.c. once every 6months for 12months arm Denosumab: denosumab 60mg s.c. once every 6months for 12months after that romosozumab 210mg s.c. once monthly for 12months Arm denosumab, in case denosumab has enough response, based on physician's dicision, denosumab can be continued. all patients: eldecalcitol 0.75microg ram p.o. once a day (Dose reduced to 0.5microg ram once a d ay depending on symptoms)	KOJIMA TOSHIHISA	NULL	Pending	Not applicable	Not applicable	Female	100	N/A	Japan
87	EUCTR2019-002810-37-HU (EUCTR)	09/03/2020	20/01/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;Hungary
88	JPRN-jRCT1041190125	09/03/2020	09/03/2020	PRECIOUS-B study	Patient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study	Rheumatoid arthritis	1) MTX* Week 0 to 12 - Reduced after registration. - The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose. - The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used. Week 12 to 52 - Discontinued if low disease activity was maintained. - Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) BAR - Continued at a stable dose and interval throughout the course of the study. 3) csDMARDs other than MTX - Continued at a stable dose and interval throughout the course of the study. 4) Glucocorticoids - Continued at a stable dose up to week 36, and allowed to taper after week 36. 5) Rescue treatments One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request - Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX. - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids. - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.	Takahashi Nobunori	NULL	Pending	>= 20age old	Not applicable	Both	51	N/A	Japan
89	ChiCTR2000030247	2020-03-01	2020-02-26	Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage	Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage	Systemic lupus erythematosus	experimental group:Integrative MTX with Guanxinning;control group:MTX;	Zhejinag University of f Chinese Medicine	NULL	Recruiting			Both	experimental group:30;control group:30;		China
90	ChiCTR2000030400	2020-03-01	2020-03-01	Effects of Tetrandrine for Rheumatoid Arthritis-Associated Usual Interstitial Pneumonia	Effects of Tetrandrine for Rheumatoid Arthritis-Associated Usual Interstitial Pneumonia	Interstitial pneumonia	Case series:Tetrandrine;	The First People's Hospital of Yancheng	NULL	Recruiting	36	78	Both	Case series:41;		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
91	NCT02903212 (ClinicalTrials.gov)	March 2020	1/9/2016	Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis	Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis	Arthritis, Rheumatoid	Biological: Autologous apoptotic cells injection	Centre Hospitalier Universitaire de Besancon	NULL	Not yet recruiting	18 Years	80 Years	All	22	Phase 1;Phase 2	NULL
92	EUCTR2019-000878-30-CZ (EUCTR)	26/02/2020	06/01/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	Serbia;United States;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan
93	EUCTR2018-003351-37-FR (EUCTR)	19/02/2020	28/05/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
94	EUCTR2019-001185-15-NO (EUCTR)	19/02/2020	07/11/2019	A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Denmark;Norway;Sweden
95	EUCTR2019-000878-30-LT (EUCTR)	13/02/2020	25/11/2019	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
96	EUCTR2019-004468-23-GB (EUCTR)	10/02/2020	26/02/2020	Biologics for RA Pain ( BIORA-PAIN)	Comparison of abatacept with tumor necrosis factor inhibitors in the treatment of rheumatoid arthritis pain: A phase IV trial - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Abatacept Product Name: Abatacept INN or Proposed INN: Abatacept Trade Name: Humira Product Name: Humira INN or Proposed INN: Humira	St George's, University of London	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	United Kingdom
97	EUCTR2018-004558-30-PT (EUCTR)	03/02/2020	21/05/2019	A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.	A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Ledertrexato Product Name: Metotrexato Product Code: Metotrexato INN or Proposed INN: metotrexato Other descriptive name: METHOTREXATE SODIUM Trade Name: Metex Pen Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	186	Phase 4	Portugal;Spain
98	EUCTR2019-000284-24-CZ (EUCTR)	03/02/2020	17/10/2019	A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.	A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.	Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 4	United States;Serbia;Czech Republic;Poland;Ukraine;Lithuania;South Africa;Russian Federation;Bulgaria;Bosnia and Herzegovina
99	EUCTR2018-004429-94-NL (EUCTR)	21/01/2020	17/06/2019	Monitoring of respons to therapy in rheumatoid arthritis with the help of a PET scan.	[18F]PEG-folate PET-CT imaging for monitoring of therapy response in rheumatoid arthritis patients	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: [18F]PEG-Folate	VU Medical Center, department of Rheumatology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	10	Phase 4	Netherlands
100	EUCTR2019-004101-27-NL (EUCTR)	15/01/2020	12/12/2019	Research into injecting golimumab less frequently by using increased doses	INDIGO: Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study’ - INDIGO	rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Sint Maartenskliniek	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	35	Phase 4	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
101	JPRN-UMIN000039116	2020/01/15	15/01/2020	Effects of Sleep Management on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study.	Effects of zolpidem tartrate on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study. - SMAPP	Osteoarthritis, Rheumatoid arthritis	Administration of zolpidem tartrate of 5mg for 7 days after surgery No administration of zolpidem tartrate	Mito medical center, Mito Kyodo General Hospital, University of Tsukuba	NULL	Pending	20years-old	Not applicable	Male and Female	84	Not selected	Japan
102	NCT04230213 (ClinicalTrials.gov)	January 13, 2020	14/1/2020	A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis	A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis	Drug: PF-06410293;Drug: adalimumab	Pfizer	NULL	Recruiting	18 Years	70 Years	All	420	Phase 3	United States;Bosnia and Herzegovina;Bulgaria;Czechia;Lithuania;Poland;Russian Federation;Serbia;South Africa;Ukraine
103	EUCTR2019-004179-38-SE (EUCTR)	10/01/2020	19/11/2019	Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis	Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis - PULMORA	Patients with early active rheumatoid arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Västra Götalandsregionen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	145	Phase 4	Sweden
104	NCT04186871 (ClinicalTrials.gov)	January 7, 2020	28/11/2019	Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis	Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome	Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo	Bristol-Myers Squibb	NULL	Recruiting	18 Years	65 Years	All	185	Phase 2	United States;Argentina;Australia;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom
105	JPRN-UMIN000042632	2020/01/01	03/12/2020	THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS	THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS - laser effectiveness in rheumatoid arthritis	Rheumatoid arthritis	low level laser therapy. Each patient in group 1 takes 20 sessions of LLLT , in the form of 2 courses, each course contains 10 sessions ,as 3 sessions every week ,10 days free between 2 courses. The laser apparatuses used for therapy in this study were the following, 1.HeNe Laser wavelength 632,8 nm, continuous emission, output power 7.3 mW. 2.GaAIAs diode laser (830 nm, maximum output power 300 mW). 12 patients placebo laser and naproxen Naproxen is given as tablet 500mg twice per day. 12 patients naproxen Naproxen is given as tablet 500mg twice per day. 10 patients	Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	34	Not applicable	Asia(except Japan)
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	NCT04115397 (ClinicalTrials.gov)	January 2020	2/10/2019	Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints	Towards Efficient Prediction and Prevention of Rheumatoid Arthritis	Seropositive Muskuloskeletal Complaints	Drug: Zoledronic Acid;Drug: Placebo	Karolinska Institutet	NULL	Not yet recruiting	18 Years	N/A	All	80	Phase 4	NULL
107	EUCTR2019-000284-24-LT (EUCTR)	18/12/2019	07/11/2019	A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.	A RANDOMIZED COMPARATIVE STUDY ASSESSING THE INTERCHANGEABILITY OF PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.	Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Serbia;Ukraine;Lithuania;Russian Federation;Czech Republic;Mexico;Argentina;Poland;Peru;South Africa;Bulgaria;Bosnia and Herzegovina
108	NCT04046146 (ClinicalTrials.gov)	December 15, 2019	23/7/2019	Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport	Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport	Rheumatoid Arthritis	Drug: Indocyanine Green;Device: MultiSpectral Imaging System	University of Rochester	NULL	Completed	18 Years	89 Years	All	2	Phase 1	United States
109	EUCTR2018-003351-37-LT (EUCTR)	13/12/2019	29/08/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
110	EUCTR2019-000867-26-GB (EUCTR)	10/12/2019	12/06/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Xeljanz INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1800	Phase 3	United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	NCT04163991 (ClinicalTrials.gov)	December 9, 2019	12/11/2019	A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of VIB4920 in Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: VIB4920;Drug: Placebo	Viela Bio	NULL	Recruiting	18 Years	99 Years	All	75	Phase 2	United States;Poland
112	EUCTR2019-000868-18-GB (EUCTR)	02/12/2019	11/06/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Kevzara INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colo	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Czechia;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of
113	ChiCTR1900027855	2019-11-29	2019-11-30	Pharmacokinetics of CYP2C9 * 3 homozygous mutant subjects in a single oral meloxicam tablet	Pharmacokinetics of CYP2C9 * 3 homozygous mutant subjects in a single oral meloxicam tablet	Osteoarthritis, rheumatoid arthritis	Case:Meloxicam 15mg;	Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University	NULL	Pending	18	45	Male	Case:1;	Phase 1	China
114	EUCTR2019-001754-25-NL (EUCTR)	25/11/2019	25/11/2019	Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment	Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch)	rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel , Benepali, Erelzi Product Name: Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab INN or Proposed INN: ETANERCEPT INN or Proposed INN: RITUXIMAB INN or Proposed INN: ABATACEPT INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB INN or Proposed INN: SARILUMAB	Reade	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 4	Netherlands
115	EUCTR2019-000797-39-GB (EUCTR)	22/11/2019	10/06/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Xeljanz INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China;United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
116	EUCTR2018-004287-56-FR (EUCTR)	21/11/2019	31/01/2020	Methotrexate and Metformin in rheumatoid arthritis patients	Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study - METorMET2	rheumatoid arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		CHU de Bordeaux	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	128	Phase 2	France
117	NCT04227366 (ClinicalTrials.gov)	November 19, 2019	25/12/2019	Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis	An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: BCD-089;Biological: Placebo;Drug: Methotrexat	Biocad	NULL	Active, not recruiting	18 Years	N/A	All	150	Phase 3	Russian Federation
118	EUCTR2019-000797-39-PL (EUCTR)	18/11/2019	15/07/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China
119	EUCTR2019-000867-26-PL (EUCTR)	15/11/2019	15/07/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1800	Phase 3	United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of
120	EUCTR2019-000868-18-PL (EUCTR)	15/11/2019	11/07/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
121	EUCTR2019-000867-26-ES (EUCTR)	14/11/2019	09/07/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	1800	Phase 3	United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of
122	EUCTR2019-000868-18-ES (EUCTR)	14/11/2019	26/07/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;Japan;China;Korea, Republic of
123	EUCTR2019-000797-39-ES (EUCTR)	14/11/2019	09/07/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	1700	Phase 3	United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China
124	NCT04038970 (ClinicalTrials.gov)	November 8, 2019	29/7/2019	Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate	A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KN019 in Patients With Active Rheumatoid Arthritis While Receiving Methotrexate	Rheumatoid Arthritis	Biological: KN019, 5mg/kg;Biological: KN019, 10 mg/kg;Biological: Placebo;Combination Product: Methotrexate	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	NULL	Recruiting	18 Years	N/A	All	141	Phase 2	China
125	EUCTR2019-001185-15-SE (EUCTR)	06/11/2019	01/07/2019	A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization). The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		SynAct Pharma ApS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Denmark;Norway;Moldova, Republic of;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
126	EUCTR2019-001793-28-NL (EUCTR)	05/11/2019	05/11/2019	Adalimumab dose reduction aiming low drug levels with control of disease activity (ADDORA-LOW)	Adalimumab dose reduction aiming low serum concentration with control of disease activity (ADDORA-LOW) : a single blind, non-inferiority, randomised clinical trial - ADDORA-Low	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Reade	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	89	Phase 4	Netherlands
127	NCT04170504 (ClinicalTrials.gov)	November 2019	14/11/2019	Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis	Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial	Rheumatoid Arthritis	Drug: Qing Re Huo Xue (QRHX);Drug: Methotrexate;Drug: dummy Qing Re Huo Xue (QRHX)	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	NULL	Not yet recruiting	18 Years	N/A	All	204	Phase 2;Phase 3	NULL
128	EUCTR2019-001554-25-NL (EUCTR)	29/10/2019	29/10/2019	Adalimumab dose optimization in rheumatoid arthritis using drug concentration in blood (ADDORA): multi-center open label randomized controlled trail	Adalimumab dose optimization in rheumatoid arthritis using therapeutic drug monitoring (ADDORA): multi-center open label randomized controlled trail - ADalimumab Dose Optimization in Rheumatoid Arthritis using (ADDORA)	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Reade	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	267	Phase 1;Phase 4	Netherlands
129	NCT04049448 (ClinicalTrials.gov)	October 24, 2019	6/8/2019	Study Evaluating the One-Year Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis	A Follow-up Phase 2a Open-label Study to Evaluate the One-year Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: ABX464	Abivax S.A.	NULL	Recruiting	18 Years	76 Years	All	60	Phase 2	Belgium;Czechia;France;Hungary;Poland
130	EUCTR2019-000867-26-HU (EUCTR)	24/10/2019	28/10/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs. - contRAst-2	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Other descriptive name: TOFACITINIB CITRATE Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	1800	Phase 3	United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
131	EUCTR2019-000868-18-HU (EUCTR)	24/10/2019	28/10/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
132	EUCTR2019-000797-39-HU (EUCTR)	24/10/2019	28/10/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China
133	NCT04130178 (ClinicalTrials.gov)	October 15, 2019	11/10/2019	Nerve Block of the Proximal Interphalangeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study	Nerve Block of the Proximal Interphalyngeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study	Rheumatoid Arthritis	Drug: Nerve block	Sohag University	NULL	Completed	18 Years	N/A	All	48	N/A	Egypt
134	EUCTR2019-001578-27-HU (EUCTR)	15/10/2019	02/09/2019	Follow-up Phase 2a study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.	A follow-up Phase 2a open-label study to evaluate the one-year safety and efficacy profile of ABX464 in patients with moderate to severe active Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		Abivax	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	Hungary
135	EUCTR2019-000867-26-BG (EUCTR)	11/10/2019	30/07/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1800	Phase 3	Germany;China;Japan;Korea, Republic of;United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
136	EUCTR2019-000797-39-LT (EUCTR)	11/10/2019	19/07/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) MONOCLONAL Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China
137	EUCTR2019-000867-26-EE (EUCTR)	10/10/2019	01/08/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1800	Phase 3	United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of
138	EUCTR2018-003351-37-HU (EUCTR)	07/10/2019	24/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
139	NCT04120831 (ClinicalTrials.gov)	October 7, 2019	4/10/2019	TOLERA: Tolerance Enhancement in RA	Sequential B Cell/T Cell Therapy to Re-induce Humoral Immune TOLErance in ACPA- Positive Rheumatoid Arthritis A Prospective, Randomized Controlled Open Label Single-centre Clinical Trial in Adult Subjects With Active ACPA-positive Rheumatoid Arthritis Failing Methotrexate	Rheumatoid Arthritis	Drug: Abatacept Injection	University of Erlangen-Nürnberg Medical School	NULL	Recruiting	18 Years	N/A	All	20	Phase 2	Germany
140	EUCTR2017-003037-28-NL (EUCTR)	02/10/2019	22/07/2019	Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs.	Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs. - TOPIRA	RA patients with active RA despite treatment with csDMARDs and previous use of max 1 TNFi. MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		University Medical Center Utrecht	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 4	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
141	NCT04273334 (ClinicalTrials.gov)	October 1, 2019	15/2/2020	Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders	Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders, Including Lymphedema, Lymphangioma, Lymphangioleiomyomatosis, Plastic Bronchitis, Lymphadenopathy Caused by Rheumatoid Arthritis, Etc.	Lymphatic Disorders	Drug: 68Ga-NEB	Peking Union Medical College Hospital	NULL	Recruiting	18 Years	80 Years	All	90	Phase 1	China
142	NCT03194204 (ClinicalTrials.gov)	October 1, 2019	10/6/2017	Re-evaluation of Some Old Rheumatoid Arthritis Therapy: A Randomized Controlled Trial	Efficacy of Doxycycline as a Combination Therapy in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Doxycycline Tablets	Assiut University	NULL	Completed	18 Years	60 Years	All	160	N/A	Egypt
143	NCT04077567 (ClinicalTrials.gov)	October 1, 2019	29/8/2019	An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis	An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: TS-152	Taisho Pharmaceutical Co., Ltd.	NULL	Active, not recruiting	20 Years	N/A	All	401	Phase 3	Japan
144	JPRN-JapicCTI-194932	01/10/2019	28/08/2019	An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis	An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis	Intervention name : ozoralizumab INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection of TS-152 30mg or TS-152 80mg every 4 weeks Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Taisho Pharmaceutical Co.Ltd	NULL	complete	20		BOTH	505	Phase 3	Japan
145	ChiCTR1900026257	2019-09-28	2019-09-28	A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue	Efficacy, dose comparison, and safety of Wisconsin Ginseng (Panax quinquefolius) in patients with rheumatoid arthritis associated fatigue: Three-arm parallel, multicenter, randomized, double-blind, placebo-controlled, phase 2 trial	Rheumatoid arthritis (RA)	High-dose experimental group :6000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;Low-dose experimental group:3000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg); 3000mg Placebo: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg) ;Control group :6000mg Placebo: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;	Zhejiang Provincal Hospital of TCM	NULL	Pending	18	70	Both	High-dose experimental group :30;Low-dose experimental group:30;Control group :30;	Phase 2	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
146	EUCTR2019-000868-18-CZ (EUCTR)	20/09/2019	20/08/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;Japan;China;Korea, Republic of
147	EUCTR2019-000797-39-CZ (EUCTR)	19/09/2019	18/09/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China
148	EUCTR2018-004677-27-BE (EUCTR)	16/09/2019	25/03/2019	Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.	Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy.	Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	Abivax	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	Hungary;Belgium
149	EUCTR2019-000797-39-LV (EUCTR)	13/09/2019	25/06/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China
150	EUCTR2018-003351-37-GR (EUCTR)	13/09/2019	29/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
151	NCT04472481 (ClinicalTrials.gov)	September 6, 2019	7/7/2020	Vitamin D Effect in Rheumatoid Arthritis.	Vitamin D: Does It Help Tregs in Active Rheumatoid Arthritis Patients.	Active Rheumatoid Arthritis	Drug: Ergocalciferol 1.25 mg tablet	Tanta University	NULL	Completed	33 Years	60 Years	All	20	Phase 4	Egypt
152	EUCTR2018-003351-37-ES (EUCTR)	05/09/2019	16/09/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Lilly S.A	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
153	EUCTR2018-003351-37-PL (EUCTR)	04/09/2019	09/08/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
154	NCT03971253 (ClinicalTrials.gov)	September 2, 2019	30/5/2019	Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis	Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis	Rheumatoid Arthritis (RA)	Drug: Peficitinib	Astellas Pharma Inc	NULL	Recruiting	N/A	N/A	All	3000		Japan
155	NCT04136262 (ClinicalTrials.gov)	September 1, 2019	21/10/2019	Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis	Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial	Rheumatoid Arthritis	Drug: Tripterygium wilfordii Hook F (TwHF);Drug: Methotrexate;Other: Dummy Tripterygium wilfordii Hook F (TwHF)	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	NULL	Recruiting	N/A	N/A	Female	300	Phase 2;Phase 3	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
156	EUCTR2018-003351-37-NL (EUCTR)	29/08/2019	08/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Germany;Netherlands
157	EUCTR2018-003351-37-DK (EUCTR)	29/08/2019	07/08/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;South Africa;Germany;Netherlands
158	JPRN-JapicCTI-194928	26/8/2019	22/08/2019	-An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101	An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101	Rheumatoid Arthritis	Intervention name : methotrexate INN of the intervention : methotrexate Dosage And administration of the intervention : Part 1: 7.5 mg MJK101 (SC) or dummy MJK101 (SC) will be administered once a week over a period of 12 weeks. Part 2: All subjects will receive once-weekly MJK101 (SC) for 12 months. At Trial Week 12, the once-weekly dose of MJK101 (SC) will be determined according to the disease activity status of the subject and an assessment of safety. If the subject has not met a low disease activity status at the visits every 4 weeks and has been well tolerated, then the once-weekly MJK101 (SC) dose will be increased by 2.5 mg to a maximum dose of 15 mg. Control intervention name : methotrexate INN of the control intervention : methotrexate Dosage And administration of the control intervention : Part 1: 8 mg MTX (oral) or placebo MTX (oral) will be administered once a week over a period of 12 weeks. The oral administration of MTX or placebo MTX will be divided into 2 doses to be administered approximately within a 12-hour interval.	medac GmbH	NULL	complete	20	75	BOTH	100	Phase 3	Japan
159	NCT04004429 (ClinicalTrials.gov)	August 26, 2019	26/6/2019	A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease	A Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint Disease	Rheumatoid Arthritis	Drug: 50 mg AP1189;Drug: AP1189;Drug: Placebo	SynAct Pharma Aps	NULL	Recruiting	18 Years	85 Years	All	90	Phase 2	Denmark;Norway
160	NCT04179513 (ClinicalTrials.gov)	August 15, 2019	25/11/2019	A Study to Evaluate the Safety and Tolerability of Multiple Doses of Gerilimzumab in Rheumatoid Arthritis Patients	Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Gerilimzumab for Injection in Combination With Oral Methotrexate in Rheumatoid Arthritis Patients in Two Dose Groups	Rheumatoid Arthritis	Biological: GB224 10mg;Biological: GB224 20mg	Genor Biopharma Co., Ltd.	NULL	Recruiting	18 Years	45 Years	All	24	Phase 1	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
161	EUCTR2018-003351-37-AT (EUCTR)	13/08/2019	31/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
162	EUCTR2018-003351-37-GB (EUCTR)	08/08/2019	16/05/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
163	ChiCTR1900025013	2019-08-08	2019-08-07	Clinical observation of multiple dose use of tranexamic acid in patients with rheumatoid arthritis after total knee arthroplasty	Effects of multiple dose use of tranexamic acid on blood loss and inflammatory factors after total knee arthroplasty in patients with rheumatoid arthritis	Total knee arthroplasty	group 1:Intravenous infusion of 1g of tranexamic acid at 3 hours after surgery ;group 2:Intravenous infusion of 1g of tranexamic acid at 3, 6, and 12 hours after surgery;	Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine	NULL	Recruiting	50	75	Both	group 1:52;group 2:52;	Phase 4	China
164	EUCTR2018-004605-57-NL (EUCTR)	06/08/2019	24/07/2019	Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients	Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients: a randomised, multicenter, non-inferiority trial (TODORA) - Use of TOcilizumab Drug levels to Optimize treatment in RA (TODORA)	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Reade	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	98	Phase 1;Phase 4	Netherlands
165	EUCTR2018-003351-37-DE (EUCTR)	02/08/2019	24/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	South Africa;Germany;Netherlands;United States;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Australia;Denmark
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
166	NCT04068246 (ClinicalTrials.gov)	August 1, 2019	21/8/2019	The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients	The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.	Rheumatoid Arthritis	Drug: Metformin;Drug: Placebo	Sadat City University	NULL	Recruiting	18 Years	N/A	All	150	Early Phase 1	Egypt
167	NCT02418273 (ClinicalTrials.gov)	August 1, 2019	6/4/2015	Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders	Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study	Osteoporosis;Juvenile Rheumatoid Arthritis;Dermatomyositis;Polyarthritis;Systemic Lupus Erythematosis;Vasculitis;Glucocorticoid-induced Osteoporosis	Drug: denosumab	Indiana University	NULL	Withdrawn	4 Years	16 Years	All	0	Phase 1;Phase 2	United States
168	ChiCTR1900024902	2019-08-01	2019-08-03	A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis	A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis	Rheumatoid Arthritis	Experimental group:Traditional Chinese medicine (Yi-Shen Tong-Bi Tang);Positive control group:Methotrexate;	The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine	NULL	Pending	18	65	Both	Experimental group:50;Positive control group:50;	N/A	China
169	ChiCTR1900025021	2019-07-25	2019-08-07	Safety, Tolerance and Pharmacokinetics of Single Administration of Meloxicam Suspension Injection in Healthy Chinese Subjects	Safety, Tolerance and Pharmacokinetics of Single Administration of Meloxicam Suspension Injection in Healthy Chinese Subjects	Osteoarthritis, rheumatoid arthritis	A:TR group: phase I: Meloxicam Suspension Injection (T) 7.5 mg, phase II: Mobi (R) 7.5 mg; RT group: phase I: R, phase II: T.;B:Meloxicam Suspension Injection 15 mg;C:Meloxicam Suspension Injection 30 mg;D:Meloxicam Suspension Injection 60 mg;	Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University	NULL	Recruiting			Both	A:12;B:12;C:12;D:12;	Phase 1	China
170	EUCTR2018-004677-27-HU (EUCTR)	25/07/2019	25/07/2019	Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.	Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy.	Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		Abivax	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	Hungary
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
171	NCT04037111 (ClinicalTrials.gov)	July 23, 2019	25/7/2019	Clinical Study of Escitalopram Oxalate Combined With taVNS in Depression and Concomitant Inflammatory Symptoms	Clinical Study of Escitalopram Oxalate Combined With Transcutaneous Vagus Nerve Stimulation in the Treatment of Depression and Concomitant Inflammatory Symptoms	Major Depressive Disorder;Rheumatoid Arthritis	Device: Transcutaneous electrical vagus nerve stimulation;Device: Sham vagus nerve stimulation;Drug: drug treatment	Xijing Hospital	NULL	Recruiting	18 Years	65 Years	All	90	N/A	China
172	EUCTR2018-003330-32-PL (EUCTR)	19/07/2019	06/05/2019	Efficacy and Safety of Oral SKI-O-703 in Refractory Rheumatoid Arthritis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies	Rheumatoid Arthritis Despite Treatment With Conventional Therapies MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Cevidoplenib Product Code: SKI-O-703 INN or Proposed INN: Cevidoplenib	Oscotec Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	148	Phase 2	United States;Serbia;Czech Republic;Poland;Ukraine;Russian Federation;Korea, Republic of
173	EUCTR2018-003933-14-BE (EUCTR)	19/07/2019	24/04/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Galapagos NV	NULL	Not Recruiting			Female: no Male: yes	250	Phase 2	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
174	ChiCTR1900024261	2019-07-15	2019-07-03	Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China	Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China	rheumatoid arthritis	A:methotrexate (7.5~15 mg/week)+ placbo (1 mg/d);B:sirolimus (1 mg/d) + methotrexate (7.5~15 mg/week);	The Second Hospital of Shanxi Medical University	NULL	Pending	18	65	Both	A:30;B:30;	Phase 4	China
175	EUCTR2016-003682-26-PL (EUCTR)	11/07/2019	17/05/2018	Phase 3 trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of patients suffering of Early Rheumatoid Arthritis	A Phase 3, Randomized, Double-Blind, Active- and Placebo controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis	Early Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CF101 Product Code: CF101 INN or Proposed INN: Piclidenoson Other descriptive name: IB-MECA Product Name: CF101 Product Code: CF101 INN or Proposed INN: Piclidenoson Other descriptive name: IB-MECA Product Name: METHOTREXATE Product Code: METHOTREXATE INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Can-Fite BioPharma, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	Serbia;Canada;Poland;Romania;Israel;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
176	NCT04464642 (ClinicalTrials.gov)	July 10, 2019	6/7/2020	Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis	Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Tofacitinib	Dr. Mohammad Mamun Khan	NULL	Active, not recruiting	18 Years	N/A	All	110	Phase 4	Bangladesh
177	EUCTR2019-000660-25-PL (EUCTR)	09/07/2019	20/05/2019	Evaluating Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis	A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis	Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CT-P17 Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB	CELLTRION, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 3	Poland
178	NCT03813199 (ClinicalTrials.gov)	July 4, 2019	15/1/2019	Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis	Phase IIa Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to an Anti- Tumor Necrosis Factor Alpha (Tnfa) Therapy, or Intolerance to Anti-Tnfa Therapy	Rheumatoid Arthritis	Drug: ABX464 50mg;Drug: Matching Placebo;Drug: ABX464 100mg;Drug: Methotrexate	Abivax S.A.	NULL	Recruiting	18 Years	75 Years	All	60	Phase 2	Belgium;Czechia;France;Hungary;Poland
179	NCT04188249 (ClinicalTrials.gov)	July 1, 2019	27/6/2019	Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis	A Prospective Multicenter Registry of Golimumab in Chinese Patients With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: Golimumab	Peking Union Medical College Hospital	NULL	Recruiting	18 Years	80 Years	All	200		China
180	JPRN-UMIN000037359	2019/07/01	13/07/2019	Double-blind randomized comparison of femoral triangle block and adductor canal block for total knee arthroplasty	Double-blind randomized comparison of femoral triangle block and adductor canal block for total knee arthroplasty - Double-blind randomized comparison of femoral triangle block and adductor canal block for total knee arthroplasty	knee osteoarthritis or knee rheumatoid arthritis	Group ACB: Preoperative administration of 0.25% levobupivacaine 10 mL into the branch of femoral nerve at the apex of femoral triangle Group FTB: Preoperative administration of 0.25% levobupivacaine 10 mL into the branch of femoral nerve at the midthigh level (midpoint between anterior superior iliac spine and upper edge of patella)	Daiyukai General Hospital	NULL	Complete: follow-up continuing	20years-old	100years-old	Male and Female	80	Phase 3	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
181	EUCTR2018-003053-21-PL (EUCTR)	27/06/2019	16/04/2019	A Clinical Study Testing the Safety, Properties, and Treatment Effects of an Antibody Drug Conjugate ABBV-3373 in Comparison with the Antibody Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis	Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects with Moderate to Severe Rheumatoid Arthritis	Moderate to Severe Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: ABBV-3373 INN or Proposed INN: ABBV-3373 Trade Name: Humira (adalimumab) Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	45	Phase 2	United States;Puerto Rico;Poland;Israel
182	EUCTR2018-003933-14-BG (EUCTR)	21/06/2019	27/03/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Estonia;Czech Republic;Spain;Poland;Ukraine;Bulgaria;Latvia
183	NCT03912428 (ClinicalTrials.gov)	June 14, 2019	10/4/2019	Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis	Evaluation of Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis	Myositis	Drug: Celecoxib;Diagnostic Test: 11C-MC1;Diagnostic Test: 11C-ER176	National Institute of Mental Health (NIMH)	NULL	Recruiting	18 Years	N/A	All	86	Phase 4	United States
184	EUCTR2018-003877-91-DE (EUCTR)	13/06/2019	26/02/2019	B cell therapy followed by T cell therapy to achieve immune tolerance in rheumatoid arthritis with ACPA antiboidies (TOLERA): an unblinded clinical trial in one centre with random assignment to treatment groups in adult patients who failed methotrexate therapy	Sequential B cell/T cell therapy to re-induce humoral immune tolerance in ACPA-positive Rheumatoid Arthritis (TOLERA): a prospective randomized controlled open-label single-centre clinical trial in adult subjects with active ACPA-positive Rheumatoid Arthritis failing Methotrexate - TOLERA	Active rheumatoid arthritis with ACPA antibodies failing methotrexate MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	INN or Proposed INN: RITUXIMAB Trade Name: Orencia INN or Proposed INN: ABATACEPT	Universitätsklinikum Erlangen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Germany
185	EUCTR2019-001185-15-DK (EUCTR)	06/06/2019	12/04/2019	A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect	A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: AP1189 INN or Proposed INN: Not applicable	SynAct Pharma ApS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Denmark;Norway;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
186	EUCTR2018-004539-54-DE (EUCTR)	03/06/2019	10/04/2019	Capability of Tofacitinib or Etanercept to accelerate clinical relevant dose reduction of non-steroidal anti-inflammatory drugs and treat-to-target guided minimization of intake of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy	Capability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy - AcceleRAte	Patients with active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Xeljanz Trade Name: Enbrel Trade Name: Celebrex	Fraunhofer Fraunhofer Gesellschaft for its Fraunhofer Institute for Molecular Biology and Applied Ecology IME	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	192	Phase 4	Germany
187	NCT04344405 (ClinicalTrials.gov)	June 1, 2019	9/4/2020	Vitamin D as a Key Player in Rheumatoid Arthritis	Vitamin D as a Key Player in Rheumatoid Arthritis Immune Response	the Immunomodulatory Effect	Drug: Vitamin D;Drug: Placebo	Assiut University	NULL	Recruiting	20 Years	70 Years	All	60	Phase 3	Egypt
188	NCT04033809 (ClinicalTrials.gov)	May 30, 2019	16/7/2019	Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients	Effectiveness of High Fiber Multigrain Supplementation Among the Rheumatoid Arthritis Patients: A Randomized, Open Label Trial	Rheumatoid Arthritis	Dietary Supplement: Multigrain powder (S)	Universiti Sains Malaysia	NULL	Completed	21 Years	N/A	All	54	N/A	Malaysia
189	EUCTR2018-003933-14-CZ (EUCTR)	28/05/2019	29/04/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of
190	EUCTR2018-003933-14-LV (EUCTR)	27/05/2019	07/03/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Latvia;Germany;Moldova, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
191	EUCTR2018-004558-30-ES (EUCTR)	16/05/2019	11/04/2019	Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.	Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.	rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	186	Phase 4	Spain
192	ChiCTR2000032534	2019-05-15	2020-05-01	Pharmacoeconomic evaluation of Anbainuo in the treatment of moderate to severe rheumatoid arthritis - a single center, control study	Pharmacoeconomic evaluation of Anbainuo in the treatment of moderate to severe rheumatoid arthritis - a single center, control study	Rheumatoid arthritis	Experimental group:Anbainuo plus methotrexate;Control group:Methotrexate, salazopyridine, leflumide, hydroxychloroquine;	The Affiliated ZhuZhou Hospital Of XiangYa School Of Medicine CSU.	NULL	Completed			Both	Experimental group:47;Control group:43;	Phase 4	China
193	EUCTR2018-002306-31-GB (EUCTR)	15/05/2019	14/02/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Germany;United Kingdom
194	NCT03823378 (ClinicalTrials.gov)	May 13, 2019	8/1/2019	A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial With ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599)	Rheumatoid Arthritis (RA)	Drug: Upadacitinib;Drug: Upadacitinib placebo;Drug: ABBV-105 placebo;Drug: ABBV-105	AbbVie	NULL	Completed	18 Years	N/A	All	97	Phase 2	Belgium;Canada;Czechia;Hungary;Poland;Spain;United Kingdom
195	EUCTR2019-000505-72-NL (EUCTR)	13/05/2019	18/02/2019	Baricitinib in patients suffering from Rheumatoid Arthritis	Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT)	Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Transparency in Healthcare	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 4	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
196	NCT03944096 (ClinicalTrials.gov)	April 30, 2019	8/5/2019	Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Rheumatoid Arthritis Refractory to Methotrexate	Efficacy and Safety of Faecal Microbiota Transplantation in Patients With Rheumatoid Arthritis Refractory to Methotrexate: a 24-week, Double-Blind, Randomised Trial	Rheumatoid Arthritis	Procedure: FMT+MTX	Peking Union Medical College Hospital	NULL	Recruiting	18 Years	65 Years	All	30	Phase 2	China
197	EUCTR2018-002306-31-BE (EUCTR)	30/04/2019	07/02/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Hungary;Czech Republic;Canada;Spain;Poland;Belgium;United Kingdom
198	EUCTR2018-003933-14-ES (EUCTR)	30/04/2019	21/05/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina
199	EUCTR2018-003933-14-EE (EUCTR)	09/04/2019	14/03/2019	A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.	Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GLPG0634 INN or Proposed INN: FILGOTINIB	Galapagos NV	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Czech Republic;Estonia;Spain;Poland;Ukraine;Bulgaria;Latvia
200	NCT03938636 (ClinicalTrials.gov)	April 8, 2019	24/4/2019	Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging	Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging	Rheumatoid Arthritis	Drug: TC99m-tilmanocept	Navidea Biopharmaceuticals	NULL	Recruiting	18 Years	N/A	All	105	Phase 2	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
201	NCT03816345 (ClinicalTrials.gov)	April 4, 2019	24/1/2019	Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer	A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)	Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Neoplasm	Biological: Nivolumab	National Cancer Institute (NCI)	NULL	Recruiting	18 Years	N/A	All	264	Phase 1	United States
202	EUCTR2018-002306-31-ES (EUCTR)	04/04/2019	12/04/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 INN or Proposed INN: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom
203	NCT03669367 (ClinicalTrials.gov)	April 1, 2019	26/7/2018	EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)	EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)	Palindromic Rheumatism, Wrist	Drug: Abatacept Injection;Drug: hydroxycloroquina	Fundacion Clinic per a la Recerca Biomédica	NULL	Not yet recruiting	18 Years	N/A	All	98	Phase 4	NULL
204	NCT03700021 (ClinicalTrials.gov)	April 2019	2/10/2018	Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis	Single-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs	Rheumatoid Arthritis	Drug: Abatacept + csDMARD	New York University School of Medicine	NULL	Not yet recruiting	18 Years	N/A	All	25	Phase 4	United States
205	NCT03823391 (ClinicalTrials.gov)	March 27, 2019	29/1/2019	A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis (RA)	Drug: ABBV-3373;Drug: Placebo for ABBV-3373;Drug: Adalimumab;Drug: Placebo for adalimumab	AbbVie	NULL	Completed	18 Years	75 Years	All	48	Phase 2	United States;Germany;Hungary;Israel;Netherlands;Poland;Puerto Rico
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
206	EUCTR2018-002202-31-BG (EUCTR)	27/03/2019	30/11/2018	A Phase 3 study to compare BAT1806 with RoActemra in patients with Rheumatoid Arthritis	A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate	Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BAT1806 INN or Proposed INN: BAT1806 Other descriptive name: TOCILIZUMAB Trade Name: RoActemra Product Name: RoActerma INN or Proposed INN: RoActemra Other descriptive name: TOCILIZUMAB	Bio-Thera Solutions, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	612	Phase 3	Poland;Ukraine;Georgia;Bulgaria;China
207	NCT03885037 (ClinicalTrials.gov)	March 20, 2019	4/3/2019	Infliximab Biosimilar for Intravenous Drip Infusion 100 mg Pfizer Drug Use Investigation (Rheumatoid Arthritis)	Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Rheumatoid Arthritis)	Rheumatoid Arthritis	Drug: Infliximab [infliximab biosimilar 3]	Pfizer	NULL	Recruiting	N/A	N/A	All	300		Japan
208	NCT04057118 (ClinicalTrials.gov)	March 20, 2019	13/8/2019	A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies	Rheumatoid Arthritis	Drug: SKI-O-703;Drug: Placebo	Oscotec Inc.	NULL	Active, not recruiting	18 Years	N/A	All	148	Phase 2	United States;Czechia;Poland;Russian Federation;Ukraine
209	NCT03886038 (ClinicalTrials.gov)	March 15, 2019	2/1/2019	Subunit Vaccine Against Herpes Zoster in RA Patients Treated With JAK-inhibitors (VACCIMIL-ZOSTER)	The Immunogenicity and Efficacy of Subunit Vaccine Against Herpes Zoster in RA Treated With JAK-inhibitors (VACCIMIL-ZOSTER)	Rheumatoid Arthritis;Healthy Controls	Biological: Shingrix	Region Skane	NULL	Recruiting	18 Years	N/A	All	150	Phase 4	Sweden
210	ChiCTR1900021686	2019-03-15	2019-03-05	A observational study for iguratimod combined with methotrexate in remission or reversion bone erosion of rheumatoid arthritis	A observational study for iguratimod combined with methotrexate in remission or reversion bone erosion of rheumatoid arthritis	Rheumatoid arthritis	Case Series:IGU combined with MTX ;	Nanjing Drum Tower Hospital	NULL	Pending	18	70	Both	Case Series:30;	Phase 4	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
211	EUCTR2018-002306-31-HU (EUCTR)	08/03/2019	11/02/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	Czech Republic;Hungary;Canada;Spain;Poland;Belgium;United Kingdom
212	ChiCTR1900021808	2019-03-08	2019-03-11	A Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male Subjects	A Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male Subjects	Active rheumatoid arthritis	1:8 mg/kg QX003S ;2:Tocilizumab, 8 mg/kg;	JiangSu Qyuns Therapeutics Co., Ltd	NULL	Recruiting	18	50	Male	1:43;2:43;	Phase 1	China
213	NCT03858725 (ClinicalTrials.gov)	February 26, 2019	27/2/2019	Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteers	A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteer	Rheumatoid Arthritis	Drug: D569 Tab.;Drug: CKD-374 5mg Tab.	Chong Kun Dang Pharmaceutical	NULL	Completed	19 Years	54 Years	All	36	Phase 1	Korea, Republic of
214	NCT03852355 (ClinicalTrials.gov)	February 25, 2019	22/2/2019	the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis	the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled Trial	Rheumatoid Arthritis;Headache	Drug: Radiofrequency;Drug: Steroids	Assiut University	NULL	Completed	18 Years	60 Years	All	60	N/A	Egypt
215	NCT03868072 (ClinicalTrials.gov)	February 22, 2019	6/3/2019	Study to Evaluate the Bioequivalence of Pfizer Korea Inc. XELJANZ 5Mg Tablet in Healthy Volunteers	An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical Chong Kun Dang Tofacitinib Tablet and Pfizer Korea Inc. XELJANZ 5Mg Tablet in Healthy Volunteers	Rheumatoid Arthritis	Drug: XELJANZ 5Mg Tablet;Drug: Chong Kun Dang Tofacitinib Tablet	Chong Kun Dang Pharmaceutical	NULL	Completed	19 Years	N/A	All	40	Phase 1	Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
216	EUCTR2018-000666-10-BE (EUCTR)	19/02/2019	16/11/2018	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Germany;United Kingdom
217	NCT03737708 (ClinicalTrials.gov)	February 13, 2019	8/11/2018	A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)	Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial	Rheumatoid Arthritis (RA)	Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abatacept	Astellas Pharma Korea, Inc.	NULL	Completed	19 Years	75 Years	All	22	Phase 4	Korea, Republic of
218	EUCTR2018-001690-25-LT (EUCTR)	08/02/2019	29/08/2018	Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	648	Phase 3	Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria
219	EUCTR2018-003162-13-IT (EUCTR)	23/01/2019	08/11/2018	A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib	A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib - WI232128	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 4	Italy
220	EUCTR2018-000666-10-ES (EUCTR)	23/01/2019	22/01/2019	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
221	EUCTR2017-004543-20-ES (EUCTR)	22/01/2019	25/10/2018	EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA).	EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA). - PALABA	PALINDROMIC RHEUMATISM;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Fundació Clínic per a la Recerca Biomèdica	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	98	Phase 4	Spain
222	NCT03729349 (ClinicalTrials.gov)	January 15, 2019	1/11/2018	Golimumab for Adherence in Rheumatoid Arthritis	Golimumab for Adherence in Rheumatoid Arthritis	Arthritis, Rheumatoid	Biological: Golimumab	Janssen Inc.	NULL	Recruiting	18 Years	85 Years	All	300		Canada
223	NCT03981900 (ClinicalTrials.gov)	January 4, 2019	7/6/2019	IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis	IDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study.	Arthritis, Rheumatoid	Drug: Tofacitinib	Pfizer	NULL	Recruiting	18 Years	N/A	All	500		France
224	EUCTR2018-000666-10-HU (EUCTR)	03/01/2019	29/10/2018	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 , A-1519938.0 Product Code: ABBV-105 Other descriptive name: ABBV-105 , A-1519938.0 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Germany;United Kingdom
225	NCT04297475 (ClinicalTrials.gov)	January 1, 2019	13/7/2019	The Clinical Feasibilityof a Multi-modal Photoacoustic/Ultrasonic Imaging System in Rheumatoid Arthritis	The Clinical Feasibility and Added Value of a Multi-modal Photoacoustic/Ultrasonic Imaging System in the Evaluation of Rheumatoid Arthritis	Rheumatoid Arthritis;Ultrasonography	Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system	Peking Union Medical College Hospital	NULL	Recruiting	N/A	N/A	All	200		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
226	ChiCTR1800018338	2019-01-01	2018-09-12	A Clinical Trial for Human Gingiva Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis	A Clinical Trial for Human Gingiva Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Control:Normal Saline iv. besides MTX treatment;Treatment:GMSC iv. besides MTX treatment;	theThird Affiliated Hospital of Sun Yat-sen University	NULL	Pending	18	65	Both	Control:123;Treatment:123;	I (Phase 1 study)	China
227	NCT03896594 (ClinicalTrials.gov)	December 24, 2018	28/3/2019	A Multiple Dose of HL237 in Healthy Male Subject	A Dose Block-randomized, Double-blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Oral Dose of HL237 in Healthy Male Subject	Rheumatoid Arthritis	Drug: HL237;Drug: Placebo Oral Tablet	Hanlim Pharm. Co., Ltd.	NULL	Recruiting	20 Years	45 Years	Male	36	Phase 1	Korea, Republic of
228	NCT03574545 (ClinicalTrials.gov)	December 19, 2018	21/6/2018	Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis	A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: ianalumab	Novartis Pharmaceuticals	NULL	Recruiting	18 Years	65 Years	All	50	Phase 1	Germany;Jordan
229	NCT03830203 (ClinicalTrials.gov)	December 19, 2018	22/1/2019	Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate	A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: BAT1806;Drug: Actemra (EU-licensed)	Bio-Thera Solutions	NULL	Active, not recruiting	18 Years	N/A	All	621	Phase 3	China
230	EUCTR2018-000666-10-GB (EUCTR)	17/12/2018	24/10/2018	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 , A-1519938.0 Product Code: ABBV-105 Other descriptive name: ABBV-105 , A-1519938.0 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Hungary;Czech Republic;Puerto Rico;Canada;Spain;Poland;Belgium;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
231	NCT03784261 (ClinicalTrials.gov)	December 17, 2018	17/12/2018	Usefulness of Non TNF Usage in RA Patients	Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Drug: Drug: Salirumab;Drug: Drug: Tocilizmab;Drug: Drug: Abatacept	Shinshu University	NULL	Recruiting	20 Years	100 Years	All	90	Phase 2	Japan
232	EUCTR2018-001690-25-PL (EUCTR)	11/12/2018	25/09/2018	Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	564	Phase 3	Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Korea, Republic of;Bosnia and Herzegovina
233	NCT04204603 (ClinicalTrials.gov)	November 30, 2018	17/12/2019	A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects With Moderate-to- Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: CKD-506;Drug: Placebo	Chong Kun Dang Pharmaceutical	NULL	Completed	18 Years	65 Years	All	122	Phase 2	Czechia;Georgia;Poland;Russian Federation;Ukraine
234	NCT03789292 (ClinicalTrials.gov)	November 26, 2018	27/12/2018	A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis	A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: CT-P17 SC;Biological: Humira SC	Celltrion	NULL	Active, not recruiting	18 Years	75 Years	All	564	Phase 3	Bulgaria
235	NCT03755466 (ClinicalTrials.gov)	November 21, 2018	21/11/2018	Examination of Efficacy and Safety of Baricitinib in RA Patients	Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib	Rheumatoid Arthritis	Drug: Baricitinib , olumiant®;Drug: Biologics;Drug: Tofacitinib 5 MG [Xeljanz]	Shinshu University	NULL	Recruiting	20 Years	N/A	All	90	Phase 2	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
236	NCT03980639 (ClinicalTrials.gov)	November 20, 2018	18/1/2019	Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase	Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase	Rheumatoid Arthritis	Drug: patient treated with DMARD	University Hospital, Toulouse	NULL	Recruiting	18 Years	N/A	All	594226		France
237	NCT03852888 (ClinicalTrials.gov)	November 14, 2018	7/2/2019	Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients	Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients	Rheumatoid Arthritis	Biological: Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level	CHU de Reims	NULL	Recruiting	18 Years	N/A	All	60	N/A	France
238	EUCTR2018-001690-25-HU (EUCTR)	13/11/2018	14/08/2018	Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	564	Phase 3	Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Bosnia and Herzegovina
239	NCT03707535 (ClinicalTrials.gov)	November 12, 2018	12/10/2018	To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: CT-P13;Biological: Remicade	Celltrion	NULL	Active, not recruiting	18 Years	75 Years	All	270	Phase 3	China
240	NCT03714022 (ClinicalTrials.gov)	November 9, 2018	18/10/2018	A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes	A Randomized, Open-Label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of the Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process Relative to the Current Abatacept Drug Process in Healthy Participants	Rheumatoid Arthritis	Drug: Abatacept	Bristol-Myers Squibb	NULL	Completed	18 Years	55 Years	All	140	Phase 1	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
241	EUCTR2018-001690-25-BG (EUCTR)	05/11/2018	19/09/2018	Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis	Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	648	Phase 3	Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria;Korea, Republic of
242	ChiCTR1800019277	2018-11-01	2018-11-02	The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients	The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients	Rheumatoid Arthritis	Control group:MTX;Treatment group 1:Zoledronate Acid(ZA);Treatment group 2:MTX+Zoledronate Acid;	Shanghai Traditional Medicine University Affiliated Guanghua Hospital	NULL	Recruiting	18	65	Both	Control group:22;Treatment group 1:22;Treatment group 2:22;		China
243	NCT04267614 (ClinicalTrials.gov)	November 1, 2018	11/2/2020	This Study is to Investigate the Effect of Etanercept in Early Versus Delayed Referral for Management of Rheumatoid Arthritis Patients.	Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Rheumatoid Arthritis With Etanercept	Arthritis Rheumatoid	Drug: Etanercept	Pfizer	NULL	Completed	N/A	N/A	All	1226		Iraq
244	EUCTR2017-004226-15-DK (EUCTR)	26/10/2018	05/01/2018	Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied.	CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art	Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		King Christian 10th Hospital for Rheumatology	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	Denmark
245	ChiCTR1900026079	2018-10-25	2019-09-20	Wangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical study	Wangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical study	Rheumatoid Arthritis	Experimental group:Wangbi capsule combined methotrexate tablets;Control group:Simulation of Wangbi capsule combined methotrexate tablets;	Longhua Hospital Shanghai University of Traditional Chinese Medicine	NULL	Recruiting	18	70	Both	Experimental group:60;Control group:60;	Phase 4	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
246	NCT03718611 (ClinicalTrials.gov)	October 22, 2018	23/10/2018	To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects	A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects	Rheumatoid Arthritis	Drug: BR9001;Drug: BR900A	Boryung Pharmaceutical Co., Ltd	NULL	Completed	19 Years	50 Years	All	36	Phase 1	Korea, Republic of
247	EUCTR2018-001377-24-CZ (EUCTR)	09/10/2018	14/10/2019	Not available.	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects with Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate	Rheumatoid arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Chong Kun Dang Pharmaceutical Corporation (CKD)	NULL	Not Recruiting			Female: yes Male: yes	120	Phase 2	Czech Republic;Poland;Ukraine;Russian Federation;Georgia
248	NCT03682705 (ClinicalTrials.gov)	October 8, 2018	21/9/2018	A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis.	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis (RA)	Drug: Upadacitinib;Drug: ABBV-105;Drug: Upadacitinib placebo;Drug: ABBV-105 placebo	AbbVie	NULL	Completed	18 Years	N/A	All	242	Phase 2	United States;Belgium;Canada;Czechia;Hungary;Poland;Puerto Rico;Spain;United Kingdom;Germany;Ireland
249	JPRN-JapicCTI-184031	02/10/2018	09/07/2018	A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy	A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy	Rheumatoid Arthritis (RA)	Intervention name : TS-152 INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection every 4 weeks Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Taisho Pharmaceutical co., LTD	NULL	complete	20		BOTH	135	Phase 3	Japan
250	NCT03546335 (ClinicalTrials.gov)	October 1, 2018	30/4/2018	Zr-89 Cimzia PET Imaging Rheumatoid Arthritis	Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: 89Zr-DFO-CZP	Robert Flavell, MD, PhD	NULL	Suspended	18 Years	N/A	All	10	Phase 1	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
251	NCT03770923 (ClinicalTrials.gov)	October 1, 2018	7/12/2018	Effect of Some Drugs on Rheumatoid Arithritis Activity	Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis	Rheumatoid Arthritis	Drug: Rupatadine;Drug: Montelukast	Sherief Abd-Elsalam	NULL	Recruiting	18 Years	N/A	All	75	Phase 3	Egypt
252	NCT03770702 (ClinicalTrials.gov)	October 1, 2018	7/12/2018	Statins and ARBs on Rheumatoid Activity	Investigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian Patients	Rheumatoid Arthritis	Drug: Angiotensin receptor blockers;Drug: Statins	Sherief Abd-Elsalam	NULL	Recruiting	18 Years	65 Years	All	45	Phase 3	Egypt
253	NCT03593837 (ClinicalTrials.gov)	October 1, 2018	10/7/2018	Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis	A Multicenter, Randomized, Double-blind,Placebo-controlled Trial Evaluating the Efficacy and Safety of Huang Qi GuiZhi Wu Wu Tang Granulesin Patients With Rheumatoid Arthritis	Huang Qi Gui Zhi Wu Wu Granule;Rheumatoid Arthritis	Drug: Huang qi gui zhi wu wu granule;Drug: Huang qi gui zhi wu wu granule placebo	Cui xuejun	NULL	Unknown status	18 Years	80 Years	All	100	Phase 2;Phase 3	NULL
254	NCT03660059 (ClinicalTrials.gov)	September 27, 2018	26/8/2018	A Study to Assess Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)	A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTX	Rheumatoid Arthritis (RA)	Drug: Peficitinib;Drug: Plaebo;Drug: Disease-modifying antirheumatic drugs (DMARDs)	Astellas Pharma China, Inc.	NULL	Active, not recruiting	18 Years	N/A	All	385	Phase 3	China;Korea, Republic of;Taiwan
255	ChiCTR1800018637	2018-09-26	2018-09-30	Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis	Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis	rheumatoid arthritis	Gold Standard:Clinical outcome, meet the 2010 ACR/EULAR rheumatoid arthritis classification criteria.;Index test:Human epididymis protein 4,anti-cyclic citrullinated peptide, creatinine, rheumatoid factor;	Affiliated Hospital of North Sichuan Medical College	NULL	Recruiting			Both	Target condition:150;Difficult condition:100		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
256	NCT03691909 (ClinicalTrials.gov)	September 25, 2018	27/9/2018	A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis	A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: HB-adMSCs	Hope Biosciences	NULL	Completed	18 Years	65 Years	All	15	Phase 1;Phase 2	United States
257	NCT03699293 (ClinicalTrials.gov)	September 22, 2018	21/9/2018	NSAIDs vs. Coxibs in the Presence of Aspirin	NSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects With Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular Disease	Rheumatoid Arthritis;Cardiovascular Diseases	Drug: celecoxib 200mg capsule;Drug: naproxen sodium 550mg tablet;Drug: Aspirin 81mg tablet	Inova Health Care Services	NULL	Unknown status	18 Years	75 Years	All	30	Phase 4	United States
258	EUCTR2018-001114-15-NL (EUCTR)	18/09/2018	28/05/2018	Predicting the risk for rheumatoid arthritis with the help of a PET scan.	Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis. - Early diagnostics in RA	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		VU Medical Center, department of Rheumatology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	Netherlands
259	JPRN-JapicCTI-184229	12/9/2018	03/12/2018	Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe	Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe -Medical Information Database Network-based Cohort Study-	Rheumatoid Arthritis	Intervention name : PRALIA 60mg Subcutaneous Injection Syringe(denosumab) INN of the intervention : denosumab Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	DAIICHISANKYO Co., Ltd.	NULL	other			BOTH	2000	NA	Japan
260	NCT03701789 (ClinicalTrials.gov)	September 11, 2018	4/10/2018	Effect of Baricitinib Treatment on Peripheral Bone in RA	Evaluation of Bone Quality in Patients With Rheumatoid Arthritis Treated With Baricitinib: Single Centre, Mode of Action Study (BARE BONE)	Rheumatoid Arthritis;Bone Density;Finger Joints	Drug: Baricitinib	University of Erlangen-Nürnberg Medical School	NULL	Recruiting	18 Years	74 Years	All	15	Phase 3	Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
261	JPRN-JapicCTI-184029	04/9/2018	09/07/2018	A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy	A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy	Rheumatoid Arthritis (RA)	Intervention name : TS-152 INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection every 4 weeks Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : Usage: Subcutaneous injection every 4 weeks, Dosage: No active ingredients contain	Taisho Pharmaceutical co., LTD	NULL	complete	20	75	BOTH	370	Phase 2;Phase 3	Japan
262	NCT03605251 (ClinicalTrials.gov)	August 30, 2018	3/7/2018	Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.	An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: TAS5315 low dose;Drug: TAS5315 high dose;Drug: Placebos	Taiho Pharmaceutical Co., Ltd.	NULL	Completed	20 Years	64 Years	All	91	Phase 2	Japan
263	EUCTR2015-004386-91-PL (EUCTR)	26/08/2018	20/07/2016	Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis.	A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: INN not available Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody	GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Poland;Germany
264	NCT03636984 (ClinicalTrials.gov)	August 24, 2018	13/8/2018	Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World	Efficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational Study	Rheumatoid Arthritis;Ankylosing Spondylitis	Drug: recombinant TNF-a receptor: IgG Fc fusion protein	Zhejiang Hisun Pharmaceutical Co. Ltd.	NULL	Not yet recruiting	18 Years	N/A	All	1000		NULL
265	NCT03580681 (ClinicalTrials.gov)	August 22, 2018	26/6/2018	A Nutrition Intervention for Arthritis -4 (WCCR-ARTH4)	A Nutrition Intervention for Arthritis-4	Rheumatoid Arthritis	Other: Plant-based diet;Dietary Supplement: Supplement	Physicians Committee for Responsible Medicine	NULL	Active, not recruiting	18 Years	90 Years	All	2	N/A	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
266	NCT04056039 (ClinicalTrials.gov)	August 14, 2018	21/6/2019	Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity in Patients With Rheumatoid Arthritis.	Efficacy of Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity as a Biomarker of Myocardial Damage in Patients With Rheumatoid Arthritis With Severe Activity.	Cardiovascular Diseases;Arthritis, Rheumatoid	Drug: Atorvastatin;Drug: Colchicine	Hospital Central Dr. Ignacio Morones Prieto	NULL	Completed	18 Years	N/A	All	60	Phase 2	Mexico
267	EUCTR2017-004079-30-PT (EUCTR)	09/08/2018	29/06/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	207	Phase 3	Portugal;Belgium;Spain;Italy
268	EUCTR2018-002368-18-ES (EUCTR)	25/07/2018	25/07/2018	Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load	Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load	1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.2. breast and lung cancer undertreated by chemotherapy3. HIV4. Haematopoietic progenitor cell transplantation (TCPH). MedDRA version: 20.0;Level: PT;Classification code 10006187;Term: Breast cancer;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 20.0;Classification code 10058467;Term: Lung neoplasm malignant;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1;Classification code 10020161;Term: HIV infection;System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Fendrix suspension for injection Product Name: Fendrix Product Code: Fendrix INN or Proposed INN: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). Other descriptive name: HEPATITIS B VACCINE (RDNA) Trade Name: HBVAXPRO 5 micrograms/0.5 ml Product Name: HBVAXPRO ® 40 micrograms Product Code: HBVAXPRO ® 40 micrograms INN or Proposed INN: HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA) Other descriptive name: HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN)	FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	740	Phase 4	Spain
269	NCT03618784 (ClinicalTrials.gov)	July 11, 2018	24/7/2018	Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis	A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: FURESTEM-RA Inj;Other: sterile saline	Kang Stem Biotech Co., Ltd.	NULL	Recruiting	19 Years	80 Years	All	33	Phase 1;Phase 2	Korea, Republic of
270	EUCTR2017-004079-30-ES (EUCTR)	10/07/2018	21/03/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rhuematoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	207	Phase 3	Portugal;Belgium;Spain;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
271	NCT03445871 (ClinicalTrials.gov)	July 2, 2018	20/2/2018	Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate	Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate	Rheumatoid Arthritis	Biological: Blood sample;Diagnostic Test: CRQ	Centre Hospitalier Universitaire de Saint Etienne	NULL	Completed	18 Years	N/A	All	60	Phase 4	France
272	NCT03589833 (ClinicalTrials.gov)	July 2018	5/7/2018	Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA	Effectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: Tripterygium Wilfordii;Drug: Methotrexate;Drug: Yisaipu	Peking Union Medical College Hospital	NULL	Unknown status	18 Years	65 Years	All	504	Phase 2	China
273	EUCTR2016-002344-16-GB (EUCTR)	28/06/2018	29/11/2017	Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency.	Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification. - TEEMS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		University of Leeds	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	106	Phase 4	United Kingdom
274	JPRN-UMIN000033059	2018/06/20	20/06/2018	The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial	The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial - The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial	Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture	A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty	Hokusuikai Kinen Hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	120	Not selected	Japan
275	NCT03550833 (ClinicalTrials.gov)	June 13, 2018	28/5/2018	Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model	Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model	Arthritis, Rheumatoid;Stress Disorder	Behavioral: Questionnaire;Biological: blood sample	University Hospital, Bordeaux	NULL	Completed	18 Years	N/A	All	152		France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
276	NCT03606876 (ClinicalTrials.gov)	June 13, 2018	12/7/2018	Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects	A Randomized, Double-blinded, Single-dose, 3-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT1806 Injection vs Actemra® in Healthy Chinese Male Subjects	Rheumatoid Arthritis	Drug: BAT1806 injection	Bio-Thera Solutions	NULL	Unknown status	18 Years	55 Years	Male	138	Phase 1	China
277	NCT03535402 (ClinicalTrials.gov)	June 1, 2018	9/5/2018	Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics	Measurement of the Structural Efficacy in Active Rheumatoid Arthritis (RA) Patients Treated With Sarilumab in Combination With Methotrexate (MTX) and Naive to Biologics as Measured by Low-field MRI Using a Modified OMERACT-RAMRIS Score.	Rheumatoid Arthritis	Drug: Sarilumab	Gaylis, Norman B., M.D.	NULL	Active, not recruiting	18 Years	N/A	All	20	Phase 3	United States
278	NCT03559686 (ClinicalTrials.gov)	May 30, 2018	5/6/2018	Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Aarthritis (RA)	Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Arthritis (RA) Who Participated in Open Label Studies C87015, C87028 and C87051	Rheumatoid Arthritis	Drug: Certolizumab Pegol	UCB Biopharma S.P.R.L.	NULL	Available	18 Years	N/A	All			NULL
279	NCT03522415 (ClinicalTrials.gov)	May 28, 2018	29/4/2018	Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis	A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate	Moderately to Severely Active Rheumatoid Arthritis	Drug: HLX01;Drug: Methotrexate (MTX)	Shanghai Henlius Biotech	NULL	Completed	18 Years	75 Years	All	275	Phase 3	China
280	NCT03410056 (ClinicalTrials.gov)	May 22, 2018	3/1/2018	Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis	A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy	Rheumatoid Arthritis RA	Drug: AMG 592;Drug: Placebo	Amgen	NULL	Terminated	18 Years	70 Years	All	36	Phase 1;Phase 2	United States;Bulgaria;Germany;Poland;Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
281	EUCTR2017-001944-36-ES (EUCTR)	21/05/2018	10/10/2017	Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis	A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: AMG592 INN or Proposed INN: AMG 592 Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN	Amgen Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	137	Phase 1;Phase 2	United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom
282	NCT03492658 (ClinicalTrials.gov)	May 17, 2018	3/4/2018	Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA)	Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA).	Rheumatoid Arthritis;Rheumatic Diseases	Drug: Abatacept;Drug: Methotrexate	Leiden University Medical Center	NULL	Recruiting	18 Years	N/A	All	46	Phase 4	Netherlands
283	NCT03508713 (ClinicalTrials.gov)	May 13, 2018	4/6/2017	Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND)	Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND): a Multicenter Prospective Observational Study in Southern China	Rheumatoid Arthritis	Drug: disease modified antirheumatic drugs or biological agents	Nanfang Hospital of Southern Medical University	Southern Medical University, China	Not yet recruiting	18 Years	N/A	All	200		NULL
284	EUCTR2016-000933-37-BG (EUCTR)	09/05/2018	12/01/2018	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Belarus;Portugal;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden
285	EUCTR2017-004054-41-BE (EUCTR)	07/05/2018	15/03/2018	COBRA-Slim with or without fast access to TNF blockade for remission induction in early RA	CareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. - CareRA2020	early active Rheumatoid Arthritis, previously untreated with DMARDs MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		University Hospitals Leuven	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 4	Belgium
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
286	EUCTR2016-002569-68-GB (EUCTR)	04/05/2018	18/05/2018	Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease	Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease: A feasibility study - APRIL	Rheumatoid-associated Interstitial Lung Disease (RA-ILD) MedDRA version: 20.0;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	United Kingdom
287	ChiCTR1800015615	2018-05-01	2018-04-11	Clinical observation of the protective effect of iguratimod on rheumatoid arthritis	Clinical observation of the protective effect of iguratimod on rheumatoid arthritis	Rheumatoid Arthritis	first:MTX;second:MTX in combination with Irammod;third:MTX and LEF;fourth:MTX, LEF and Irammod;	Tianjin First Central Hospital	NULL	Pending	18	75	Both	first:30;second:30;third:30;fourth:30;		China
288	NCT03435601 (ClinicalTrials.gov)	April 18, 2018	31/1/2018	A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)	A Randomised, Double-blind, Placebo-controlled Phase II Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)	Rheumatoid Arthritis	Drug: Anifrolumab;Drug: Placebos	Josef Smolen, Univ. Prof. Dr.	NULL	Recruiting	18 Years	70 Years	All	24	Phase 2	Austria
289	JPRN-UMIN000030575	2018/03/31	26/12/2017	Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT.	Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. - Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT.	Rheumatoid arthritis	Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.	Daiichi Sankyo Company, Limited	NULL	Complete: follow-up continuing	20years-old	Not applicable	Male and Female	44	Not applicable	Japan
290	NCT03478111 (ClinicalTrials.gov)	March 30, 2018	16/3/2018	CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis	A Randomized, Double-blind, Methotrexate (MTX) Based, Parallel-group, Multicenter Phase III Study to Evaluate Efficacy and Safety of CMAB008 in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis, Compared to Remicade	Rheumatoid Arthritis	Drug: CMAB008;Drug: MTX;Drug: Remicade	Shanghai Biomabs Pharmaceutical Co., Ltd.	NULL	Completed	18 Years	N/A	All	390	Phase 3	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
291	JPRN-UMIN000031890	2018/03/21	25/03/2018	Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty	Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty - Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty	knee osteoarthritis or knee rheumatoid arthritis	Group LV(Low volume): preoperative femoral triangle block with 0.5% levobupivacaine 5mL Group HV(High volume): preoperative femoral triangle block with 0.125% levobupivacaine 20mL	Daiyukai General Hospital	NULL	Recruiting	20years-old	100years-old	Male and Female	120	Phase 3	Japan
292	EUCTR2017-001944-36-BG (EUCTR)	13/03/2018	24/10/2017	Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis	A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: AMG592 INN or Proposed INN: N/A Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	153	Phase 1;Phase 2	United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand
293	ChiCTR1800014872	2018-03-01	2018-02-12	Role of parecoxib sodium in the multimodal analgesia after total knee arthroplasty	Safety and efficacy of parecoxib sodium in the multimodal analgesia after total knee arthroplasty: a prospective randomized controlled trial	osteoarthritis or rheumatoid arthritis	Experimental group:Preoperative intravenous injection of parecoxib sodium and postoperative intravenous patient-controlled analgesia;Control group:Preoperative normal saline injection and postoperative intravenous patient-controlled analgesia;	Peking Union Medical College Hospital	NULL	Pending			Both	Experimental group:50;Control group:50;		China
294	NCT03100253 (ClinicalTrials.gov)	March 1, 2018	17/3/2017	Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation	Open-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNF	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Golimumab;Drug: Certolizumab Pegol	Mario Negri Institute for Pharmacological Research	NULL	Recruiting	18 Years	N/A	All	208	Phase 4	Italy
295	ChiCTR1800014584	2018-03-01	2018-01-22	Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty.	Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty.	Knee osteoartritis;Rheumatoid arthritis	Experimental group:Asprin;Controlled group:Rivaroxaban;	Department of Orthopaedics, West China Hospital, Sichuan University	NULL	Pending	70	100	Both	Experimental group:90;Controlled group:30;		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
296	JPRN-UMIN000031692	2018/03/01	12/03/2018	Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty	Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty - Efficacy of intravenous acetaminophen injection for pain management after TKA	knee osteoarthritis rheumatoid arthritis	Study group:Fentanyl sustained intravenous administration given after operation end. And use the Intravenous acetaminophen 4 times per 6 hour.Dosage is 15 mg/kg for the patient less than 50 kg in weight and 1000 mg for the patient more than 50 kg in weight. Control group:Fentanyl sustained intravenous administration given after operation end.	Yamaguchi University	NULL	Recruiting	20years-old	Not applicable	Male and Female	60	Not selected	Japan
297	EUCTR2017-004079-30-BE (EUCTR)	19/02/2018	19/02/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	219	Phase 3	Portugal;Spain;Belgium;Italy
298	EUCTR2017-004348-39-FR (EUCTR)	15/02/2018	16/01/2018	Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients	Association between methotrexate erythrocyte polyglutamate concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate - POLYGLU	rheumatoid arthritis MedDRA version: 20.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: methotrexate Product Code: 1	CHU Saint-Etienne	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 4	France
299	JPRN-UMIN000030760	2018/02/09	09/02/2018	A pilot study of a simple navigation system for artificial hip joint surgery using augmented reality technology		Hip joint disease scheduled for total hip arthroplasty(THA) (Osteoarthritis, Rheumatoid Arthritis, Femoral head necrosis, Femoral neck fracture)	Using patient specific guide linked with 3D surgical support software for THA	National Hospital Organization Nagoya Medical Center	NULL	Complete: follow-up continuing	20years-old	Not applicable	Male and Female	3	Not selected	Japan
300	EUCTR2016-003630-25-NL (EUCTR)	08/02/2018	06/09/2017	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	2640	Phase 3	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
301	EUCTR2017-002878-38-NL (EUCTR)	07/02/2018	12/09/2017	Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis	Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis - ASCARA	Patients with early, methotrexate-naïve, ACPA-positive rheumatoid arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000018818;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Orencia 125 mg INN or Proposed INN: ABATACEPT	Leiden University Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	46	Phase 4	Netherlands
302	NCT03455842 (ClinicalTrials.gov)	February 1, 2018	22/2/2018	The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis	International Multicenter Comparative Randomized Double-blind Placebo-controlled Clinical Study of Efficacy and Safety of BCD-089 in Different Dosing Regimens in Patients With Active Rheumatoid Arthritis	Seropositive RA	Biological: BCD-089, 162 mg, s/c, qw;Biological: BCD-089, 162 mg, s/c, q2w;Drug: placebo	Biocad	NULL	Completed	18 Years	80 Years	All	105	Phase 2	Belarus;Russian Federation
303	NCT04022525 (ClinicalTrials.gov)	February 1, 2018	15/7/2019	Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches	Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches	Rheumatoid Arthritis	Drug: Leflunomide 20Mg Tab	Assiut University	NULL	Completed	18 Years	N/A	All	80		Egypt
304	NCT03430388 (ClinicalTrials.gov)	January 31, 2018	30/1/2018	Yellow Fever Vaccine in Patients With Rheumatic Diseases	Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area	Systemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile Dermatomyositis	Biological: Yellow Fever vaccine (17D)	University of Sao Paulo General Hospital	NULL	Completed	2 Years	60 Years	All	600	N/A	Brazil
305	NCT01694693 (ClinicalTrials.gov)	January 31, 2018	24/9/2012	Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study	Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study	Rheumatoid Arthritis	Drug: Orencia	Bristol-Myers Squibb	NULL	Withdrawn	18 Years	N/A	All	0	N/A	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
306	EUCTR2017-002753-11-FI (EUCTR)	25/01/2018	08/11/2017	The effect of the new anti-rheumatic drug tofacitinib on cytokine-induced inflammatory pathways in patients with rheumatoid arthritis	The effect of tofacitinib on the activity of JAK-STAT pathways in patients with rheumatoid arthritis (RA) - TofaSTAT17	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Tampere University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 4	Finland
307	NCT03227419 (ClinicalTrials.gov)	January 22, 2018	19/7/2017	Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate Responders	Abatacept Versus Tocilizumab by Subcutaneous Administration for the Treatment of Rheumatoid Arthritis in TNF Alpha Inhibitor Inadequate Responder Patients: A Randomized, Open-labeled, Superiority Trial	Arthritis, Rheumatoid	Drug: Tocilizumab Prefilled Syringe;Drug: Abatacept Prefilled Syringe	Lille Catholic University	NULL	Recruiting	18 Years	N/A	All	224	Phase 4	France
308	NCT03368235 (ClinicalTrials.gov)	January 18, 2018	3/11/2017	Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 Compared to Prednisolone 20 mg in Patients With Active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: AZD9567;Drug: Prednisolone	AstraZeneca	NULL	Completed	18 Years	80 Years	All	21	Phase 2	Netherlands;Sweden;Denmark
309	JPRN-UMIN000030828	2018/01/15	15/01/2018	The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis.		Rheumatoid ArthritisOsteoporosis	zoledronic acid denosumab	Osaka City University Graduate School of Medicine	NULL	Recruiting	20years-old	Not applicable	Male and Female	500	Not selected	Japan
310	ChiCTR1800014404	2018-01-11	2018-01-11	Evaluation of clinical curative effect of Bushen Quhan Wang Decoction in the treatment of kidney deficiency and cold dampness syndrome of rheumatoid arthritis	Evaluation of clinical curative effect of Bushen Quhan Wang Decoction in the treatment of kidney deficiency and cold dampness syndrome of rheumatoid arthritis	rheumatoid arthritis	treatment group :MTX+traditional Chinese medicine ;control group :MTX;	China-Japan Friendship Hospital	NULL	Recruiting	16	70	Both	treatment group :36;control group :36;		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
311	EUCTR2017-003259-40-ES (EUCTR)	04/01/2018	24/10/2017	Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.	Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.	Patients with rheumatoid arthritis with high clinical activity and chronical peirodontitis moderate-severe. MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: amoxicilina INN or Proposed INN: AMOXICILLIN Product Name: metronidazol INN or Proposed INN: METRONIDAZOLE Other descriptive name: metronidazol	Dra Beatriz Lozano-Hospital Universitario de Canarias	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 4	Spain
312	NCT02955212 (ClinicalTrials.gov)	January 3, 2018	2/11/2016	A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)	A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)	Rheumatoid Arthritis (RA)	Drug: Upadacitinib;Drug: Placebo	AbbVie	NULL	Completed	18 Years	N/A	All	338	Phase 3	Brazil;China;Korea, Republic of
313	JPRN-UMIN000030237	2018/01/01	03/12/2017	Additional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial	Additional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial - Additional postoperative intravenous tranexamic acid administration versus placebo in total knee arthroplasty	Osteoarthritis of the knee, rheumatoid arthritis, avascular necrosis	Additional postoperative intravenous tranexamic acid group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. In addition, patients received 1000mg/100mL of tranexamic acid administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery. Placebo group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. Patients received 100 mL of normal saline administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery.	Hokusuikai Kinen Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	100	Not selected	Japan
314	NCT02795299 (ClinicalTrials.gov)	January 2018	2/5/2016	Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFa Antagonist Failed in Rheumatoid Arthritis	Phase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFa Antagonist	Rheumatoid Arthritis	Drug: Gerilimzumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Placebo	Bird Rock Bio, Inc.	Techtrials Pesquisa e Tecnologia Ltda;Pharmagenix	Withdrawn	18 Years	80 Years	All	0	Phase 2	NULL
315	NCT04312815 (ClinicalTrials.gov)	December 28, 2017	16/3/2020	A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX	A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severely Active Rheumatoid Arthritis Receiving Methotrexate	Rheumatoid Arthritis(RA)	Drug: SM03;Drug: Placebo;Drug: MTX	SinoMab Pty Ltd	NULL	Recruiting	18 Years	70 Years	All	510	Phase 3	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
316	JPRN-jRCTs031180050	26/12/2017	07/12/2018	Hydroxychloroquine for Japanese patients with rheumatoid arthritis	Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis	Rheumatoid arthritis;D001172	Treatment with hydroxychloroquine for 24 weeks	Kaneko Yuko	NULL	Recruiting	>= 18age old	Not applicable	Both	120		Japan
317	EUCTR2017-001970-41-DK (EUCTR)	21/12/2017	15/09/2017	Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial	Dose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, parallel-group, multi-centre trial - The BIODOPT trial (BIOlogical Dose OPTimisation)	Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis MedDRA version: 21.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10062719;Term: Seronegative rheumatoid arthritis;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859 MedDRA version: 21.1;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;Classification code 10045966;Term: Unspecified inflammatory spondylopathy;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		MD, PhD Salome Kristensen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 4	Denmark
318	NCT03457792 (ClinicalTrials.gov)	December 19, 2017	13/2/2018	A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis	Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice	Rheumatoid Arthritis	Drug: Abatacept	Bristol-Myers Squibb	NULL	Recruiting	18 Years	N/A	All	400		Germany
319	EUCTR2014-000555-93-ES (EUCTR)	18/12/2017	10/10/2017	Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia	Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia	Diagnosis of Initial phase of Rheumatoid Arthritis with arthralgia for at least 6 weeks without signs of joints swelling but with presence of ACPA antibodies and signs of joints swelling detected in MRI.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ORENCIA Product Name: Abatacept INN or Proposed INN: ABATACEPT	Universitätsklinikum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 3	Czech Republic;Brazil;Spain;Germany
320	EUCTR2017-001717-92-AT (EUCTR)	11/12/2017	17/08/2017	A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in patients with rheumatoid arthritis who have a high interferon signature (TarIFNiRA)	A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA) - TarIFNiRA	High IFN siganture in patients with rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab (MEDI-546) INN or Proposed INN: ANIFROLUMAB Other descriptive name: ANIFROLUMAB	Medical University of Vienna	NULL	Not Recruiting			Female: yes Male: yes	24	Phase 2	Austria;Switzerland;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
321	EUCTR2017-001944-36-PL (EUCTR)	23/11/2017	11/10/2017	Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis	A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: AMG 592 INN or Proposed INN: AMG592 Other descriptive name: AMG592	Amgen Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	153	Phase 1;Phase 2	United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom
322	NCT03334851 (ClinicalTrials.gov)	November 17, 2017	3/11/2017	Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis	A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS	Systemic Lupus Erythematosus;Rheumatoid Arthritis	Drug: PF-06835375;Drug: Placebo	Pfizer	NULL	Recruiting	18 Years	70 Years	All	112	Phase 1	United States;Puerto Rico
323	NCT03911830 (ClinicalTrials.gov)	November 11, 2017	1/10/2018	Aerobic Exercise Program Followed by Cold Water Immersion: Effects on Arthritis Patients Arterial Stiffness	Effects of an Aerobic Exercise Program on Cycloergometer Followed by Cold Water Immersion Recovery in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Cryotherapy Effect;Physical Activity	Other: Exercise followed cold water immersion	Centre Hospitalier Universitaire de Besancon	NULL	Completed	20 Years	80 Years	All	18	N/A	France
324	EUCTR2017-003425-15-DK (EUCTR)	10/11/2017	12/09/2017	Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian)	Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian)	Treatment of synovitis among rheumatoid arthritis patients MedDRA version: 21.0;Level: PT;Classification code 10042868;Term: Synovitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 4	Denmark
325	EUCTR2017-000838-64-NL (EUCTR)	10/11/2017	13/06/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: AZD9567 monohydrate INN or Proposed INN: AZD9567 Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: Prednisolone	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
326	NCT04178070 (ClinicalTrials.gov)	November 6, 2017	24/11/2019	Phase ? Clinical Trial of Gerilimzumab Injection in Healthy Subjects	A Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalated Phase ? Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Gerilimzumab in Healthy Adult Subjects.	Rheumatoid Arthritis	Biological: GB224 2mg;Biological: GB224 5mg;Biological: GB224 10mg;Biological: GB224 15mg;Biological: GB224 20mg;Biological: GB224 30mg;Other: Placebo, 2mg;Other: Placebo, 5mg;Other: Placebo, 10mg;Other: Placebo, 15mg;Other: Placebo, 20mg;Other: Placebo, 30mg	Genor Biopharma Co., Ltd.	NULL	Recruiting	18 Years	45 Years	All	58	Phase 1	China
327	NCT03357471 (ClinicalTrials.gov)	November 3, 2017	23/11/2017	Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease	A Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease	Moderate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's Disease	Drug: e-Device	UCB Biopharma S.P.R.L.	NULL	Completed	18 Years	N/A	All	70	Phase 3	United States
328	NCT03329885 (ClinicalTrials.gov)	November 2, 2017	31/10/2017	A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis	A Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe Psoriasis	Rheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic Steatohepatitis	Drug: BMS-986251;Other: Placebo	Bristol-Myers Squibb	NULL	Terminated	18 Years	70 Years	All	38	Phase 1;Phase 2	Netherlands
329	NCT03387423 (ClinicalTrials.gov)	November 2, 2017	7/12/2017	Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis	ESCALATE-RA A NON-INTERVENTIONAL STUDY OF CRITICAL FACTORS FOR ESCALATING DRUG TREATMENT IN PATIENTS TREATED WITH TOFACITINIB FOR MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS	Arthritis, Rheumatoid	Drug: Tofacitinib	Pfizer	NULL	Recruiting	18 Years	N/A	All	1500		Germany
330	EUCTR2017-000384-32-BG (EUCTR)	02/11/2017	12/07/2017	Phase IIb in Rheumatoid Arthritis	A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	363	Phase 2	United States;Serbia;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;Bulgaria;South Africa;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
331	JPRN-UMIN000029797	2017/11/02	02/11/2017	Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial	Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial - Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial	Osteoarthritis of the hip, Avascular necrosis of the femoral head, Rheumatoid arthritis	The combined tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first hip. After closure of fascia, 1000 mg of tranexamic acid (10 mL of 100 mg/mL tranexamic acid) was administered intra-articularly for each hip. Five hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously. The intravenous tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first hip. After closure of the fascia, 10 mL of normal saline was administered intra-articularly for each hip. Five hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously.	Hokusuikai Kinen Hospital	NULL	Complete: follow-up complete	18years-old	Not applicable	Male and Female	40	Not selected	Japan
332	JPRN-JapicCTI-173747	01/11/2017	25/10/2017	Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis -	Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis -	Rheumatoid Arthritis	Intervention name : PRALIA 60 mg Subcutaneous Injection Syringe(denosumab) Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months.	DAIICHISANKYO Co., Ltd.	NULL	recruiting			BOTH	1000	NA	NULL
333	JPRN-UMIN000029759	2017/11/01	01/11/2017	Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial		Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis	Percutaneous periarticular analgesic injection including methylprednisolone 80 mg [2 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.2 mg [0.2 mL] at one day after simultaneous bilateral total knee arthroplasty No percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty	Nekoyama Miyao Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	32	Not selected	Japan
334	NCT03440892 (ClinicalTrials.gov)	November 1, 2017	14/2/2018	Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients	Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin	Rheumatoid Arthritis	Drug: methotrexate;Drug: sulfasalazine;Drug: abatacept;Drug: tocilizumab;Drug: tofacitinib /baricitinib	Vastra Gotaland Region	NULL	Recruiting	20 Years	N/A	All	2500		Sweden
335	NCT02647762 (ClinicalTrials.gov)	October 30, 2017	16/12/2015	CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis	A Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: CF101 1 mg;Drug: CF101 2 mg;Drug: Placebo;Drug: MTX	Can-Fite BioPharma	NULL	Active, not recruiting	18 Years	75 Years	All	525	Phase 3	Bosnia and Herzegovina;Canada;Israel;Moldova, Republic of;Poland;Romania;Serbia
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
336	NCT03337815 (ClinicalTrials.gov)	October 28, 2017	22/10/2017	A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis	A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model	Rheumatoid Arthritis	Drug: Treatment of MTX and TwHF placebo;Drug: Treatment of TwHF and MTX placebo	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	NULL	Recruiting	45 Years	70 Years	All	264	Phase 2;Phase 3	China
337	NCT03324412 (ClinicalTrials.gov)	October 28, 2017	25/10/2017	Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis	A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Treatment of MTX;Drug: Treatment of MTX and TwHF	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	NULL	Not yet recruiting	45 Years	70 Years	All	216	Phase 2;Phase 3	NULL
338	NCT03288584 (ClinicalTrials.gov)	October 27, 2017	16/9/2017	Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis	The Effect of Inhibition of Interleukin-6 Activity on Vascular, Endothelial and Left Ventricular Function in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Inflammation	Drug: Tocilizumab (Actemra®);Drug: Other biological agent;Drug: Corticosteroid and non-biological agents.	University of Athens	NULL	Recruiting	18 Years	80 Years	All	60		Greece
339	EUCTR2016-002126-36-IT (EUCTR)	26/10/2017	31/01/2018	A study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO7123520 AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-a INHIBITORS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RO7123520 Product Code: RO7123520 /F03-01	F. Hoffmann - Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	204	Phase 2	United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy
340	EUCTR2017-000149-30-GB (EUCTR)	25/10/2017	05/09/2017	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease - TRAIL1	Rheumatoid arthritis associated interstitial lung disease (RA-ILD);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]		University Hospitals of Leicester NHS Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	United States;Canada;Australia;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
341	EUCTR2016-004834-11-GB (EUCTR)	23/10/2017	16/08/2017	A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis	A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis - CR6086-2-02	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: CR6086 Other descriptive name: CR0686 Product Name: CR6086 Product Code: CR6086Z INN or Proposed INN: CR6086 Other descriptive name: CR6086 Trade Name: Methotrexate ® 2.5mg Tablets Product Name: Methotrexate ® 2.5mg Tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE 2.5 mg tablets	Rottapharm Biotech S.r.l.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
342	NCT04178850 (ClinicalTrials.gov)	October 13, 2017	25/11/2019	Clinical Comparative Study to Evaluate the Efficacy and Safety of Recombinant Anti-TNF-alpha Antibodies for Injection	A Randomized, Double-blind, Multi-center Phase ? Comparative Study to Evaluate the Efficacy and Safety of Recombinant Human-mouse Chimeric Anti-TNF-alpha Monoclonal Antibody for Injection.	Rheumatoid Arthritis	Biological: GB242;Biological: Infliximab	Genor Biopharma Co., Ltd.	NULL	Recruiting	18 Years	45 Years	All	568	Phase 3	China
343	NCT03163966 (ClinicalTrials.gov)	October 5, 2017	8/5/2017	A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis	A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Oral CR6086 Administered at the Doses of 30, 90 or 180 mg Bid for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis	Rheumatoid Arthritis, DMARD-naive and Early Disease Patients	Drug: CR6086;Drug: Methotrexate;Drug: Placebo	Rottapharm Biotech	NULL	Recruiting	18 Years	N/A	All	240	Phase 2	Czechia
344	JPRN-UMIN000029003	2017/10/01	05/09/2017	Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial		Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis	Percutaneous periarticular analgesic injection including methylprednisolone 40 mg [1 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.1 mg [0.1 mL] at one day after total knee arthroplasty No percutaneous periarticular analgesic injection at one day after total knee arthroplasty	Nekoyama Miyao Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	40	Not selected	Japan
345	NCT03257852 (ClinicalTrials.gov)	September 29, 2017	20/8/2017	A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate	A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate	Rheumatoid Arthritis (RA)	Drug: ASP5094;Drug: Placebo;Other: Methotrexate therapy	Astellas Pharma Inc	NULL	Completed	20 Years	N/A	All	66	Phase 2	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
346	NCT03312465 (ClinicalTrials.gov)	September 28, 2017	12/10/2017	Anatomical Shoulder Domelock System Study	Anatomical Shoulder™ Domelock System A Multicenter, Prospective, Non-Controlled Post-Market Clinical Follow-up Study	Advanced Wear and Tear of the Shoulder Joint;Avascular Necrosis;Conditions Consequent to Earlier Operations;Omarthrosis;Rheumatoid Arthritis;Revision of Shoulder Prosthesis	Device: AS Domelock System	Zimmer Biomet	NULL	Recruiting	18 Years	80 Years	All	123		Belgium;Germany;Switzerland;United Kingdom
347	EUCTR2016-005017-45-PL (EUCTR)	27/09/2017	19/06/2017	A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody	NovImmune S.A.	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
348	EUCTR2016-004300-65-BE (EUCTR)	26/09/2017	20/01/2017	Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®).	Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®). - SCINTRA TRIS	rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: 99mTc-S-HYNIC Certolizumab pegol INN or Proposed INN: CERTOLIZUMAB PEGOL	Ghent University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 4	Belgium
349	EUCTR2017-000384-32-CZ (EUCTR)	26/09/2017	26/07/2017	Phase IIb in Rheumatoid Arthritis	A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	363	Phase 2	Serbia;United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;South Africa;Bulgaria;Germany;Japan
350	EUCTR2012-003655-11-FR (EUCTR)	18/09/2017	28/09/2015	Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life	A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis	moderately to severely active rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Galapagos NV	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 2	United States;Spain;Guatemala;Ukraine;Austria;Russian Federation;Israel;Chile;Colombia;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
351	NCT03262740 (ClinicalTrials.gov)	September 11, 2017	24/8/2017	The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients	The Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects	Rheumatoid Arthritis	Drug: BMS-986195;Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol)	Bristol-Myers Squibb	NULL	Completed	18 Years	40 Years	Female	58	Phase 1	United States
352	EUCTR2017-000838-64-SE (EUCTR)	11/09/2017	19/05/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: AZD9567 Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: -	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
353	EUCTR2016-004834-11-PL (EUCTR)	05/09/2017	17/07/2017	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Rottapharm Biotech S.r.l.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of
354	EUCTR2016-004834-11-BG (EUCTR)	04/09/2017	01/06/2017	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Rottapharm Biotech S.r.l.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of
355	NCT04177173 (ClinicalTrials.gov)	September 1, 2017	7/4/2019	Methotrexate and Statins With Methotrexate Alone in the Treatment of Rheumatoid Arthritis	Comparison of Combination of Methotrexate and Statins With Methotrexate Alone as an Anti-inflammatory Agent in the Treatment of Rheumatoid Arthritis.	Arthritis, Rheumatoid	Drug: Simvastatin 20 mg;Drug: Methotrexate 10 mg	King Edward Medical University	NULL	Completed	18 Years	N/A	All	100	Phase 4	Pakistan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
356	NCT03254966 (ClinicalTrials.gov)	September 2017	15/8/2017	Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients	Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: SHR0302;Drug: Placebo	Jiangsu HengRui Medicine Co., Ltd.	NULL	Not yet recruiting	18 Years	70 Years	All	170	Phase 2	China
357	NCT03241446 (ClinicalTrials.gov)	September 2017	25/7/2017	Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)	A Phase I, Open-Label Study to Investigate the Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: Tilmanocept	Navidea Biopharmaceuticals	NULL	Withdrawn	30 Years	65 Years	All	0	Phase 1	NULL
358	EUCTR2017-000838-64-DK (EUCTR)	25/08/2017	13/06/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: -	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
359	EUCTR2017-000947-41-FR (EUCTR)	18/08/2017	21/06/2017	ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS.	ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTAR	Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor. MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie Trade Name: RoActemra 162 mg solution injectable en seringue préremplie	Groupement des Hôpitaux de l’Institut Catholique de Lille	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	France
360	EUCTR2016-004834-11-CZ (EUCTR)	16/08/2017	02/08/2017	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Rottapharm Biotech S.r.l.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
361	NCT03160001 (ClinicalTrials.gov)	August 15, 2017	11/5/2017	Niclosamide With Etanercept in Rheumatoid Arthritis	Adjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical Study	Rheumatoid Arthritis (RA)	Drug: Placebo;Drug: Niclosamide;Drug: Etanercept	Faiq Gorial	NULL	Completed	18 Years	N/A	All	110	Phase 1;Phase 2	Iraq
362	NCT03245515 (ClinicalTrials.gov)	August 15, 2017	8/8/2017	A Study of BMS-986195 in Healthy Male Subjects	Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects	Rheumatoid Arthritis	Drug: BMS-986195	Bristol-Myers Squibb	NULL	Completed	18 Years	55 Years	Male	24	Phase 1	Netherlands
363	NCT03156023 (ClinicalTrials.gov)	August 14, 2017	15/5/2017	Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis	A Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: AMG 570;Drug: Placebo	Amgen	NULL	Completed	18 Years	75 Years	All	34	Phase 1	United States;Germany
364	EUCTR2016-003630-25-DE (EUCTR)	14/08/2017	13/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
365	NCT03327454 (ClinicalTrials.gov)	August 10, 2017	11/10/2017	Benepali® PEN Patient Satisfaction Survey	Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen	Rheumatoid Arthritis;Spondyloarthropathies	Biological: Benepali	Biogen	NULL	Completed	18 Years	N/A	All	500		Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
366	EUCTR2013-005543-90-EE (EUCTR)	07/08/2017	02/06/2017	This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 Biosimilar to Rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
367	NCT03188081 (ClinicalTrials.gov)	August 4, 2017	12/6/2017	A Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous (SC) Abatacept	A Prospective, Multicentric, Observational Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life RA Patients Treated With Abatacept SC	Rheumatoid Arthritis	Drug: Abatacept	Bristol-Myers Squibb	NULL	Recruiting	18 Years	N/A	All	300		Italy
368	EUCTR2015-005309-35-LV (EUCTR)	04/08/2017	19/05/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		R-Pharm	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1880	Phase 3	United States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of
369	NCT03155347 (ClinicalTrials.gov)	August 2, 2017	15/5/2017	An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy	A Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD Therapy	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to Tocilizumab	Hoffmann-La Roche	NULL	Recruiting	18 Years	70 Years	All	340	Phase 3	China
370	NCT03250767 (ClinicalTrials.gov)	August 1, 2017	11/8/2017	Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement	A Post-Market, Prospective, Multi-Center, Open-Label, Single Arm Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement	Osteo Arthritis Shoulders;Traumatic Arthritis;Rheumatoid Arthritis	Device: Integra Titan Modular Shoulder System 2.5	Integra LifeSciences Corporation	NULL	Recruiting	18 Years	N/A	All	140		United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
371	EUCTR2016-003630-25-BE (EUCTR)	01/08/2017	12/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
372	NCT03215407 (ClinicalTrials.gov)	August 1, 2017	22/6/2017	The Comparative Study of Intra-articular Injection of Tocilizumab and Compound Betamethasone	The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee	Rheumatoid Arthritis of Knee	Drug: Intra-articular Tocilizumab;Drug: Intra-articular Compound Betamethasone	Chinese PLA General Hospital	NULL	Not yet recruiting	18 Years	65 Years	All	60	Phase 4	NULL
373	EUCTR2016-002126-36-ES (EUCTR)	31/07/2017	02/06/2017	A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors	A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RO7123520 Product Code: RO7123520 /F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	204	Phase 2	United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy
374	JPRN-UMIN000028376	2017/07/26	01/08/2017	Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis	Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis - Study of ultrasound detected residual synovitis in rheumatoid arthritis	rheumatoid arthritis	Combination of anti-rheumatic therapy and denosumab Anti-rheumatic therapy alone	Hokkaido Medical Center for Rheumatic Diseases	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	30	Not selected	Japan
375	NCT02541955 (ClinicalTrials.gov)	July 20, 2017	1/9/2015	Use of Acthar in Rheumatoid Arthritis (RA) Related Flares	Use of Acthar in Rheumatoid Arthritis Related Flares	Rheumatoid Arthritis (RA)	Drug: Acthar	Dr. Veena Ranganath	NULL	Recruiting	18 Years	N/A	All	40	Phase 4	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
376	EUCTR2016-003630-25-GB (EUCTR)	19/07/2017	15/08/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
377	EUCTR2016-001064-11-GB (EUCTR)	18/07/2017	31/03/2017	Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis	A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Nichi-Iko Pharmaceutical Co., Ltd.	NULL	Not Recruiting			Female: yes Male: yes	585	Phase 3	United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom
378	EUCTR2016-000569-21-NL (EUCTR)	18/07/2017	29/06/2017	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
379	EUCTR2016-000568-41-NL (EUCTR)	18/07/2017	29/06/2017	Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1650	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan
380	JPRN-jRCT2071200057	08/07/2017	25/11/2020	Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects; Multicenter study	A Phase I, Randomized, Single-Blind, Multicenter, Parallel-Group, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-006 Study	Rheumatoid arthritis;D001172	Experimental: FKB327 (Adalimumab biosimilar) Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1. Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug Active Comparator: US licenced Adalimumab Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1. Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug	Yazawa Rie	NULL	Complete	>= 20age old	< 45age old	Male	130	Phase 1	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
381	EUCTR2016-002125-11-ES (EUCTR)	06/07/2017	08/05/2017	Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB Trade Name: REMSIMA Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc	NULL	Not Recruiting			Female: yes Male: yes	258	Phase 1;Phase 3	Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of;Estonia;Slovakia;Spain;Ukraine
382	EUCTR2016-004834-11-DK (EUCTR)	06/07/2017	11/05/2017	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Rottapharm Biotech S.r.l.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom
383	NCT03189017 (ClinicalTrials.gov)	July 3, 2017	12/6/2017	A Phase I Study of ICP-022 in Healthy Subjects	A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose	Systemic Lupus Erythematosus;Rheumatoid Arthritis	Drug: ICP-022;Drug: Placebos	Innocare Pharma Australia Pty Ltd	NULL	Completed	18 Years	55 Years	Male	64	Phase 1	Australia
384	NCT03285191 (ClinicalTrials.gov)	July 3, 2017	29/6/2017	Subject Insights to Understand Rheumatoid Arthritis (RA)	Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Rheumatoid Arthritis	Arthritis, Rheumatoid	Other: Numerical rating scale;Other: Real-time data capture app	GlaxoSmithKline	NULL	Completed	18 Years	N/A	All	30		United Kingdom
385	ChiCTR-IPR-17011566	2017-07-01	2017-06-05	The efficacy and safety of sirolimus in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China	The efficacy and safety of sirolimus in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China	Rheumatoid Arthritis;M05.901	Sirolimus group: Sirolimus; Non-Sirolimus group:Glucocorticoids and Immunosuppressant;	the Second Hospital of Shanxi Medical University	NULL	Recruiting	18	65	Both	Sirolimus group:200; Non-Sirolimus group:100;		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
386	NCT03394131 (ClinicalTrials.gov)	July 1, 2017	25/12/2017	?Efficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients	Treatment of Carpal Tunnel in Rheumatoid Arthritis	Treatment Resistant Carpal Tunnel in RA Patients	Drug: Hylase;Drug: Insulin;Other: saline	Assiut University	NULL	Unknown status	20 Years	80 Years	All	90	N/A	Egypt
387	EUCTR2016-001825-15-IT (EUCTR)	28/06/2017	16/02/2018	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION - A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREAT	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinb Product Code: CP 690,550 INN or Proposed INN: tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Methotrexate 2.5mg Tablets BP Product Name: methotrexate INN or Proposed INN: METHOTREXATE	PFIZER INC	NULL	Not Recruiting			Female: yes Male: yes	580	Phase 3	Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Germany;Italy
388	ChiCTR-INR-17011772	2017-06-27	2017-06-28	The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents	The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents	Rheumatoid Arthritis	test group:Metformin tablets, 0.25g, 3 / day, oral, atorvastatin tablets 10mg, 1 / night, oral;;Control group:Traditional DMARDs group;	Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated Hospital	NULL	Recruiting	18	65	Both	test group:80;Control group:40;		China
389	EUCTR2016-001825-15-DE (EUCTR)	26/06/2017	01/03/2017	A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG	A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, New York	NULL	Not Recruiting			Female: yes Male: yes	580	Phase 3;Phase 4	United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
390	NCT03278470 (ClinicalTrials.gov)	June 26, 2017	7/9/2017	A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject	A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single Oral Dose of HL237 in Healthy Male Subject	Rheumatoid Arthritis	Drug: HL237;Drug: Placebo Oral Tablet	Hanlim Pharm. Co., Ltd.	NULL	Completed	20 Years	45 Years	Male	57	Phase 1	Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
391	EUCTR2015-005309-35-BG (EUCTR)	22/06/2017	02/05/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		R-Pharm International, LLC.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1880	Phase 3	United States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of
392	NCT03239080 (ClinicalTrials.gov)	June 19, 2017	1/8/2017	Effect of Denosumab in Erosion Healing in RA	Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT	Rheumatoid Arthritis	Drug: Denosumab;Other: Placebo	Chinese University of Hong Kong	NULL	Completed	18 Years	N/A	All	110	Phase 2	China
393	EUCTR2016-000933-37-NL (EUCTR)	19/06/2017	18/04/2017	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	313	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
394	EUCTR2015-002887-17-FR (EUCTR)	19/06/2017	16/02/2016	Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis	Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors	Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	610	Phase 2	United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
395	EUCTR2015-005309-35-GB (EUCTR)	16/06/2017	09/06/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		R-Pharm	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1880	Phase 3	United States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
396	EUCTR2016-005017-45-GB (EUCTR)	15/06/2017	27/10/2017	A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		NovImmune S.A.	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
397	EUCTR2016-000933-37-SK (EUCTR)	15/06/2017	24/04/2017	Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	313	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
398	EUCTR2016-003630-25-SK (EUCTR)	15/06/2017	04/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3068	Phase 3	United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan
399	JPRN-UMIN000027719	2017/06/12	12/06/2017	Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy.		rheumatoid arthritis/remission	add-on iguratimod tapering MTX continuing the treatment	Osaka Medical College	NULL	Recruiting	20years-old	100years-old	Male and Female	100	Not selected	Japan
400	EUCTR2016-003630-25-ES (EUCTR)	09/06/2017	09/06/2017	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
401	EUCTR2016-000569-21-FR (EUCTR)	08/06/2017	04/11/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
402	EUCTR2016-003630-25-PL (EUCTR)	07/06/2017	24/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
403	EUCTR2016-002337-30-HR (EUCTR)	05/06/2017	12/09/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
404	NCT03139136 (ClinicalTrials.gov)	May 30, 2017	26/4/2017	Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis	A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients With Active Rheumatoid Arthritis Receiving Methotrexate	Rheumatoid Arthritis	Drug: MBS2320;Drug: Placebo	Modern Biosciences plc	NULL	Completed	18 Years	75 Years	All	121	Phase 2	Georgia;Moldova, Republic of;Romania
405	EUCTR2016-003630-25-HU (EUCTR)	29/05/2017	12/04/2017	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan;United States;Taiwan;Hong Kong
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
406	EUCTR2016-002337-30-DE (EUCTR)	24/05/2017	06/02/2017	A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment	A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	269	Phase 2	Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina
407	EUCTR2015-005309-35-DE (EUCTR)	23/05/2017	24/01/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm International LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1880	Phase 3	United States;Belarus;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
408	EUCTR2015-005309-35-PL (EUCTR)	19/05/2017	17/03/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		R-Pharm International LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1880	Phase 3	United States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
409	JPRN-UMIN000027250	2017/05/15	08/05/2017	Precision medicine of methotrexate in the patients with rheumatoid arthritis		Rheumatoid arthritis	MTX administration	Keio UniversityFukuoka Tokushukai Hospital	NULL	Complete: follow-up complete	20years-old	90years-old	Male and Female	50	Not selected	Japan
410	NCT03193957 (ClinicalTrials.gov)	May 15, 2017	19/6/2017	An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis	An Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept;Device: Autoinjector	Samsung Bioepis Co., Ltd.	NULL	Completed	18 Years	55 Years	All	50	Phase 2	Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
411	NCT03131973 (ClinicalTrials.gov)	May 13, 2017	25/4/2017	Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin	Effects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy Participants	Rheumatoid Arthritis	Drug: BMS-986195;Drug: Methotrexate;Drug: Leucovorin;Drug: Caffeine;Drug: Montelukast;Drug: Flurbiprofen;Drug: Omeprazole;Drug: Midazolam;Drug: Digoxin;Drug: Pravastatin	Bristol-Myers Squibb	NULL	Completed	18 Years	50 Years	All	26	Phase 1	United States
412	EUCTR2016-005017-45-HU (EUCTR)	12/05/2017	13/03/2017	A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: NI-0101 Product Code: NI-0101 INN or Proposed INN: N/A Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody	NovImmune S.A.	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
413	EUCTR2016-005017-45-BG (EUCTR)	11/05/2017	06/04/2017	A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		NovImmune S.A.	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina
414	NCT03241108 (ClinicalTrials.gov)	May 10, 2017	26/6/2017	Study of an Anti-TLR4 mAb in Rheumatoid Arthritis	Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an Anti-Toll Like Receptor 4 Monoclonal Antibody in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: NI-0101;Other: Placebo	NovImmune SA	NULL	Completed	18 Years	N/A	All	90	Phase 2	Bosnia and Herzegovina;Bulgaria;Georgia;Hungary;Moldova, Republic of;Poland;Serbia
415	EUCTR2016-000897-39-DE (EUCTR)	10/05/2017	27/10/2016	An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.	Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	75	Phase 2	United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
416	EUCTR2014-005368-13-IT (EUCTR)	10/05/2017	16/02/2018	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB	ARCHIGEN BIOTECH LIMITED	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
417	NCT03086343 (ClinicalTrials.gov)	May 9, 2017	20/3/2017	A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs	A Phase 3, Randomized, Active-Controlled, Double-Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Rheumatoid Arthritis (RA)	Drug: Abatacept;Drug: Placebo for abatacept;Drug: Upadacitinib;Drug: Placebo for upadacitinib	AbbVie	NULL	Active, not recruiting	18 Years	N/A	All	613	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Chile;Colombia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04585711
(ClinicalTrials.gov)

September 2022

7/10/2020

Pharmacokinetics and Pharmacodynamics of Biologic Drugs in Obese Patients With Arthritis

Juvenile Idiopathic Arthritis;Rheumatoid Arthritis;Obesity

Drug: Etanercept Optimal dosing

Duke University

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Not yet recruiting

2 Years

65 Years

All

Phase 1

NULL

NCT04117165
(ClinicalTrials.gov)

March 1, 2021

30/9/2019

Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis

Assessment of the Clinical and Medico-economic Impact of SinnoTest®, a Software That Predicts the Effectiveness of Biotherapy Treatments, in Patients With Rheumatoid Arthritis (RA)

Arthritis, Rheumatoid;Biological Therapy

Diagnostic Test: Biotherapy Prescription with SinnoTest® software;Drug: Patient Current Care

University Hospital, Grenoble

NULL

Not yet recruiting

18 Years

70 Years

All

180

N/A

France

NCT04170426
(ClinicalTrials.gov)

January 10, 2021

18/11/2019

Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid Arthritis

Phase 1/2a Clinical Study for Subjects With Rheumatoid Arthritis (RA) Using Multiple Dose Intravenous Infusions of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)

Rheumatoid Arthritis

Biological: autologous adipose derived stem cells

Celltex Therapeutics Corporation

NULL

Not yet recruiting

18 Years

75 Years

All

Phase 1;Phase 2

NULL

NCT04535427
(ClinicalTrials.gov)

January 1, 2021

22/8/2020

Role of L-Arginine Supplementation in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: L-arginine;Drug: Placebo

RenJi Hospital

NULL

Not yet recruiting

18 Years

45 Years

All

144

Phase 2

China

JPRN-jRCTs071200007

01/01/2021

20/04/2020

Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments

Rheumatoid arthritis

Rheumatoid arthritis patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I period and persisted with clinical remission or low disease activity discontinue infliximab BS.
If they have relapse after discontinuation of infliximab BS,infliximab BS will be re-administered.

Kawakami Atsushi

NULL

Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

ChiCTR2000036094

2021-01-01

2020-08-21

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage

Rheumatoid Arthritis

Experimental group:Duhuo Jisheng Tang, MTX as base treatment.;Control group:Duhuo Jisheng Tang placebo, MTX as base treatment.;

Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine

NULL

Pending

Both

Experimental group:60;Control group:60;

China

ChiCTR2000036164

2021-01-01

2020-08-21

Effects of dexmedetomidine on periarticular infiltration analgesia in total hip arthroplasty: a prospective, double-blind, randomized controlled trial

knee osteoarthritis/ knee rheumatoid arthritis

A:Drug composition of local infiltration around the joint: Ropivacaine ;B:Drug composition of local infiltration around the joint is: Ropivacaine and dexmedetomidine ;

West China Hospital, Sichuan University

NULL

Pending

Both

A:40;B:40;

china

ChiCTR2000036316

2021-01-01

2020-08-22

Effects of dexmedetomidine on periarticular infiltration analgesia in total knee arthroplasty: a prospective, double-blind, randomized controlled trial

knee osteoarthritis/ knee rheumatoid arthritis

A:Drug composition of local infiltration around the joint: Ropivacaine ;B:Drug composition of local infiltration around the joint is: Ropivacaine and dexmedetomidine;

West China Hospital, Sichuan University

NULL

Pending

Both

A:40;B:40;

China

NCT04349046
(ClinicalTrials.gov)

January 1, 2021

14/4/2020

Exception Cementless Hip Stem

Exception Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)

Osteoarthritis, Hip;Rheumatoid Arthritis;Inflammatory Arthritis;Congenital Hip Dysplasia;Avascular Necrosis of Hip;Femoral Neck Fractures

Device: Total hip arthoplasty (THA)

Zimmer Biomet

NULL

Not yet recruiting

18 Years

100 Years

All

332

Belgium;France

NCT04539964
(ClinicalTrials.gov)

January 2021

31/8/2020

Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid Arthritis

A Randomized, Sham-Controlled, Double-Blind Study of Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid Arthritis: The RESET-RA Study

Rheumatoid Arthritis

Procedure: Implant Procedure;Drug: Conventional Synthetic DMARD;Device: Active stimulation;Device: Sham stimulation

SetPoint Medical Corporation

NULL

Not yet recruiting

22 Years

75 Years

All

250

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-003955-14-DE
(EUCTR)

21/12/2020

04/11/2020

A Placebo controlled trial in adult patients with active rheumatoid arthritis with inadequate (partial) response to anti-TNF therapy

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Adults with Active Rheumatoid Arthritis who have demonstrated an inadequate Response to anti-TNF therapy.

Active Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: AMT -101
Other descriptive name: AMT -101

Applied Molecular Transport Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

NCT04569890
(ClinicalTrials.gov)

December 1, 2020

20/9/2020

Treatment of Pregnancy RA

Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China

Rheumatoid Arthritis;Pregnancy Related

Drug: Certolizumab Pegol 200 MG/ML [Cimzia];Drug: Hydroxychloroquine;Drug: Prednisone

RenJi Hospital

NULL

Not yet recruiting

20 Years

40 Years

Female

100

N/A

China

NCT04649697
(ClinicalTrials.gov)

December 1, 2020

26/10/2020

Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients

Evaluation of Topical Rebamipide Versus Topical Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients: Randomized-Controlled Clinical Trial

Rheumatoid Arthritis

Drug: Rebamipide;Drug: Nanoparticulated Rebamipide;Drug: Clobetasol Propionate

Cairo University

NULL

Not yet recruiting

20 Years

70 Years

All

Phase 3

NULL

NCT04634253
(ClinicalTrials.gov)

December 1, 2020

17/11/2020

A Study of LY3462817 in Participants With Rheumatoid Arthritis

A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants With Moderately to Severely Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Placebo;Drug: LY3462817

Eli Lilly and Company

NULL

Not yet recruiting

18 Years

N/A

All

Phase 2

United States;Czechia;Hungary;Mexico;Poland;Puerto Rico

NCT04559412
(ClinicalTrials.gov)

December 2020

3/9/2020

Study to Assess the Safety and Efficacy of Enbrel Administered by Sofusa DoseConnect for Rheumatoid Arthritis

Phase 1b Proof-of-concept, Open-label Study to Assess the Safety and Pilot Efficacy of Enbrel® Administered by the Sofusa® DoseConnect™ Delivery System for the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Device: Sofusa DoseConnect;Drug: Enbrel

Sorrento Therapeutics, Inc.

NULL

Not yet recruiting

18 Years

75 Years

All

Phase 1

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03828344
(ClinicalTrials.gov)

December 2020

30/1/2019

Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid Arthritis

A Phase 1 Randomized, Placebo-Controlled, Double-Blind Study of the Safety and Tolerability of a Single Intravenous Infusion of BX-U001, a Human Umbilical Cord Tissue Derived Mesenchymal Stem Cell Product, for Refractory Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: hUC-MSC suspension;Biological: Placebo

Baylx Inc.

NULL

Not yet recruiting

18 Years

70 Years

All

Phase 1

NULL

NCT04292067
(ClinicalTrials.gov)

November 23, 2020

26/2/2020

Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis

Spondyloarthritis;Rheumatoid Arthritis

Biological: Faecal sampling

Assistance Publique - Hôpitaux de Paris

NULL

Recruiting

18 Years

N/A

All

400

France

EUCTR2019-000878-30-BE
(EUCTR)

18/11/2020

21/09/2020

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: otilimab
Product Code: GSK 3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK 3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK 3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan

JPRN-jRCTs071200054

18/11/2020

Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial

Rheumatoid arthritis

Rheumatoid arthritis patients with moderate or high disease activity will be introduce for etanercept BS MA within 14 days of case enrollment. The etanercept BS MA is given as a weekly subcutaneous injection of 50 mg for 24 weeks.

Kawakami Atsushi

NULL

Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

NCT04470453
(ClinicalTrials.gov)

November 2020

9/7/2020

Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug

Rheumatoid Arthritis

Biological: Blood sample;Diagnostic Test: CRQ

Centre Hospitalier Universitaire de Saint Etienne

NULL

Not yet recruiting

18 Years

N/A

All

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04286789
(ClinicalTrials.gov)

November 2020

25/2/2020

Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Study in RA Patients Managed With DMARDs

A Randomized, Double-blind, Parallel, Vehicle Controlled, Repeat Dose Comparative Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ORTD-1 in Rheumatoid Arthritis Patients With Mild Disease Managed With DMARDs

Rheumatoid Arthritis

Drug: Low dose ORTD-1;Drug: Low dose vehicle control;Drug: High dose ORTD-1;Drug: High dose vehicle control

Oryn Therapeutics, LLC

NULL

Recruiting

18 Years

N/A

All

Phase 1

United States

ChiCTR2000034924

2020-10-30

2020-07-24

Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese

Rheumatoid arthritis, Sjogren's syndrome

Group 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets;

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

NULL

Pending

Both

Group 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose toler

Phase 1

China

EUCTR2020-000658-83-BG
(EUCTR)

21/10/2020

07/10/2020

A study evaluating the effects of GLPG3970 given as an oral treatment for 6 weeks in adults with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate

A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, efficacy and pharmacokinetics of GLPG3970, administered orally for 6 weeks in adult subjects with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate

Rheumatoid arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: GLPG3970
Product Code: G1567970
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3970

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Poland;Ukraine;Georgia;Bulgaria

NCT04577781
(ClinicalTrials.gov)

October 12, 2020

30/9/2020

A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Arthritis, Rheumatoid

Drug: GLPG3970;Drug: Placebo

Galapagos NV

NULL

Recruiting

18 Years

64 Years

All

Phase 2

Georgia;Poland;Ukraine

JPRN-jRCTs041200048

02/10/2020

Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state

Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state - PRIMERA study

Rheumatoid arthritis

1) MTX*
- Continued group:
Continued at a stable dose and interval throughout the cours of the study.
Folic acid is continued if concomitantly used.
- Withdrawn group:
Week 0 to 12
Reduced after registration.
The dose of MTX is reduced to half, regardless of the initial dose.
Folic acid is continued if concomitantly used.
Week 12 to 52
Discontinued if low disease activity was maintained.
Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) CZP and csDMARDs other than MTX
Continued at a stable dose and interval throughout the course of the study in both groups.

3) Glucocorticoids
Continued at a stable dose up to week 36, and allowedto taper after week 36 in both group.

4) Rescue treatment
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request.
- Restoring, restarting, or increasing doses of MTX
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.

Kojima Toshihisa

NULL

Recruiting

>= 20age old

Not applicable

Both

114

N/A

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

ChiCTR2000037008

2020-10-01

2020-08-26

The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study

rheumatoid arthritis

experimental group:MTX 15mg qw po+Bushen Jiedu Tongluo Decoction Granule One dose a day, two times a day;control group:MTX 15mg qw po+placebo Granule One dose a day, two times a day;

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

NULL

Pending

Both

experimental group:53;control group:53;

China

ChiCTR2000036141

2020-10-01

2020-08-21

A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluation

Rheumatoid arthritis

1:Guizhi Decoction;1:MTX;

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

NULL

Recruiting

Both

1:80;1:80;

China

EUCTR2019-002205-22-FR
(EUCTR)

01/10/2020

13/01/2020

Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.

SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom

ChiCTR2000037675

2020-10-01

2020-08-30

Clinical study of Shenshi Qianghuo Dihuang Decoction in the treatment of Rheumatoid arthritis from the perspective of ''7+1''

Rheumatoid arthritis

control group:Methotrexate;experimental group:Qianghuo Dihuang Decoction + Methotrexate;

Shanghai Traditional Chinese Medicine Hospital

NULL

Recruiting

Both

control group:72;experimental group:72;

China

NCT04514614
(ClinicalTrials.gov)

October 1, 2020

7/8/2020

Characterizing Rheumatoid Arthritis With 68Ga-FAPI PET/CT

Arthritis

Drug: 68Ga-FAPI

Peking Union Medical College Hospital

NULL

Not yet recruiting

18 Years

90 Years

All

100

Early Phase 1

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04530305
(ClinicalTrials.gov)

October 2020

24/8/2020

Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor

Rheumatoid Arthritis

Drug: Tofacitinib 5 MG [Xeljanz]

University Hospital, Montpellier

NULL

Not yet recruiting

18 Years

N/A

All

NULL

NCT04509427
(ClinicalTrials.gov)

October 2020

29/6/2020

EXercise and PosturE in Individuals With Rheumatoid ArthriTIs and OStEoporosis

Comparison of Video-based and Paper Instructional Material to Promote EXercise and PosturE in Individuals With Rheumatoid ArthrTIs and OStEoporosis

Rheumatoid Arthritis;Osteoporosis

Behavioral: Instructional handouts;Behavioral: Physical therapist instruction and monitoring via teleconferencing;Behavioral: Web-based instructional videos;Behavioral: Posture training;Behavioral: Resistance exercise;Behavioral: Balance exercise;Behavioral: Marching in place

University of Alabama at Birmingham

NULL

Not yet recruiting

51 Years

N/A

Female

N/A

NULL

NCT04638426
(ClinicalTrials.gov)

September 10, 2020

13/11/2020

Phase 2a Clinical Trial of HL237 for Rheumatoid Arthritis

For 12 Weeks, the Multi Center, Randomized, Double Blinded, Placebo Controlled, Parallel, Dose-finding Clinical Study for the Therapeutic Exploration of Safety and Efficacy Assessment of HL237 Tablet in Patients With Rheumatoid Arthritis (Phase IIa)

Rheumatoid Arthritis

Drug: HL237 tablet;Drug: Placebo of HL237 tablet

Hanlim Pharm. Co., Ltd.

NULL

Enrolling by invitation

19 Years

N/A

All

196

Phase 2

Korea, Republic of

NCT04255134
(ClinicalTrials.gov)

September 7, 2020

14/11/2019

Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)

Comparison of Abatacept With Tumor Necrosis Factor Inhibitors in the Treatment of Rheumatoid Arthritis Pain: A Phase IV Trial

Rheumatoid Arthritis

Drug: Abatacept Injection;Drug: Adalimumab Injection

St George's, University of London

NULL

Recruiting

18 Years

75 Years

All

Phase 4

United Kingdom

EUCTR2020-002507-19-NL
(EUCTR)

07/09/2020

03/09/2020

Research into administration of lower dosed rituximab with an injection

Comparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial - RTX-SC

rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: rituximab
Trade Name: Rixathon
Product Name: rituximab

Sint Maartenskliniek

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000878-30-BG
(EUCTR)

04/09/2020

11/08/2020

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

NCT04378621
(ClinicalTrials.gov)

September 1, 2020

8/4/2020

Effect of Antiinflammatory Treatment Versus Hand Training on Neuropsychiatric Comorbidity in RA-patients

Treatment of Inflammation Versus Hand Training to Prevent and Revert Neuropsychiatric Comorbidity in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis;Pain;Fatigue;Cognitive Decline;Depression;Brain Diseases;Hand Rheumatism

Drug: TNF-a inhibitor OR JAK inhibitor;Other: Hand training

Vastra Gotaland Region

NULL

Not yet recruiting

45 Years

75 Years

All

212

N/A

Sweden

EUCTR2019-004369-42-CZ
(EUCTR)

01/09/2020

05/08/2020

A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)

A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: MSB11456
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: RoActemra (R)
Product Name: RoActemra (R)
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

Fresenius Kabi SwissBioSim GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

542

Phase 3

United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of

NCT04347798
(ClinicalTrials.gov)

September 2020

13/4/2020

IMPACT: IMPact of Antimalarials on Covid-19 Infections in RAPPORT

IMPACT RAPPORT: IMPact of Antimalarials on Covid Infections: a Case Control sTudy of RAPPORT

Covid-19 Infection;Rheumatoid Arthritis;Psoriatic Arthritis;Hydroxychloroquine

Other: Hydroxychloroquine/Chloroquine

University of Alberta

NULL

Enrolling by invitation

18 Years

N/A

All

500

Canada

NCT04421313
(ClinicalTrials.gov)

September 2020

18/5/2020

Fibres Supplementation in Rheumatoid Arthritis

Supplementation of Rheumatoid Arthritis Patients With Dietary Fibre to Improve Their Gut Microbiota

Rheumatoid Arthritis

Drug: Dietary Fiber Supplementation

University Hospital, Montpellier

University of Sydney;Institut de Génétique Moléculaire de Montpellier

Not yet recruiting

18 Years

85 Years

All

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002676-14-BG
(EUCTR)

20/08/2020

27/05/2020

A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS

A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet
Product Name: tofacitinib (Xeljanz®)
Product Code: CP 690550 MR
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: IRAK 4
Product Code: PF-06650833
INN or Proposed INN: IRAK 4
Other descriptive name: PF-06650833
Product Name: JAK 3
Product Code: PF-06651600
INN or Proposed INN: JAK 3
Other descriptive name: PF-06651600

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina

EUCTR2019-002205-22-DE
(EUCTR)

12/08/2020

07/07/2020

SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom

NCT04457856
(ClinicalTrials.gov)

August 6, 2020

28/6/2020

A Study of TJ003234 in Rheumatoid Arthritis Patients

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Ascending Doses of TJ003234 in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Biological: TJ003234 injection

I-Mab Biopharma Co. Ltd.

NULL

Recruiting

18 Years

70 Years

All

Phase 1

China

ChiCTR2000035146

2020-08-01

2020-08-02

The effect of the IPACK block on pain after primary TKA in different levels of knee flexion deformity patients: a prospective, cohort trial

knee osteoarthritis/ knee rheumatoid arthritis

The knee flexion deformities of different degrees were divided into different groups, and the patients without knee flexion deformity were the control group:Under the guidance of ultrasound, 20 ml 0.25% ropivacaine was injected between popliteal artery and knee joint capsule;

West China Hospital, Sichuan University

NULL

Pending

Both

The knee flexion deformities of different degrees were divided into different groups, and the patients without knee flexion deformity were the control group:80;

N/A

China

ChiCTR2000035179

2020-08-01

2020-08-02

The effect of the iPACK block on pain and knee function in knee flexion deformity patients after primary TKA: a double-blinded, prospective, randomized controlled triala

The effect of the iPACK block on pain in knee flexion deformity patients after primary TKA: a double-blinded, prospective, randomized controlled trial

knee osteoarthritis/ knee rheumatoid arthritis

IPACK group:infiltration of 20 ml ropivacaine 0.25% between the interspace between the popliteal artery and capsule of the knee;control group:infiltration of 20ml 0.9% salinebetween the interspace between the popliteal artery and capsule of the knee;

West China Hospital, Sichuan University

NULL

Pending

Both

IPACK group:40;control group:40;

N/A

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04333771
(ClinicalTrials.gov)

July 31, 2020

2/4/2020

A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.

Rheumatoid Arthritis

Drug: SHR0302;Drug: Placebo

Jiangsu HengRui Medicine Co., Ltd.

NULL

Recruiting

18 Years

75 Years

All

600

Phase 3

China

NCT04413617
(ClinicalTrials.gov)

July 29, 2020

19/5/2020

TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

Rheumatoid Arthritis

Drug: PF-06650833;Drug: PF-06651600;Drug: Tofacitinib

Pfizer

NULL

Recruiting

18 Years

70 Years

All

450

Phase 2

Bulgaria;Canada;Chile;Czechia;Georgia;Hungary;Poland;Slovakia;Spain;Ukraine

JPRN-jRCTs071190030

28/07/2020

11/10/2019

Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments

Rheumatoid arthritis

Rheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS from Remicade.
The dose and infusion intervals of infliximab BS are kept unchanged from those of Remicade.

Kawakami Atsushi

NULL

Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

NCT04512001
(ClinicalTrials.gov)

July 27, 2020

11/8/2020

MSB11456 in Participants With Moderately to Severely Active Rheumatoid Arthritis

A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union-approved RoActemra® in Patients With Moderately to Severely Active Rheumatoid Arthritis (APTURA I Study)

Rheumatoid Arthritis

Drug: MSB11456;Drug: EU-approved RoActemra

Fresenius Kabi SwissBioSim GmbH

NULL

Recruiting

18 Years

N/A

All

542

Phase 3

Bulgaria;Czechia;Georgia;Hungary;Moldova, Republic of;Poland;Russian Federation;Serbia;Slovakia

NCT04324892
(ClinicalTrials.gov)

July 12, 2020

25/3/2020

Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study

Rheumatoid Arthritis

Drug: Treat to target

Chinese University of Hong Kong

NULL

Not yet recruiting

18 Years

N/A

All

110

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002676-14-CZ
(EUCTR)

07/07/2020

11/05/2020

A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS

Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina

NCT04428424
(ClinicalTrials.gov)

July 5, 2020

10/6/2020

Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients

The Impact of RF, and Anti-CCP on RA Patients in Response to Etanercept

Arthritis, Rheumatoid

Drug: Enbrel

Pfizer

NULL

Completed

18 Years

N/A

All

Iraq

JPRN-UMIN000040094

2020/07/01

01/07/2020

Development of chronotherapeutics in rheumatoid arthritis

Development of chronotherapeutics in rheumatoid arthritis - Development of chronotherapeutics in rheumatoid arthritis

rheumatoid arthritis

baricitinib 4mg morning
baricitinib 4mg evening
baricitinib 2mg evening

Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo college of Medicine

NULL

Pending

18years-old

100years-old

Male and Female

Not applicable

Japan

JPRN-jRCTs071190046

29/06/2020

20/02/2020

Efficacy of Etanercept Biosimilar Switching from Etanercept Reference Product, using Ultrasound and Clinical Data in Outcomes of Real World Therapy (ESCORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial

Rheumatoid arthritis

Rheumatoid arthritis patients who have been treated with enbrel (Subcutaneous injection of 25 mg once weekly or 25 mg twice weekly or 50 mg once weekly or 50 mg once biweekly) over 24 weeks and persisted with LDA/remission are switched to the same dose of etanercept BS MA from enbrel. In addition, for patients receiving etanercept BS MA 50 mg weekly, the dose will be reduced from 24 weeks to etanercept BS MA 25 mg weekly to test whether LDA/remission persists until week 52.

Kawakami Atsushi

NULL

Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

NCT04163016
(ClinicalTrials.gov)

June 19, 2020

24/10/2019

A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

Rheumatoid Arthritis;Psoriatic Arthritis;Crohn's Disease;Axial Spondyloarthritis;Plaque Psoriasis

Drug: Pharmacokinetics of certolizumab pegol

UCB Biopharma S.P.R.L.

NULL

Recruiting

18 Years

N/A

Female

Phase 1

United States;Canada;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002676-14-HU
(EUCTR)

18/06/2020

14/04/2020

A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina

EUCTR2019-002810-37-PL
(EUCTR)

16/06/2020

11/03/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Trade Name: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 100mg
INN or Proposed INN: RITUXIMAB
Trade Name: Reditux
Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg
Product Code: DRL_RI
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

Bulgaria;United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Germany

EUCTR2019-002810-37-BG
(EUCTR)

15/06/2020

28/04/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

United States;Czechia;Estonia;Hungary;Poland;Lithuania;Bulgaria;Germany

NCT04584541
(ClinicalTrials.gov)

June 11, 2020

10/6/2020

SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism

Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments

Spondyloarthritis;Rheumatoid Arthritis;Covid19

Biological: blood tests;Biological: Nasopharyngeal swabs;Biological: Stools

Assistance Publique - Hôpitaux de Paris

NULL

Recruiting

18 Years

N/A

All

150

N/A

France

EUCTR2019-002676-14-SE
(EUCTR)

01/06/2020

14/04/2020

A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

ChiCTR2000033004

2020-06-01

2020-05-17

Clinical study of intravenous lidocaine infusion in patients with rheumatoid arthritis

Rheumatoid arthritis

Group 1:glucocorticoid;Group 2:intravenous lidocaine infusion and glucocorticoid;Group 3:intravenous lidocaine infusion;Group 4:NSAIDS;

Department of Pain, Guizhou Provincial People's Hospita

NULL

Pending

Both

Group 1:30;Group 2:30;Group 3:30;Group 4:30;

China

NCT04269993
(ClinicalTrials.gov)

June 1, 2020

12/2/2020

Impact of Cannabis on Pain and Inflammation Among Patients With Rheumatoid or Psoriatic Arthritis

Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers Among Patients With Rheumatoid or Psoriatic Arthritis

Rheumatoid Arthritis;Psoriatic Arthritis

Drug: Cannabis: placebo and medium THC/medium CBD

Brown University

NULL

Not yet recruiting

18 Years

65 Years

All

Phase 2

NULL

ChiCTR2000033214

2020-06-01

2020-05-24

Evaluation of the benefits of early standard control in the treatment of rheumatoid arthritis

Rheumatoid Arthritis

Group 1:Tofacitinib;Group 2:cDMARDs;

Department of Rheumatology, Anqing Hospital Affiliated to Anhui Medical University

NULL

Pending

Both

Group 1:52;Group 2:52;

Phase 4

NULL

NCT04402554
(ClinicalTrials.gov)

June 2020

15/5/2020

Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis

Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis

Behavioral: Cannabis questionnaire

University Hospital, Clermont-Ferrand

NULL

Not yet recruiting

18 Years

N/A

All

500

France

EUCTR2019-001185-15-BG
(EUCTR)

29/05/2020

15/05/2020

A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization).The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect

A double-blind, multi-center, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis (RA) patients with active joint disease - SynAct-CS002

Product Code: AP1189
INN or Proposed INN: Not applicable

SynAct Pharma ApS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Bulgaria;Norway;Moldova, Republic of;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003418-41-GB
(EUCTR)

18/05/2020

22/11/2019

A comparison of a radioactive imaging method with an existing immunological (involving cells from the Immune System) based method that involves staining of tissues from a patient with a known rheumatoid arthritic joint.

A Comparison of Tc 99m Tilmanocept Quantitative Imaging with Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue from Subjects Clinically Diagnosed with Rheumatoid Arthritis (RA)

Trade Name: Lymphoseek
Product Name: technetium Tc 99m tilmanocept
INN or Proposed INN: not applicable
Other descriptive name: TILMANOCEPT

Navidea Biopharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;European Union;United Kingdom

EUCTR2019-004369-42-SK
(EUCTR)

12/05/2020

09/03/2020

A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)

Product Code: MSB11456
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: RoActemra (R)
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

Fresenius Kabi SwissBioSim GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

542

Phase 3

United States;Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of

EUCTR2019-004078-24-ES
(EUCTR)

07/05/2020

21/02/2020

Effect of Sarilumab on atherosclerotic disease in Rheumatoid Arthritis

Effect of Sarilumab on atherosclerotic disease measured by PET/CT (Positron Emission Tomography/Computed Tomography) in Rheumatoid Arthritis - SARIPET

RHEUMATOID ARTHRITIS
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trade Name: KEVZARA
INN or Proposed INN: SARILUMAB

IDIVAL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Spain

EUCTR2019-004369-42-PL
(EUCTR)

05/05/2020

23/03/2020

A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)

Fresenius Kabi SwissBioSim GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

542

Phase 3

United States;Serbia;Czechia;Czech Republic;Hungary;Slovakia;Spain;Poland;Bulgaria;Russian Federation;Georgia;Moldova, Republic of

EUCTR2019-002205-22-GB
(EUCTR)

01/05/2020

07/01/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04078191
(ClinicalTrials.gov)

May 2020

21/8/2019

Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue of Subjects With Rheumatoid Arthritis (RA)

A Comparison of Tc 99m Tilmanocept Quantitative Imaging With Immunohistochemical (IHC) Analysis of CD206 Expression in Synovial Tissue From Subjects Clinically Diagnosed With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Tc 99m tilmanocept

Navidea Biopharmaceuticals

NULL

Not yet recruiting

18 Years

N/A

All

Phase 2

United Kingdom

NCT04350216
(ClinicalTrials.gov)

April 30, 2020

8/4/2020

Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET)

Effect of Sarilumab Therapy on Atherosclerotic Disease Assessed by Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis;Atherosclerosis

Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]

Instituto de Investigación Marqués de Valdecilla

NULL

Not yet recruiting

18 Years

100 Years

All

Phase 4

NULL

EUCTR2019-004369-42-HU
(EUCTR)

27/04/2020

03/03/2020

A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Fresenius Kabi SwissBioSim GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

542

Phase 3

United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of

EUCTR2019-002810-37-LT
(EUCTR)

17/04/2020

03/03/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany

NCT04361513
(ClinicalTrials.gov)

April 15, 2020

22/4/2020

Genicular Nerve Block in Rheuamtoid Arthritis

Genicular Nerve Block in Rheumatoid Arthritis: a Prospective Randomized Clinical Trial

Pain;Joint Function Disorder;Inflammation

Drug: Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer);Drug: triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)

Sohag University

NULL

Completed

18 Years

N/A

All

Phase 4

Egypt

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000867-26-DE
(EUCTR)

08/04/2020

04/07/2019

Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs

A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Phase 3

United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of

JPRN-UMIN000040054

2020/04/06

04/04/2020

The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block

The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block - The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block

knee osteoarthritis or knee rheumatoid arthritis

Popliteal Plexus Block with 0.25% levobupivacaine 10 mL
Tibial Nerve Block(TNB) with 0.25% levobupivacaine 10 mL

Daiyukai General Hospital

NULL

Recruiting

20years-old

100years-old

Male and Female

120

Phase 3

Japan

EUCTR2019-002205-22-ES
(EUCTR)

06/04/2020

23/01/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom

EUCTR2019-002205-22-PL
(EUCTR)

29/03/2020

07/02/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom

EUCTR2019-000878-30-HU
(EUCTR)

26/03/2020

28/02/2020

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

Product Name: GSK 3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

Japan;Serbia;United States;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04434118
(ClinicalTrials.gov)

March 20, 2020

13/6/2020

Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients

Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study

Rheumatoid Arthritis;COVID

Drug: Traditional antirheumatic drugs

Sadat City University

NULL

Enrolling by invitation

18 Years

60 Years

All

600

Egypt

NCT04247815
(ClinicalTrials.gov)

March 16, 2020

16/1/2020

Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA

A Phase 2a, Randomized, Investigator and Patient-blind, Sponsor-unblinded, Parallel Group, Placebo-controlled Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ATI-450;Drug: Placebo oral tablet;Drug: Methotrexate

Aclaris Therapeutics, Inc.

NULL

Active, not recruiting

18 Years

70 Years

All

Phase 2

United States

NCT04389320
(ClinicalTrials.gov)

March 15, 2020

11/5/2020

Antimalarial and Covid 19 in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Hydroxychloroquine

Assiut University

NULL

Completed

20 Years

70 Years

All

Egypt

EUCTR2019-003700-12-FR
(EUCTR)

13/03/2020

04/06/2020

Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients

Association between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug

rheumatoid arthritis
MedDRA version: 21.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Methotrexate
Product Code: MTX
Other descriptive name: METHOTREXATE DISODIUM
Product Code: bDMARD
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: ADALIMUMAB
INN or Proposed INN: CERTOLIZUMAB PEGOL
INN or Proposed INN: GOLIMUMAB

CHU Saint-Etienne

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France

EUCTR2019-000868-18-DE
(EUCTR)

13/03/2020

08/07/2019

Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.

A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3

Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

JPRN-jRCT1041190127

10/03/2020

Romosozumab Against GLucocorticoid-induced Osteoporosis in Rheumatoid arthritis despite bisphosphonate over a Year

Randomized controlled trial of romosozumab and denosumab for glucocorticoid-induced osteoporosis with inadequate response to bisphosphonate in rheumatoid arthritis patients

Rheumatoid arthritis, Glucocoluticoid-induced osteoporosis
Rheumatoid arthritis, Glucocoluticoid-induced osteoporosis

arm Romosozumab-denosumab: romosozumab 210mg s.c. once monthly for 12months, after that, denosumab 60mg s.c. once every 6months for 12months
arm Denosumab: denosumab 60mg s.c. once every 6months for 12months after that romosozumab 210mg s.c. once monthly for 12months
Arm denosumab, in case denosumab has enough response, based on physician's dicision, denosumab can be continued.
all patients: eldecalcitol 0.75microg ram p.o. once a day (Dose reduced to 0.5microg ram once a d
ay depending on symptoms)

KOJIMA TOSHIHISA

NULL

Pending

Not applicable

Female

100

N/A

Japan

EUCTR2019-002810-37-HU
(EUCTR)

09/03/2020

20/01/2020

A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

United States;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;Hungary

JPRN-jRCT1041190125

09/03/2020

PRECIOUS-B study

Patient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study

Rheumatoid arthritis

1) MTX*
Week 0 to 12
- Reduced after registration.
- The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose.
- The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used.
Week 12 to 52
- Discontinued if low disease activity was maintained.
- Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) BAR
- Continued at a stable dose and interval throughout the course of the study.

3) csDMARDs other than MTX
- Continued at a stable dose and interval throughout the course of the study.

4) Glucocorticoids
- Continued at a stable dose up to week 36, and allowed to taper after week 36.

5) Rescue treatments
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request
- Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX.
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids.
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.

Takahashi Nobunori

NULL

Pending

>= 20age old

Not applicable

Both

N/A

Japan

ChiCTR2000030247

2020-03-01

2020-02-26

Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage

Systemic lupus erythematosus

experimental group:Integrative MTX with Guanxinning;control group:MTX;

Zhejinag University of f Chinese Medicine

NULL

Recruiting

Both

experimental group:30;control group:30;

China

ChiCTR2000030400

2020-03-01

Effects of Tetrandrine for Rheumatoid Arthritis-Associated Usual Interstitial Pneumonia

Interstitial pneumonia

Case series:Tetrandrine;

The First People's Hospital of Yancheng

NULL

Recruiting

Both

Case series:41;

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02903212
(ClinicalTrials.gov)

March 2020

1/9/2016

Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: Autologous apoptotic cells injection

Centre Hospitalier Universitaire de Besancon

NULL

Not yet recruiting

18 Years

80 Years

All

Phase 1;Phase 2

NULL

EUCTR2019-000878-30-CZ
(EUCTR)

26/02/2020

06/01/2020

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

Product Name: GSK 3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

Serbia;United States;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan

EUCTR2018-003351-37-FR
(EUCTR)

19/02/2020

28/05/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

2600

Phase 3;Phase 4

United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany

EUCTR2019-001185-15-NO
(EUCTR)

19/02/2020

07/11/2019

Product Code: AP1189
INN or Proposed INN: Not applicable

SynAct Pharma ApS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Norway;Sweden

EUCTR2019-000878-30-LT
(EUCTR)

13/02/2020

25/11/2019

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-004468-23-GB
(EUCTR)

10/02/2020

26/02/2020

Biologics for RA Pain ( BIORA-PAIN)

Comparison of abatacept with tumor necrosis factor inhibitors in the treatment of rheumatoid arthritis pain: A phase IV trial - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Abatacept
Product Name: Abatacept
INN or Proposed INN: Abatacept
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Humira

St George's, University of London

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

United Kingdom

EUCTR2018-004558-30-PT
(EUCTR)

03/02/2020

21/05/2019

A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.

Trade Name: Olumiant
Product Name: Olumiant
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Ledertrexato
Product Name: Metotrexato
Product Code: Metotrexato
INN or Proposed INN: metotrexato
Other descriptive name: METHOTREXATE SODIUM
Trade Name: Metex Pen
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

186

Phase 4

Portugal;Spain

EUCTR2019-000284-24-CZ
(EUCTR)

03/02/2020

17/10/2019

A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.

A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: Adalimumab
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB HUMIRA
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB HUMIRA

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 4

United States;Serbia;Czech Republic;Poland;Ukraine;Lithuania;South Africa;Russian Federation;Bulgaria;Bosnia and Herzegovina

EUCTR2018-004429-94-NL
(EUCTR)

21/01/2020

17/06/2019

Monitoring of respons to therapy in rheumatoid arthritis with the help of a PET scan.

[18F]PEG-folate PET-CT imaging for monitoring of therapy response in rheumatoid arthritis patients

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: [18F]PEG-Folate

VU Medical Center, department of Rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

100

EUCTR2019-004101-27-NL
(EUCTR)

15/01/2020

12/12/2019

Research into injecting golimumab less frequently by using increased doses

INDIGO: Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study’ - INDIGO

rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.1;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Sint Maartenskliniek

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

101

JPRN-UMIN000039116

2020/01/15

15/01/2020

Effects of Sleep Management on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study.

Effects of zolpidem tartrate on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study. - SMAPP

Osteoarthritis, Rheumatoid arthritis

Administration of zolpidem tartrate of 5mg for 7 days after surgery
No administration of zolpidem tartrate

Mito medical center, Mito Kyodo General Hospital, University of Tsukuba

NULL

Pending

20years-old

Not applicable

Male and Female

Not selected

Japan

102

NCT04230213
(ClinicalTrials.gov)

January 13, 2020

14/1/2020

A Comparative Study Between PF-06410293 and Humira® in Combination With Methotrexate in Participants With Active Rheumatoid Arthritis

A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA (REGISTERED) IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis

Drug: PF-06410293;Drug: adalimumab

Pfizer

NULL

Recruiting

18 Years

70 Years

All

420

Phase 3

United States;Bosnia and Herzegovina;Bulgaria;Czechia;Lithuania;Poland;Russian Federation;Serbia;South Africa;Ukraine

103

EUCTR2019-004179-38-SE
(EUCTR)

10/01/2020

19/11/2019

Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis

Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis - PULMORA

Patients with early active rheumatoid arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Västra Götalandsregionen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

145

Phase 4

Sweden

104

NCT04186871
(ClinicalTrials.gov)

January 7, 2020

28/11/2019

Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis

Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome

Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo

Bristol-Myers Squibb

NULL

Recruiting

18 Years

65 Years

All

185

Phase 2

United States;Argentina;Australia;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom

105

JPRN-UMIN000042632

2020/01/01

03/12/2020

THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS

THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS - laser effectiveness in rheumatoid arthritis

Rheumatoid arthritis

low level laser therapy. Each patient in group 1 takes 20 sessions of LLLT , in the form of 2 courses, each course contains 10 sessions ,as 3 sessions every week ,10 days free between 2 courses.
The laser apparatuses used for therapy in this study were the following,
1.HeNe Laser wavelength 632,8 nm, continuous emission, output power 7.3 mW.
2.GaAIAs diode laser (830 nm, maximum output power 300 mW).
12 patients
placebo laser and naproxen
Naproxen is given as tablet 500mg twice per day.
12 patients
naproxen
Naproxen is given as tablet 500mg twice per day.
10 patients

Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq

NULL

Complete: follow-up complete

20years-old

80years-old

Male and Female

Not applicable

Asia(except Japan)

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

NCT04115397
(ClinicalTrials.gov)

January 2020

2/10/2019

Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints

Towards Efficient Prediction and Prevention of Rheumatoid Arthritis

Seropositive Muskuloskeletal Complaints

Drug: Zoledronic Acid;Drug: Placebo

Karolinska Institutet

NULL

Not yet recruiting

18 Years

N/A

All

Phase 4

NULL

107

EUCTR2019-000284-24-LT
(EUCTR)

18/12/2019

07/11/2019

A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.

A RANDOMIZED COMPARATIVE STUDY ASSESSING THE INTERCHANGEABILITY OF PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 3

United States;Serbia;Ukraine;Lithuania;Russian Federation;Czech Republic;Mexico;Argentina;Poland;Peru;South Africa;Bulgaria;Bosnia and Herzegovina

108

NCT04046146
(ClinicalTrials.gov)

December 15, 2019

23/7/2019

Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport

Rheumatoid Arthritis

Drug: Indocyanine Green;Device: MultiSpectral Imaging System

University of Rochester

NULL

Completed

18 Years

89 Years

All

Phase 1

United States

109

EUCTR2018-003351-37-LT
(EUCTR)

13/12/2019

29/08/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

110

EUCTR2019-000867-26-GB
(EUCTR)

10/12/2019

12/06/2019

Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Xeljanz
INN or Proposed INN: Tofacitinib citrate
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Phase 3

United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

111

NCT04163991
(ClinicalTrials.gov)

December 9, 2019

12/11/2019

A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of the Efficacy and Safety of VIB4920 in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: VIB4920;Drug: Placebo

Viela Bio

NULL

Recruiting

18 Years

99 Years

All

Phase 2

United States;Poland

112

EUCTR2019-000868-18-GB
(EUCTR)

02/12/2019

11/06/2019

Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Kevzara
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colo

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Czechia;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of

113

ChiCTR1900027855

2019-11-29

2019-11-30

Pharmacokinetics of CYP2C9 * 3 homozygous mutant subjects in a single oral meloxicam tablet

Osteoarthritis, rheumatoid arthritis

Case:Meloxicam 15mg;

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

NULL

Pending

Male

Case:1;

Phase 1

China

114

EUCTR2019-001754-25-NL
(EUCTR)

25/11/2019

Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment

Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch)

rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel , Benepali, Erelzi
Product Name: Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: RITUXIMAB
INN or Proposed INN: ABATACEPT
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB
INN or Proposed INN: SARILUMAB

Reade

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

115

EUCTR2019-000797-39-GB
(EUCTR)

22/11/2019

10/06/2019

Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.

A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China;United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

116

EUCTR2018-004287-56-FR
(EUCTR)

21/11/2019

31/01/2020

Methotrexate and Metformin in rheumatoid arthritis patients

Randomized placebo-controlled trial comparing Methotrexate vs. Methotrexate/Metformin association in rheumatoid arthritis patients: METorMET² study - METorMET2

rheumatoid arthritis (RA)
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]

CHU de Bordeaux

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

128

Phase 2

France

117

NCT04227366
(ClinicalTrials.gov)

November 19, 2019

25/12/2019

Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

An International, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study of the Efficacy and Safety of BCD-089 (JSC BIOCAD, Russia) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: BCD-089;Biological: Placebo;Drug: Methotrexat

Biocad

NULL

Active, not recruiting

18 Years

N/A

All

150

Phase 3

Russian Federation

118

EUCTR2019-000797-39-PL
(EUCTR)

18/11/2019

15/07/2019

Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China

119

EUCTR2019-000867-26-PL
(EUCTR)

15/11/2019

15/07/2019

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Phase 3

United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of

120

EUCTR2019-000868-18-PL
(EUCTR)

15/11/2019

11/07/2019

Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

121

EUCTR2019-000867-26-ES
(EUCTR)

14/11/2019

09/07/2019

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of

122

EUCTR2019-000868-18-ES
(EUCTR)

14/11/2019

26/07/2019

Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;Japan;China;Korea, Republic of

123

EUCTR2019-000797-39-ES
(EUCTR)

14/11/2019

09/07/2019

Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

1700

Phase 3

United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China

124

NCT04038970
(ClinicalTrials.gov)

November 8, 2019

29/7/2019

Efficacy and Safety Study of KN019 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KN019 in Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

Rheumatoid Arthritis

Biological: KN019, 5mg/kg;Biological: KN019, 10 mg/kg;Biological: Placebo;Combination Product: Methotrexate

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

NULL

Recruiting

18 Years

N/A

All

141

Phase 2

China

125

EUCTR2019-001185-15-SE
(EUCTR)

06/11/2019

01/07/2019

A double blind trial in two parts in people with active newly discovered rheumatoid arthritis. The experiment takes place in several hospitals. In order to better assess the mechanism of action of the active study drug AP1189, AP1189 is compared to an inactive substance (placebo). Which treatment the person should have is determined by random distribution (randomization). The purpose of the experiment is to investigate the safety of the new drug, how well it is tolerated and its effect

rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

SynAct Pharma ApS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Norway;Moldova, Republic of;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

126

EUCTR2019-001793-28-NL
(EUCTR)

05/11/2019

Adalimumab dose reduction aiming low drug levels with control of disease activity (ADDORA-LOW)

Adalimumab dose reduction aiming low serum concentration with control of disease activity (ADDORA-LOW) : a single blind, non-inferiority, randomised clinical trial - ADDORA-Low

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Reade

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

127

NCT04170504
(ClinicalTrials.gov)

November 2019

14/11/2019

Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis

Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial

Rheumatoid Arthritis

Drug: Qing Re Huo Xue (QRHX);Drug: Methotrexate;Drug: dummy Qing Re Huo Xue (QRHX)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

NULL

Not yet recruiting

18 Years

N/A

All

204

Phase 2;Phase 3

NULL

128

EUCTR2019-001554-25-NL
(EUCTR)

29/10/2019

Adalimumab dose optimization in rheumatoid arthritis using drug concentration in blood (ADDORA): multi-center open label randomized controlled trail

Adalimumab dose optimization in rheumatoid arthritis using therapeutic drug monitoring (ADDORA): multi-center open label randomized controlled trail - ADalimumab Dose Optimization in Rheumatoid Arthritis using (ADDORA)

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Reade

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

267

Phase 1;Phase 4

Netherlands

129

NCT04049448
(ClinicalTrials.gov)

October 24, 2019

6/8/2019

Study Evaluating the One-Year Safety and Efficacy of ABX464 in Patients With Moderate to Severe Rheumatoid Arthritis

A Follow-up Phase 2a Open-label Study to Evaluate the One-year Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ABX464

Abivax S.A.

NULL

Recruiting

18 Years

76 Years

All

Phase 2

Belgium;Czechia;France;Hungary;Poland

130

EUCTR2019-000867-26-HU
(EUCTR)

24/10/2019

28/10/2019

Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
Other descriptive name: TOFACITINIB CITRATE
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

131

EUCTR2019-000868-18-HU
(EUCTR)

24/10/2019

28/10/2019

A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3

Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan

132

EUCTR2019-000797-39-HU
(EUCTR)

24/10/2019

28/10/2019

Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.

Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China

133

NCT04130178
(ClinicalTrials.gov)

October 15, 2019

11/10/2019

Nerve Block of the Proximal Interphalangeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study

Nerve Block of the Proximal Interphalyngeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study

Rheumatoid Arthritis

Drug: Nerve block

Sohag University

NULL

Completed

18 Years

N/A

All

N/A

Egypt

134

EUCTR2019-001578-27-HU
(EUCTR)

15/10/2019

02/09/2019

Follow-up Phase 2a study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.

A follow-up Phase 2a open-label study to evaluate the one-year safety and efficacy profile of ABX464 in patients with moderate to severe active Rheumatoid Arthritis.

Rheumatoid Arthritis
MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]

Abivax

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary

135

EUCTR2019-000867-26-BG
(EUCTR)

11/10/2019

30/07/2019

Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Phase 3

Germany;China;Japan;Korea, Republic of;United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

136

EUCTR2019-000797-39-LT
(EUCTR)

11/10/2019

19/07/2019

Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.

Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) MONOCLONAL
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China

137

EUCTR2019-000867-26-EE
(EUCTR)

10/10/2019

01/08/2019

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Phase 3

United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of

138

EUCTR2018-003351-37-HU
(EUCTR)

07/10/2019

24/07/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

139

NCT04120831
(ClinicalTrials.gov)

October 7, 2019

4/10/2019

TOLERA: Tolerance Enhancement in RA

Sequential B Cell/T Cell Therapy to Re-induce Humoral Immune TOLErance in ACPA- Positive Rheumatoid Arthritis A Prospective, Randomized Controlled Open Label Single-centre Clinical Trial in Adult Subjects With Active ACPA-positive Rheumatoid Arthritis Failing Methotrexate

Rheumatoid Arthritis

Drug: Abatacept Injection

University of Erlangen-Nürnberg Medical School

NULL

Recruiting

18 Years

N/A

All

Phase 2

Germany

140

EUCTR2017-003037-28-NL
(EUCTR)

02/10/2019

22/07/2019

Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs.

Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs. - TOPIRA

RA patients with active RA despite treatment with csDMARDs and previous use of max 1 TNFi.
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

University Medical Center Utrecht

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

141

NCT04273334
(ClinicalTrials.gov)

October 1, 2019

15/2/2020

Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders

Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders, Including Lymphedema, Lymphangioma, Lymphangioleiomyomatosis, Plastic Bronchitis, Lymphadenopathy Caused by Rheumatoid Arthritis, Etc.

Lymphatic Disorders

Drug: 68Ga-NEB

Peking Union Medical College Hospital

NULL

Recruiting

18 Years

80 Years

All

Phase 1

China

142

NCT03194204
(ClinicalTrials.gov)

October 1, 2019

10/6/2017

Re-evaluation of Some Old Rheumatoid Arthritis Therapy: A Randomized Controlled Trial

Efficacy of Doxycycline as a Combination Therapy in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Doxycycline Tablets

Assiut University

NULL

Completed

18 Years

60 Years

All

160

N/A

Egypt

143

NCT04077567
(ClinicalTrials.gov)

October 1, 2019

29/8/2019

An Extension Study of TS-152 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: TS-152

Taisho Pharmaceutical Co., Ltd.

NULL

Active, not recruiting

20 Years

N/A

All

401

Phase 3

Japan

144

JPRN-JapicCTI-194932

01/10/2019

28/08/2019

An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : ozoralizumab
INN of the intervention : ozoralizumab
Dosage And administration of the intervention : Subcutaneous injection of TS-152 30mg or TS-152 80mg every 4 weeks
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Taisho Pharmaceutical Co.Ltd

NULL

complete

BOTH

505

Phase 3

Japan

145

ChiCTR1900026257

2019-09-28

A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue

Efficacy, dose comparison, and safety of Wisconsin Ginseng (Panax quinquefolius) in patients with rheumatoid arthritis associated fatigue: Three-arm parallel, multicenter, randomized, double-blind, placebo-controlled, phase 2 trial

Rheumatoid arthritis (RA)

High-dose experimental group :6000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;Low-dose experimental group:3000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg); 3000mg Placebo: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg) ;Control group :6000mg Placebo: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;

Zhejiang Provincal Hospital of TCM

NULL

Pending

Both

High-dose experimental group :30;Low-dose experimental group:30;Control group :30;

Phase 2

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

146

EUCTR2019-000868-18-CZ
(EUCTR)

20/09/2019

20/08/2019

Product Code: GSK3196165
INN or Proposed INN: Otilimab
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;Japan;China;Korea, Republic of

147

EUCTR2019-000797-39-CZ
(EUCTR)

19/09/2019

18/09/2019

Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China

148

EUCTR2018-004677-27-BE
(EUCTR)

16/09/2019

25/03/2019

Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.

Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy.

Rheumatoid Arthritis
MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

Abivax

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Belgium

149

EUCTR2019-000797-39-LV
(EUCTR)

13/09/2019

25/06/2019

Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.

Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Xeljanz
Product Name: Tofacitinib
INN or Proposed INN: Tofacitinib citrate
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China

150

EUCTR2018-003351-37-GR
(EUCTR)

13/09/2019

29/07/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis - RA-BRIDGE

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

151

NCT04472481
(ClinicalTrials.gov)

September 6, 2019

7/7/2020

Vitamin D Effect in Rheumatoid Arthritis.

Vitamin D: Does It Help Tregs in Active Rheumatoid Arthritis Patients.

Active Rheumatoid Arthritis

Drug: Ergocalciferol 1.25 mg tablet

Tanta University

NULL

Completed

33 Years

60 Years

All

Phase 4

Egypt

152

EUCTR2018-003351-37-ES
(EUCTR)

05/09/2019

16/09/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE

Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Lilly S.A

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

153

EUCTR2018-003351-37-PL
(EUCTR)

04/09/2019

09/08/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE

Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

154

NCT03971253
(ClinicalTrials.gov)

September 2, 2019

30/5/2019

Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis

Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis

Rheumatoid Arthritis (RA)

Drug: Peficitinib

Astellas Pharma Inc

NULL

Recruiting

N/A

All

3000

Japan

155

NCT04136262
(ClinicalTrials.gov)

September 1, 2019

21/10/2019

Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis

Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial

Rheumatoid Arthritis

Drug: Tripterygium wilfordii Hook F (TwHF);Drug: Methotrexate;Other: Dummy Tripterygium wilfordii Hook F (TwHF)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

NULL

Recruiting

N/A

Female

300

Phase 2;Phase 3

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

156

EUCTR2018-003351-37-NL
(EUCTR)

29/08/2019

08/07/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

157

EUCTR2018-003351-37-DK
(EUCTR)

29/08/2019

07/08/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

United States;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;South Africa;Germany;Netherlands

158

JPRN-JapicCTI-194928

26/8/2019

22/08/2019

-An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101

An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101

Rheumatoid Arthritis

Intervention name : methotrexate
INN of the intervention : methotrexate
Dosage And administration of the intervention : Part 1: 7.5 mg MJK101 (SC) or dummy MJK101 (SC) will be administered once a week over a period of 12 weeks. Part 2: All subjects will receive once-weekly MJK101 (SC) for 12 months. At Trial Week 12, the once-weekly dose of MJK101 (SC) will be determined according to the disease activity status of the subject and an assessment of safety. If the subject has not met a low disease activity status at the visits every 4 weeks and has been well tolerated, then the once-weekly MJK101 (SC) dose will be increased by 2.5 mg to a maximum dose of 15 mg.
Control intervention name : methotrexate
INN of the control intervention : methotrexate
Dosage And administration of the control intervention : Part 1: 8 mg MTX (oral) or placebo MTX (oral) will be administered once a week over a period of 12 weeks. The oral administration of MTX or placebo MTX will be divided into 2 doses to be administered approximately within a 12-hour interval.

medac GmbH

NULL

complete

BOTH

100

Phase 3

Japan

159

NCT04004429
(ClinicalTrials.gov)

August 26, 2019

26/6/2019

A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease

A Double-blind, Multicenter, Two-part, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of 4 Weeks Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients With Active Joint Disease

Rheumatoid Arthritis

Drug: 50 mg AP1189;Drug: AP1189;Drug: Placebo

SynAct Pharma Aps

NULL

Recruiting

18 Years

85 Years

All

Phase 2

Denmark;Norway

160

NCT04179513
(ClinicalTrials.gov)

August 15, 2019

25/11/2019

A Study to Evaluate the Safety and Tolerability of Multiple Doses of Gerilimzumab in Rheumatoid Arthritis Patients

Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Gerilimzumab for Injection in Combination With Oral Methotrexate in Rheumatoid Arthritis Patients in Two Dose Groups

Rheumatoid Arthritis

Biological: GB224 10mg;Biological: GB224 20mg

Genor Biopharma Co., Ltd.

NULL

Recruiting

18 Years

45 Years

All

Phase 1

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

161

EUCTR2018-003351-37-AT
(EUCTR)

13/08/2019

31/07/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE

Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

162

EUCTR2018-003351-37-GB
(EUCTR)

08/08/2019

16/05/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany

163

ChiCTR1900025013

2019-08-08

2019-08-07

Clinical observation of multiple dose use of tranexamic acid in patients with rheumatoid arthritis after total knee arthroplasty

Effects of multiple dose use of tranexamic acid on blood loss and inflammatory factors after total knee arthroplasty in patients with rheumatoid arthritis

Total knee arthroplasty

group 1:Intravenous infusion of 1g of tranexamic acid at 3 hours after surgery ;group 2:Intravenous infusion of 1g of tranexamic acid at 3, 6, and 12 hours after surgery;

Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai University of Traditional Chinese Medicine

NULL

Recruiting

Both

group 1:52;group 2:52;

Phase 4

China

164

EUCTR2018-004605-57-NL
(EUCTR)

06/08/2019

24/07/2019

Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients

Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients: a randomised, multicenter, non-inferiority trial (TODORA) - Use of TOcilizumab Drug levels to Optimize treatment in RA (TODORA)

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Reade

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1;Phase 4

Netherlands

165

EUCTR2018-003351-37-DE
(EUCTR)

02/08/2019

24/07/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

South Africa;Germany;Netherlands;United States;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Australia;Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

NCT04068246
(ClinicalTrials.gov)

August 1, 2019

21/8/2019

The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients

The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial.

Rheumatoid Arthritis

Drug: Metformin;Drug: Placebo

Sadat City University

NULL

Recruiting

18 Years

N/A

All

150

Early Phase 1

Egypt

167

NCT02418273
(ClinicalTrials.gov)

August 1, 2019

6/4/2015

Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders

Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study

Osteoporosis;Juvenile Rheumatoid Arthritis;Dermatomyositis;Polyarthritis;Systemic Lupus Erythematosis;Vasculitis;Glucocorticoid-induced Osteoporosis

Drug: denosumab

Indiana University

NULL

Withdrawn

4 Years

16 Years

All

Phase 1;Phase 2

United States

168

ChiCTR1900024902

2019-08-01

2019-08-03

A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis

Rheumatoid Arthritis

Experimental group:Traditional Chinese medicine (Yi-Shen Tong-Bi Tang);Positive control group:Methotrexate;

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

NULL

Pending

Both

Experimental group:50;Positive control group:50;

N/A

China

169

ChiCTR1900025021

2019-07-25

2019-08-07

Safety, Tolerance and Pharmacokinetics of Single Administration of Meloxicam Suspension Injection in Healthy Chinese Subjects

Osteoarthritis, rheumatoid arthritis

A:TR group: phase I: Meloxicam Suspension Injection (T) 7.5 mg, phase II: Mobi (R) 7.5 mg; RT group: phase I: R, phase II: T.;B:Meloxicam Suspension Injection 15 mg;C:Meloxicam Suspension Injection 30 mg;D:Meloxicam Suspension Injection 60 mg;

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

NULL

Recruiting

Both

A:12;B:12;C:12;D:12;

Phase 1

China

170

EUCTR2018-004677-27-HU
(EUCTR)

25/07/2019

Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.

Abivax

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

171

NCT04037111
(ClinicalTrials.gov)

July 23, 2019

25/7/2019

Clinical Study of Escitalopram Oxalate Combined With taVNS in Depression and Concomitant Inflammatory Symptoms

Clinical Study of Escitalopram Oxalate Combined With Transcutaneous Vagus Nerve Stimulation in the Treatment of Depression and Concomitant Inflammatory Symptoms

Major Depressive Disorder;Rheumatoid Arthritis

Device: Transcutaneous electrical vagus nerve stimulation;Device: Sham vagus nerve stimulation;Drug: drug treatment

Xijing Hospital

NULL

Recruiting

18 Years

65 Years

All

N/A

China

172

EUCTR2018-003330-32-PL
(EUCTR)

19/07/2019

06/05/2019

Efficacy and Safety of Oral SKI-O-703 in Refractory Rheumatoid Arthritis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies

Rheumatoid Arthritis Despite Treatment With Conventional Therapies
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Cevidoplenib
Product Code: SKI-O-703
INN or Proposed INN: Cevidoplenib

Oscotec Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

148

Phase 2

United States;Serbia;Czech Republic;Poland;Ukraine;Russian Federation;Korea, Republic of

173

EUCTR2018-003933-14-BE
(EUCTR)

19/07/2019

24/04/2019

A study evaluating the effect of filgotinib on sperm parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis.

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males with active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis or Non-radiographic Axial Spondyloarthritis.

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB

Galapagos NV

NULL

Not Recruiting

Female: no
Male: yes

250

Phase 2

Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina

174

ChiCTR1900024261

2019-07-15

2019-07-03

Efficacy and safety of sirolimus in new-onset rheumatoid arthritis: a prospective, double-blinded, randomized, placebo-controlled, monocentric study in China

rheumatoid arthritis

A:methotrexate (7.5~15 mg/week)+ placbo (1 mg/d);B:sirolimus (1 mg/d) + methotrexate (7.5~15 mg/week);

The Second Hospital of Shanxi Medical University

NULL

Pending

Both

A:30;B:30;

Phase 4

China

175

EUCTR2016-003682-26-PL
(EUCTR)

11/07/2019

17/05/2018

Phase 3 trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of patients suffering of Early Rheumatoid Arthritis

A Phase 3, Randomized, Double-Blind, Active- and Placebo controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis

Early Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: CF101
Product Code: CF101
INN or Proposed INN: Piclidenoson
Other descriptive name: IB-MECA
Product Name: CF101
Product Code: CF101
INN or Proposed INN: Piclidenoson
Other descriptive name: IB-MECA
Product Name: METHOTREXATE
Product Code: METHOTREXATE
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE

Can-Fite BioPharma, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

Serbia;Canada;Poland;Romania;Israel;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

176

NCT04464642
(ClinicalTrials.gov)

July 10, 2019

6/7/2020

Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Tofacitinib

Dr. Mohammad Mamun Khan

NULL

Active, not recruiting

18 Years

N/A

All

110

Phase 4

Bangladesh

177

EUCTR2019-000660-25-PL
(EUCTR)

09/07/2019

20/05/2019

Evaluating Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis

A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis

Moderate to Severe Active Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: CT-P17
Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB

CELLTRION, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Poland

178

NCT03813199
(ClinicalTrials.gov)

July 4, 2019

15/1/2019

Study of Two Doses of ABX464 in Participants With Moderate to Severe Rheumatoid Arthritis

Phase IIa Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to an Anti- Tumor Necrosis Factor Alpha (Tnfa) Therapy, or Intolerance to Anti-Tnfa Therapy

Rheumatoid Arthritis

Drug: ABX464 50mg;Drug: Matching Placebo;Drug: ABX464 100mg;Drug: Methotrexate

Abivax S.A.

NULL

Recruiting

18 Years

75 Years

All

Phase 2

Belgium;Czechia;France;Hungary;Poland

179

NCT04188249
(ClinicalTrials.gov)

July 1, 2019

27/6/2019

Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis

A Prospective Multicenter Registry of Golimumab in Chinese Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Golimumab

Peking Union Medical College Hospital

NULL

Recruiting

18 Years

80 Years

All

200

China

180

JPRN-UMIN000037359

2019/07/01

13/07/2019

Double-blind randomized comparison of femoral triangle block and adductor canal block for total knee arthroplasty

Double-blind randomized comparison of femoral triangle block and adductor canal block for total knee arthroplasty - Double-blind randomized comparison of femoral triangle block and adductor canal block for total knee arthroplasty

knee osteoarthritis or knee rheumatoid arthritis

Group ACB: Preoperative administration of 0.25% levobupivacaine 10 mL into the branch of femoral nerve at the apex of femoral triangle
Group FTB: Preoperative administration of 0.25% levobupivacaine 10 mL into the branch of femoral nerve at the midthigh level (midpoint between anterior superior iliac spine and upper edge of patella)

Daiyukai General Hospital

NULL

Complete: follow-up continuing

20years-old

100years-old

Male and Female

Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

181

EUCTR2018-003053-21-PL
(EUCTR)

27/06/2019

16/04/2019

A Clinical Study Testing the Safety, Properties, and Treatment Effects of an Antibody Drug Conjugate ABBV-3373 in Comparison with the Antibody Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects with Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: ABBV-3373
INN or Proposed INN: ABBV-3373
Trade Name: Humira (adalimumab)
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Puerto Rico;Poland;Israel

182

EUCTR2018-003933-14-BG
(EUCTR)

21/06/2019

27/03/2019

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Estonia;Czech Republic;Spain;Poland;Ukraine;Bulgaria;Latvia

183

NCT03912428
(ClinicalTrials.gov)

June 14, 2019

10/4/2019

Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis

Evaluation of Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis

Myositis

Drug: Celecoxib;Diagnostic Test: 11C-MC1;Diagnostic Test: 11C-ER176

National Institute of Mental Health (NIMH)

NULL

Recruiting

18 Years

N/A

All

Phase 4

United States

184

EUCTR2018-003877-91-DE
(EUCTR)

13/06/2019

26/02/2019

B cell therapy followed by T cell therapy to achieve immune tolerance in rheumatoid arthritis with ACPA antiboidies (TOLERA): an unblinded clinical trial in one centre with random assignment to treatment groups in adult patients who failed methotrexate therapy

Sequential B cell/T cell therapy to re-induce humoral immune tolerance in ACPA-positive Rheumatoid Arthritis (TOLERA): a prospective randomized controlled open-label single-centre clinical trial in adult subjects with active ACPA-positive Rheumatoid Arthritis failing Methotrexate - TOLERA

Active rheumatoid arthritis with ACPA antibodies failing methotrexate
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

INN or Proposed INN: RITUXIMAB
Trade Name: Orencia
INN or Proposed INN: ABATACEPT

Universitätsklinikum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

185

EUCTR2019-001185-15-DK
(EUCTR)

06/06/2019

12/04/2019

Product Code: AP1189
INN or Proposed INN: Not applicable

SynAct Pharma ApS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

186

EUCTR2018-004539-54-DE
(EUCTR)

03/06/2019

10/04/2019

Capability of Tofacitinib or Etanercept to accelerate clinical relevant dose reduction of non-steroidal anti-inflammatory drugs and treat-to-target guided minimization of intake of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy

Capability of Tofacitinib or Etanercept to accelerate clinical relevant tapering of non-steroidal anti-inflammatory drugs and treat-to-target guided de-escalation of corticosteroids in patients with active Rheumatoid Arthrtis and an inadequate response to previous csDMARD therapy - AcceleRAte

Patients with active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Xeljanz
Trade Name: Enbrel
Trade Name: Celebrex

Fraunhofer Fraunhofer Gesellschaft for its Fraunhofer Institute for Molecular Biology and Applied Ecology IME

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

192

Phase 4

Germany

187

NCT04344405
(ClinicalTrials.gov)

June 1, 2019

9/4/2020

Vitamin D as a Key Player in Rheumatoid Arthritis

Vitamin D as a Key Player in Rheumatoid Arthritis Immune Response

the Immunomodulatory Effect

Drug: Vitamin D;Drug: Placebo

Assiut University

NULL

Recruiting

20 Years

70 Years

All

Phase 3

Egypt

188

NCT04033809
(ClinicalTrials.gov)

May 30, 2019

16/7/2019

Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients

Effectiveness of High Fiber Multigrain Supplementation Among the Rheumatoid Arthritis Patients: A Randomized, Open Label Trial

Rheumatoid Arthritis

Dietary Supplement: Multigrain powder (S)

Universiti Sains Malaysia

NULL

Completed

21 Years

N/A

All

N/A

Malaysia

189

EUCTR2018-003933-14-CZ
(EUCTR)

28/05/2019

29/04/2019

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Germany;Latvia;Moldova, Republic of

190

EUCTR2018-003933-14-LV
(EUCTR)

27/05/2019

07/03/2019

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Latvia;Germany;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

191

EUCTR2018-004558-30-ES
(EUCTR)

16/05/2019

11/04/2019

Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.

rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

186

Phase 4

Spain

192

ChiCTR2000032534

2019-05-15

2020-05-01

Pharmacoeconomic evaluation of Anbainuo in the treatment of moderate to severe rheumatoid arthritis - a single center, control study

Rheumatoid arthritis

Experimental group:Anbainuo plus methotrexate;Control group:Methotrexate, salazopyridine, leflumide, hydroxychloroquine;

The Affiliated ZhuZhou Hospital Of XiangYa School Of Medicine CSU.

NULL

Completed

Both

Experimental group:47;Control group:43;

Phase 4

China

193

EUCTR2018-002306-31-GB
(EUCTR)

15/05/2019

14/02/2019

A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.

A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)

Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Code: ABBV-105
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Hungary;Czech Republic;Canada;Spain;Poland;Belgium;Germany;United Kingdom

194

NCT03823378
(ClinicalTrials.gov)

May 13, 2019

8/1/2019

A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib.

A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial With ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599)

Rheumatoid Arthritis (RA)

Drug: Upadacitinib;Drug: Upadacitinib placebo;Drug: ABBV-105 placebo;Drug: ABBV-105

AbbVie

NULL

Completed

18 Years

N/A

All

Phase 2

Belgium;Canada;Czechia;Hungary;Poland;Spain;United Kingdom

195

EUCTR2019-000505-72-NL
(EUCTR)

13/05/2019

18/02/2019

Baricitinib in patients suffering from Rheumatoid Arthritis

Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT)

Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Transparency in Healthcare

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

196

NCT03944096
(ClinicalTrials.gov)

April 30, 2019

8/5/2019

Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Rheumatoid Arthritis Refractory to Methotrexate

Efficacy and Safety of Faecal Microbiota Transplantation in Patients With Rheumatoid Arthritis Refractory to Methotrexate: a 24-week, Double-Blind, Randomised Trial

Rheumatoid Arthritis

Procedure: FMT+MTX

Peking Union Medical College Hospital

NULL

Recruiting

18 Years

65 Years

All

Phase 2

China

197

EUCTR2018-002306-31-BE
(EUCTR)

30/04/2019

07/02/2019

A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Hungary;Czech Republic;Canada;Spain;Poland;Belgium;United Kingdom

198

EUCTR2018-003933-14-ES
(EUCTR)

30/04/2019

21/05/2019

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Estonia;Spain;Ukraine;Russian Federation;India;Czech Republic;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Latvia;Moldova, Republic of;Bosnia and Herzegovina

199

EUCTR2018-003933-14-EE
(EUCTR)

09/04/2019

14/03/2019

Product Name: Filgotinib
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Czech Republic;Estonia;Spain;Poland;Ukraine;Bulgaria;Latvia

200

NCT03938636
(ClinicalTrials.gov)

April 8, 2019

24/4/2019

Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging

Rheumatoid Arthritis

Drug: TC99m-tilmanocept

Navidea Biopharmaceuticals

NULL

Recruiting

18 Years

N/A

All

105

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

201

NCT03816345
(ClinicalTrials.gov)

April 4, 2019

24/1/2019

Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer

A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)

Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Neoplasm

Biological: Nivolumab

National Cancer Institute (NCI)

NULL

Recruiting

18 Years

N/A

All

264

Phase 1

United States

202

EUCTR2018-002306-31-ES
(EUCTR)

04/04/2019

12/04/2019

A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.

Product Code: ABBV-105
INN or Proposed INN: ABBV-105
Other descriptive name: ABBV-105
Product Code: ABBV-105
INN or Proposed INN: ABBV-105
Other descriptive name: ABBV-105
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom

203

NCT03669367
(ClinicalTrials.gov)

April 1, 2019

26/7/2018

EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)

EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)

Palindromic Rheumatism, Wrist

Drug: Abatacept Injection;Drug: hydroxycloroquina

Fundacion Clinic per a la Recerca Biomédica

NULL

Not yet recruiting

18 Years

N/A

All

Phase 4

NULL

204

NCT03700021
(ClinicalTrials.gov)

April 2019

2/10/2018

Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis

Single-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs

Rheumatoid Arthritis

Drug: Abatacept + csDMARD

New York University School of Medicine

NULL

Not yet recruiting

18 Years

N/A

All

Phase 4

United States

205

NCT03823391
(ClinicalTrials.gov)

March 27, 2019

29/1/2019

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis (RA)

Drug: ABBV-3373;Drug: Placebo for ABBV-3373;Drug: Adalimumab;Drug: Placebo for adalimumab

AbbVie

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Germany;Hungary;Israel;Netherlands;Poland;Puerto Rico

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

206

EUCTR2018-002202-31-BG
(EUCTR)

27/03/2019

30/11/2018

A Phase 3 study to compare BAT1806 with RoActemra in patients with Rheumatoid Arthritis

A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BAT1806
INN or Proposed INN: BAT1806
Other descriptive name: TOCILIZUMAB
Trade Name: RoActemra
Product Name: RoActerma
INN or Proposed INN: RoActemra
Other descriptive name: TOCILIZUMAB

Bio-Thera Solutions, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

612

Phase 3

Poland;Ukraine;Georgia;Bulgaria;China

207

NCT03885037
(ClinicalTrials.gov)

March 20, 2019

4/3/2019

Infliximab Biosimilar for Intravenous Drip Infusion 100 mg Pfizer Drug Use Investigation (Rheumatoid Arthritis)

Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Rheumatoid Arthritis)

Rheumatoid Arthritis

Drug: Infliximab [infliximab biosimilar 3]

Pfizer

NULL

Recruiting

N/A

All

300

Japan

208

NCT04057118
(ClinicalTrials.gov)

March 20, 2019

13/8/2019

A Study to Evaluate the Effectiveness and Safety of SKI-O-703 in Patients Experiencing Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies.

Rheumatoid Arthritis

Drug: SKI-O-703;Drug: Placebo

Oscotec Inc.

NULL

Active, not recruiting

18 Years

N/A

All

148

Phase 2

United States;Czechia;Poland;Russian Federation;Ukraine

209

NCT03886038
(ClinicalTrials.gov)

March 15, 2019

2/1/2019

Subunit Vaccine Against Herpes Zoster in RA Patients Treated With JAK-inhibitors (VACCIMIL-ZOSTER)

The Immunogenicity and Efficacy of Subunit Vaccine Against Herpes Zoster in RA Treated With JAK-inhibitors (VACCIMIL-ZOSTER)

Rheumatoid Arthritis;Healthy Controls

Biological: Shingrix

Region Skane

NULL

Recruiting

18 Years

N/A

All

150

Phase 4

Sweden

210

ChiCTR1900021686

2019-03-15

2019-03-05

A observational study for iguratimod combined with methotrexate in remission or reversion bone erosion of rheumatoid arthritis

Rheumatoid arthritis

Case Series:IGU combined with MTX ;

Nanjing Drum Tower Hospital

NULL

Pending

Both

Case Series:30;

Phase 4

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

211

EUCTR2018-002306-31-HU
(EUCTR)

08/03/2019

11/02/2019

A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

Czech Republic;Hungary;Canada;Spain;Poland;Belgium;United Kingdom

212

ChiCTR1900021808

2019-03-08

2019-03-11

A Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male Subjects

Active rheumatoid arthritis

1:8 mg/kg QX003S ;2:Tocilizumab, 8 mg/kg;

JiangSu Qyuns Therapeutics Co., Ltd

NULL

Recruiting

Male

1:43;2:43;

Phase 1

China

213

NCT03858725
(ClinicalTrials.gov)

February 26, 2019

27/2/2019

Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteers

A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteer

Rheumatoid Arthritis

Drug: D569 Tab.;Drug: CKD-374 5mg Tab.

Chong Kun Dang Pharmaceutical

NULL

Completed

19 Years

54 Years

All

Phase 1

Korea, Republic of

214

NCT03852355
(ClinicalTrials.gov)

February 25, 2019

22/2/2019

the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis

the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled Trial

Rheumatoid Arthritis;Headache

Drug: Radiofrequency;Drug: Steroids

Assiut University

NULL

Completed

18 Years

60 Years

All

N/A

Egypt

215

NCT03868072
(ClinicalTrials.gov)

February 22, 2019

6/3/2019

Study to Evaluate the Bioequivalence of Pfizer Korea Inc. XELJANZ 5Mg Tablet in Healthy Volunteers

An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical Chong Kun Dang Tofacitinib Tablet and Pfizer Korea Inc. XELJANZ 5Mg Tablet in Healthy Volunteers

Rheumatoid Arthritis

Drug: XELJANZ 5Mg Tablet;Drug: Chong Kun Dang Tofacitinib Tablet

Chong Kun Dang Pharmaceutical

NULL

Completed

19 Years

N/A

All

Phase 1

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

216

EUCTR2018-000666-10-BE
(EUCTR)

19/02/2019

16/11/2018

A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy

A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Hungary;Czech Republic;Canada;Poland;Spain;Belgium;Germany;United Kingdom

217

NCT03737708
(ClinicalTrials.gov)

February 13, 2019

8/11/2018

A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)

Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial

Rheumatoid Arthritis (RA)

Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abatacept

Astellas Pharma Korea, Inc.

NULL

Completed

19 Years

75 Years

All

Phase 4

Korea, Republic of

218

EUCTR2018-001690-25-LT
(EUCTR)

08/02/2019

29/08/2018

Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 with Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis

Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

648

Phase 3

Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria

219

EUCTR2018-003162-13-IT
(EUCTR)

23/01/2019

08/11/2018

A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib

A Study to investigate Bone turnover Markers in patients planned to receive tofacitinib - WI232128

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Italy

220

EUCTR2018-000666-10-ES
(EUCTR)

23/01/2019

22/01/2019

Rheumatoid Arthritis
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

221

EUCTR2017-004543-20-ES
(EUCTR)

22/01/2019

25/10/2018

EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA).

EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA). - PALABA

PALINDROMIC RHEUMATISM;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Fundació Clínic per a la Recerca Biomèdica

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Spain

222

NCT03729349
(ClinicalTrials.gov)

January 15, 2019

1/11/2018

Golimumab for Adherence in Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: Golimumab

Janssen Inc.

NULL

Recruiting

18 Years

85 Years

All

300

Canada

223

NCT03981900
(ClinicalTrials.gov)

January 4, 2019

7/6/2019

IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis

IDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study.

Arthritis, Rheumatoid

Drug: Tofacitinib

Pfizer

NULL

Recruiting

18 Years

N/A

All

500

France

224

EUCTR2018-000666-10-HU
(EUCTR)

03/01/2019

29/10/2018

Product Code: ABBV-105
Other descriptive name: ABBV-105 , A-1519938.0
Product Code: ABBV-105
Other descriptive name: ABBV-105 , A-1519938.0
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Germany;United Kingdom

225

NCT04297475
(ClinicalTrials.gov)

January 1, 2019

13/7/2019

The Clinical Feasibilityof a Multi-modal Photoacoustic/Ultrasonic Imaging System in Rheumatoid Arthritis

The Clinical Feasibility and Added Value of a Multi-modal Photoacoustic/Ultrasonic Imaging System in the Evaluation of Rheumatoid Arthritis

Rheumatoid Arthritis;Ultrasonography

Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system

Peking Union Medical College Hospital

NULL

Recruiting

N/A

All

200

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

226

ChiCTR1800018338

2019-01-01

2018-09-12

A Clinical Trial for Human Gingiva Mesenchymal Stem Cells in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Control:Normal Saline iv. besides MTX treatment;Treatment:GMSC iv. besides MTX treatment;

theThird Affiliated Hospital of Sun Yat-sen University

NULL

Pending

Both

Control:123;Treatment:123;

I (Phase 1 study)

China

227

NCT03896594
(ClinicalTrials.gov)

December 24, 2018

28/3/2019

A Multiple Dose of HL237 in Healthy Male Subject

A Dose Block-randomized, Double-blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Oral Dose of HL237 in Healthy Male Subject

Rheumatoid Arthritis

Drug: HL237;Drug: Placebo Oral Tablet

Hanlim Pharm. Co., Ltd.

NULL

Recruiting

20 Years

45 Years

Male

Phase 1

Korea, Republic of

228

NCT03574545
(ClinicalTrials.gov)

December 19, 2018

21/6/2018

Study Comparing Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: ianalumab

Novartis Pharmaceuticals

NULL

Recruiting

18 Years

65 Years

All

Phase 1

Germany;Jordan

229

NCT03830203
(ClinicalTrials.gov)

December 19, 2018

22/1/2019

Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: BAT1806;Drug: Actemra (EU-licensed)

Bio-Thera Solutions

NULL

Active, not recruiting

18 Years

N/A

All

621

Phase 3

China

230

EUCTR2018-000666-10-GB
(EUCTR)

17/12/2018

24/10/2018

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Hungary;Czech Republic;Puerto Rico;Canada;Spain;Poland;Belgium;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

231

NCT03784261
(ClinicalTrials.gov)

December 17, 2018

17/12/2018

Usefulness of Non TNF Usage in RA Patients

Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: Drug: Salirumab;Drug: Drug: Tocilizmab;Drug: Drug: Abatacept

Shinshu University

NULL

Recruiting

20 Years

100 Years

All

Phase 2

Japan

232

EUCTR2018-001690-25-PL
(EUCTR)

11/12/2018

25/09/2018

Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis

Moderate to Severe Active Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

564

Phase 3

Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Korea, Republic of;Bosnia and Herzegovina

233

NCT04204603
(ClinicalTrials.gov)

November 30, 2018

17/12/2019

A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects With Moderate-to- Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: CKD-506;Drug: Placebo

Chong Kun Dang Pharmaceutical

NULL

Completed

18 Years

65 Years

All

122

Phase 2

Czechia;Georgia;Poland;Russian Federation;Ukraine

234

NCT03789292
(ClinicalTrials.gov)

November 26, 2018

27/12/2018

A Study to Compare Efficacy and Safety of CT-P17 With Humira in Patients With Active Rheumatoid Arthritis

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: CT-P17 SC;Biological: Humira SC

Celltrion

NULL

Active, not recruiting

18 Years

75 Years

All

564

Phase 3

Bulgaria

235

NCT03755466
(ClinicalTrials.gov)

November 21, 2018

21/11/2018

Examination of Efficacy and Safety of Baricitinib in RA Patients

Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib

Rheumatoid Arthritis

Drug: Baricitinib , olumiant®;Drug: Biologics;Drug: Tofacitinib 5 MG [Xeljanz]

Shinshu University

NULL

Recruiting

20 Years

N/A

All

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

236

NCT03980639
(ClinicalTrials.gov)

November 20, 2018

18/1/2019

Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase

Rheumatoid Arthritis

Drug: patient treated with DMARD

University Hospital, Toulouse

NULL

Recruiting

18 Years

N/A

All

594226

France

237

NCT03852888
(ClinicalTrials.gov)

November 14, 2018

7/2/2019

Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients

Rheumatoid Arthritis

Biological: Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level

CHU de Reims

NULL

Recruiting

18 Years

N/A

All

N/A

France

238

EUCTR2018-001690-25-HU
(EUCTR)

13/11/2018

14/08/2018

Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis

Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

564

Phase 3

Hungary;Poland;Ukraine;Lithuania;Peru;Russian Federation;Bulgaria;Bosnia and Herzegovina

239

NCT03707535
(ClinicalTrials.gov)

November 12, 2018

12/10/2018

To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: CT-P13;Biological: Remicade

Celltrion

NULL

Active, not recruiting

18 Years

75 Years

All

270

Phase 3

China

240

NCT03714022
(ClinicalTrials.gov)

November 9, 2018

18/10/2018

A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes

A Randomized, Open-Label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of the Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process Relative to the Current Abatacept Drug Process in Healthy Participants

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

55 Years

All

140

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

241

EUCTR2018-001690-25-BG
(EUCTR)

05/11/2018

19/09/2018

Evaluating efficacy and safety between CT-P17 and Humira when Co-administered with Methotrexate in Patients with Moderate to Severe Active Rheumatoid Arthritis

Product Code: CT-P17
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

648

Phase 3

Hungary;Poland;Ukraine;Lithuania;Peru;Bulgaria;Korea, Republic of

242

ChiCTR1800019277

2018-11-01

2018-11-02

The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients

Rheumatoid Arthritis

Control group:MTX;Treatment group 1:Zoledronate Acid(ZA);Treatment group 2:MTX+Zoledronate Acid;

Shanghai Traditional Medicine University Affiliated Guanghua Hospital

NULL

Recruiting

Both

Control group:22;Treatment group 1:22;Treatment group 2:22;

China

243

NCT04267614
(ClinicalTrials.gov)

November 1, 2018

11/2/2020

This Study is to Investigate the Effect of Etanercept in Early Versus Delayed Referral for Management of Rheumatoid Arthritis Patients.

Clinical Outcomes of Early Versus Delayed Management of Iraqi Patients With Rheumatoid Arthritis With Etanercept

Arthritis Rheumatoid

Drug: Etanercept

Pfizer

NULL

Completed

N/A

All

1226

Iraq

244

EUCTR2017-004226-15-DK
(EUCTR)

26/10/2018

05/01/2018

Can-Art Effect and safety of using Canabis derivatives for the treatment of pain in patients with inflammatory Arthritis, such as reumatoid arthritis and ankylosing spondylitis, the latter being a type of arthritis that causes a long term inflammation of the joints of the spine. A randomized, double blinded, placebo controlled trial, i.e. in this drug trial, a control group is given a placebo while another group is given the Cannabis derivative being studied.

CAN-ART The efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC) for the treatment of pain in patients with inflammatory arthritis (RA, AS). A randomized, double blinded, placebo controlled trial - Can-Art

Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

King Christian 10th Hospital for Rheumatology

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

Denmark

245

ChiCTR1900026079

2018-10-25

2019-09-20

Wangbi capsule combined methotrexate tablets for treatment of Rheumatoid Arthritis: A Randomized,Double-blind,Single analog,Positive Drug Parallel-group controlled clinical study

Rheumatoid Arthritis

Experimental group:Wangbi capsule combined methotrexate tablets;Control group:Simulation of Wangbi capsule combined methotrexate tablets;

Longhua Hospital Shanghai University of Traditional Chinese Medicine

NULL

Recruiting

Both

Experimental group:60;Control group:60;

Phase 4

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

246

NCT03718611
(ClinicalTrials.gov)

October 22, 2018

23/10/2018

To Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects

A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Oral Administration of BR9001 Compared With BR900A in Healthy Subjects

Rheumatoid Arthritis

Drug: BR9001;Drug: BR900A

Boryung Pharmaceutical Co., Ltd

NULL

Completed

19 Years

50 Years

All

Phase 1

Korea, Republic of

247

EUCTR2018-001377-24-CZ
(EUCTR)

09/10/2018

14/10/2019

Not available.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of CKD-506 Administered to Adult Subjects with Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Chong Kun Dang Pharmaceutical Corporation (CKD)

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Czech Republic;Poland;Ukraine;Russian Federation;Georgia

248

NCT03682705
(ClinicalTrials.gov)

October 8, 2018

21/9/2018

A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis.

A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs

Rheumatoid Arthritis (RA)

Drug: Upadacitinib;Drug: ABBV-105;Drug: Upadacitinib placebo;Drug: ABBV-105 placebo

AbbVie

NULL

Completed

18 Years

N/A

All

242

Phase 2

United States;Belgium;Canada;Czechia;Hungary;Poland;Puerto Rico;Spain;United Kingdom;Germany;Ireland

249

JPRN-JapicCTI-184031

02/10/2018

09/07/2018

A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy

Rheumatoid Arthritis (RA)

Intervention name : TS-152
INN of the intervention : ozoralizumab
Dosage And administration of the intervention : Subcutaneous injection every 4 weeks
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Taisho Pharmaceutical co., LTD

NULL

complete

BOTH

135

Phase 3

Japan

250

NCT03546335
(ClinicalTrials.gov)

October 1, 2018

30/4/2018

Zr-89 Cimzia PET Imaging Rheumatoid Arthritis

Zirconium-89 Certolizumab PET Imaging in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: 89Zr-DFO-CZP

Robert Flavell, MD, PhD

NULL

Suspended

18 Years

N/A

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

251

NCT03770923
(ClinicalTrials.gov)

October 1, 2018

7/12/2018

Effect of Some Drugs on Rheumatoid Arithritis Activity

Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis

Rheumatoid Arthritis

Drug: Rupatadine;Drug: Montelukast

Sherief Abd-Elsalam

NULL

Recruiting

18 Years

N/A

All

Phase 3

Egypt

252

NCT03770702
(ClinicalTrials.gov)

October 1, 2018

7/12/2018

Statins and ARBs on Rheumatoid Activity

Investigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian Patients

Rheumatoid Arthritis

Drug: Angiotensin receptor blockers;Drug: Statins

Sherief Abd-Elsalam

NULL

Recruiting

18 Years

65 Years

All

Phase 3

Egypt

253

NCT03593837
(ClinicalTrials.gov)

October 1, 2018

10/7/2018

Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis

A Multicenter, Randomized, Double-blind,Placebo-controlled Trial Evaluating the Efficacy and Safety of Huang Qi GuiZhi Wu Wu Tang Granulesin Patients With Rheumatoid Arthritis

Huang Qi Gui Zhi Wu Wu Granule;Rheumatoid Arthritis

Drug: Huang qi gui zhi wu wu granule;Drug: Huang qi gui zhi wu wu granule placebo

Cui xuejun

NULL

Unknown status

18 Years

80 Years

All

100

Phase 2;Phase 3

NULL

254

NCT03660059
(ClinicalTrials.gov)

September 27, 2018

26/8/2018

A Study to Assess Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)

A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTX

Rheumatoid Arthritis (RA)

Drug: Peficitinib;Drug: Plaebo;Drug: Disease-modifying antirheumatic drugs (DMARDs)

Astellas Pharma China, Inc.

NULL

Active, not recruiting

18 Years

N/A

All

385

Phase 3

China;Korea, Republic of;Taiwan

255

ChiCTR1800018637

2018-09-26

2018-09-30

Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis

rheumatoid arthritis

Gold Standard:Clinical outcome, meet the 2010 ACR/EULAR rheumatoid arthritis classification criteria.;Index test:Human epididymis protein 4,anti-cyclic citrullinated peptide, creatinine, rheumatoid factor;

Affiliated Hospital of North Sichuan Medical College

NULL

Recruiting

Both

Target condition:150;Difficult condition:100

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

256

NCT03691909
(ClinicalTrials.gov)

September 25, 2018

27/9/2018

A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis

A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: HB-adMSCs

Hope Biosciences

NULL

Completed

18 Years

65 Years

All

Phase 1;Phase 2

United States

257

NCT03699293
(ClinicalTrials.gov)

September 22, 2018

21/9/2018

NSAIDs vs. Coxibs in the Presence of Aspirin

NSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects With Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular Disease

Rheumatoid Arthritis;Cardiovascular Diseases

Drug: celecoxib 200mg capsule;Drug: naproxen sodium 550mg tablet;Drug: Aspirin 81mg tablet

Inova Health Care Services

NULL

Unknown status

18 Years

75 Years

All

Phase 4

United States

258

EUCTR2018-001114-15-NL
(EUCTR)

18/09/2018

28/05/2018

Predicting the risk for rheumatoid arthritis with the help of a PET scan.

Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis. - Early diagnostics in RA

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

VU Medical Center, department of Rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

259

JPRN-JapicCTI-184229

12/9/2018

03/12/2018

Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe

Investigation of the Risk of Hypocalcemia in Patients With Rheumatoid Arthritis Who Were Treated for the First Time With Pralia Subcutaneous Injection 60 mg Syringe -Medical Information Database Network-based Cohort Study-

Rheumatoid Arthritis

Intervention name : PRALIA 60mg Subcutaneous Injection Syringe(denosumab)
INN of the intervention : denosumab
Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

DAIICHISANKYO Co., Ltd.

NULL

other

BOTH

2000

Japan

260

NCT03701789
(ClinicalTrials.gov)

September 11, 2018

4/10/2018

Effect of Baricitinib Treatment on Peripheral Bone in RA

Evaluation of Bone Quality in Patients With Rheumatoid Arthritis Treated With Baricitinib: Single Centre, Mode of Action Study (BARE BONE)

Rheumatoid Arthritis;Bone Density;Finger Joints

Drug: Baricitinib

University of Erlangen-Nürnberg Medical School

NULL

Recruiting

18 Years

74 Years

All

Phase 3

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

261

JPRN-JapicCTI-184029

04/9/2018

09/07/2018

A Phase II/III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to Methotrexate (MTX) Therapy

Rheumatoid Arthritis (RA)

Intervention name : TS-152
INN of the intervention : ozoralizumab
Dosage And administration of the intervention : Subcutaneous injection every 4 weeks
Control intervention name : Placebo
INN of the control intervention : Placebo
Dosage And administration of the control intervention : Usage: Subcutaneous injection every 4 weeks, Dosage: No active ingredients contain

Taisho Pharmaceutical co., LTD

NULL

complete

BOTH

370

Phase 2;Phase 3

Japan

262

NCT03605251
(ClinicalTrials.gov)

August 30, 2018

3/7/2018

Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.

An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: TAS5315 low dose;Drug: TAS5315 high dose;Drug: Placebos

Taiho Pharmaceutical Co., Ltd.

NULL

Completed

20 Years

64 Years

All

Phase 2

Japan

263

EUCTR2015-004386-91-PL
(EUCTR)

26/08/2018

20/07/2016

Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis.

A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs

Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Poland;Germany

264

NCT03636984
(ClinicalTrials.gov)

August 24, 2018

13/8/2018

Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World

Efficacy and Safety Study of Anbainuo in Chinese Patients With Rheumatoid Arthritis/ Ankylosing Spondylitis in the Real World: a Prospective, Open-label, Multi-center Observational Study

Rheumatoid Arthritis;Ankylosing Spondylitis

Drug: recombinant TNF-a receptor: IgG Fc fusion protein

Zhejiang Hisun Pharmaceutical Co. Ltd.

NULL

Not yet recruiting

18 Years

N/A

All

1000

NULL

265

NCT03580681
(ClinicalTrials.gov)

August 22, 2018

26/6/2018

A Nutrition Intervention for Arthritis -4 (WCCR-ARTH4)

A Nutrition Intervention for Arthritis-4

Rheumatoid Arthritis

Other: Plant-based diet;Dietary Supplement: Supplement

Physicians Committee for Responsible Medicine

NULL

Active, not recruiting

18 Years

90 Years

All

N/A

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

266

NCT04056039
(ClinicalTrials.gov)

August 14, 2018

21/6/2019

Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity in Patients With Rheumatoid Arthritis.

Efficacy of Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity as a Biomarker of Myocardial Damage in Patients With Rheumatoid Arthritis With Severe Activity.

Cardiovascular Diseases;Arthritis, Rheumatoid

Drug: Atorvastatin;Drug: Colchicine

Hospital Central Dr. Ignacio Morones Prieto

NULL

Completed

18 Years

N/A

All

Phase 2

Mexico

267

EUCTR2017-004079-30-PT
(EUCTR)

09/08/2018

29/06/2018

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU

Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: Rituximab
Other descriptive name: Rituximab
Trade Name: RoActmera
Product Name: RoActmera
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB SC
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

207

Phase 3

Portugal;Belgium;Spain;Italy

268

EUCTR2018-002368-18-ES
(EUCTR)

25/07/2018

Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load

1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.2. breast and lung cancer undertreated by chemotherapy3. HIV4. Haematopoietic progenitor cell transplantation (TCPH).
MedDRA version: 20.0;Level: PT;Classification code 10006187;Term: Breast cancer;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 20.0;Classification code 10058467;Term: Lung neoplasm malignant;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 20.1;Classification code 10020161;Term: HIV infection;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.0;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Fendrix suspension for injection
Product Name: Fendrix
Product Code: Fendrix
INN or Proposed INN: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Other descriptive name: HEPATITIS B VACCINE (RDNA)
Trade Name: HBVAXPRO 5 micrograms/0.5 ml
Product Name: HBVAXPRO ® 40 micrograms
Product Code: HBVAXPRO ® 40 micrograms
INN or Proposed INN: HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA)
Other descriptive name: HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN)

FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

740

Phase 4

Spain

269

NCT03618784
(ClinicalTrials.gov)

July 11, 2018

24/7/2018

Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: FURESTEM-RA Inj;Other: sterile saline

Kang Stem Biotech Co., Ltd.

NULL

Recruiting

19 Years

80 Years

All

Phase 1;Phase 2

Korea, Republic of

270

EUCTR2017-004079-30-ES
(EUCTR)

10/07/2018

21/03/2018

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

Rhuematoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: Rituximab
Other descriptive name: Rituximab
Trade Name: RoActmera
Product Name: RoActmera
Trade Name: Enbrel
Product Name: Enbrel

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

207

Phase 3

Portugal;Belgium;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

271

NCT03445871
(ClinicalTrials.gov)

July 2, 2018

20/2/2018

Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate

Rheumatoid Arthritis

Biological: Blood sample;Diagnostic Test: CRQ

Centre Hospitalier Universitaire de Saint Etienne

NULL

Completed

18 Years

N/A

All

Phase 4

France

272

NCT03589833
(ClinicalTrials.gov)

July 2018

5/7/2018

Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA

Effectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Tripterygium Wilfordii;Drug: Methotrexate;Drug: Yisaipu

Peking Union Medical College Hospital

NULL

Unknown status

18 Years

65 Years

All

504

Phase 2

China

273

EUCTR2016-002344-16-GB
(EUCTR)

28/06/2018

29/11/2017

Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency.

Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification. - TEEMS

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

University of Leeds

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

106

Phase 4

United Kingdom

274

JPRN-UMIN000033059

2018/06/20

20/06/2018

The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial

The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial - The impact of including corticosteroid in a periarticular injection for pain control after total hip arthroplasty: a double blind randomized controlled trial

Osteoarthritis of the hip, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture

A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty
A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total hip arthroplasty

Hokusuikai Kinen Hospital

NULL

Complete: follow-up complete

18years-old

Not applicable

Male and Female

120

Not selected

Japan

275

NCT03550833
(ClinicalTrials.gov)

June 13, 2018

28/5/2018

Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model

Arthritis, Rheumatoid;Stress Disorder

Behavioral: Questionnaire;Biological: blood sample

University Hospital, Bordeaux

NULL

Completed

18 Years

N/A

All

152

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

276

NCT03606876
(ClinicalTrials.gov)

June 13, 2018

12/7/2018

Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects

A Randomized, Double-blinded, Single-dose, 3-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT1806 Injection vs Actemra® in Healthy Chinese Male Subjects

Rheumatoid Arthritis

Drug: BAT1806 injection

Bio-Thera Solutions

NULL

Unknown status

18 Years

55 Years

Male

138

Phase 1

China

277

NCT03535402
(ClinicalTrials.gov)

June 1, 2018

9/5/2018

Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics

Measurement of the Structural Efficacy in Active Rheumatoid Arthritis (RA) Patients Treated With Sarilumab in Combination With Methotrexate (MTX) and Naive to Biologics as Measured by Low-field MRI Using a Modified OMERACT-RAMRIS Score.

Rheumatoid Arthritis

Drug: Sarilumab

Gaylis, Norman B., M.D.

NULL

Active, not recruiting

18 Years

N/A

All

Phase 3

United States

278

NCT03559686
(ClinicalTrials.gov)

May 30, 2018

5/6/2018

Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Aarthritis (RA)

Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Arthritis (RA) Who Participated in Open Label Studies C87015, C87028 and C87051

Rheumatoid Arthritis

Drug: Certolizumab Pegol

UCB Biopharma S.P.R.L.

NULL

Available

18 Years

N/A

All

NULL

279

NCT03522415
(ClinicalTrials.gov)

May 28, 2018

29/4/2018

Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Moderately to Severely Active Rheumatoid Arthritis

Drug: HLX01;Drug: Methotrexate (MTX)

Shanghai Henlius Biotech

NULL

Completed

18 Years

75 Years

All

275

Phase 3

China

280

NCT03410056
(ClinicalTrials.gov)

May 22, 2018

3/1/2018

Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis

A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy

Rheumatoid Arthritis RA

Drug: AMG 592;Drug: Placebo

Amgen

NULL

Terminated

18 Years

70 Years

All

Phase 1;Phase 2

United States;Bulgaria;Germany;Poland;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

281

EUCTR2017-001944-36-ES
(EUCTR)

21/05/2018

10/10/2017

Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis

A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy

Product Name: AMG592
INN or Proposed INN: AMG 592
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

137

Phase 1;Phase 2

United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom

282

NCT03492658
(ClinicalTrials.gov)

May 17, 2018

3/4/2018

Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA)

Abatacept to Silence Anti-citrullinated Protein Antibody-expressing B Cells in Rheumatoid Arthritis (ASCARA).

Rheumatoid Arthritis;Rheumatic Diseases

Drug: Abatacept;Drug: Methotrexate

Leiden University Medical Center

NULL

Recruiting

18 Years

N/A

All

Phase 4

Netherlands

283

NCT03508713
(ClinicalTrials.gov)

May 13, 2018

4/6/2017

Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND)

Long-term Prognosis and Quality of Life in Early Rheumatoid Arthritis Patients Treated by 2015 ACR Guideline (LELAND): a Multicenter Prospective Observational Study in Southern China

Rheumatoid Arthritis

Drug: disease modified antirheumatic drugs or biological agents

Nanfang Hospital of Southern Medical University

Southern Medical University, China

Not yet recruiting

18 Years

N/A

All

200

NULL

284

EUCTR2016-000933-37-BG
(EUCTR)

09/05/2018

12/01/2018

Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)

A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

United States;Belarus;Portugal;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden

285

EUCTR2017-004054-41-BE
(EUCTR)

07/05/2018

15/03/2018

COBRA-Slim with or without fast access to TNF blockade for remission induction in early RA

CareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. - CareRA2020

early active Rheumatoid Arthritis, previously untreated with DMARDs
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

University Hospitals Leuven

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

440

Phase 4

Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

286

EUCTR2016-002569-68-GB
(EUCTR)

04/05/2018

18/05/2018

Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease

Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease: A feasibility study - APRIL

Rheumatoid-associated Interstitial Lung Disease (RA-ILD)
MedDRA version: 20.0;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT

Cambridge University Hospitals NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United Kingdom

287

ChiCTR1800015615

2018-05-01

2018-04-11

Clinical observation of the protective effect of iguratimod on rheumatoid arthritis

Rheumatoid Arthritis

first:MTX;second:MTX in combination with Irammod;third:MTX and LEF;fourth:MTX, LEF and Irammod;

Tianjin First Central Hospital

NULL

Pending

Both

first:30;second:30;third:30;fourth:30;

China

288

NCT03435601
(ClinicalTrials.gov)

April 18, 2018

31/1/2018

A Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)

A Randomised, Double-blind, Placebo-controlled Phase II Study to Target the Type I IFN Receptor by Administrating Anifrolumab in RA Patients With a High IFN Signature (TarIFNiRA)

Rheumatoid Arthritis

Drug: Anifrolumab;Drug: Placebos

Josef Smolen, Univ. Prof. Dr.

NULL

Recruiting

18 Years

70 Years

All

Phase 2

Austria

289

JPRN-UMIN000030575

2018/03/31

26/12/2017

Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. - Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT.

Rheumatoid arthritis

Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6.
Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.

Daiichi Sankyo Company, Limited

NULL

Complete: follow-up continuing

20years-old

Not applicable

Male and Female

Not applicable

Japan

290

NCT03478111
(ClinicalTrials.gov)

March 30, 2018

16/3/2018

CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis

A Randomized, Double-blind, Methotrexate (MTX) Based, Parallel-group, Multicenter Phase III Study to Evaluate Efficacy and Safety of CMAB008 in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis, Compared to Remicade

Rheumatoid Arthritis

Drug: CMAB008;Drug: MTX;Drug: Remicade

Shanghai Biomabs Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

N/A

All

390

Phase 3

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

291

JPRN-UMIN000031890

2018/03/21

25/03/2018

Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty

Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty - Triple-masked randomized comparison of 5mL or 20mL levobupivacaine to femoral triangle block for total knee arthroplasty

knee osteoarthritis or knee rheumatoid arthritis

Group LV(Low volume): preoperative femoral triangle block with 0.5% levobupivacaine 5mL
Group HV(High volume): preoperative femoral triangle block with 0.125% levobupivacaine 20mL

Daiyukai General Hospital

NULL

Recruiting

20years-old

100years-old

Male and Female

120

Phase 3

Japan

292

EUCTR2017-001944-36-BG
(EUCTR)

13/03/2018

24/10/2017

Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis

A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy

Product Name: AMG592
INN or Proposed INN: N/A
Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

153

Phase 1;Phase 2

United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;United Kingdom;New Zealand

293

ChiCTR1800014872

2018-03-01

2018-02-12

Role of parecoxib sodium in the multimodal analgesia after total knee arthroplasty

Safety and efficacy of parecoxib sodium in the multimodal analgesia after total knee arthroplasty: a prospective randomized controlled trial

osteoarthritis or rheumatoid arthritis

Experimental group:Preoperative intravenous injection of parecoxib sodium and postoperative intravenous patient-controlled analgesia;Control group:Preoperative normal saline injection and postoperative intravenous patient-controlled analgesia;

Peking Union Medical College Hospital

NULL

Pending

Both

Experimental group:50;Control group:50;

China

294

NCT03100253
(ClinicalTrials.gov)

March 1, 2018

17/3/2017

Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation

Open-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNF

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Golimumab;Drug: Certolizumab Pegol

Mario Negri Institute for Pharmacological Research

NULL

Recruiting

18 Years

N/A

All

208

Phase 4

Italy

295

ChiCTR1800014584

2018-03-01

2018-01-22

Clinical efficacy of small dose aspirin in the prevention of deep venous thrombosis and pulmonary embolism after total knee arthroplasty.

Knee osteoartritis;Rheumatoid arthritis

Experimental group:Asprin;Controlled group:Rivaroxaban;

Department of Orthopaedics, West China Hospital, Sichuan University

NULL

Pending

100

Both

Experimental group:90;Controlled group:30;

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

296

JPRN-UMIN000031692

2018/03/01

12/03/2018

Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty

Efficacy and Safety of repeated administration of intravenous acetaminophen injection for pain management after total knee arthroplasty - Efficacy of intravenous acetaminophen injection for pain management after TKA

knee osteoarthritis rheumatoid arthritis

Study group:Fentanyl sustained intravenous administration given after operation end. And use the Intravenous acetaminophen 4 times per 6 hour.Dosage is 15 mg/kg for the patient less than 50 kg in weight and 1000 mg for the patient more than 50 kg in weight.
Control group:Fentanyl sustained intravenous administration given after operation end.

Yamaguchi University

NULL

Recruiting

20years-old

Not applicable

Male and Female

Not selected

Japan

297

EUCTR2017-004079-30-BE
(EUCTR)

19/02/2018

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

219

Phase 3

Portugal;Spain;Belgium;Italy

298

EUCTR2017-004348-39-FR
(EUCTR)

15/02/2018

16/01/2018

Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients

Association between methotrexate erythrocyte polyglutamate concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate - POLYGLU

rheumatoid arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: methotrexate
Product Code: 1

CHU Saint-Etienne

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

France

299

JPRN-UMIN000030760

2018/02/09

09/02/2018

A pilot study of a simple navigation system for artificial hip joint surgery using augmented reality technology

Hip joint disease scheduled for total hip arthroplasty(THA) (Osteoarthritis, Rheumatoid Arthritis, Femoral head necrosis, Femoral neck fracture)

Using patient specific guide linked with 3D surgical support software for THA

National Hospital Organization Nagoya Medical Center

NULL

Complete: follow-up continuing

20years-old

Not applicable

Male and Female

Not selected

Japan

300

EUCTR2016-003630-25-NL
(EUCTR)

08/02/2018

06/09/2017

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

2640

Phase 3

United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

301

EUCTR2017-002878-38-NL
(EUCTR)

07/02/2018

12/09/2017

Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis

Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis - ASCARA

Patients with early, methotrexate-naïve, ACPA-positive rheumatoid arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000018818;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Orencia 125 mg
INN or Proposed INN: ABATACEPT

Leiden University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

302

NCT03455842
(ClinicalTrials.gov)

February 1, 2018

22/2/2018

The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis

International Multicenter Comparative Randomized Double-blind Placebo-controlled Clinical Study of Efficacy and Safety of BCD-089 in Different Dosing Regimens in Patients With Active Rheumatoid Arthritis

Seropositive RA

Biological: BCD-089, 162 mg, s/c, qw;Biological: BCD-089, 162 mg, s/c, q2w;Drug: placebo

Biocad

NULL

Completed

18 Years

80 Years

All

105

Phase 2

Belarus;Russian Federation

303

NCT04022525
(ClinicalTrials.gov)

February 1, 2018

15/7/2019

Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches

Rheumatoid Arthritis

Drug: Leflunomide 20Mg Tab

Assiut University

NULL

Completed

18 Years

N/A

All

Egypt

304

NCT03430388
(ClinicalTrials.gov)

January 31, 2018

30/1/2018

Yellow Fever Vaccine in Patients With Rheumatic Diseases

Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area

Systemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile Dermatomyositis

Biological: Yellow Fever vaccine (17D)

University of Sao Paulo General Hospital

NULL

Completed

2 Years

60 Years

All

600

N/A

Brazil

305

NCT01694693
(ClinicalTrials.gov)

January 31, 2018

24/9/2012

Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study

Rheumatoid Arthritis

Drug: Orencia

Bristol-Myers Squibb

NULL

Withdrawn

18 Years

N/A

All

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

306

EUCTR2017-002753-11-FI
(EUCTR)

25/01/2018

08/11/2017

The effect of the new anti-rheumatic drug tofacitinib on cytokine-induced inflammatory pathways in patients with rheumatoid arthritis

The effect of tofacitinib on the activity of JAK-STAT pathways in patients with rheumatoid arthritis (RA) - TofaSTAT17

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Tampere University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Finland

307

NCT03227419
(ClinicalTrials.gov)

January 22, 2018

19/7/2017

Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate Responders

Abatacept Versus Tocilizumab by Subcutaneous Administration for the Treatment of Rheumatoid Arthritis in TNF Alpha Inhibitor Inadequate Responder Patients: A Randomized, Open-labeled, Superiority Trial

Arthritis, Rheumatoid

Drug: Tocilizumab Prefilled Syringe;Drug: Abatacept Prefilled Syringe

Lille Catholic University

NULL

Recruiting

18 Years

N/A

All

224

Phase 4

France

308

NCT03368235
(ClinicalTrials.gov)

January 18, 2018

3/11/2017

Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 Compared to Prednisolone 20 mg in Patients With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: AZD9567;Drug: Prednisolone

AstraZeneca

NULL

Completed

18 Years

80 Years

All

Phase 2

Netherlands;Sweden;Denmark

309

JPRN-UMIN000030828

2018/01/15

15/01/2018

The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis.

Rheumatoid ArthritisOsteoporosis

zoledronic acid
denosumab

Osaka City University Graduate School of Medicine

NULL

Recruiting

20years-old

Not applicable

Male and Female

500

Not selected

Japan

310

ChiCTR1800014404

2018-01-11

Evaluation of clinical curative effect of Bushen Quhan Wang Decoction in the treatment of kidney deficiency and cold dampness syndrome of rheumatoid arthritis

rheumatoid arthritis

treatment group :MTX+traditional Chinese medicine ;control group :MTX;

China-Japan Friendship Hospital

NULL

Recruiting

Both

treatment group :36;control group :36;

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

311

EUCTR2017-003259-40-ES
(EUCTR)

04/01/2018

24/10/2017

Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.

Patients with rheumatoid arthritis with high clinical activity and chronical peirodontitis moderate-severe.
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: amoxicilina
INN or Proposed INN: AMOXICILLIN
Product Name: metronidazol
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: metronidazol

Dra Beatriz Lozano-Hospital Universitario de Canarias

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 4

Spain

312

NCT02955212
(ClinicalTrials.gov)

January 3, 2018

2/11/2016

A Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study With Upadacitinib (ABT-494) in Subjects From China and Selected Countries With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs)

Rheumatoid Arthritis (RA)

Drug: Upadacitinib;Drug: Placebo

AbbVie

NULL

Completed

18 Years

N/A

All

338

Phase 3

Brazil;China;Korea, Republic of

313

JPRN-UMIN000030237

2018/01/01

03/12/2017

Additional postoperative intravenous tranexamic acid administration versus placebo administration for patients treated with intraoperative combined intravenous and intra-articular tranexamic acid in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial

Osteoarthritis of the knee, rheumatoid arthritis, avascular necrosis

Additional postoperative intravenous tranexamic acid group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. In addition, patients received 1000mg/100mL of tranexamic acid administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery.
Placebo group: Patients received 1000 mg of tranexamic acid administered intravenously just before skin incision and 1000 mg of tranexamic acid administered intra-articularly after closure of the capsule and retinaculum. Patients received 100 mL of normal saline administered intravenously 6 hours after the first intravenous administration of tranexamic acid, and 08:00 and 20:00 one day after surgery.

Hokusuikai Kinen Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

100

Not selected

Japan

314

NCT02795299
(ClinicalTrials.gov)

January 2018

2/5/2016

Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFa Antagonist Failed in Rheumatoid Arthritis

Phase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFa Antagonist

Rheumatoid Arthritis

Drug: Gerilimzumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Placebo

Bird Rock Bio, Inc.

Techtrials Pesquisa e Tecnologia Ltda;Pharmagenix

Withdrawn

18 Years

80 Years

All

Phase 2

NULL

315

NCT04312815
(ClinicalTrials.gov)

December 28, 2017

16/3/2020

A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX

A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severely Active Rheumatoid Arthritis Receiving Methotrexate

Rheumatoid Arthritis(RA)

Drug: SM03;Drug: Placebo;Drug: MTX

SinoMab Pty Ltd

NULL

Recruiting

18 Years

70 Years

All

510

Phase 3

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

316

JPRN-jRCTs031180050

26/12/2017

07/12/2018

Hydroxychloroquine for Japanese patients with rheumatoid arthritis

Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis

Rheumatoid arthritis;D001172

Treatment with hydroxychloroquine for 24 weeks

Kaneko Yuko

NULL

Recruiting

>= 18age old

Not applicable

Both

120

Japan

317

EUCTR2017-001970-41-DK
(EUCTR)

21/12/2017

15/09/2017

Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial

Dose reduction and discontinuation of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months randomised, open label, parallel-group, multi-centre trial - The BIODOPT trial (BIOlogical Dose OPTimisation)

Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis
MedDRA version: 21.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 21.0;Classification code 10062719;Term: Seronegative rheumatoid arthritis;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10076297;Term: Non-radiographic axial spondyloarthritis;System Organ Class: 100000004859
MedDRA version: 21.1;Classification code 10041672;Term: Spondylitis ankylosing;Classification code 10002557;Term: Ankylosing spondylitis and other inflammatory spondylopathies;Classification code 10045966;Term: Unspecified inflammatory spondylopathy;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

MD, PhD Salome Kristensen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 4

Denmark

318

NCT03457792
(ClinicalTrials.gov)

December 19, 2017

13/2/2018

A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis

Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Recruiting

18 Years

N/A

All

400

Germany

319

EUCTR2014-000555-93-ES
(EUCTR)

18/12/2017

10/10/2017

Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia

Diagnosis of Initial phase of Rheumatoid Arthritis with arthralgia for at least 6 weeks without signs of joints swelling but with presence of ACPA antibodies and signs of joints swelling detected in MRI.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: ORENCIA
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Universitätsklinikum Erlangen

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Czech Republic;Brazil;Spain;Germany

320

EUCTR2017-001717-92-AT
(EUCTR)

11/12/2017

17/08/2017

A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in patients with rheumatoid arthritis who have a high interferon signature (TarIFNiRA)

A randomised, double-blind, placebo-controlled Phase II study to target the type I IFN receptor by administrating Anifrolumab in RA patients with a high IFN signature (TarIFNiRA) - TarIFNiRA

High IFN siganture in patients with rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Anifrolumab (MEDI-546)
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: ANIFROLUMAB

Medical University of Vienna

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Austria;Switzerland;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

321

EUCTR2017-001944-36-PL
(EUCTR)

23/11/2017

11/10/2017

Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis

A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy

Product Name: AMG 592
INN or Proposed INN: AMG592
Other descriptive name: AMG592

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

153

Phase 1;Phase 2

United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom

322

NCT03334851
(ClinicalTrials.gov)

November 17, 2017

3/11/2017

Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis

A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS

Systemic Lupus Erythematosus;Rheumatoid Arthritis

Drug: PF-06835375;Drug: Placebo

Pfizer

NULL

Recruiting

18 Years

70 Years

All

112

Phase 1

United States;Puerto Rico

323

NCT03911830
(ClinicalTrials.gov)

November 11, 2017

1/10/2018

Aerobic Exercise Program Followed by Cold Water Immersion: Effects on Arthritis Patients Arterial Stiffness

Effects of an Aerobic Exercise Program on Cycloergometer Followed by Cold Water Immersion Recovery in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis;Cryotherapy Effect;Physical Activity

Other: Exercise followed cold water immersion

Centre Hospitalier Universitaire de Besancon

NULL

Completed

20 Years

80 Years

All

N/A

France

324

EUCTR2017-003425-15-DK
(EUCTR)

10/11/2017

12/09/2017

Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian)

Treatment of synovitis among rheumatoid arthritis patients
MedDRA version: 21.0;Level: PT;Classification code 10042868;Term: Synovitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 4

Denmark

325

EUCTR2017-000838-64-NL
(EUCTR)

10/11/2017

13/06/2017

An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)

Product Code: AZD9567 monohydrate
INN or Proposed INN: AZD9567
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: Prednisolone

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

326

NCT04178070
(ClinicalTrials.gov)

November 6, 2017

24/11/2019

Phase ? Clinical Trial of Gerilimzumab Injection in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled, Single Dose, Dose-escalated Phase ? Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Gerilimzumab in Healthy Adult Subjects.

Rheumatoid Arthritis

Biological: GB224 2mg;Biological: GB224 5mg;Biological: GB224 10mg;Biological: GB224 15mg;Biological: GB224 20mg;Biological: GB224 30mg;Other: Placebo, 2mg;Other: Placebo, 5mg;Other: Placebo, 10mg;Other: Placebo, 15mg;Other: Placebo, 20mg;Other: Placebo, 30mg

Genor Biopharma Co., Ltd.

NULL

Recruiting

18 Years

45 Years

All

Phase 1

China

327

NCT03357471
(ClinicalTrials.gov)

November 3, 2017

23/11/2017

Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease

A Multicenter, Open-Label Study to Evaluate the Safe and Effective Use of an Electro-Mechanical Injection Device (E-Device) for the Subcutaneous Self-Injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease

Moderate and Severe Active Rheumatoid Arthritis;Active Psoriatic Arthritis;Active Ankylosing Spondylitis;Moderately to Severely Active Crohn's Disease

Drug: e-Device

UCB Biopharma S.P.R.L.

NULL

Completed

18 Years

N/A

All

Phase 3

United States

328

NCT03329885
(ClinicalTrials.gov)

November 2, 2017

31/10/2017

A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis

A Double-Blind Randomized Placebo-Controlled Single and Multiple Ascending Doses Study of the Safety and Tolerability, Pharmacokinetics (Including Bioavailability Comparison and Food Effect) and Pharmacodynamics of Oral BMS-986251 Administration in Healthy Subjects, With Efficacy Assessment of Multiple Doses in Patients With Moderate-to-Severe Psoriasis

Rheumatoid Arthritis;Psoriasis;Ankylosing Spondylitis;Inflammatory Bowel Diseases;Nonalcoholic Steatohepatitis

Drug: BMS-986251;Other: Placebo

Bristol-Myers Squibb

NULL

Terminated

18 Years

70 Years

All

Phase 1;Phase 2

Netherlands

329

NCT03387423
(ClinicalTrials.gov)

November 2, 2017

7/12/2017

Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis

ESCALATE-RA A NON-INTERVENTIONAL STUDY OF CRITICAL FACTORS FOR ESCALATING DRUG TREATMENT IN PATIENTS TREATED WITH TOFACITINIB FOR MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS

Arthritis, Rheumatoid

Drug: Tofacitinib

Pfizer

NULL

Recruiting

18 Years

N/A

All

1500

Germany

330

EUCTR2017-000384-32-BG
(EUCTR)

02/11/2017

12/07/2017

Phase IIb in Rheumatoid Arthritis

A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A

Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: Evobrutinib
Other descriptive name: M2951

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

363

Phase 2

United States;Serbia;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;Bulgaria;South Africa;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

331

JPRN-UMIN000029797

2017/11/02

02/11/2017

Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial

Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial - Intravenous versus combined intravenous and intra-articular tranexamic acid for simultaneous bilateral total hip arthroplasty: randomized controlled trial

Osteoarthritis of the hip, Avascular necrosis of the femoral head, Rheumatoid arthritis

The combined tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first hip. After closure of fascia, 1000 mg of tranexamic acid (10 mL of 100 mg/mL tranexamic acid) was administered intra-articularly for each hip. Five hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously.
The intravenous tranexamic acid group received 1000 mg of tranexamic acid administered intravenously just before skin incision of the first hip. After closure of the fascia, 10 mL of normal saline was administered intra-articularly for each hip. Five hours after the first intravenous administration of tranexamic acid, 1000 mg of tranexamic acid was again given intravenously.

Hokusuikai Kinen Hospital

NULL

Complete: follow-up complete

18years-old

Not applicable

Male and Female

Not selected

Japan

332

JPRN-JapicCTI-173747

01/11/2017

25/10/2017

Specific Use Result Survey of PRALIA 60 mg Subcutaneous Injection Syringe - A Long-term Use Survey in Patients with Rheumatoid Arthritis -

Rheumatoid Arthritis

Intervention name : PRALIA 60 mg Subcutaneous Injection Syringe(denosumab)
Dosage And administration of the intervention : For adults under normal conditions, 60 mg of denosumab (genetic recombination) is injected subcutaneously every six months. If bone erosion progression occurs when denosumab is injected once every 6 months, denosumab can be injected subcutaneously once every 3 months.

DAIICHISANKYO Co., Ltd.

NULL

recruiting

BOTH

1000

NULL

333

JPRN-UMIN000029759

2017/11/01

01/11/2017

Percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty as a component of multimodal pain management: a randomized control trial

Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis

Percutaneous periarticular analgesic injection including methylprednisolone 80 mg [2 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.2 mg [0.2 mL] at one day after simultaneous bilateral total knee arthroplasty
No percutaneous periarticular analgesic injection at one day after simultaneous bilateral total knee arthroplasty

Nekoyama Miyao Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

334

NCT03440892
(ClinicalTrials.gov)

November 1, 2017

14/2/2018

Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients

Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin

Rheumatoid Arthritis

Drug: methotrexate;Drug: sulfasalazine;Drug: abatacept;Drug: tocilizumab;Drug: tofacitinib /baricitinib

Vastra Gotaland Region

NULL

Recruiting

20 Years

N/A

All

2500

Sweden

335

NCT02647762
(ClinicalTrials.gov)

October 30, 2017

16/12/2015

CF101 Therapy Compared to Methotrexate Therapy for Active Rheumatoid Arthritis

A Phase 3, Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CF101 1 mg;Drug: CF101 2 mg;Drug: Placebo;Drug: MTX

Can-Fite BioPharma

NULL

Active, not recruiting

18 Years

75 Years

All

525

Phase 3

Bosnia and Herzegovina;Canada;Israel;Moldova, Republic of;Poland;Romania;Serbia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

336

NCT03337815
(ClinicalTrials.gov)

October 28, 2017

22/10/2017

A Specification Clinical Application Research of Tripterygium Wilfordii Treating Rheumatoid Arthritis

A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of Tripterygium Wilfordii Treating Rheumatoid Arthritis and Establish A Prediction Model

Rheumatoid Arthritis

Drug: Treatment of MTX and TwHF placebo;Drug: Treatment of TwHF and MTX placebo

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

NULL

Recruiting

45 Years

70 Years

All

264

Phase 2;Phase 3

China

337

NCT03324412
(ClinicalTrials.gov)

October 28, 2017

25/10/2017

Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis

A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Treatment of MTX;Drug: Treatment of MTX and TwHF

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

NULL

Not yet recruiting

45 Years

70 Years

All

216

Phase 2;Phase 3

NULL

338

NCT03288584
(ClinicalTrials.gov)

October 27, 2017

16/9/2017

Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis

The Effect of Inhibition of Interleukin-6 Activity on Vascular, Endothelial and Left Ventricular Function in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis;Inflammation

Drug: Tocilizumab (Actemra®);Drug: Other biological agent;Drug: Corticosteroid and non-biological agents.

University of Athens

NULL

Recruiting

18 Years

80 Years

All

Greece

339

EUCTR2016-002126-36-IT
(EUCTR)

26/10/2017

31/01/2018

A study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO7123520 AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-a INHIBITORS

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: RO7123520
Product Code: RO7123520 /F03-01

F. Hoffmann - Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

204

Phase 2

United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy

340

EUCTR2017-000149-30-GB
(EUCTR)

25/10/2017

05/09/2017

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease - TRAIL1

Rheumatoid arthritis associated interstitial lung disease (RA-ILD);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

University Hospitals of Leicester NHS Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

United States;Canada;Australia;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

341

EUCTR2016-004834-11-GB
(EUCTR)

23/10/2017

16/08/2017

A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis

Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: CR6086
Other descriptive name: CR0686
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: CR6086
Other descriptive name: CR6086
Trade Name: Methotrexate ® 2.5mg Tablets
Product Name: Methotrexate ® 2.5mg Tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE 2.5 mg tablets

Rottapharm Biotech S.r.l.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom

342

NCT04178850
(ClinicalTrials.gov)

October 13, 2017

25/11/2019

Clinical Comparative Study to Evaluate the Efficacy and Safety of Recombinant Anti-TNF-alpha Antibodies for Injection

A Randomized, Double-blind, Multi-center Phase ? Comparative Study to Evaluate the Efficacy and Safety of Recombinant Human-mouse Chimeric Anti-TNF-alpha Monoclonal Antibody for Injection.

Rheumatoid Arthritis

Biological: GB242;Biological: Infliximab

Genor Biopharma Co., Ltd.

NULL

Recruiting

18 Years

45 Years

All

568

Phase 3

China

343

NCT03163966
(ClinicalTrials.gov)

October 5, 2017

8/5/2017

A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis

A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Oral CR6086 Administered at the Doses of 30, 90 or 180 mg Bid for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis, DMARD-naive and Early Disease Patients

Drug: CR6086;Drug: Methotrexate;Drug: Placebo

Rottapharm Biotech

NULL

Recruiting

18 Years

N/A

All

240

Phase 2

Czechia

344

JPRN-UMIN000029003

2017/10/01

05/09/2017

Percutaneous periarticular analgesic injection at one day after total knee arthroplasty as a component of multimodal pain management: a randomized control trial

Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis

Percutaneous periarticular analgesic injection including methylprednisolone 40 mg [1 mL], ropivacaine 150 mg [20 mL], and epinephrine 0.1 mg [0.1 mL] at one day after total knee arthroplasty
No percutaneous periarticular analgesic injection at one day after total knee arthroplasty

Nekoyama Miyao Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

345

NCT03257852
(ClinicalTrials.gov)

September 29, 2017

20/8/2017

A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate

A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate

Rheumatoid Arthritis (RA)

Drug: ASP5094;Drug: Placebo;Other: Methotrexate therapy

Astellas Pharma Inc

NULL

Completed

20 Years

N/A

All

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

346

NCT03312465
(ClinicalTrials.gov)

September 28, 2017

12/10/2017

Anatomical Shoulder Domelock System Study

Anatomical Shoulder™ Domelock System A Multicenter, Prospective, Non-Controlled Post-Market Clinical Follow-up Study

Advanced Wear and Tear of the Shoulder Joint;Avascular Necrosis;Conditions Consequent to Earlier Operations;Omarthrosis;Rheumatoid Arthritis;Revision of Shoulder Prosthesis

Device: AS Domelock System

Zimmer Biomet

NULL

Recruiting

18 Years

80 Years

All

123

Belgium;Germany;Switzerland;United Kingdom

347

EUCTR2016-005017-45-PL
(EUCTR)

27/09/2017

19/06/2017

A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis

A Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an anti-Toll Like Receptor 4 Monoclonal Antibody in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: NI-0101
Product Code: NI-0101
INN or Proposed INN: N/A
Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody

NovImmune S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina

348

EUCTR2016-004300-65-BE
(EUCTR)

26/09/2017

20/01/2017

Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®).

rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: 99mTc-S-HYNIC Certolizumab pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL

Ghent University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 4

Belgium

349

EUCTR2017-000384-32-CZ
(EUCTR)

26/09/2017

26/07/2017

Phase IIb in Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

363

Phase 2

Serbia;United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;South Africa;Bulgaria;Germany;Japan

350

EUCTR2012-003655-11-FR
(EUCTR)

18/09/2017

28/09/2015

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

moderately to severely active rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 2

United States;Spain;Guatemala;Ukraine;Austria;Russian Federation;Israel;Chile;Colombia;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

351

NCT03262740
(ClinicalTrials.gov)

September 11, 2017

24/8/2017

The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients

The Effect of BMS-986195 on the Pharmacokinetics of a Combined Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Subjects

Rheumatoid Arthritis

Drug: BMS-986195;Drug: Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol)

Bristol-Myers Squibb

NULL

Completed

18 Years

40 Years

Female

Phase 1

United States

352

EUCTR2017-000838-64-SE
(EUCTR)

11/09/2017

19/05/2017

An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)

Product Name: AZD9567
Product Code: AZD9567 monohydrate
INN or Proposed INN: N/A
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: -

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

353

EUCTR2016-004834-11-PL
(EUCTR)

05/09/2017

17/07/2017

A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Rottapharm Biotech S.r.l.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of

354

EUCTR2016-004834-11-BG
(EUCTR)

04/09/2017

01/06/2017

A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Rottapharm Biotech S.r.l.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of

355

NCT04177173
(ClinicalTrials.gov)

September 1, 2017

7/4/2019

Methotrexate and Statins With Methotrexate Alone in the Treatment of Rheumatoid Arthritis

Comparison of Combination of Methotrexate and Statins With Methotrexate Alone as an Anti-inflammatory Agent in the Treatment of Rheumatoid Arthritis.

Arthritis, Rheumatoid

Drug: Simvastatin 20 mg;Drug: Methotrexate 10 mg

King Edward Medical University

NULL

Completed

18 Years

N/A

All

100

Phase 4

Pakistan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

356

NCT03254966
(ClinicalTrials.gov)

September 2017

15/8/2017

Study of SHR0302 Tablets (SHR0302) as Monotherapy in Active Rheumatoid Arthritis (RA) Patients

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Assess the Safety and Efficacy of SHR0302 in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: SHR0302;Drug: Placebo

Jiangsu HengRui Medicine Co., Ltd.

NULL

Not yet recruiting

18 Years

70 Years

All

170

Phase 2

China

357

NCT03241446
(ClinicalTrials.gov)

September 2017

25/7/2017

Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)

A Phase I, Open-Label Study to Investigate the Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Tilmanocept

Navidea Biopharmaceuticals

NULL

Withdrawn

30 Years

65 Years

All

Phase 1

NULL

358

EUCTR2017-000838-64-DK
(EUCTR)

25/08/2017

13/06/2017

An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone

A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)

Product Code: AZD9567 monohydrate
INN or Proposed INN: N/A
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: -

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

359

EUCTR2017-000947-41-FR
(EUCTR)

18/08/2017

21/06/2017

ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS.

ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTAR

Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor.
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie
Trade Name: RoActemra 162 mg solution injectable en seringue préremplie

Groupement des Hôpitaux de l’Institut Catholique de Lille

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France

360

EUCTR2016-004834-11-CZ
(EUCTR)

16/08/2017

02/08/2017

A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Rottapharm Biotech S.r.l.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

361

NCT03160001
(ClinicalTrials.gov)

August 15, 2017

11/5/2017

Niclosamide With Etanercept in Rheumatoid Arthritis

Adjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical Study

Rheumatoid Arthritis (RA)

Drug: Placebo;Drug: Niclosamide;Drug: Etanercept

Faiq Gorial

NULL

Completed

18 Years

N/A

All

110

Phase 1;Phase 2

Iraq

362

NCT03245515
(ClinicalTrials.gov)

August 15, 2017

8/8/2017

A Study of BMS-986195 in Healthy Male Subjects

Pharmacokinetics and Metabolism of [14C] BMS-986195 in Healthy Male Subjects

Rheumatoid Arthritis

Drug: BMS-986195

Bristol-Myers Squibb

NULL

Completed

18 Years

55 Years

Male

Phase 1

Netherlands

363

NCT03156023
(ClinicalTrials.gov)

August 14, 2017

15/5/2017

Multiple Ascending Doses of AMG 570 in Subjects With Rheumatoid Arthritis

A Randomized, Double Blind Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Subcutaneous Doses of AMG 570 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AMG 570;Drug: Placebo

Amgen

NULL

Completed

18 Years

75 Years

All

Phase 1

United States;Germany

364

EUCTR2016-003630-25-DE
(EUCTR)

14/08/2017

13/04/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand

365

NCT03327454
(ClinicalTrials.gov)

August 10, 2017

11/10/2017

Benepali® PEN Patient Satisfaction Survey

Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen

Rheumatoid Arthritis;Spondyloarthropathies

Biological: Benepali

Biogen

NULL

Completed

18 Years

N/A

All

500

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

366

EUCTR2013-005543-90-EE
(EUCTR)

07/08/2017

02/06/2017

This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable

Product Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: rituximab
Other descriptive name: ABP 798 Biosimilar to Rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

367

NCT03188081
(ClinicalTrials.gov)

August 4, 2017

12/6/2017

A Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous (SC) Abatacept

A Prospective, Multicentric, Observational Study to Investigate the Effectiveness of an Education Support Program on Medication Adherence in Italian Real Life RA Patients Treated With Abatacept SC

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Recruiting

18 Years

N/A

All

300

Italy

368

EUCTR2015-005309-35-LV
(EUCTR)

04/08/2017

19/05/2017

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis

A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4

Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

R-Pharm

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1880

Phase 3

United States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Germany;Latvia;Korea, Republic of

369

NCT03155347
(ClinicalTrials.gov)

August 2, 2017

15/5/2017

An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy

A Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD Therapy

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to Tocilizumab

Hoffmann-La Roche

NULL

Recruiting

18 Years

70 Years

All

340

Phase 3

China

370

NCT03250767
(ClinicalTrials.gov)

August 1, 2017

11/8/2017

Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

A Post-Market, Prospective, Multi-Center, Open-Label, Single Arm Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

Osteo Arthritis Shoulders;Traumatic Arthritis;Rheumatoid Arthritis

Device: Integra Titan Modular Shoulder System 2.5

Integra LifeSciences Corporation

NULL

Recruiting

18 Years

N/A

All

140

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

371

EUCTR2016-003630-25-BE
(EUCTR)

01/08/2017

12/04/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand

372

NCT03215407
(ClinicalTrials.gov)

August 1, 2017

22/6/2017

The Comparative Study of Intra-articular Injection of Tocilizumab and Compound Betamethasone

The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee

Rheumatoid Arthritis of Knee

Drug: Intra-articular Tocilizumab;Drug: Intra-articular Compound Betamethasone

Chinese PLA General Hospital

NULL

Not yet recruiting

18 Years

65 Years

All

Phase 4

NULL

373

EUCTR2016-002126-36-ES
(EUCTR)

31/07/2017

02/06/2017

A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors

A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors

Product Name: RO7123520
Product Code: RO7123520 /F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

204

Phase 2

United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy

374

JPRN-UMIN000028376

2017/07/26

01/08/2017

Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis

Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis - Study of ultrasound detected residual synovitis in rheumatoid arthritis

rheumatoid arthritis

Combination of anti-rheumatic therapy and denosumab
Anti-rheumatic therapy alone

Hokkaido Medical Center for Rheumatic Diseases

NULL

Complete: follow-up complete

20years-old

75years-old

Male and Female

Not selected

Japan

375

NCT02541955
(ClinicalTrials.gov)

July 20, 2017

1/9/2015

Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

Use of Acthar in Rheumatoid Arthritis Related Flares

Rheumatoid Arthritis (RA)

Drug: Acthar

Dr. Veena Ranganath

NULL

Recruiting

18 Years

N/A

All

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

376

EUCTR2016-003630-25-GB
(EUCTR)

19/07/2017

15/08/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

United States;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand

377

EUCTR2016-001064-11-GB
(EUCTR)

18/07/2017

31/03/2017

Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis

A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Nichi-Iko Pharmaceutical Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

585

Phase 3

United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom

378

EUCTR2016-000569-21-NL
(EUCTR)

18/07/2017

29/06/2017

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

379

EUCTR2016-000568-41-NL
(EUCTR)

18/07/2017

29/06/2017

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

380

JPRN-jRCT2071200057

08/07/2017

25/11/2020

Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects; Multicenter study

A Phase I, Randomized, Single-Blind, Multicenter, Parallel-Group, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-006 Study

Rheumatoid arthritis;D001172

Experimental: FKB327 (Adalimumab biosimilar)
Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1.
Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug

Active Comparator: US licenced Adalimumab
Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1.
Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug

Yazawa Rie

NULL

Complete

>= 20age old

< 45age old

Male

130

Phase 1

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

381

EUCTR2016-002125-11-ES
(EUCTR)

06/07/2017

08/05/2017

Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

258

Phase 1;Phase 3

Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of;Estonia;Slovakia;Spain;Ukraine

382

EUCTR2016-004834-11-DK
(EUCTR)

06/07/2017

11/05/2017

A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Rottapharm Biotech S.r.l.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom

383

NCT03189017
(ClinicalTrials.gov)

July 3, 2017

12/6/2017

A Phase I Study of ICP-022 in Healthy Subjects

A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose

Systemic Lupus Erythematosus;Rheumatoid Arthritis

Drug: ICP-022;Drug: Placebos

Innocare Pharma Australia Pty Ltd

NULL

Completed

18 Years

55 Years

Male

Phase 1

Australia

384

NCT03285191
(ClinicalTrials.gov)

July 3, 2017

29/6/2017

Subject Insights to Understand Rheumatoid Arthritis (RA)

Patient Interviews to Better Understand Disease Experience and Unmet Treatment Needs in Rheumatoid Arthritis

Arthritis, Rheumatoid

Other: Numerical rating scale;Other: Real-time data capture app

GlaxoSmithKline

NULL

Completed

18 Years

N/A

All

United Kingdom

385

ChiCTR-IPR-17011566

2017-07-01

2017-06-05

The efficacy and safety of sirolimus in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China

Rheumatoid Arthritis;M05.901

Sirolimus group: Sirolimus; Non-Sirolimus group:Glucocorticoids and Immunosuppressant;

the Second Hospital of Shanxi Medical University

NULL

Recruiting

Both

Sirolimus group:200; Non-Sirolimus group:100;

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

386

NCT03394131
(ClinicalTrials.gov)

July 1, 2017

25/12/2017

?Efficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients

Treatment of Carpal Tunnel in Rheumatoid Arthritis

Treatment Resistant Carpal Tunnel in RA Patients

Drug: Hylase;Drug: Insulin;Other: saline

Assiut University

NULL

Unknown status

20 Years

80 Years

All

N/A

Egypt

387

EUCTR2016-001825-15-IT
(EUCTR)

28/06/2017

16/02/2018

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION - A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREAT

Product Name: Tofacitinb
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE

PFIZER INC

NULL

Not Recruiting

Female: yes
Male: yes

580

Phase 3

Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Germany;Italy

388

ChiCTR-INR-17011772

2017-06-27

2017-06-28

The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents

Rheumatoid Arthritis

test group:Metformin tablets, 0.25g, 3 / day, oral, atorvastatin tablets 10mg, 1 / night, oral;;Control group:Traditional DMARDs group;

Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated Hospital

NULL

Recruiting

Both

test group:80;Control group:40;

China

389

EUCTR2016-001825-15-DE
(EUCTR)

26/06/2017

01/03/2017

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, New York

NULL

Not Recruiting

Female: yes
Male: yes

580

Phase 3;Phase 4

United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of

390

NCT03278470
(ClinicalTrials.gov)

June 26, 2017

7/9/2017

A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject

A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single Oral Dose of HL237 in Healthy Male Subject

Rheumatoid Arthritis

Drug: HL237;Drug: Placebo Oral Tablet

Hanlim Pharm. Co., Ltd.

NULL

Completed

20 Years

45 Years

Male

Phase 1

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

391

EUCTR2015-005309-35-BG
(EUCTR)

22/06/2017

02/05/2017

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis

Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

R-Pharm International, LLC.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1880

Phase 3

United States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of

392

NCT03239080
(ClinicalTrials.gov)

June 19, 2017

1/8/2017

Effect of Denosumab in Erosion Healing in RA

Effect of RANKL Inhibition on Healing of Bone Erosion in Rheumatoid Arthritis Using HR-pQCT

Rheumatoid Arthritis

Drug: Denosumab;Other: Placebo

Chinese University of Hong Kong

NULL

Completed

18 Years

N/A

All

110

Phase 2

China

393

EUCTR2016-000933-37-NL
(EUCTR)

19/06/2017

18/04/2017

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

313

Phase 3

Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden

394

EUCTR2015-002887-17-FR
(EUCTR)

19/06/2017

16/02/2016

Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis

Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects with Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate with or without TNF Inhibitors

Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

610

Phase 2

United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of

395

EUCTR2015-005309-35-GB
(EUCTR)

16/06/2017

09/06/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis

R-Pharm

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1880

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

396

EUCTR2016-005017-45-GB
(EUCTR)

15/06/2017

27/10/2017

A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

NovImmune S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina

397

EUCTR2016-000933-37-SK
(EUCTR)

15/06/2017

24/04/2017

Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)

A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

313

Phase 3

Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden

398

EUCTR2016-003630-25-SK
(EUCTR)

15/06/2017

04/04/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3068

Phase 3

United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan

399

JPRN-UMIN000027719

2017/06/12

12/06/2017

Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy.

rheumatoid arthritis/remission

add-on iguratimod
tapering MTX
continuing the treatment

Osaka Medical College

NULL

Recruiting

20years-old

100years-old

Male and Female

100

Not selected

Japan

400

EUCTR2016-003630-25-ES
(EUCTR)

09/06/2017

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

401

EUCTR2016-000569-21-FR
(EUCTR)

08/06/2017

04/11/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Moderately to severely active rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

402

EUCTR2016-003630-25-PL
(EUCTR)

07/06/2017

24/04/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand

403

EUCTR2016-002337-30-HR
(EUCTR)

05/06/2017

12/09/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Poland;Romania;Croatia;Australia;Bulgaria;Georgia;Germany;Korea, Republic of;Bosnia and Herzegovina

404

NCT03139136
(ClinicalTrials.gov)

May 30, 2017

26/4/2017

Safety, Tolerability and Efficacy of MBS2320 in Patients With Rheumatoid Arthritis

A 12-Week, Double-Blind, Placebo-Controlled, Phase 2a Study to Investigate the Safety, Tolerability and Efficacy of MBS2320 in Patients With Active Rheumatoid Arthritis Receiving Methotrexate

Rheumatoid Arthritis

Drug: MBS2320;Drug: Placebo

Modern Biosciences plc

NULL

Completed

18 Years

75 Years

All

121

Phase 2

Georgia;Moldova, Republic of;Romania

405

EUCTR2016-003630-25-HU
(EUCTR)

29/05/2017

12/04/2017

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan;United States;Taiwan;Hong Kong

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

406

EUCTR2016-002337-30-DE
(EUCTR)

24/05/2017

06/02/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

269

Phase 2

407

EUCTR2015-005309-35-DE
(EUCTR)

23/05/2017

24/01/2017

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis

Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038

R-Pharm International LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1880

Phase 3

United States;Belarus;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of

408

EUCTR2015-005309-35-PL
(EUCTR)

19/05/2017

17/03/2017

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis

R-Pharm International LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1880

Phase 3

409

JPRN-UMIN000027250

2017/05/15

08/05/2017

Precision medicine of methotrexate in the patients with rheumatoid arthritis

Rheumatoid arthritis

MTX administration

Keio UniversityFukuoka Tokushukai Hospital

NULL

Complete: follow-up complete

20years-old

90years-old

Male and Female

Not selected

Japan

410

NCT03193957
(ClinicalTrials.gov)

May 15, 2017

19/6/2017

An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

An Open-label, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept;Device: Autoinjector

Samsung Bioepis Co., Ltd.

NULL

Completed

18 Years

55 Years

All

Phase 2

Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

411

NCT03131973
(ClinicalTrials.gov)

May 13, 2017

25/4/2017

Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

Effects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy Participants

Rheumatoid Arthritis

Drug: BMS-986195;Drug: Methotrexate;Drug: Leucovorin;Drug: Caffeine;Drug: Montelukast;Drug: Flurbiprofen;Drug: Omeprazole;Drug: Midazolam;Drug: Digoxin;Drug: Pravastatin

Bristol-Myers Squibb

NULL

Completed

18 Years

50 Years

All

Phase 1

United States

412

EUCTR2016-005017-45-HU
(EUCTR)

12/05/2017

13/03/2017

A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 19.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: NI-0101
Product Code: NI-0101
INN or Proposed INN: N/A
Other descriptive name: Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody

NovImmune S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina

413

EUCTR2016-005017-45-BG
(EUCTR)

11/05/2017

06/04/2017

A study to explore the effect of a new antibody to treat patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

NovImmune S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Hungary;Poland;Georgia;Bulgaria;Moldova, Republic of;United Kingdom;Bosnia and Herzegovina

414

NCT03241108
(ClinicalTrials.gov)

May 10, 2017

26/6/2017

Study of an Anti-TLR4 mAb in Rheumatoid Arthritis

Randomized, Placebo-Controlled, Double Blind, Multicenter Phase 2 Study to Explore Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Intravenous Multiple Infusions of NI-0101, an Anti-Toll Like Receptor 4 Monoclonal Antibody in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: NI-0101;Other: Placebo

NovImmune SA

NULL

Completed

18 Years

N/A

All

Phase 2

Bosnia and Herzegovina;Bulgaria;Georgia;Hungary;Moldova, Republic of;Poland;Serbia

415

EUCTR2016-000897-39-DE
(EUCTR)

10/05/2017

27/10/2016

An investigational study to assess the effectiveness and safety of a new investigational drug as a add-on therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate regimen in patients with moderate to severe Rheumatoid Arthritis.

Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

416

EUCTR2014-005368-13-IT
(EUCTR)

10/05/2017

16/02/2018

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SAIT101 (rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB

ARCHIGEN BIOTECH LIMITED

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

417

NCT03086343
(ClinicalTrials.gov)

May 9, 2017

20/3/2017

A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs

A Phase 3, Randomized, Active-Controlled, Double-Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)

Rheumatoid Arthritis (RA)

Drug: Abatacept;Drug: Placebo for abatacept;Drug: Upadacitinib;Drug: Placebo for upadacitinib

AbbVie

NULL

Active, not recruiting

18 Years

N/A

All

613

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Chile;Colombia

418

EUCTR2016-001825-15-BE
(EUCTR)

08/05/2017

28/02/2017

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, New York

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3;Phase 4

United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of

419

EUCTR2016-002337-30-CZ
(EUCTR)

03/05/2017

06/02/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

Product Code: PF-06650833
INN or Proposed INN: PF-06650833 100 mg
Product Code: PF-06650833
INN or Proposed INN: PF-06650833 20 mg
Product Name: Tofacitinib
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

420

EUCTR2016-000569-21-DE
(EUCTR)

02/05/2017

04/11/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

421

EUCTR2016-000933-37-CZ
(EUCTR)

02/05/2017

22/11/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

313

Phase 3

422

EUCTR2016-001825-15-HU
(EUCTR)

01/05/2017

22/03/2017

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, New York

NULL

Not Recruiting

Female: yes
Male: yes

580

Phase 3;Phase 4

United States;Philippines;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of

423

EUCTR2016-000933-37-DE
(EUCTR)

27/04/2017

17/10/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

424

EUCTR2016-001064-11-CZ
(EUCTR)

20/04/2017

31/03/2017

Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis

A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Nichi-Iko Pharmaceutical Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

585

Phase 3

United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom

425

EUCTR2016-000570-37-DE
(EUCTR)

19/04/2017

24/10/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy

Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Methotrexate tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

426

EUCTR2016-000568-41-DE
(EUCTR)

19/04/2017

24/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand

427

EUCTR2016-002126-36-DE
(EUCTR)

18/04/2017

23/11/2016

A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors

Product Name: RO7123520
Product Code: RO7123520 /F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

204

Phase 2

United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Colombia;Germany;Italy;United Kingdom

428

EUCTR2016-001064-11-PL
(EUCTR)

13/04/2017

12/04/2017

Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis

A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Nichi-Iko Pharmaceutical Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

585

Phase 3

United States;Czech Republic;Puerto Rico;Spain;Poland;Ukraine;Russian Federation;United Kingdom

429

EUCTR2016-002337-30-BG
(EUCTR)

11/04/2017

30/01/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

430

EUCTR2016-001825-15-BG
(EUCTR)

11/04/2017

07/02/2017

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, New York

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3;Phase 4

United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;Bulgaria;South Africa;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

431

EUCTR2016-001064-11-ES
(EUCTR)

07/04/2017

Efficacy and safety study of Remicade® (infliximab) and NI-071 (a proposed infliximab biosimilar) for the treatment of patients with rheumatoid arthritis

A Randomized, Double-Blind, Multicenter, 3-Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Nichi-Iko Pharmaceutical Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

585

Phase 3

United States;Czech Republic;Puerto Rico;Poland;Spain;Ukraine;Russian Federation;United Kingdom

432

NCT02808871
(ClinicalTrials.gov)

April 7, 2017

20/3/2016

Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)

Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients With Rheumatoid Arthritis Interstitial Lung Disease (TRAIL1)

Rheumatoid Arthritis Interstitial Lung Disease

Drug: Pirfenidone;Drug: Placebo

Ivan O. Rosas

NULL

Recruiting

18 Years

85 Years

All

270

Phase 2

United States;Australia;Canada;United Kingdom

433

EUCTR2016-001825-15-GB
(EUCTR)

03/04/2017

01/03/2017

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

Product Name: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE

Pfizer Inc., 235 East 42nd Street, New York, New York

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3;Phase 4

Korea, Republic of;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Poland;Australia;South Africa;Bulgaria;Germany

434

EUCTR2016-000897-39-BE
(EUCTR)

03/04/2017

02/02/2017

Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany

435

NCT03275025
(ClinicalTrials.gov)

April 1, 2017

28/8/2017

A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of YRA-1909 in Patients With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

Rheumatoid Arthritis

Drug: YRA-1909 low dose;Drug: YRA-1909 mid dose;Drug: YRA-1909 high dose;Drug: Placebo

Yungjin Pharm. Co., Ltd.

NULL

Recruiting

19 Years

80 Years

All

200

Phase 2

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

436

NCT02908490
(ClinicalTrials.gov)

April 1, 2017

8/7/2016

Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?

Arthritis, Rheumatoid;Atherosclerosis

Drug: Sildenafil;Other: Placebo

Kimberly Liang

NULL

Active, not recruiting

18 Years

N/A

All

Phase 2

United States

437

NCT03291457
(ClinicalTrials.gov)

March 30, 2017

20/9/2017

A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice

A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Glucocorticoid Agent

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

101

Belgium

438

EUCTR2016-001825-15-PL
(EUCTR)

29/03/2017

08/03/2017

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

Pfizer Inc., 235 East 42nd Street, New York, New York

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3;Phase 4

Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;South Africa;Bulgaria;Germany;Korea, Republic of

439

EUCTR2016-002862-30-PL
(EUCTR)

28/03/2017

03/04/2017

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

440

EUCTR2016-002337-30-ES
(EUCTR)

27/03/2017

10/03/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

441

NCT03178955
(ClinicalTrials.gov)

March 27, 2017

2/6/2017

Circadian RA Study in Rheumatoid Arthritis Subjects

The Effects of Biologic Therapy With Disease Activity and Circadian Rhythm

Rheumatoid Arthritis

Drug: Etanercept

University of California, Davis

NULL

Withdrawn

18 Years

80 Years

All

United States

442

EUCTR2011-004720-35-NL
(EUCTR)

22/03/2017

22/02/2017

A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.

Rheumatoid arthritis (RA)
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
INN or Proposed INN: PREDNISOLONE

The Karolinska Institute, ClinTRID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Finland;Denmark;Norway;Iceland;Netherlands;Sweden

443

EUCTR2016-002862-30-CZ
(EUCTR)

22/03/2017

14/12/2016

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc 235 East 42nd Street, New York, NY10017 US

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

444

EUCTR2016-000568-41-BG
(EUCTR)

21/03/2017

24/01/2017

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

445

EUCTR2016-000570-37-BG
(EUCTR)

21/03/2017

13/02/2017

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

446

EUCTR2016-001825-15-CZ
(EUCTR)

21/03/2017

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3;Phase 4

United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of

447

NCT03245320
(ClinicalTrials.gov)

March 20, 2017

3/5/2017

Clinical Evaluation of the TITAN™ Total Shoulder System

A Post-Market Observational Study to Evaluate Performance and Safety of the TITAN™ Total Shoulder System

Arthritis;Arthritis, Degenerative;Rheumatoid Arthritis;Post-traumatic Arthrosis of Other Joints, Shoulder Region;Rotator Cuff Syndrome of Shoulder and Allied Disorders;Fracture;Avascular Necrosis;Joint Instability;Joint Trauma;Dislocation, Shoulder;Pain, Shoulder

Device: Integra TITAN™ Total Shoulder Generation 1.0

Integra LifeSciences Corporation

NULL

Active, not recruiting

18 Years

N/A

All

United States

448

EUCTR2016-002337-30-HU
(EUCTR)

16/03/2017

06/02/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

449

EUCTR2015-005309-35-HU
(EUCTR)

16/03/2017

02/02/2017

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis

Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038

R-Pharm

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1880

Phase 3

450

NCT03755258
(ClinicalTrials.gov)

March 16, 2017

21/11/2018

Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis

A Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GCK in Rheumatoid Arthritis Patients

Early Rheumatoid Arthritis

Drug: GCK 100 mg + Placebo 200 mg;Drug: GCK 200 mg + Placebo 100 mg;Drug: GCK 300 mg;Drug: Placebo 300mg

Zhejiang Hisun Pharmaceutical Co. Ltd.

NULL

Unknown status

18 Years

65 Years

All

128

Phase 1

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

451

EUCTR2015-005309-35-CZ
(EUCTR)

16/03/2017

31/01/2017

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis

R-Pharm International LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1880

Phase 3

452

EUCTR2016-002862-30-DE
(EUCTR)

15/03/2017

26/01/2017

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc 235 East 42nd Street, New York, NY10017 US

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

453

EUCTR2016-000933-37-BE
(EUCTR)

14/03/2017

24/11/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

454

NCT03110094
(ClinicalTrials.gov)

March 13, 2017

10/3/2017

Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis

Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis, With Analysis of CD4 + Follicular Helper T Subpopulations

Rheumatoid Arthritis

Other: Adalimumab;Other: Healthy volunteers

Rennes University Hospital

NULL

Unknown status

18 Years

N/A

All

N/A

France

455

EUCTR2015-003289-97-DE
(EUCTR)

09/03/2017

30/11/2016

A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis

Protocol I8K-MC-JPDA(c)A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

276

Phase 2

United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

456

EUCTR2016-001825-15-ES
(EUCTR)

09/03/2017

10/03/2017

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

Pfizer Inc., 235 East 42nd Street, New York, New York

NULL

Not Recruiting

Female: yes
Male: yes

580

Phase 3;Phase 4

457

EUCTR2016-002852-26-DE
(EUCTR)

09/03/2017

06/10/2016

MSB11022 in moderately to severely active rheumatoid arthritis

A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA

moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom

458

EUCTR2015-005309-35-LT
(EUCTR)

06/03/2017

31/01/2017

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis

R-Pharm International LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1880

Phase 3

459

EUCTR2015-005307-83-LV
(EUCTR)

03/03/2017

16/03/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2

R-Pharm

NULL

Not Recruiting

Female: yes
Male: yes

1575

Phase 3

United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of

460

EUCTR2016-002126-36-AT
(EUCTR)

01/03/2017

11/11/2016

A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors

A randomized, double-blind, placebo-controlled, multi-center, three-part phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors

Product Name: RO7123520
Product Code: RO7123520 /F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

204

Phase 2

United States;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

461

NCT03161457
(ClinicalTrials.gov)

February 27, 2017

21/4/2017

A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis

A Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Efficacy of JHL1101 Versus EU-sourced MabThera® in Anti TNF Inadequate Responder Patients With Moderate to Severe Rheumatoid Arthritis (RA) on Background Methotrexate (MTX) Therapy

Rheumatoid Arthritis;Arthritis, Rheumatoid

Biological: JHL1101;Biological: MabThera

JHL Biotech, Inc.

NULL

Terminated

18 Years

80 Years

All

153

Phase 1

Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;Lithuania;Poland;Russian Federation;Taiwan;Ukraine;United Kingdom

462

EUCTR2014-004868-38-DE
(EUCTR)

23/02/2017

25/05/2016

A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

358

Phase 3

France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany

463

EUCTR2015-003289-97-ES
(EUCTR)

20/02/2017

21/02/2017

A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available

Lilly S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

276

Phase 2

United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of

464

EUCTR2016-001825-15-SK
(EUCTR)

16/02/2017

14/12/2016

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3;Phase 4

United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;South Africa;Bulgaria;Germany;Korea, Republic of

465

EUCTR2016-002862-30-SK
(EUCTR)

16/02/2017

14/12/2016

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc 235 East 42nd Street, New York, NY10017 US

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

466

EUCTR2016-002862-30-BG
(EUCTR)

16/02/2017

10/01/2017

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc 235 East 42nd Street, New York, NY10017 US

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

467

EUCTR2016-000569-21-PL
(EUCTR)

15/02/2017

14/02/2017

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

468

EUCTR2016-000568-41-PL
(EUCTR)

15/02/2017

14/02/2017

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

469

EUCTR2016-000570-37-PL
(EUCTR)

15/02/2017

13/02/2017

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

470

NCT03667131
(ClinicalTrials.gov)

February 13, 2017

10/9/2018

Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.

Effect of Prophylactic Treatment With Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis Patients.

Rheumatoid Arthritis

Drug: Enalapril Maleate;Drug: Placebo

University of Guadalajara

NULL

Completed

18 Years

80 Years

Female

Phase 2

Mexico

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

471

EUCTR2016-002862-30-HU
(EUCTR)

31/01/2017

23/11/2016

A medical research study to evaluate the safety and effectiveness of an investigational medication for rheumatoid arthritis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP,PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THEEFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITHMODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-06651600
INN or Proposed INN: not yet assigned

Pfizer Inc 235 East 42nd Street, New York, NY10017 US

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Czech Republic;Hungary;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany

472

ChiCTR-IPR-17010325

2017-01-31

2017-01-04

The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial

rheumatic disease;M05.901

Metformin Group:Metformin combined Glucocorticoids and DMARDs;Non-Metformin Group:Glucocorticoids and DMARDs;Metformin combined with Coenzyme Q10 Group:Metformin and Coenzyme Q10 combined Glucocorticoids and DMARDs;

the Second Hospital of Shanxi Medical University

NULL

Pending

Both

Metformin Group:100;Non-Metformin Group:100;Metformin combined with Coenzyme Q10 Group:100;

China

473

NCT03052322
(ClinicalTrials.gov)

January 31, 2017

29/1/2017

MSB11022 in Moderate to Severe Rheumatoid Arthritis

A Multicenter, Randomized, Double-blind, Phase III Trial to Evaluate the Safety, Immunogenicity, and Efficacy of MSB11022 Compared With Humira® in Patients With Moderately to Severely Active Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis

Drug: MSB11022;Drug: EU-Humira

Fresenius Kabi SwissBioSim GmbH

NULL

Completed

18 Years

N/A

All

288

Phase 3

Bulgaria;Czechia;Germany;Hungary;Poland;United Kingdom;Czech Republic

474

NCT02997605
(ClinicalTrials.gov)

January 31, 2017

15/12/2016

Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients

Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.

RheumatoId Arthritis

Drug: GlucoCorticoid

University Hospital, Toulouse

NULL

Recruiting

18 Years

N/A

All

122

Phase 4

France

475

EUCTR2016-000569-21-BE
(EUCTR)

30/01/2017

28/10/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

423

Phase 3

Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of;United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

476

EUCTR2016-000570-37-BE
(EUCTR)

30/01/2017

17/10/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan

477

EUCTR2016-000933-37-PT
(EUCTR)

30/01/2017

09/11/2016

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

478

EUCTR2013-003413-18-NL
(EUCTR)

30/01/2017

28/09/2015

Arthritis prevention with abatacept

Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept. - APIPPRA

The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPA; rheumatoid factor – RF) and who have joint pains (arthralgia) but no joint swelling. These subjects are deemed to be at highest risk of developing rheumatoid arthritis.
MedDRA version: 20.0;Level: PT;Classification code 10003239;Term: Arthralgia;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: ORENCIA 125 mg solution for injection

Leiden University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

206

Phase 2

Netherlands;United Kingdom

479

NCT03028467
(ClinicalTrials.gov)

January 24, 2017

10/1/2017

Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis

A Phase 1/2, Double-Blind, Placebo-Controlled Study of the Pharmacokinetics, Safety and Tolerability of GSK3196165 in Combination With Methotrexate Therapy, in Japanese Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Methotrexate

Arthritis, Rheumatoid

Drug: GSK3196165 Dose 1;Drug: GSK3196165 Dose 2;Drug: GSK3196165 Dose 3;Drug: Methotrexate;Drug: Placebo;Drug: Folic acid

GlaxoSmithKline

NULL

Completed

20 Years

N/A

All

Phase 1;Phase 2

Japan

480

NCT03085940
(ClinicalTrials.gov)

January 20, 2017

7/2/2017

Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Hydroxychloroquine;Drug: Placebo

Indonesia University

NULL

Completed

18 Years

N/A

All

N/A

Indonesia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

481

NCT02984943
(ClinicalTrials.gov)

January 19, 2017

15/11/2016

The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis

The Effects of Hyperbaric Oxygen on Rheumatoid Arthritis: A Pilot Study

RheumatoId Arthritis

Device: Hyperbaric Oxygen

David Grant U.S. Air Force Medical Center

NULL

Completed

18 Years

N/A

All

N/A

United States

482

EUCTR2016-000569-21-ES
(EUCTR)

13/01/2017

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Moderately to severely active rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Belgium;Australia;Germany;Japan;Korea, Republic of

483

EUCTR2016-000568-41-ES
(EUCTR)

13/01/2017

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Moderately to severely active rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan

484

EUCTR2016-000570-37-ES
(EUCTR)

13/01/2017

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Moderately to severely active rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

485

NCT03112213
(ClinicalTrials.gov)

January 12, 2017

10/4/2017

Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment

CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: NSAIDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

135

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

486

EUCTR2016-000897-39-HU
(EUCTR)

09/01/2017

19/10/2016

Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects with Moderate to Severe Rheumatoid Arthritis.

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Taiwan;Hungary;Mexico;Belgium;Australia;Germany

487

EUCTR2015-003140-39-PL
(EUCTR)

09/01/2017

11/01/2017

A Study to EValuate the Efficacy and Safety of JTE-051 on Subjects with Active Rheumatoid Arthritis (MOVE-RA)

A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis (MOVE-RA) - MOVE-RA

Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: JTE-051
Product Code: JTE-051
INN or Proposed INN: No proposed INN available
Other descriptive name: JTE-051

Akros Pharma Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia

488

EUCTR2016-002852-26-BG
(EUCTR)

05/01/2017

03/01/2017

MSB11022 in moderately to severely active rheumatoid arthritis

moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom

489

EUCTR2016-000568-41-CZ
(EUCTR)

05/01/2017

21/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40 mg s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: FILGOTINIB
Trade Name: Humira (adalimumab) 40mg in 0.4 ml s.c. injection
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

490

EUCTR2016-002852-26-GB
(EUCTR)

05/01/2017

23/09/2016

MSB11022 in moderately to severely active rheumatoid arthritis

moderately to severely active rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

491

EUCTR2016-001532-35-BG
(EUCTR)

05/01/2017

14/11/2016

A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.

A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.

Moderate to Severe Rheumatoid Arthritis.
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: LNP1955

Lupin Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Poland;Bulgaria

492

EUCTR2016-000570-37-CZ
(EUCTR)

05/01/2017

22/11/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

493

EUCTR2016-000568-41-BE
(EUCTR)

04/01/2017

17/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan

494

ChiCTR-IPR-17010307

2017-01-01

The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China

Rheumatoid Arthritis;M05.901

Rapamycin group:Rapamycin;Non-rapamycin group :conventional glucocorticoids and DMARDs;

the Second Hospital of Shanxi Medical University

NULL

Recruiting

Both

Rapamycin group:200;Non-rapamycin group :100;

China

495

NCT03855007
(ClinicalTrials.gov)

January 1, 2017

15/2/2019

The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment

Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China

Arthritis, Rheumatoid

Drug: Iguratimod;Drug: MTX;Drug: HCQ;Drug: Pred

Qilu Hospital of Shandong University

NULL

Recruiting

16 Years

90 Years

All

200

Phase 4

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

496

ChiCTR-INR-16010290

2017-01-01

2016-12-28

The research for the treatment of Rheumatoid Arthritis with Warming yang and Smoothening Meridians

Rheumatoid Arthritis

treatment group:MTX+Wen yang tong luo granule;control group:MTX;

The First Hospital Affiliated to Henan University of TCM

NULL

Recruiting

Both

treatment group:180;control group:180;

China

497

NCT03016884
(ClinicalTrials.gov)

January 2017

1/1/2017

Safety and Tolerability of Herpes Zoster Vaccine Rheumatologic Patients

Safety and Tolerability of Herpes Zoster Vaccine in Patients With Rheumatoid Arthritis Immunized Prior to Biologics and Tofacitinib Therapy Initiation

Herpes Zoster

Biological: Zostavax vaccine

HaEmek Medical Center, Israel

NULL

Active, not recruiting

50 Years

N/A

All

Phase 4

Israel

498

NCT02865434
(ClinicalTrials.gov)

January 2017

5/8/2016

Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA

An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and Skeletal Joint Imaging With SPECT in Subjects With Active Rheumatoid Arthritis (RA) and Healthy Controls

Arthritis, Rheumatoid

Drug: Tc99m-tilmanocept;Procedure: SPECT Imaging (60 Minutes post-injection);Procedure: SPECT Imaging (180 Minutes post-injection);Procedure: Whole body planar SPECT imaging (15 Minutes post-injection);Procedure: Whole body planar SPECT imaging (60 Minutes post-injection);Procedure: Whole body planar SPECT imaging (180 Minutes post-injection);Procedure: Whole body planar SPECT imaging (18-20 Hours post-injection);Procedure: Blood Collection for PK Testing (15 Mins Before Injection);Procedure: Blood Collection for PK Testing (after injection);Procedure: Blood Collection for PK Testing (15 minutes post injection);Procedure: Blood Collection for PK Testing (60 minutes post injection);Procedure: Blood Collection for PK Testing (180 minutes post injection);Procedure: Blood Collection for PK Testing (18-20 hours post injection);Procedure: Planar Image with both Hands in Field of View

Navidea Biopharmaceuticals

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

499

EUCTR2016-000933-37-ES
(EUCTR)

28/12/2016

17/11/2016

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 3

United States;Belarus;Spain;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Israel;Colombia;Switzerland;Hungary;Mexico;European Union;Puerto Rico;Canada;Argentina;Brazil;Australia;Latvia;Norway;New Zealand

500

NCT02965599
(ClinicalTrials.gov)

December 27, 2016

14/11/2016

Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Rheumatoid Arthritis

A Randomised, Multi-center, Double Blind (Sponsor Open), Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Severe, Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: GSK3117391;Drug: Placebo

GlaxoSmithKline

NULL

Terminated

18 Years

N/A

All

Phase 2

Poland;Romania;Mexico

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

501

EUCTR2016-000568-41-GB
(EUCTR)

23/12/2016

13/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Slovakia;Thailand;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;United States;Serbia;Taiwan;Hong Kong;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;Japan;New Zealand

502

EUCTR2016-000569-21-GB
(EUCTR)

23/12/2016

01/11/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

503

NCT03001219
(ClinicalTrials.gov)

December 22, 2016

20/12/2016

A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors

Rheumatoid Arthritis

Drug: Anti-TNF-alpha;Drug: Methotrexate;Drug: Placebo;Drug: RO7123520

Hoffmann-La Roche

NULL

Terminated

18 Years

N/A

All

109

Phase 2

United States;Argentina;Austria;Colombia;Germany;Guatemala;Italy;Mexico;Peru;Spain;United Kingdom;Czech Republic;Czechia;Poland

504

EUCTR2016-001496-75-CZ
(EUCTR)

20/12/2016

30/09/2016

A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Arthritis on Background Therapy with Methotrexate

Product Name: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
INN or Proposed INN: GS-9876
Product Name: filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria

505

NCT02969044
(ClinicalTrials.gov)

December 20, 2016

17/11/2016

Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate

Rheumatoid Arthritis

Drug: Placebo;Drug: PF-06651600

Pfizer

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Bulgaria;Czechia;Georgia;Germany;Hungary;Poland;Serbia;Slovakia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

506

EUCTR2014-004704-29-DE
(EUCTR)

19/12/2016

23/08/2016

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

507

EUCTR2014-004704-29-CZ
(EUCTR)

15/12/2016

02/08/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 710
Product Code: ABP 710
INN or Proposed INN: ABP 710
Other descriptive name: ABP 710 - Biosimilar to infliximab
Trade Name: Remicade
Product Name: infliximab
INN or Proposed INN: INFLIXIMAB

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

508

NCT02862574
(ClinicalTrials.gov)

December 15, 2016

8/8/2016

Andecaliximab as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Adults With Moderately to Severely Active Rheumatoid Arthritis

Evaluation of the Efficacy and Safety of GS-5745 as Add-On Therapy to a Tumor Necrosis Factor Inhibitor and Methotrexate Regimen in Subjects With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Andecaliximab;Drug: Placebo;Drug: Methotrexate;Drug: TNF Inhibitor

Gilead Sciences

NULL

Terminated

18 Years

80 Years

All

Phase 2

United States;Australia;Hungary;Taiwan

509

EUCTR2016-001496-75-PL
(EUCTR)

13/12/2016

03/11/2016

A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.

Product Name: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
INN or Proposed INN: GS-9876
Product Name: filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria

510

EUCTR2016-000569-21-HU
(EUCTR)

12/12/2016

07/11/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

511

EUCTR2015-003289-97-SK
(EUCTR)

12/12/2016

11/08/2016

A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis

Protocol I8K-MC-JPDAA Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study

Product Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

276

Phase 2

United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of

512

EUCTR2016-002852-26-CZ
(EUCTR)

07/12/2016

21/09/2016

MSB11022 in moderately to severely active rheumatoid arthritis

moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom

513

EUCTR2016-002852-26-LT
(EUCTR)

07/12/2016

24/10/2016

MSB11022 in moderately to severely active rheumatoid arthritis

moderately to severely active rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

United States;Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom

514

EUCTR2016-000933-37-LV
(EUCTR)

06/12/2016

31/10/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 3

United States;Belarus;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Israel;Colombia;Switzerland;Hungary;Mexico;European Union;Puerto Rico;Canada;Argentina;Brazil;Australia;Norway;Latvia;New Zealand

515

EUCTR2015-003140-39-BG
(EUCTR)

05/12/2016

23/11/2016

A Study to EValuate the Efficacy and Safety of JTE-051 in Subjects with Active Rheumatoid Arthritis (MOVE-RA)

Product Name: JTE-051
Product Code: JTE-051
INN or Proposed INN: No proposed INN available
Other descriptive name: JTE-051

Akros Pharma Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Mexico;Argentina;Poland;Ukraine;Romania;Peru;Russian Federation;Bulgaria;Colombia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

516

EUCTR2016-000568-41-HU
(EUCTR)

02/12/2016

19/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Moderately to severely active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

517

EUCTR2016-000570-37-HU
(EUCTR)

02/12/2016

19/10/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Ukraine;Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;New Zealand;Japan

518

NCT02982083
(ClinicalTrials.gov)

December 2016

1/12/2016

Clinical Trial on the Efficacy of Raloxifene on Disease Activity in Rheumatoid Arthritis

Clinical Trial on the Efficacy of Raloxifene on Disease Activity and Glucocorticoid-induced Osteoporosis in Postmenopausal Women With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Raloxifene hydrochloride;Drug: Placebo Oral Tablet

Sara Saeidi Shahri

NULL

Not yet recruiting

50 Years

N/A

Female

N/A

NULL

519

NCT02990806
(ClinicalTrials.gov)

December 2016

21/11/2016

A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis (RADIANCE)

A Randomized, Double-Blind, Multicenter, 3 Stage, Efficacy and Safety Study of NI-071 and US-Licensed Remicade® (Infliximab) for the Treatment of Patients With Rheumatoid Arthritis

Rheumatoid Arthritis (RA)

Biological: NI-071;Biological: Infliximab

Nichi-Iko Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

75 Years

All

683

Phase 3

United States;Czechia;Poland;Puerto Rico;Russian Federation;Spain;Ukraine;United Kingdom

520

NCT03337165
(ClinicalTrials.gov)

December 2016

3/11/2017

Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis

Safety/Efficacy of Intra-articular Administration of Autologous Tolerogenic Dendritic Cells for Treatment of Patients With Rheumatoid Arthritis

Musculoskeletal Diseases;Joint Disease;Arthritis;Arthritis, Rheumatoid;Rheumatic Diseases;Connective Tissue Diseases;Autoimmune Diseases;Immune System Diseases

Biological: tolerogenic dendritic cells

Russian Academy of Medical Sciences

NULL

Completed

18 Years

75 Years

All

Phase 1

Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

521

NCT02983227
(ClinicalTrials.gov)

November 30, 2016

29/11/2016

A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350

A Phase II Open-Label Extension Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: GDC-0853

Genentech, Inc.

NULL

Completed

18 Years

76 Years

All

496

Phase 2

United States;Argentina;Brazil;Bulgaria;Colombia;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile;Korea, Republic of

522

EUCTR2014-004704-29-BG
(EUCTR)

29/11/2016

15/09/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

523

EUCTR2016-000570-37-SK
(EUCTR)

29/11/2016

04/10/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

524

NCT02986139
(ClinicalTrials.gov)

November 29, 2016

2/11/2016

Study to Assess the Injection Site Pain Associated With a New Etanercept Formulation in Adults With Rheumatoid Arthritis or Psoriatic Arthritis

A Multicenter, Randomized, Double-blind, Crossover Study to Assess the Injection Site Pain Associated With a Modified Etanercept Formulation in Adult Subjects With Either Rheumatoid Arthritis or Psoriatic Arthritis

Arthritis, Rheumatoid; Arthritis, Psoriatic

Drug: Commercial Formulation Etanercept;Drug: New Formulation Etanercept

Amgen

NULL

Completed

18 Years

N/A

All

111

Phase 3

United States;Puerto Rico

525

NCT02960490
(ClinicalTrials.gov)

November 26, 2016

3/11/2016

A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics

Rheumatoid Arthritis

Drug: E6011;Drug: Placebo

Eisai Co., Ltd.

NULL

Completed

18 Years

75 Years

All

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

526

EUCTR2014-004704-29-PL
(EUCTR)

25/11/2016

04/10/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Spain;Poland;Romania;Australia;Bulgaria;Germany

527

EUCTR2016-000933-37-HU
(EUCTR)

24/11/2016

12/10/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

313

Phase 3

Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden

528

EUCTR2014-005368-13-DE
(EUCTR)

22/11/2016

04/07/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Product Name: SAIT101 (proposed rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB

Archigen Biotech Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

529

JPRN-UMIN000026819

2016/11/21

01/04/2017

A randomized controlled trial of low-dose Enoxaparin versus low-dose Edoxavan for prevention of venous thromboembolism after total hip arthroprasty in elderly or underweight or moderate renal insufficient patients. - A RCT of anticoagulant agents for prevention of VTE after THA in elderly or underweight or moderate renal insufficient patients.

osteoarthritis of the hip, osteonecrosis of the femoral head, femoral neck fracture, rheumatoid arthritis, rapidly destructive coxarthropathy, septic arthritis of the hip

Dose:
Edoxaban group; Edoxaban 15mg per day
Enoxaparin gropu; Enoxaparin 2000 IU per day
Intervention period:
for 10 days after the surgery

Department of Orthopaedic Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

530

NCT02874092
(ClinicalTrials.gov)

November 15, 2016

17/8/2016

Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Ticagrelor;Drug: MTX therapy

NYU Langone Health

NULL

Completed

18 Years

N/A

All

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

531

EUCTR2016-002852-26-HU
(EUCTR)

15/11/2016

29/09/2016

MSB11022 in moderately to severely active rheumatoid arthritis

moderately to severely active rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: adalimumab
Product Code: MSB11022
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

United States;Czech Republic;Hungary;Poland;Lithuania;Bulgaria;Germany;United Kingdom

532

EUCTR2016-000570-37-GB
(EUCTR)

14/11/2016

17/10/2016

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

533

NCT02996500
(ClinicalTrials.gov)

November 10, 2016

13/10/2016

Safety and Efficacy of Pf-06650833 In Subjects With Rheumatoid Arthritis, With An Inadequate Response To Methotrexate

Rheumatoid Arthritis

Drug: PF-06650833;Drug: Placebo;Drug: Tofacitinib

Pfizer

NULL

Completed

18 Years

75 Years

All

269

Phase 2

United States;Australia;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Ukraine

534

EUCTR2015-005307-83-DE
(EUCTR)

10/11/2016

24/03/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

R-Pharm

NULL

Not Recruiting

Female: yes
Male: yes

1575

Phase 3

United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of

535

EUCTR2015-005800-27-PL
(EUCTR)

08/11/2016

03/10/2016

Study of a new drug’s effect in people with severe rheumatoid arthritis who have not responded sufficiently well to treatment with DMARDs

A randomised, multi-center, double blind (sponsor open), placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK3117391 in subjects with moderate to severe, active rheumatoid arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GSK3117391
Product Code: GSK3117391
INN or Proposed INN: Not applicable
Other descriptive name: GSK3117391

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Romania;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

536

EUCTR2015-005308-27-DE
(EUCTR)

08/11/2016

09/05/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3

Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038

R-Pharm

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Turkey;Russian Federation;Colombia;Germany;Korea, Republic of

537

EUCTR2016-002908-15-NL
(EUCTR)

08/11/2016

23/08/2016

REDO study: Research into the effects of lower doses rituximab in patients with rheumatoid arthritis

REDO study: RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization - REDO

Rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Sint Maartenskliniek

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 4

Netherlands

538

NCT02919761
(ClinicalTrials.gov)

November 7, 2016

26/9/2016

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment

Arthritis, Rheumatoid

Drug: Acthar Gel;Drug: Placebo

Mallinckrodt

NULL

Completed

18 Years

N/A

All

259

Phase 4

United States;Argentina;Mexico;Peru;Puerto Rico;Colombia

539

EUCTR2015-003334-27-FI
(EUCTR)

02/11/2016

17/06/2016

A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

975

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;New Zealand;Japan

540

NCT02960438
(ClinicalTrials.gov)

November 2, 2016

3/11/2016

A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Methotrexate

Rheumatoid Arthritis

Drug: E6011;Drug: Placebo

Eisai Co., Ltd.

NULL

Completed

18 Years

75 Years

All

190

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

541

ChiCTR-IPR-16009029

2016-11-01

2016-08-15

Clinical Study of the Bone Protection Effect of Biqi Capsule for Treatment of Rheumatoid Arthritis

Rheumatoid arthritis

RA:the experimental group:MTX 10-15mg po qw+BiQi Capsule, 1.2g po bid;RA:the control group:MTX 10-15mg po qw+LEF, 10mg, po, bid;OA:The traditional Chinese group:BiQi Capsule, 1.2g po bid+Celecoxib capsules 0.2g po take as needed;OA:The western medicine control group:Calcitriol Soft Capsules 0.25ug, po, bid+Celecoxib capsules 0.2g po take as needed;

Guangdong Provincial Hospital of Chinese Medicine

NULL

Pending

Both

RA:the experimental group:60;RA:the control group:60;OA:The traditional Chinese group:60;OA:The western medicine control group:60;

China

542

ChiCTR-INR-16009546

2016-11-01

2016-10-21

The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis

rheumatoid arthritis;M05.901

IL-2 group:lL-2;IL-2 + IL-6 antagonist group:Tocilizumab;non IL-2 or IL-6 antagonist group:glucocorticoids and DMARDs;

the Second Hospital of Shanxi Medical University

NULL

Recruiting

Both

IL-2 group:15;IL-2 + IL-6 antagonist group:15;non IL-2 or IL-6 antagonist group:15;

China

543

NCT03067870
(ClinicalTrials.gov)

November 2016

25/2/2017

Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With Rheumatoid Arthritis

Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis

RheumatoId Arthritis;Osteoarthritis, Knee;Osteoarthritis, Hip

Biological: Stem Cell Transplantation

Stem Cells Arabia

NULL

Active, not recruiting

17 Years

75 Years

All

100

Phase 1

NULL

544

NCT03061838
(ClinicalTrials.gov)

October 27, 2016

20/2/2017

Safety, Tolerability, PK and PD of Biosimilar Drug Ritumax® Compared to Original Drug MabThera®

Multicenter Double-blind Randomized Clinical Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Biosimilar Drug Ritumax® Compared to Original Drug MabThera® in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MabThera ®;Drug: Ritumax®

Biointegrator LLC

NULL

Terminated

18 Years

N/A

All

Phase 1

Russian Federation

545

EUCTR2016-002125-11-BG
(EUCTR)

27/10/2016

13/10/2016

Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

258

Phase 1;Phase 3

Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;Bulgaria;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

546

EUCTR2015-003289-97-PL
(EUCTR)

25/10/2016

17/08/2016

A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study

Product Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

276

Phase 2

United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of

547

EUCTR2015-003289-97-AT
(EUCTR)

20/10/2016

12/08/2016

A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis

Product Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

276

Phase 2

United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of

548

EUCTR2016-002125-11-CZ
(EUCTR)

17/10/2016

21/07/2016

Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

258

Phase 1;Phase 3

Estonia;Spain;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Poland;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

549

NCT02858492
(ClinicalTrials.gov)

October 17, 2016

20/7/2016

Safety and Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Repeat Doses of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)

A Multicenter, Randomized, Double-blind (Sponsor-unblinded), Placebo-controlled Study to Investigate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: GSK2982772 60 mg;Drug: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

75 Years

All

Phase 2

Germany;Italy;Poland;Russian Federation;Spain;United Kingdom

550

EUCTR2016-002061-54-IT
(EUCTR)

13/10/2016

15/11/2018

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.

Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases.Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®)

Rheumatoid arthritis, seronegative spondylo arthritis,Crohn's Disease, Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10039073;Term: Rheumatoid arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10075634;Term: Acute haemorrhagic ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO
Product Name: Remsima
Product Code: 42942019

UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 4

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

551

JPRN-jRCTs041180071

13/10/2016

07/03/2019

T-ReX study

Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study

Rheumatoid arthritis

At week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request: changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX; increasing doses of or adding csDMARDs other than MTX or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.

Kojima Toshihisa

NULL

Complete

>= 20age old

Not applicable

Both

N/A

Japan

552

EUCTR2016-000498-19-BG
(EUCTR)

13/10/2016

19/08/2016

A Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Rheumatoid Arthritis

A PHASE II OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA29350 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Product Name: GDC-0853
Product Code: RO7010939
INN or Proposed INN: not available
Other descriptive name: GDC-0853 RO7010939

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

580

Phase 2

United States;Serbia;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of

553

EUCTR2016-000568-41-SK
(EUCTR)

11/10/2016

04/10/2016

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan

554

NCT02819726
(ClinicalTrials.gov)

October 11, 2016

20/6/2016

PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Biological: SAIT101;Biological: MabThera;Biological: Rituxan

Archigen Biotech Limited

NULL

Completed

18 Years

80 Years

All

294

Phase 1

United States;Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;India;Korea, Republic of;Mexico;Poland;Spain

555

NCT02937701
(ClinicalTrials.gov)

October 10, 2016

30/8/2016

Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: ABP 710;Biological: Infliximab

Amgen

NULL

Completed

18 Years

80 Years

All

558

Phase 3

United States;Australia;Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Spain;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

556

EUCTR2014-004704-29-HU
(EUCTR)

05/10/2016

08/08/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Czech Republic;Hungary;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

557

EUCTR2015-004858-17-NL
(EUCTR)

05/10/2016

28/09/2016

REMission INDuction in very early Rheumatoid Arthritis

REMission INDuction in very early Rheumatoid Arthritis - REMINDRA

Very early Rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

University Medical Center Utrecht (UMCU)

NULL

Not Recruiting

Female: yes
Male: yes

267

Phase 4

Netherlands

558

EUCTR2016-000912-13-PL
(EUCTR)

04/10/2016

26/07/2016

A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.

subjects with moderate to severe rheumatoid arthritis.
MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GSK2982772
Product Code: GSK2982772
INN or Proposed INN: Not Available
Other descriptive name: GSK2982772A, where A denotes the free base

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Spain;Poland;Romania;Germany;Italy;United Kingdom

559

EUCTR2014-004704-29-ES
(EUCTR)

03/10/2016

05/08/2016

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis - Not applicable

Rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

560

JPRN-UMIN000024025

2016/10/01

01/10/2016

The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study

The clinical impact of methotrexate dose reduction at combination therapy with adalimumab plus methotrexate in rheumatoid arthritis; ALIBABA study - ALIBABA study

Rheumatoid Arthritis

receiving 40 mg open-label ADA every other week for 26 weeks with low dose MTX (6mg/week)
receiving 40 mg open-label ADA every other week for 26 weeks with high dose MTX (12mg/week)

Search Institute for Bone and Arthritis Disease (SINBAD), Shirahama Foundation for Health and Welfare

NULL

Recruiting

20years-old

Not applicable

Male and Female

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

561

NCT02881307
(ClinicalTrials.gov)

October 2016

19/8/2016

Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

Rheumatoid Arthritis;Overweight

Dietary Supplement: Whey Protein&Prebiotic Supplement;Behavioral: Dietary Counseling;Behavioral: Dietary recommendations

Dr. Veena Ranganath

NULL

Active, not recruiting

18 Years

N/A

All

N/A

United States

562

NCT02805010
(ClinicalTrials.gov)

October 2016

12/6/2016

Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously

A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects

Rheumatoid Arthritis (RA)

Drug: Abatacept;Other: Placebo

Jiangsu Simcere Pharmaceutical Co., Ltd.

Bristol-Myers Squibb

Active, not recruiting

18 Years

45 Years

Both

Phase 1

NULL

563

NCT02037737
(ClinicalTrials.gov)

September 30, 2016

21/11/2013

Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting

Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION Study

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

153

NULL

564

EUCTR2014-005368-13-ES
(EUCTR)

23/09/2016

15/07/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SAIT101 (rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

565

NCT02648035
(ClinicalTrials.gov)

September 22, 2016

5/1/2016

EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis

Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.

Rheumatoid Arthritis

Biological: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

200

Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

566

EUCTR2014-004904-31-BE
(EUCTR)

21/09/2016

29/07/2016

A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.

An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.

Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remsima (infliximab)

Mundipharma Pharmaceuticals B.V.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 4

Belgium;Netherlands

567

NCT02885181
(ClinicalTrials.gov)

September 21, 2016

26/8/2016

Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects With Active Rheumatoid Arthritis on Background Therapy With Methotrexate

Rheumatoid Arthritis

Drug: GS-9876;Drug: Filgotinib;Drug: GS-9876 placebo;Drug: Filgotinib placebo;Drug: Methotrexate

Gilead Sciences

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Bulgaria;Czechia;Georgia;Moldova, Republic of;Poland;Ukraine;Czech Republic;Hungary

568

EUCTR2014-005368-13-HU
(EUCTR)

19/09/2016

11/07/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy

569

NCT02884635
(ClinicalTrials.gov)

September 16, 2016

26/8/2016

A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate

Phase IIa Study of ASP1707 A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Phase 2a Study of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

Rheumatoid Arthritis

Drug: ASP1707;Drug: Placebo;Drug: Methotrexate

Astellas Pharma Inc

NULL

Completed

N/A

Female

Phase 2

Japan

570

NCT02919475
(ClinicalTrials.gov)

September 14, 2016

27/9/2016

Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis

A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis (MOVE-RA)

Rheumatoid Arthritis

Drug: JTE-051;Drug: Placebo

Akros Pharma Inc.

NULL

Completed

18 Years

75 Years

All

260

Phase 2

United States;Argentina;Bulgaria;Colombia;Mexico;Peru;Poland;Romania;Russian Federation;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

571

EUCTR2014-005368-13-CZ
(EUCTR)

13/09/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

572

EUCTR2012-002535-28-NL
(EUCTR)

13/09/2016

01/09/2016

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Rheumatoid Arthritis
MedDRA version: 19.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: MabThera
Product Code: L01X CO2
Trade Name: RoActemra
Product Name: RoActemra
Product Code: L04AC07

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

144

Phase 4

Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom

573

NCT03147248
(ClinicalTrials.gov)

September 12, 2016

7/5/2017

A Phase I/III Study to Evaluate Efficacy, PK and Safety Between CT-P13 SC and CT-P13 IV in Patients With Active RA

A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: CT-P13

Celltrion

NULL

Completed

18 Years

75 Years

All

407

Phase 3

Korea, Republic of

574

EUCTR2015-003335-35-SI
(EUCTR)

12/09/2016

28/09/2016

A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

575

EUCTR2015-002729-21-PT
(EUCTR)

12/09/2016

27/04/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria

Rheumatoid artritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Portugal;Hungary;Slovakia;Finland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

576

NCT02833350
(ClinicalTrials.gov)

September 9, 2016

12/7/2016

Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)

A Two-Cohort Randomized Phase II, Double-Blind, Parallel Group Study in Patients With Active Rheumatoid Arthritis Evaluating the Efficacy and Safety of GDC-0853 Compared With Placebo and Adalimumab in Patients With an Inadequate Response to Previous Methotrexate Therapy (Cohort 1) and Compared With Placebo in Patients With an Inadequate Response or Intolerance to Previous TNF Therapy (Cohort 2)

Rheumatoid Arthritis

Drug: GDC-0853;Drug: Adalimumab;Drug: Folic Acid;Drug: MTX;Drug: Placebo

Genentech, Inc.

NULL

Completed

18 Years

75 Years

All

578

Phase 2

United States;Argentina;Brazil;Bulgaria;Colombia;Korea, Republic of;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile

577

EUCTR2016-002125-11-HU
(EUCTR)

08/09/2016

11/07/2016

Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Trade Name: REMSIMA
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

258

Phase 1;Phase 3

Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Hungary;Czech Republic;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

578

EUCTR2015-003334-27-SI
(EUCTR)

07/09/2016

14/12/2015

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand

579

EUCTR2016-000912-13-GB
(EUCTR)

05/09/2016

12/06/2017

subjects with moderate to severe rheumatoid arthritis.
MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Spain;Romania;Germany;Italy;United Kingdom

580

NCT02831855
(ClinicalTrials.gov)

September 1, 2016

11/7/2016

Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CP -690,550;Drug: Methotrexate;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

694

Phase 4

United States;Australia;Belgium;Bulgaria;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Philippines;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

581

NCT02930343
(ClinicalTrials.gov)

September 2016

13/9/2016

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: Sulfasalazine

Jawaharlal Institute of Postgraduate Medical Education & Research

NULL

Completed

18 Years

65 Years

All

136

Phase 3

India

582

NCT03011281
(ClinicalTrials.gov)

September 2016

30/12/2016

Effectiveness and Safety of Tofacitinib in Korean Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tofacitinib

Hanyang University

NULL

Recruiting

19 Years

N/A

All

378

Korea, Republic of

583

NCT02666443
(ClinicalTrials.gov)

September 2016

24/1/2016

Low Dose Dexamethasone in Supraclavicular Blocks

Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study

Rheumatoid Arthritis;Osteoarthritis;Nerve Entrapment;Ligament Injury

Drug: Control intervention (no dexamethasone);Drug: Peri-neural Dexamethasone 1 mg;Drug: Intravenous Dexamethasone 1 mg

University of Calgary

NULL

Recruiting

18 Years

80 Years

Both

306

N/A

Canada

584

NCT03016013
(ClinicalTrials.gov)

September 2016

8/1/2017

A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.

A Phase III Study of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Poor Efficacy of MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.

Moderate and Severe RheumatoId Arthritis

Biological: Placebo plus MTX;Biological: RC18 160 mg plus MTX

RemeGen

NULL

Recruiting

18 Years

65 Years

All

480

Phase 3

China

585

NCT02897011
(ClinicalTrials.gov)

September 2016

7/9/2016

2-week dc of MTX and Influenza Vaccination in RA

Effect of Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial

Rheumatoid Arthritis;Influenza;Methotrexate

Drug: Methotrexate

Seoul National University Hospital

NULL

Recruiting

18 Years

65 Years

Both

318

N/A

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

586

EUCTR2015-003334-27-LT
(EUCTR)

30/08/2016

06/06/2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand

587

EUCTR2016-000912-13-DE
(EUCTR)

30/08/2016

29/06/2016

subjects with moderate to severe rheumatoid arthritis.
MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Spain;Romania;Germany;Italy;United Kingdom

588

EUCTR2015-003335-35-BG
(EUCTR)

29/08/2016

01/08/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

589

EUCTR2016-002125-11-LV
(EUCTR)

23/08/2016

01/07/2016

Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

258

Phase 1;Phase 3

Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Korea, Republic of;Bosnia and Herzegovina

590

EUCTR2016-000335-40-BG
(EUCTR)

23/08/2016

08/07/2016

A Study examining the treatment effect and Safety of GDC-0853 when compared With Placebo and a biologic therapy (Adalimumab) in Rheumatoid Arthritis Patients who have not responded or intolerance to Previous therapies.

A TWO-COHORT RANDOMIZED PHASE II, DOUBLEBLIND, PARALLEL GROUP STUDY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS EVALUATING THE EFFICACY AND SAFETY OF GDC-0853 COMPARED WITH PLACEBO AND ADALIMUMAB IN PATIENTS WITH AN INADEQUATE RESPONSE TO PREVIOUS METHOTREXATE THERAPY (COHORT 1) AND COMPARED WITH PLACEBO IN PATIENTS WITH AN INADEQUATE RESPONSE OR INTOLERANCE TO PREVIOUS TNF THERAPY (COHORT 2)

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 2

Serbia;United States;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

591

EUCTR2016-002125-11-EE
(EUCTR)

22/08/2016

05/07/2016

Evaluating efficacy, pharmacokinetics and safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Celltrion, Inc

NULL

Not Recruiting

Female: yes
Male: yes

258

Phase 1;Phase 3

Estonia;Slovakia;Spain;Ukraine;Lithuania;Russian Federation;Chile;Italy;Czech Republic;Hungary;Mexico;Poland;Belgium;Peru;South Africa;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

592

EUCTR2015-004386-91-DE
(EUCTR)

22/08/2016

18/05/2016

Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis.

A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs

Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Poland;Germany

593

NCT02628028
(ClinicalTrials.gov)

August 22, 2016

9/12/2015

A Study of LY3337641 in Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects With Rheumatoid Arthritis: The RAjuvenate Study

Rheumatoid Arthritis

Drug: LY3337641;Drug: Placebo

Eli Lilly and Company

NULL

Terminated

18 Years

65 Years

All

286

Phase 2

United States;Argentina;Australia;Austria;Italy;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Slovakia;South Africa;Spain;Germany

594

ChiCTR-IIR-16008693

2016-08-20

2016-06-20

Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously

A Randomized, Double-blind, Placebo-controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of Single Dose of Abatacept 125mg Administered Subcutaneously in Chinese Healthy Subjects

Rheumatoid Arthritis

Abatacept Group:Single dose of abatacept;Placebo Group:Single dose of placebo;

The First Hospital, Jilin University

NULL

Pending

Both

Abatacept Group:20;Placebo Group:2;

I (Phase 1 study)

China

595

NCT02705989
(ClinicalTrials.gov)

August 18, 2016

7/3/2016

Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects

A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD), and Non-Randomized, Bioavailability(BA) Study of BMS-986195 in Healthy Subjects

Rheumatoid Arthritis

Drug: BMS-986195;Other: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

55 Years

All

439

Phase 1

Australia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

596

EUCTR2015-003334-27-BG
(EUCTR)

18/08/2016

18/07/2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

597

EUCTR2015-003335-35-HU
(EUCTR)

18/08/2016

18/03/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Norway;Germany;New Zealand;Sweden

598

EUCTR2016-000064-42-BG
(EUCTR)

11/08/2016

28/06/2016

Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis

Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;Bulgaria

599

EUCTR2015-003333-95-FI
(EUCTR)

10/08/2016

19/04/2016

A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

600

EUCTR2015-003335-35-FI
(EUCTR)

10/08/2016

22/04/2016

A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

601

EUCTR2016-001532-35-HU
(EUCTR)

08/08/2016

15/06/2016

A Phase II, Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.

A Phase II, Dose Ranging, Exploratory Clinical Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of LNP1955 in Patients with Moderate to Severe Rheumatoid Arthritis.

Moderate to Severe Rheumatoid Arthritis.
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: LNP1955

Lupin Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Bulgaria

602

EUCTR2016-000393-37-BG
(EUCTR)

08/08/2016

17/06/2016

A study to test the effectiveness of bimekizumab as a treatment for rheumatoid arthritis, to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.

A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY/TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE INTRAVENOUS DOSES OF BIMEKIZUMAB (UCB4940) ADMINISTERED TO SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

RHEUMATOID ARTHRITIS
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940

UCB Biopharma Sprl

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Russian Federation;Georgia;Bulgaria;Moldova, Republic of;United Kingdom

603

EUCTR2016-000064-42-HU
(EUCTR)

05/08/2016

06/06/2016

Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis

Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A

Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Estonia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Romania;Bulgaria;South Africa

604

EUCTR2015-005307-83-BG
(EUCTR)

04/08/2016

17/06/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

R-Pharm International LLC

NULL

Not Recruiting

Female: yes
Male: yes

1575

Phase 3

United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of

605

EUCTR2015-003376-75-BG
(EUCTR)

02/08/2016

18/07/2016

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

606

NCT03775824
(ClinicalTrials.gov)

August 1, 2016

11/12/2018

Faecal Analyses in Rheumatoid Arthritis Therapy

Faecal Analyses in Rheumatoid Arthritis Therapy: An Prospective Observational Study of the Intestinal Microbiome in Patients With Rheumatoid Arthritis Receiving Immunosuppressive Therapy

Rheumatoid Arthritis

Drug: MTX start;Drug: TNF start

Region Skane

NULL

Completed

18 Years

N/A

All

NULL

607

NCT02892370
(ClinicalTrials.gov)

August 2016

2/9/2016

Effect of a High-fat Meal on the Pharmacokinetics of SHR0302 and Mass Balance Study in Healthy Subjects

An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR0302 and Mass Balance in Healthy Volunteers

Rheumatoid Arthritis

Drug: SHR0302

Jiangsu HengRui Medicine Co., Ltd.

NULL

Recruiting

18 Years

45 Years

Male

Phase 1

China

608

EUCTR2015-003376-75-GR
(EUCTR)

28/07/2016

13/05/2016

A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Japan;New Zealand;Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary

609

JPRN-JapicCTI-163317

28/7/2016

13/07/2016

Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis

Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors

Rheumatoid Arthritis

Intervention name : BMS-986142
INN of the intervention : -
Dosage And administration of the intervention : BMS-986142 at dose level 1+ Methotrexate as specified. BMS-986142 at dose level 2 + Methotrexate as specified.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo + Methotrexate dose as specified

Bristol-Myers Squibb K.K.

NULL

complete

120

BOTH

408

Phase 2

Japan, Asia except Japan, North America, South America, Europe, Oceania

610

EUCTR2015-003334-27-CZ
(EUCTR)

27/07/2016

06/06/2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

611

EUCTR2016-000064-42-SK
(EUCTR)

27/07/2016

03/05/2016

Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis

Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A

Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria

612

EUCTR2015-003376-75-CZ
(EUCTR)

27/07/2016

03/06/2016

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

613

NCT02867306
(ClinicalTrials.gov)

July 25, 2016

11/8/2016

A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis

A Phase 1 Open-label, Single-sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ASP1707;Drug: methotrexate (MTX)

Astellas Pharma Global Development, Inc.

NULL

Completed

18 Years

65 Years

All

Phase 1

Moldova, Republic of

614

JPRN-UMIN000021247

2016/07/22

22/07/2016

Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state

Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state - Tocilizumab treatment with reducing and stopping methotrexate (T-ReX study)

Rheumatoid arthritis

Double the time between applications of MTX without changing dose for the first 12 weeks, and then stop MTX if CDAI<=10 is maintained.

Nagoya University Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

615

EUCTR2015-003333-95-LT
(EUCTR)

21/07/2016

09/05/2016

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

616

EUCTR2015-003335-35-IT
(EUCTR)

18/07/2016

28/02/2018

Product Name: ABT-494
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494

ABBVIE DEUTSCHLAND GMBH & CO. KG

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

617

ChiCTR-IPR-16008793

2016-07-15

2016-06-10

A multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritis

Rheumatoid arthritis

experimental group:ZHENGQING FENGTONGNING sustained release tablets; control group:methotrexate;The combined treatment group:ZHENGQING FENGTONGNING sustained release tablets combine methotrexate;

The First Affiliated Hospital of Third Military Medical University

NULL

Recruiting

Both

experimental group:80; control group:80;The combined treatment group:80;

China

618

EUCTR2015-003333-95-BG
(EUCTR)

13/07/2016

25/03/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Belarus;United States;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

619

EUCTR2015-003334-27-HU
(EUCTR)

13/07/2016

10/06/2016

A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Lithuania;Turkey;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand

620

EUCTR2016-001618-18-FR
(EUCTR)

08/07/2016

09/06/2016

Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients

STARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR

glucocorticoid withdrawal in rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Prednisone
Product Name: prednisone 5 mg
Trade Name: Prednisone
Product Name: prednisone 4 mg
Trade Name: Prednisone
Product Name: prednisone 3 mg
Trade Name: Prednisone
Product Name: prednisone 2 mg
Trade Name: Prednisone
Product Name: prednisone 1 mg
Trade Name: Hydrocortisone 10mg

CHU Toulouse

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

122

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

621

EUCTR2015-003334-27-ES
(EUCTR)

08/07/2016

19/01/2016

A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 15 mg Once Daily Monotherapy and ABT-494 30 mg Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;United Kingdom;Egypt;Hungary;Mexico;European Union;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;New Zealand;Japan

622

EUCTR2015-003376-75-HU
(EUCTR)

06/07/2016

09/06/2016

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand

623

EUCTR2015-005307-83-PL
(EUCTR)

06/07/2016

01/06/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira®)
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40mg solution for injection in pre-filled syringe
Product Name: Adalimumab (Humira)
Product Code: LO4AB04

R-Pharm

NULL

Not Recruiting

Female: yes
Male: yes

1575

Phase 3

United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of

624

EUCTR2015-003433-10-GB
(EUCTR)

05/07/2016

30/03/2016

ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

GP17-302 A randomized, double-blind, parallel-group, multicenter study to demonstrate similar efficacy and to compare safety and immunogenicity of GP2017 and Humira® in patients with moderate to severe active rheumatoid arthritis - ADMYRA trial

rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Hexal, AG

NULL

Not Recruiting

Female: yes
Male: yes

308

Phase 3

Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of

625

EUCTR2015-003335-35-GR
(EUCTR)

05/07/2016

26/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

626

EUCTR2015-003335-35-GB
(EUCTR)

05/07/2016

17/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

499

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

627

NCT02683421
(ClinicalTrials.gov)

July 2016

22/1/2016

Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging

Evaluation of Subcutaneous (SC) Injected Tc 99m Tilmanocept Localization in Active Rheumatoid Arthritis (RA) Subjects by SPECT and SPECT/CT Imaging

Rheumatoid Arthritis

Drug: Tilmanocept

Navidea Biopharmaceuticals

NULL

Completed

21 Years

N/A

All

Phase 1

United States

628

NCT03106259
(ClinicalTrials.gov)

June 29, 2016

3/4/2017

Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj

Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj

Rheumatoid Arthritis

Drug: FURESTEM-RA Inj.

Kang Stem Biotech Co., Ltd.

NULL

Active, not recruiting

19 Years

80 Years

All

Phase 1

Korea, Republic of

629

EUCTR2015-003334-27-PL
(EUCTR)

28/06/2016

08/06/2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand

630

EUCTR2015-003376-75-PL
(EUCTR)

28/06/2016

08/06/2016

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Belgium;Poland;Australia;Bulgaria;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

631

EUCTR2015-003376-75-ES
(EUCTR)

23/06/2016

19/01/2016

A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;United States;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;European Union;Mexico;Puerto Rico;Argentina;Australia;Japan;New Zealand

632

EUCTR2015-003334-27-GR
(EUCTR)

22/06/2016

13/05/2016

A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;New Zealand;Japan

633

EUCTR2016-000064-42-CZ
(EUCTR)

21/06/2016

08/06/2016

Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis

Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A

Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria

634

EUCTR2015-002729-21-FI
(EUCTR)

21/06/2016

30/03/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

Rheumatoid artritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 4

Portugal;Hungary;Slovakia;Finland;Germany

635

NCT03333681
(ClinicalTrials.gov)

June 20, 2016

14/9/2017

Evaluation of Stem Cell Therapy Effects on the Immune Response in Rheumatoid Arthritis Patients

Evaluation of Mesenchymal Stem Cell Therapy Effects on the Cellular and Humoral Immune Responses and Additionally Study on the Effect of Chemokines in Homing of the Immune Cells in Refractory Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Biological: Autologous mesenchymal stem cells

Mashhad University of Medical Sciences

NULL

Completed

35 Years

60 Years

Female

Phase 1

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

636

EUCTR2015-003376-75-PT
(EUCTR)

17/06/2016

09/06/2016

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Portugal;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand

637

EUCTR2015-003334-27-IE
(EUCTR)

17/06/2016

07/06/2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

638

EUCTR2015-003334-27-PT
(EUCTR)

17/06/2016

09/06/2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

United States;Belarus;Portugal;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand

639

EUCTR2015-003334-27-LV
(EUCTR)

17/06/2016

08/06/2016

A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: MTX HEXAL 2,5mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;European Union;Mexico;Canada;Argentina;Brazil;Kazakhstan;New Zealand;Japan;United States

640

EUCTR2015-003334-27-GB
(EUCTR)

15/06/2016

09/06/2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

641

EUCTR2015-003332-13-BG
(EUCTR)

15/06/2016

25/03/2016

A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

642

NCT03762824
(ClinicalTrials.gov)

June 14, 2016

3/12/2018

Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.

Rheumatoid Arthritis;Systemic Lupus;Sjögren Syndrome;Systemic Vasculitis;Spondyloarthritis

Biological: 13-valent pneumococcal conjugate vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine

Region Skane

NULL

Active, not recruiting

18 Years

N/A

All

300

Phase 4

NULL

643

EUCTR2015-003376-75-AT
(EUCTR)

10/06/2016

28/06/2016

A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand

644

EUCTR2015-003332-13-LT
(EUCTR)

10/06/2016

29/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

645

EUCTR2015-005307-83-HU
(EUCTR)

09/06/2016

28/04/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

R-Pharm

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1575

Phase 3

United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

646

EUCTR2015-005308-27-HU
(EUCTR)

09/06/2016

28/04/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

R-Pharm

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Germany;Colombia;Korea, Republic of

647

EUCTR2015-003334-27-HR
(EUCTR)

08/06/2016

06/07/2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;New Zealand;Japan

648

EUCTR2015-003433-10-IT
(EUCTR)

08/06/2016

27/02/2018

ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB

HEXAL AG

NULL

Not Recruiting

Female: yes
Male: yes

308

Phase 3

Serbia;United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of

649

EUCTR2015-001275-50-NL
(EUCTR)

08/06/2016

10/12/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive

Early Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden

650

EUCTR2015-003433-10-CZ
(EUCTR)

08/06/2016

30/03/2016

ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial

rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB

Hexal, AG

NULL

Not Recruiting

Female: yes
Male: yes

308

Phase 3

Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

651

EUCTR2015-003334-27-BE
(EUCTR)

07/06/2016

06/06/2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand;Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia

652

EUCTR2015-005307-83-CZ
(EUCTR)

07/06/2016

18/03/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

R-Pharm International LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1575

Phase 3

United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of

653

EUCTR2015-003376-75-BE
(EUCTR)

07/06/2016

06/06/2016

A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand

654

EUCTR2015-005308-27-CZ
(EUCTR)

07/06/2016

15/04/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy

Moderately to Severely Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038

R-Pharm International LLC

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Germany;Colombia;Korea, Republic of

655

EUCTR2015-002887-17-BE
(EUCTR)

07/06/2016

16/02/2016

Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

610

Phase 2

United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

656

EUCTR2015-003332-13-GR
(EUCTR)

06/06/2016

24/05/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

657

EUCTR2015-003335-35-LV
(EUCTR)

03/06/2016

13/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Norway;Germany;New Zealand;Sweden

658

ChiCTR-INR-16009031

2016-06-01

2016-08-15

Evaluation of the Effect of Huayu Qiangshen Tongbi Fomular Combined with MTX on Treating Rheumatoid Arthritis and Study of the mechanism through gut microbiomes

Evaluation of the Effect of Huayu Qiangshen Tongbi Fomular Combined with MTX on rheumatoid arthritis and Study of the mechanism through gut microbiomes

Rheumatoid Arthritis

the Treated Group:MTX 10-15mg po qw, and Huayu Qiangshen Tongbi Fang, po qd;the Controled Group:MTX 10-15mg po qw, and LEF 10mg po bid.;

Guangdong Provincial Hospital of Chinese Medicine

NULL

Recruiting

Both

the Treated Group:100;the Controled Group:100;

China

659

JPRN-UMIN000021929

2016/06/01

15/04/2016

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT Study

Rheumatoid arthritis

Discontinuation of infliximab

Chiba University

NULL

Complete: follow-up continuing

18years-old

Not applicable

Male and Female

200

Not selected

Japan

660

EUCTR2015-003335-35-PT
(EUCTR)

31/05/2016

30/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

661

JPRN-jRCTs031180001

30/05/2016

12/06/2018

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT

Rheumatoid arthritis

Infliximab Withdrawal

Ikeda Kei

NULL

Not Recruiting

>= 18age old

Not applicable

Both

200

Phase 4

Japan

662

EUCTR2015-003433-10-HU
(EUCTR)

26/05/2016

14/04/2016

ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial

rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB

Hexal, AG

NULL

Not Recruiting

Female: yes
Male: yes

308

Phase 3

Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of

663

EUCTR2015-003433-10-DE
(EUCTR)

25/05/2016

07/04/2016

ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial

Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB

Hexal, AG

NULL

Not Recruiting

Female: yes
Male: yes

308

Phase 3

Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of

664

EUCTR2015-003335-35-FR
(EUCTR)

24/05/2016

17/06/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

665

EUCTR2016-002035-15-FI
(EUCTR)

20/05/2016

12/05/2016

Outcome after total knee endoprosthesis under general or regional anesthesia, a randomized study

Outcome after total knee arthroplasty under general or spinal anesthesia, a randomized study - Outcome after total knee arthroplasty under general or spinal anesthesia

Patients undego total knee arthroplasty operation in general or spinal anaesthesia because of osteoarthritis, rheumatoid arthritis or other degenerative condition of the knee
MedDRA version: 19.0;Level: LLT;Classification code 10031174;Term: Osteoarthrosis;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10031158;Term: Osteo arthritis knees;System Organ Class: 100000004859;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trade Name: Bicain spinal
INN or Proposed INN: bupivacaine hydrochloride
Other descriptive name: BUPIVACAINE HYDROCHLORIDE
Trade Name: Propolipid
INN or Proposed INN: propofol
Other descriptive name: PROPOFOL

Helsinki University Central Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Finland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

666

EUCTR2015-003335-35-SK
(EUCTR)

19/05/2016

22/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

667

NCT02659150
(ClinicalTrials.gov)

May 18, 2016

21/12/2015

Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis

A Multicenter, Open-Label, Proof-of-Activity Study of the Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab

Massachusetts General Hospital

Brigham and Women's Hospital

Unknown status

50 Years

75 Years

Female

Phase 4

NULL

668

EUCTR2015-003333-95-HU
(EUCTR)

18/05/2016

07/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

669

NCT02792699
(ClinicalTrials.gov)

May 17, 2016

25/4/2016

Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: ABP 798;Drug: Rituximab (US);Drug: Rituximab (EU)

Amgen

NULL

Completed

18 Years

80 Years

All

311

Phase 3

United States;Bulgaria;Estonia;Germany;Hungary;Poland;Canada

670

EUCTR2014-004719-36-BG
(EUCTR)

14/05/2016

05/04/2016

Study of the Efficacy and Safety of Olokizumab in Patients withModerately to Severely Active Rheumatoid Arthritis InadequatelyControlled by Methotrexate Therapy

A Randomized, Double-Blind, Parallel-Group, Placebo Controlled,Multicenter Phase III Study of the Efficacy and Safety of Olokizumab inSubjects with Moderately to Severely Active Rheumatoid ArthritisInadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 1

Product Name: Olokizumab
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038

R-Pharm

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

Belarus;Turkey;Russian Federation;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

671

EUCTR2015-003335-35-IE
(EUCTR)

13/05/2016

10/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

672

NCT02780388
(ClinicalTrials.gov)

May 12, 2016

3/5/2016

A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis

A Phase 1b Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Clinical Response of MEDI4920 in Subjects With Adult-onset Rheumatoid Arthritis

Adult Onset Rheumatoid Arthritis

Drug: VIB4920;Other: Placebo

Viela Bio

NULL

Completed

18 Years

70 Years

All

Phase 1

United States;Poland

673

EUCTR2015-003333-95-GR
(EUCTR)

12/05/2016

10/05/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

674

EUCTR2015-003333-95-CZ
(EUCTR)

11/05/2016

22/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

675

EUCTR2015-003332-13-CZ
(EUCTR)

11/05/2016

06/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

676

EUCTR2015-003335-35-CZ
(EUCTR)

11/05/2016

15/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

677

EUCTR2015-003332-13-HR
(EUCTR)

11/05/2016

06/07/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

678

JPRN-UMIN000022364

2016/05/10

20/05/2016

Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis

Treatment strategy of minodronate in osteoporotic patients with rheumatoid arthritis - Effectiveness of minodronate in osteoporotic patients with rheumatoid arthritis

Osteoprotic patients with rheumatoid arthritis

The selection criteria is based on which treatment each patient wants to take
Minodronate group: oral intake 50mg per month
Minodronate plus active vitamin D group: oral intake 50mg minodronate per month and eldecalcitol 0.75ug per day after breakfast

Department of Orthopaedic Surgery Shinshu University School of Medicine

NULL

Complete: follow-up complete

50years-old

100years-old

Male and Female

140

Not applicable

Japan

679

EUCTR2015-003335-35-SE
(EUCTR)

10/05/2016

16/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

680

EUCTR2015-003332-13-HU
(EUCTR)

10/05/2016

05/05/2016

A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

681

EUCTR2015-003332-13-ES
(EUCTR)

09/05/2016

19/01/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Kazakhstan;Norway;New Zealand

682

EUCTR2015-003433-10-ES
(EUCTR)

09/05/2016

22/07/2016

ADMYRA Trial: Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

GP17-302A randomized, double-blind, parallel-group, multicenterstudy to demonstrate similar efficacy and to comparesafety and immunogenicity of GP2017 and Humira® inpatients with moderate to severe active rheumatoid arthritis - ADMYRA trial

Product Name: Adalimumab
Product Code: GP2017
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB

Hexal, AG

NULL

Not Recruiting

Female: yes
Male: yes

308

Phase 3

Serbia;United States;Spain;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Malaysia;Poland;Romania;Germany;Korea, Republic of

683

EUCTR2015-003333-95-ES
(EUCTR)

06/05/2016

19/01/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Kazakhstan;Germany;New Zealand

684

EUCTR2015-003333-95-PT
(EUCTR)

06/05/2016

08/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Serbia;Belarus;United States;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

685

EUCTR2015-002729-21-HU
(EUCTR)

04/05/2016

11/02/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

Rheumatoid artritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Hungary;Slovakia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

686

EUCTR2015-003335-35-BE
(EUCTR)

04/05/2016

10/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

687

EUCTR2015-005307-83-LT
(EUCTR)

04/05/2016

25/03/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

R-Pharm

NULL

Not Recruiting

Female: yes
Male: yes

1575

Phase 3

United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Latvia;Germany;Korea, Republic of

688

EUCTR2015-003335-35-AT
(EUCTR)

04/05/2016

14/04/2016

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

689

EUCTR2015-003335-35-DK
(EUCTR)

03/05/2016

14/03/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

690

EUCTR2015-003335-35-DE
(EUCTR)

03/05/2016

09/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

691

NCT02760316
(ClinicalTrials.gov)

May 2, 2016

25/4/2016

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567.

A Phase I, Randomised, Single-blind Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of AZD9567 in Healthy Volunteers Using Prednisolone as Positive Control

Rheumatoid Arthritis

Drug: AZD9567 10 mg;Drug: AZD9567 20 mg;Drug: AZD9567 40 mg;Drug: AZD9567 80 mg;Drug: Prednisolone 20 mg;Drug: AZD9567 125 mg;Drug: AZD9567 155 mg;Drug: Prednisolone 5 mg;Drug: Prednisolone 40 mg

AstraZeneca

NULL

Completed

18 Years

55 Years

All

Phase 1

Germany;United Kingdom

692

NCT02668640
(ClinicalTrials.gov)

May 1, 2016

27/1/2016

Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China

Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in China (ROCKI Study)

Rheumatoid Arthritis

Biological: Adalimumab

AbbVie

NULL

Completed

18 Years

N/A

All

China

693

NCT02762123
(ClinicalTrials.gov)

May 2016

3/5/2016

A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates

Effects of Concomitant Administration of BMS-986142 on the Single-dose Pharmacokinetics of Probe Substrates for CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-gp in Healthy Subjects

Rheumatoid Arthritis

Drug: BMS-986142 200mg;Drug: BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin);Drug: BMS-986142 350mg

Bristol-Myers Squibb

NULL

Completed

18 Years

50 Years

Both

Phase 1

United States

694

NCT02665910
(ClinicalTrials.gov)

May 2016

24/1/2016

Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients

A Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RA

Rheumatoid Arthritis

Drug: SHR0302;Drug: SHR0302 placebo comparator

Jiangsu HengRui Medicine Co., Ltd.

NULL

Not yet recruiting

18 Years

70 Years

Both

Phase 1

China

695

NCT02770794
(ClinicalTrials.gov)

May 2016

11/5/2016

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

Multicenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease Activity

Arthritis, Rheumatoid

Drug: Infliximab

Chiba University

NULL

Not yet recruiting

18 Years

N/A

Both

200

Phase 4

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

696

EUCTR2015-003335-35-ES
(EUCTR)

29/04/2016

11/03/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

United States;Hong Kong;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Korea, Republic of;Turkey;Austria;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Norway;Germany;New Zealand;Sweden

697

EUCTR2015-003332-13-PL
(EUCTR)

26/04/2016

12/04/2016

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

698

EUCTR2015-002729-21-DE
(EUCTR)

25/04/2016

02/02/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 4

Portugal;Hungary;Slovakia;Finland;Germany

699

EUCTR2015-003333-95-DE
(EUCTR)

25/04/2016

14/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

700

EUCTR2015-003332-13-NO
(EUCTR)

22/04/2016

21/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Egypt;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

701

EUCTR2015-002729-21-SK
(EUCTR)

22/04/2016

25/02/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

Rheumatoid artritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

VU University Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 4

Portugal;Hungary;Slovakia;Finland;Germany

702

EUCTR2015-003332-13-FI
(EUCTR)

22/04/2016

19/04/2016

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

703

EUCTR2015-003332-13-IE
(EUCTR)

22/04/2016

08/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

704

EUCTR2015-003332-13-PT
(EUCTR)

22/04/2016

08/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Hong Kong;United States;Belarus;Portugal;Serbia

705

EUCTR2015-003333-95-IE
(EUCTR)

22/04/2016

08/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

706

EUCTR2015-002887-17-NL
(EUCTR)

20/04/2016

22/02/2016

Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis

Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

610

Phase 2

United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of

707

EUCTR2015-003332-13-LV
(EUCTR)

20/04/2016

12/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

708

EUCTR2015-003333-95-LV
(EUCTR)

20/04/2016

12/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

709

EUCTR2015-003332-13-AT
(EUCTR)

20/04/2016

01/06/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

710

EUCTR2015-003333-95-AT
(EUCTR)

20/04/2016

12/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

711

EUCTR2014-004868-38-IT
(EUCTR)

16/04/2016

06/11/2020

A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis. - A study comparing the use of etanercept and methotrexate, used either alone or in combination, for m

Trade Name: ENBREL - 50 MG SOLUZIONE INIETTABILE IN SIRINGA (VETRO DA 1 ML) PRERIEMPITA - USO SOTTOCUTANEO 12 SIRINGHE PRERIEMPITE + 24 TAMPONI IMBEVUTI DI ALCOL
Product Name: Enbrel
Product Code: [NA]
INN or Proposed INN: ETANERCEPT
Trade Name: METOTREXATO SANDOZ - 2.5 MG COMPRESSE 50 COMPRESSE IN FLACONE PP
Product Name: methotrexate
Product Code: [NA]
INN or Proposed INN: METOTREXATO

AMGEN INC.

NULL

Not Recruiting

Female: yes
Male: yes

358

Phase 3

France;Portugal;Hungary;Czech Republic;Greece;Spain;Bulgaria;Germany;United Kingdom;Italy

712

EUCTR2015-003333-95-DK
(EUCTR)

15/04/2016

07/04/2016

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

713

EUCTR2015-003332-13-DK
(EUCTR)

15/04/2016

07/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;Denmark;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

714

EUCTR2015-003332-13-IT
(EUCTR)

15/04/2016

28/02/2018

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs - SELECT-NEXT

Product Name: ABT-494
Product Code: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: N.A.

ABBVIE DEUTSCHLAND GMBH & CO. KG

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Italy;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Japan;Colombia;Switzerland;Portugal;Serbia;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Barbados;Russian Federation;Chile;Israel

715

EUCTR2015-003333-95-GB
(EUCTR)

14/04/2016

11/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

716

EUCTR2015-003332-13-GB
(EUCTR)

14/04/2016

11/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

717

EUCTR2015-003332-13-BE
(EUCTR)

13/04/2016

07/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

718

EUCTR2015-003333-95-BE
(EUCTR)

13/04/2016

07/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

719

NCT02750800
(ClinicalTrials.gov)

April 7, 2016

13/4/2016

Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)

Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE

Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Psoriasis;Crohn's Disease;Ulcerative Colitis

Biological: Adalimumab;Behavioral: AbbVie Care 2.0

AbbVie

NULL

Completed

18 Years

99 Years

All

427

Hungary

720

EUCTR2015-003333-95-HR
(EUCTR)

05/04/2016

28/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

721

NCT02722044
(ClinicalTrials.gov)

April 2016

23/3/2016

Usability of an AI for M923 in Subjects With Moderate to Severe RA

An Open-label Single-arm Multicenter Study to Evaluate Usability of a Subcutaneous (SC) Autoinjector (AI) for a Proposed Adalimumab Biosimilar (M923) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Biological: M923;Device: Autoinjector

Momenta Pharmaceuticals, Inc.

NULL

Completed

18 Years

N/A

All

Phase 3

United States

722

NCT02715908
(ClinicalTrials.gov)

April 2016

17/3/2016

A Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 in Subjects With Active RA Despite Methotrexate (MTX)

A Extension Clinical Study to Evaluate the Long-term Safety and Efficacy of LBEC0101 When Co-administered With Methotrexate (MTX) for Additional 48 Weeks in Patients With RA Who Have Completed the Treatment Period of LG-ECCL002

Rheumatoid Arthritis

Drug: LBEC0101

LG Life Sciences

NULL

Completed

20 Years

75 Years

All

148

Phase 3

Korea, Republic of

723

NCT02714881
(ClinicalTrials.gov)

April 2016

14/3/2016

Lipids, Inflammation, and CV Risk in RA

Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis

Rheumatoid Arthritis;Cardiovascular Disease

Drug: certolizumab;Radiation: Stress myocardial perfusion PET

Brigham and Women's Hospital

NULL

Recruiting

35 Years

90 Years

All

N/A

United States

724

NCT02573012
(ClinicalTrials.gov)

March 29, 2016

1/10/2015

Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Participants

Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: Placebo matched to prednisone;Drug: Prednisone;Biological: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

314

Phase 4

France;Germany;Italy;Russian Federation;Serbia;Tunisia;Egypt;Switzerland;Turkey

725

EUCTR2015-002887-17-AT
(EUCTR)

29/03/2016

18/01/2016

Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis with an Inadequate Response to Methotrexate With or Without TNF Inhibitors
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BMS-986142
Product Code: BMS-986142
INN or Proposed INN: BMS986142
Product Name: BMS-986142
Product Code: BMS-986142
INN or Proposed INN: BMS986142

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

610

Phase 2

United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

726

EUCTR2015-002887-17-ES
(EUCTR)

28/03/2016

13/01/2016

Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis

Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

610

Phase 2

United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of

727

NCT02679001
(ClinicalTrials.gov)

March 24, 2016

8/2/2016

A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.

A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT

Rheumatoid Arthritis

Drug: TNF inhibitor/TCZ

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

200

Sweden

728

NCT02706951
(ClinicalTrials.gov)

March 23, 2016

18/2/2016

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Upadacitinib;Drug: Placebo Upadacitinib;Drug: Placebo Methotrexate

AbbVie

NULL

Active, not recruiting

18 Years

99 Years

All

648

Phase 3

United States;Argentina;Australia;Austria;Belgium;Bulgaria;Chile;Czechia;Estonia;Greece;Hungary;Israel;Italy;Japan;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;South Africa;Spain;Turkey;Ukraine;Colombia;Czech Republic;New Zealand

729

NCT02720523
(ClinicalTrials.gov)

March 22, 2016

22/3/2016

A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

A Phase 2b/3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Japanese Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Rheumatoid Arthritis

Drug: Placebo;Drug: Upadacitinib

AbbVie

NULL

Active, not recruiting

18 Years

N/A

All

197

Phase 2;Phase 3

Japan

730

NCT02682823
(ClinicalTrials.gov)

March 21, 2016

11/2/2016

Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

Tocilizumab Real-Life Human Factors Validation Study

Rheumatoid Arthritis

Device: AI-1000 G2;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

731

NCT02706847
(ClinicalTrials.gov)

March 15, 2016

18/2/2016

A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Rheumatoid Arthritis

Drug: Upadacitinib;Drug: Placebo

AbbVie

NULL

Active, not recruiting

18 Years

99 Years

All

499

Phase 3

United States;Australia;Austria;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Korea, Republic of;Latvia;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Argentina;Brazil;Bulgaria;Chile;Colombia;Czech Republic;Denmark;Hong Kong;Italy;Mexico;Norway;Slovenia

732

NCT01961310
(ClinicalTrials.gov)

March 8, 2016

9/10/2013

Evaluation of the Intestinal Microbiota and Bacterial Translocation in Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: Plasma analysis for bacterial translocation;Biological: Stool analysis

Centre Hospitalier Universitaire de Nimes

NULL

Completed

18 Years

N/A

All

France

733

EUCTR2015-002523-26-HU
(EUCTR)

08/03/2016

13/11/2015

Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects(investigator-initiated grant proposal)

Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Tofacitinib
Product Code: CP -690,55-10

Arthritis Alapítvány

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary

734

EUCTR2014-004868-38-PT
(EUCTR)

07/03/2016

18/12/2015

A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

358

Phase 3

France;United States;Portugal;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany

735

JPRN-UMIN000021492

2016/03/01

20/03/2016

To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients.

Rheumatoid arthritis

switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.

Inoue Hospital

NULL

Complete: follow-up complete

18years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

736

NCT02714634
(ClinicalTrials.gov)

March 2016

1/2/2016

Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate

Randomized Controlled Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate

Rheumatoid Arthritis;Insufficient Response to Methotrexate.

Drug: Methotrexate + biologic administration;Drug: methotrexate + salazopyrine + hydroxychloroquine administration

University Hospital, Strasbourg, France

NULL

Not yet recruiting

18 Years

N/A

Both

286

Phase 4

NULL

737

NCT02636829
(ClinicalTrials.gov)

March 2016

17/11/2015

Validation of Self-administered Questionnaire for Assessing Calcium Intake in Patients With Multiple Sclerosis or Chronic Inflammatory Arthritis

Validation of Self-administered Questionnaire Specifically for Assessing Calcium Intake (QALCIMUM®) in Patients With Multiple Sclerosis (MS) or Chronic Inflammatory Arthritis

Multiple Sclerosis;Rheumatoid Arthritis

Other: QALCIMUM questionnaire;Other: Determination of calcium intake by a dietician interview

Centre Hospitalier Universitaire de Nimes

NULL

Completed

18 Years

69 Years

Both

100

N/A

France

738

NCT02652299
(ClinicalTrials.gov)

March 2016

15/11/2015

Fibrocytes in Early and Longstanding Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Synovial biopsy

Odense University Hospital

NULL

Completed

18 Years

N/A

All

Denmark

739

NCT02728934
(ClinicalTrials.gov)

February 25, 2016

31/3/2016

Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis

Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: Golimumab Intravenous (IV);Biological: Infliximab;Biological: Biosimilar Infliximab

Janssen Scientific Affairs, LLC

NULL

Completed

18 Years

N/A

All

1279

United States

740

EUCTR2015-002634-41-DE
(EUCTR)

25/02/2016

10/11/2015

Long-term study of BI695501 in patients with active rheumatoid arthritis

Long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis (RA): an open-label extension trial for patients who have completed trial 1297.2 and are eligible for long-term treatment with adalimumab

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

741

EUCTR2015-002634-41-BG
(EUCTR)

24/02/2016

21/12/2015

Long-term study of BI695501 in patients with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of

742

EUCTR2015-002924-17-BE
(EUCTR)

24/02/2016

27/01/2016

A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis

A Phase III, Randomized, Double-Blind, Double Dummy, Active Controlled, Multi-Center Study To Evaluate The Efficacy And Safety Of Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate (Nanocort) Compared With Intramuscular Injection Of Methylprednisolone Acetate In Subjects With Active Rheumatoid Arthritis

Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Nanocort
INN or Proposed INN: prednisolone
Other descriptive name: PREDNISOLONE
Trade Name: Depo Medrol
Product Name: Depo Medrol

Sun Pharma Global FZE

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 3

Belgium;Netherlands

743

NCT02698657
(ClinicalTrials.gov)

February 23, 2016

10/2/2016

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

A Phase 1, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

Rheumatoid Arthritis (RA)

Drug: ASP5094;Drug: Placebo

Astellas Pharma Global Development, Inc.

NULL

Completed

18 Years

65 Years

All

Phase 1

United States;Poland

744

NCT02706873
(ClinicalTrials.gov)

February 23, 2016

18/2/2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Upadacitinib Placebo;Drug: Methotrexate;Drug: Methotrexate Placebo;Drug: Upadacitinib

AbbVie

NULL

Active, not recruiting

18 Years

N/A

All

1002

Phase 3

United States;Argentina;Australia;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Guatemala;Hong Kong;Hungary;Ireland;Israel;Italy;Japan;Kazakhstan;Latvia;Lithuania;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;Tunisia;Turkey;Ukraine;United Kingdom;Czech Republic;Finland;Malaysia;Netherlands

745

EUCTR2012-002009-23-DE
(EUCTR)

22/02/2016

09/10/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

A randomized, double-blind, parallel-group Phase III study to demonstrate equivalent efficacy and to compare safety and immunogenicity of GP2015 and Enbrel® (EU-authorized) in patients with moderate to severe, active rheumatoid arthritis - EQUIRA

Moderate to severe active rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: GP2015
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel 50 mg solution for injection in pre-filled syringe
INN or Proposed INN: ETANERCEPT

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

746

NCT02321930
(ClinicalTrials.gov)

February 16, 2016

23/9/2014

Musculoskeletal Ultrasound Assessment of Therapeutic Response of Tofacitinib in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: tofacitinib 5mg po bid

University of California, Los Angeles

NULL

Completed

18 Years

N/A

All

Phase 4

United States

747

NCT02638948
(ClinicalTrials.gov)

February 16, 2016

21/12/2015

Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis

Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors

Rheumatoid Arthritis

Drug: BMS-986142;Drug: Placebo;Drug: Methotrexate

Bristol-Myers Squibb

NULL

Completed

18 Years

120 Years

All

508

Phase 2

United States;Argentina;Austria;Brazil;Canada;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;South Africa;Spain;Taiwan;Belgium

748

EUCTR2015-001275-50-RO
(EUCTR)

10/02/2016

22/02/2016

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3B

United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden

749

EUCTR2015-001275-50-HU
(EUCTR)

09/02/2016

04/12/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Early Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden

750

EUCTR2014-004868-38-HU
(EUCTR)

09/02/2016

11/12/2015

A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

358

Phase 3

France;Portugal;United States;Czech Republic;Hungary;Greece;Canada;Argentina;Spain;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

751

EUCTR2014-004868-38-BG
(EUCTR)

02/02/2016

22/12/2015

A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

358

Phase 3

France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany

752

NCT03355872
(ClinicalTrials.gov)

February 2016

22/11/2017

A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs

Rheumatoid Arthritis

Drug: HLX01

Shanghai Henlius Biotech

NULL

Completed

18 Years

65 Years

All

194

Phase 1;Phase 2

NULL

753

NCT02683564
(ClinicalTrials.gov)

February 2016

9/2/2016

BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis: The UNIFORM Study

A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study

Rheumatoid Arthritis

Drug: BOW015;Drug: Remicade

Epirus Biopharmaceuticals (Switzerland) GmbH

NULL

Not yet recruiting

18 Years

80 Years

Both

548

Phase 3

NULL

754

EUCTR2015-002809-12-BG
(EUCTR)

27/01/2016

02/12/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Czech Republic;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India

755

EUCTR2014-004868-38-GR
(EUCTR)

26/01/2016

02/12/2015

A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: methotrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

720

Phase 3

France;Portugal;United States;Hungary;Czech Republic;Canada;Greece;Argentina;Spain;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

756

NCT02925351
(ClinicalTrials.gov)

January 25, 2016

8/9/2016

Fluorine F 18 Clofarabine PET/CT in Imaging Patients With Autoimmune or Inflammatory Diseases

The Biodistribution of 18F-Clofarabine in Patients With Autoimmune and Inflammatory Diseases

Autoimmune Disease;Crohn Disease;Inflammatory Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Takayasu Arteritis

Procedure: Computed Tomography;Radiation: Fluorine F 18 Clofarabine;Procedure: Positron Emission Tomography

Jonsson Comprehensive Cancer Center

NULL

Completed

18 Years

N/A

All

Early Phase 1

United States

757

NCT02640612
(ClinicalTrials.gov)

January 22, 2016

18/12/2015

Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis

Long-term Assessment of Safety, Efficacy, Pharmacokinetics and Immunogenicity of BI 695501 in Patients With Rheumatoid Arthritis (RA): an Open-label Extension Trial for Patients Who Have Completed Trial 1297.2 and Are Eligible for Long-term Treatment With Adalimumab

Arthritis, Rheumatoid

Drug: BI 695501

Boehringer Ingelheim

NULL

Completed

18 Years

80 Years

All

430

Phase 3

United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine

758

EUCTR2015-002634-41-PL
(EUCTR)

20/01/2016

16/12/2015

Long-term study of BI695501 in patients with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Poland;Malaysia;Bulgaria;Germany;Korea, Republic of

759

EUCTR2014-004868-38-ES
(EUCTR)

19/01/2016

13/01/2016

A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

720

Phase 3

France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany

760

JPRN-UMIN000018931

2016/01/17

07/09/2015

Impact of intravenous acetaminophen on multimodal pain management after total knee arthroplasty: a double-blinded randomized controlled trial

Osteoarthritis, Avascular necrosis of femoral condyle, Rheumatoid arthritis

1000 mg of intravenous acetaminophen (100 ml) after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery.
100ml of intravenous normal saline after total knee arthroplasty at 23:00 of day of surgery, 5:00, 11:00, 17:00, and 23:00 of one day after surgery, 5:00, 11:00, 17:00, and 23:00 of two days after surgery, and 5:00 of three days after surgery.

Nekoyama Miyao Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

761

EUCTR2014-000358-13-DE
(EUCTR)

14/01/2016

31/07/2015

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS - N/A

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany

762

EUCTR2014-004673-16-DE
(EUCTR)

12/01/2016

15/07/2015

Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.

Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients

Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Prednisone Tablets USP, 5 mg
Product Code: RO001-9265/F04
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednisone Tablets USP, 1 mg
Product Code: RO 001-9265/F02-01
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: RoActemra
Product Code: L04AC07
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

226

Phase 4

Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland

763

EUCTR2014-004868-38-FR
(EUCTR)

12/01/2016

18/01/2016

A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

720

Phase 3

Portugal;United States;France;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany

764

EUCTR2015-003332-13-SK
(EUCTR)

12/01/2016

04/11/2015

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

765

EUCTR2012-002009-23-HU
(EUCTR)

07/01/2016

29/09/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

Moderate to severe active rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

766

EUCTR2015-002634-41-HU
(EUCTR)

07/01/2016

16/10/2015

Long-term study of BI695501 in patients with active rheumatoid arthritis

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of

767

NCT02636907
(ClinicalTrials.gov)

January 6, 2016

18/12/2015

Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe

Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled Syringe

Arthritis, Rheumatoid

Drug: BI 695501 Autoinjector;Drug: BI 695501 Prefilled syringe

Boehringer Ingelheim

NULL

Completed

18 Years

80 Years

All

Phase 2

United States;Poland;Ukraine

768

NCT02878161
(ClinicalTrials.gov)

January 2016

12/7/2016

Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real World

Screening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway

Rheumatoid Arthritis

Drug: methotrexate (necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary)

Fen Li

NULL

Enrolling by invitation

18 Years

75 Years

Both

240

Phase 4

NULL

769

NCT02762838
(ClinicalTrials.gov)

January 2016

4/4/2016

Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

International Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: BCD-055;Biological: Remicade ®;Drug: Methotrexate;Drug: Folic acid

Biocad

NULL

Completed

18 Years

75 Years

All

426

Phase 3

Belarus;India;Russian Federation

770

NCT02608112
(ClinicalTrials.gov)

December 31, 2015

16/11/2015

Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year

Subcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 Year

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

291

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

771

NCT02644499
(ClinicalTrials.gov)

December 31, 2015

30/12/2015

Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid

Jawaharlal Institute of Postgraduate Medical Education & Research

NULL

Completed

18 Years

N/A

All

186

Phase 4

India

772

EUCTR2014-000352-29-HR
(EUCTR)

29/12/2015

01/02/2016

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand

773

EUCTR2015-002809-12-ES
(EUCTR)

23/12/2015

30/10/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India

774

EUCTR2014-004868-38-CZ
(EUCTR)

21/12/2015

03/12/2015

A study comparing the use of etanercept and methotrexate, used either alone or in combination, for maintaining remission in rheumatoid arthritis.

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis.

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

358

Phase 3

France;Portugal;United States;Hungary;Czech Republic;Greece;Canada;Argentina;Spain;Bulgaria;Germany

775

JPRN-jRCT2071200058

21/12/2015

25/11/2020

Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects

A Phase I, Randomized, Single-Blind, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-004 Study

Rheumatoid arthritis;D001172

Yonemura Takuma

NULL

Complete

>= 20age old

< 45age old

Male

130

Phase 1

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

776

EUCTR2015-001275-50-AT
(EUCTR)

20/12/2015

23/11/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Early Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

777

EUCTR2015-004173-32-DK
(EUCTR)

18/12/2015

20/10/2015

Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring.

Personalized medicine: Administration of TNF-alpha inhibitor treatment due to serum concentration measuring. A randomized and investigator initiated study.

Rheumatic diseases
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000005156;Therapeutic area: Body processes [G] - Immune system processes [G12]

Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Remsima
INN or Proposed INN: INFLIXIMAB
Trade Name: Benepali
INN or Proposed INN: ETANERCEPT
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB

Department of Clinical Biochemestry, Aarhus University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 4

Denmark

778

EUCTR2015-003333-95-SK
(EUCTR)

18/12/2015

04/11/2015

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

779

NCT02675426
(ClinicalTrials.gov)

December 17, 2015

11/12/2015

A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Rheumatoid Arthritis

Drug: Placebo;Drug: Upadacitinib

AbbVie

NULL

Active, not recruiting

18 Years

99 Years

All

661

Phase 3

United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hong Kong;Hungary;Ireland;Italy;Kazakhstan;Korea, Republic of;Latvia;Lithuania;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Belarus;Brazil;Colombia;Czech Republic;Denmark;Israel;Netherlands;Norway;Serbia;Singapore

780

EUCTR2015-002634-41-ES
(EUCTR)

17/12/2015

30/10/2015

Long-term study of BI695501 in patients with active rheumatoid arthritis

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

781

EUCTR2015-001275-50-IT
(EUCTR)

17/12/2015

05/11/2020

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis.

Early Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Abatacept
Product Code: [BMS-188667]
INN or Proposed INN: ABATACEPT
Other descriptive name: ND
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
Product Code: [na]
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
Product Code: [na]
INN or Proposed INN: METOTREXATO
Other descriptive name: METHOTREXATE

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Czechia;Finland;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden

782

EUCTR2015-000665-30-DE
(EUCTR)

17/12/2015

14/07/2015

Coherus Open-Label Safety Extension Study

An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES

Rheumatoid arthritisChronic Plaque Psoriasis
MedDRA version: 19.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: BGX-0214

Coherus BioSciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

447

Phase 3

France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom

783

EUCTR2015-001275-50-ES
(EUCTR)

15/12/2015

10/12/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Early Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

784

EUCTR2015-003334-27-SK
(EUCTR)

11/12/2015

04/11/2015

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

785

EUCTR2012-002009-23-GB
(EUCTR)

09/12/2015

07/10/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

Moderate to severe active rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

786

EUCTR2015-001275-50-SE
(EUCTR)

09/12/2015

04/12/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden

787

EUCTR2015-001275-50-FI
(EUCTR)

08/12/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

788

EUCTR2015-001275-50-GB
(EUCTR)

04/12/2015

26/11/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Chile;Israel;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden

789

EUCTR2015-001275-50-DE
(EUCTR)

01/12/2015

24/11/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

United Arab Emirates;Qatar;Taiwan;Saudi Arabia;Spain;Israel;Chile;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Germany;Japan;Sweden

790

ChiCTR-IPR-15007368

2015-12-01

2015-11-09

Clinical Research for the Effect of Chinese and Western Medicine on Treating Rheumatoid Arthritis

Comparative Study on the Influences of Gut Microbiota of Chinese and Western Medicine for Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

1:HuaYuTongBiFang;2:HuaYuTongBiFang+MTX;3:ZhengQingFengTongNing Pills+MTX;4:Methotrexate;

Guangdong Provincial Hospital of Chinese Medicine

NULL

Pending

Male

1:96;2:96;3:96;4:96;

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

791

NCT02629159
(ClinicalTrials.gov)

December 1, 2015

10/12/2015

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

Rheumatoid Arthritis

Drug: Placebo for Adalimumab;Drug: Adalimumab;Drug: Placebo for Upadacitinib;Drug: Upadacitinib

AbbVie

NULL

Active, not recruiting

18 Years

N/A

All

1629

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hong Kong;Hungary;Ireland;Israel;Italy;Kazakhstan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Czech Republic;Finland;Netherlands

792

NCT02837146
(ClinicalTrials.gov)

December 2015

7/7/2016

Ultrasound as Imaging Biomarker of Early Response to Tocilizumab and Methotrexate in Very Early Rheumatoid Arthritis

Ultrasound Scores as Imaging Biomarkers of Early Response to Subcutaneous Tocilizumab in Association With Methotrexate in Very Early Rheumatoid Arthritis (TOVERA)

Rheumatoid Arthritis

Biological: Tocilizumab (TCZ);Drug: Methotrexate (MTX)

Maria Stoenoiu

NULL

Recruiting

18 Years

75 Years

Both

Phase 3

Belgium

793

NCT02944799
(ClinicalTrials.gov)

December 2015

27/6/2016

Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis

Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis - Indication and Duration: A Randomized, Double-blind, Placebocontrolled Study to Evaluate the Effects of Discontinuation of Alendronate in Patients With Both Rheumatoid Arthritis and Low Bone Mass

Rheumatoid Arthritis;Osteoporosis

Drug: Placebo;Drug: Alendronate;Drug: Calcium;Drug: Vitamin D

University of Aarhus

NULL

Active, not recruiting

18 Years

N/A

All

Phase 2

Denmark

794

EUCTR2015-001275-50-FR
(EUCTR)

30/11/2015

04/12/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

795

EUCTR2015-002809-12-CZ
(EUCTR)

27/11/2015

02/10/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

796

EUCTR2012-002009-23-BG
(EUCTR)

25/11/2015

15/10/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

Moderate to severe active rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia

797

ChiCTR-IOR-15007418

2015-11-20

2015-11-19

Clinical Observation on Treatment of Active Refractory Rheumatoid Arthritis with Huayu Tongbi Decoction

Rheumatoid arthritis

treatment group:Huayu Tongbi Decoction combined with MTX;controlled group:MTX combined with MTX;

Guangdong Provincial Hospital of Chinese Medicine

NULL

Recruiting

Male

treatment group:30;controlled group:30;

China

798

ChiCTR-IPR-15007415

2015-11-20

2015-11-19

Study of Sinomenine Hydrochloride in the treatment of rheumatoid arthritis

Rheumatoid arthritis

treatment group:sinomenine hydrochloride combined with MTX;controlled group:LEF combined with MTX;

Guangdong Provincial Hospital of Chinese Medicine

NULL

Recruiting

Both

treatment group:25;controlled group:25;

China

799

EUCTR2012-002009-23-ES
(EUCTR)

20/11/2015

15/10/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

Moderate to severe active rheumatoid arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia

800

EUCTR2013-002777-22-IT
(EUCTR)

19/11/2015

04/12/2013

Targeted Ultrasound in Rheumatoid Arthritis (TURA)

Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 4

France;Hungary;Spain;Denmark;Germany;Japan;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

801

NCT02557100
(ClinicalTrials.gov)

November 19, 2015

4/9/2015

Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis

A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs

Rheumatoid Arthritis

Drug: Abatacept;Drug: Adalimumab;Drug: Methotrexate

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

Phase 4

United States;Canada;Mexico;Algeria

802

NCT02512575
(ClinicalTrials.gov)

November 18, 2015

6/7/2015

A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.

A Phase I, Randomized, Single-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Single Ascending Oral Doses Of AZD9567 In Healthy Subjects.

Safety;Tolerability;Pharmacokinetics;Pharmacodynamics;Healthy Subjects;Rheumatoid Arthritis

Drug: AZD9567 Monohydrat;Drug: Placebo oral suspension/ Placebo capsule;Drug: Prednisolone

AstraZeneca

NULL

Completed

18 Years

55 Years

Male

Phase 1

Germany

803

NCT03172325
(ClinicalTrials.gov)

November 18, 2015

24/5/2017

Study to Demonstrate Non-Inferiority Efficacy and Safety of CinnoRA® Produced by CinnaGen Company Versus Humira® for Treatment of Active Rheumatoid Arthritis

A Phase III, Randomized, Two-armed, Double-blind (Patient and Assessor Blinded), Parallel Active Controlled Non-Inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety of Two Disease-modifying Anti Rheumatic Drugs CinnoRA® (Produced by CinnaGen Company) Versus Humira® for Treatment of Active Rheumatoid Arthritis

Active Rheumatoid Arthritis

Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Prednisolone

Cinnagen

NULL

Completed

18 Years

75 Years

All

136

Phase 3

NULL

804

EUCTR2015-002809-12-HU
(EUCTR)

17/11/2015

26/08/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Czech Republic;Hungary;Spain;Ukraine;Romania;Bulgaria;Latvia;Japan;India

805

EUCTR2015-002809-12-LV
(EUCTR)

17/11/2015

21/09/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

806

EUCTR2014-004673-16-FR
(EUCTR)

16/11/2015

05/08/2015

Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

226

Phase 4

Serbia;Egypt;France;Slovenia;Lebanon;Turkey;Russian Federation;Germany;Tunisia;Italy;Switzerland

807

EUCTR2012-002009-23-CZ
(EUCTR)

13/11/2015

30/09/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

Moderate to severe active rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia

808

EUCTR2013-000337-13-PT
(EUCTR)

13/11/2015

11/11/2015

Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled study Prediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA)

Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled study Prediction of response to Certolizumab-Pegol in RA (PreCePRA) - PreCePRA

Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Universitätsklinikum Erlangen

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 3

Serbia;United States;Portugal;Germany

809

EUCTR2015-002924-17-NL
(EUCTR)

12/11/2015

06/10/2015

A Study To Evaluate The Efficacy And Safety Of Intravenous Nanocort Compared With A Intramuscular Injection of Methylprednisolone Acetate In Patients With Rheumatoid Arthritis

Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Sun Pharma Global FZE

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 3

Belgium;Netherlands

810

EUCTR2012-003876-38-PL
(EUCTR)

10/11/2015

16/11/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT

Rheumatoid Arthritis
MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
Product Name: MabThera ®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

811

EUCTR2012-002009-23-LT
(EUCTR)

06/11/2015

02/10/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

Moderate to severe active rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia

812

NCT02780323
(ClinicalTrials.gov)

November 2, 2015

19/5/2016

Study to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis

A Multi-center, Double-blind, Active-controlled, Randomized, Parallel-group Clinical Trial to Compare the Efficacy and Safety of CELBESTA® and CELEBREX® in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CELBESTA®;Drug: CELEBREX®;Drug: CELEBREX® placebo;Drug: CELBESTA® placebo

Dong-A ST Co., Ltd.

NULL

Completed

19 Years

N/A

All

119

Phase 4

Korea, Republic of

813

JPRN-UMIN000018848

2015/11/01

29/08/2015

Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis

Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis - Tapering and withdrawal of methotrexate and biologics in patients with rheumatoid arthritis

Rheumatoid arthritis

control: continue the present treatment
intervention: reduce the dosage of methotrexate by half every 3 months and discontinue
intervention: extend the interval of biologics to one and a half times every 3 months and discontinue

Keio University Hospital

NULL

Complete: follow-up complete

Not applicable

Male and Female

900

Not applicable

Japan

814

NCT02723760
(ClinicalTrials.gov)

November 2015

10/3/2016

99mTc-3PRGD2 SPECT/CT in Rheumatoid Arthritis Patients

Clinical Study of 99mTc-3PRGD2 SPECT/CT in Diagnosis and Efficacy Evaluation of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: 99mTc-3PRGD2

First Affiliated Hospital of Fujian Medical University

NULL

Recruiting

20 Years

70 Years

Both

Phase 0

China

815

NCT02534896
(ClinicalTrials.gov)

November 2015

25/8/2015

To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis

Active Rheumatoid Arthritis

Drug: Treatment I;Drug: Treatment II;Drug: Treatment III

Sun Pharma Global FZE

NULL

Terminated

18 Years

90 Years

All

150

Phase 3

Belgium;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

816

ChiCTR-OPB-15007284

2015-10-30

2015-10-26

Characterization of linkage between symbiotic gut microbes and fatty acid metabolism in rheumatoid arthritis patients

Rheumatoid Arthritis

RA group1:Doxycycline;RA group 2:Placebo;

Hong Kong Baptist University

NULL

Recruiting

Both

RA group1:20;RA group 2:20;

China

817

EUCTR2012-002009-23-SK
(EUCTR)

27/10/2015

07/10/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia

818

EUCTR2014-003453-34-PL
(EUCTR)

26/10/2015

29/09/2015

Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.

A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate.

Product Code: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Poland;South Africa;Bulgaria;Germany;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina

819

EUCTR2012-002009-23-LV
(EUCTR)

23/10/2015

08/10/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Latvia;Germany

820

EUCTR2012-002009-23-PL
(EUCTR)

22/10/2015

08/10/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

821

EUCTR2014-000352-29-BG
(EUCTR)

21/10/2015

31/08/2015

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Peru;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand

822

EUCTR2015-001275-50-CZ
(EUCTR)

21/10/2015

29/09/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

823

EUCTR2015-001246-28-BE
(EUCTR)

19/10/2015

23/07/2015

Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study)

Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study) - TOVERA

Trade Name: RoActemra
Product Name: RoActemra

Cliniques Universitaires Saint-Luc, Université catholique de Louvain

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

824

EUCTR2014-003307-30-GB
(EUCTR)

16/10/2015

25/08/2015

Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis

A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Multiple Doses of UCB4940 Administered as Add-On to Certolizumab Pegol Therapy in Subjects with Moderate-to-Severe Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

UCB Celltech, UK Registered Branch of UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

102

Phase 2

Czech Republic;Hungary;Slovakia;Russian Federation;United Kingdom

825

EUCTR2014-000110-61-DE
(EUCTR)

15/10/2015

04/05/2015

Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE

Product Code: FKB327 PFS
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Code: FKB327 AI
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

826

EUCTR2015-000581-58-CZ
(EUCTR)

14/10/2015

16/06/2015

A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action

A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
INN or Proposed INN: tocilizumabum
Other descriptive name: TOCILIZUMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB

Revmatologicky ustav Praha

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic

827

NCT02534311
(ClinicalTrials.gov)

October 13, 2015

25/8/2015

A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28)

Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Slovakia

828

EUCTR2012-002009-23-EE
(EUCTR)

12/10/2015

06/10/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

Moderate to severe active rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia

829

JPRN-UMIN000020833

2015/10/09

01/02/2016

The efficacy of Iguratimod, and adding Adalimumab in patients with active rheumatoid arthritis: an open label multicenter randomized parallel study.

Rheumatoid arthritis

Administer MTX 6-16mg/week for 12 weeks to patients with MDA-RA.
If patients can't take MTX, administer IGU 25-50mg/day or Tac 1.5-3.0mg/day for 12 weeks.

Administer ADA 40mg/2weeks for 24weeks additionally, in case of MDA taking MTX or IGU, Tac for 12 weeks.
If patients maintain remission for 24weeks, discontinue ADA by their own will, after 48 weeks administering ADA.

Zenjinkai Shimin-no-mori Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

240

Not selected

Japan

830

EUCTR2014-003453-34-DE
(EUCTR)

08/10/2015

26/05/2015

Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.

Product Code: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

831

NCT02778789
(ClinicalTrials.gov)

October 2015

16/5/2016

Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers

Non Randomized Parallel-group Clinical Study to Compare the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers.

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: TNF-alpha Inhibitor

University of Erlangen-Nürnberg Medical School

NULL

Completed

18 Years

N/A

All

Germany

832

NCT02882087
(ClinicalTrials.gov)

October 2015

24/8/2016

A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to TNF-a Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis

A Phase II, Placebo-Controlled, Multicenter, Dynamic Randomized, Double Blind Trial of RC18, a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Inadequate Response of TNF-a Antagonists Due to Treat Moderate and Severe Rheumatoid Arthritis

Moderate and Severe Rheumatoid Arthritis

Drug: Placebo plus MTX;Drug: RC18 160 mg plus MTX

RemeGen

NULL

Terminated

18 Years

65 Years

All

Phase 2

China

833

EUCTR2015-003638-28-DK
(EUCTR)

30/09/2015

28/08/2015

Treatment of osteoporosis in patients with rheumatoid arthritis.

ALOSTRA Alendronate treatment of osteoporosis in rheumatoid arthritis – indication and duration. A randomized, doubleblind, placebocontrolled multi-centre study to evaluate the effects of discontinuation of alendronate in patients with both rheumatoid arthritis and low bone mass. - ALOSTRA

Rheumatoid arthritis and osteoporosis
MedDRA version: 20.0;Level: LLT;Classification code 10031289;Term: Osteoporosis, unspecified;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Aarhus University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

Denmark

834

EUCTR2015-002284-42-FI
(EUCTR)

18/09/2015

28/08/2015

The rationale for this study is to gain insight in the extent and impact of immunogenicityof TNF inhibitors in the European daily clinical practice. Furthermore, an European widedatabase will give insight in factors influencing immunogenicity and treatment outcomein terms of disease activit

INTENT: immunogenicity in patients failing response on anti-TNF-Immunogenicity and pharmacokinetics in patients failing torespond to TNF inhibitors (phase 1);-Clinical effectiveness of subsequent TNF inhibitor treatment andpredictive value of pharmacokinetics and immunogenicity (phase2) - INTENT

rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis.;Therapeutic area: Not possible to specify

Trade Name: Enbrel
Product Name: etanercept
Trade Name: Humira
Product Name: adalimumab
Trade Name: Cimzia
Product Name: certolizumab pegol
Trade Name: Simponi
Product Name: golimumab
Trade Name: Remicade
Product Name: infliximab

READE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1650

Phase 1

Finland

835

EUCTR2014-003453-34-CZ
(EUCTR)

16/09/2015

23/06/2015

Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.

Product Code: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

836

EUCTR2014-003453-34-ES
(EUCTR)

03/09/2015

03/07/2015

Study of a new drug's effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.

Product Code: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Taiwan;Estonia;Spain;Ukraine;Russian Federation;Chile;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Bulgaria;Netherlands;Germany

837

NCT02553018
(ClinicalTrials.gov)

September 2015

16/9/2015

Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe

A National, Randomized, Open-label Study Comparing Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated With Methotrexate Administered by Auto-injector Versus Administration by Conventional Subcutaneous Injection.

Arthritis, Rheumatoid

Drug: Methotrexate

Nordic Pharma SAS

NULL

Completed

18 Years

N/A

All

278

Phase 3

France

838

NCT02565810
(ClinicalTrials.gov)

September 2015

23/9/2015

An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis

An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Adalimumab PFS and Pen

Samsung Bioepis Co., Ltd.

NULL

Completed

18 Years

55 Years

All

Phase 2

Poland

839

NCT02535832
(ClinicalTrials.gov)

September 2015

24/8/2015

Skeletal Muscle Dysfunction in Rheumatoid Arthritis (RA)

Rheumatoid Arthritis;Insulin Resistance

Drug: Pioglitazone;Drug: Placebo

University of Alabama at Birmingham

NULL

Recruiting

35 Years

65 Years

All

Phase 1

United States

840

NCT02748785
(ClinicalTrials.gov)

September 2015

8/9/2015

MTX Discontinuation and Vaccine Response

Effect of Methotrexate Discontinuation on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial

Arthritis, Rheumatoid

Drug: Methotrexate;Biological: Seasonal Influenza vaccine

Seoul National University Hospital

NULL

Completed

18 Years

N/A

Both

277

Phase 4

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

841

JPRN-UMIN000027241

2015/08/31

03/05/2017

the change of IMT of carotide artery in RA with treatment of tocilizumab

rheumatoid arthritis

tofacitinib

hiroshima clinic

NULL

Complete: follow-up complete

18years-old

80years-old

Male and Female

Not applicable

Japan

842

NCT02504268
(ClinicalTrials.gov)

August 31, 2015

20/7/2015

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive

Rheumatoid Arthritis

Drug: Abatacept;Drug: Methotrexate;Other: Abatacept Placebo;Other: Methotrexate Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

1067

Phase 3

United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Monaco;Netherlands;Peru;Poland;Qatar;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom;Czech Republic;Puerto Rico;Saudi Arabia;United Arab Emirates

843

EUCTR2014-003453-34-GB
(EUCTR)

24/08/2015

13/07/2015

Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.

Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;South Africa;Bulgaria;Germany

844

EUCTR2013-003177-99-AT
(EUCTR)

17/08/2015

07/05/2015

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Trade Name: XELJANZ
Product Name: Tofacitinib citrate (commercial image)
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Product Name: Tofacitinib citrate (clinical trial image)
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE CP-690550
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden;Austria;United Kingdom;Portugal;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey

845

EUCTR2013-003177-99-FI
(EUCTR)

12/08/2015

12/02/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Pfizer Inc., 235 East 42nd Street, New York, 10017

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

846

EUCTR2014-004887-39-PL
(EUCTR)

08/08/2015

07/07/2015

A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

Subjects with Rheumatoid Arthritis. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), Axial spondyloarthritis without radiographic evidence of AS, psoriasis (Ps), psoriatic arthritis (PsA), and ulcerative colitis (UC).
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: SB5
INN or Proposed INN: ADALIMUMAB
Product Code: SB5
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Poland

847

JPRN-JapicCTI-153081

01/8/2015

26/11/2015

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : Abatacept + Methotrexate
Dosage And administration of the intervention : Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
Control intervention name : Methotrexate
Dosage And administration of the control intervention : Methotrexate at least 15mg per week tablet or capsule orally
Control intervention name : Abatacept Placebo
Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week
Control intervention name : Methotrexate Placebo
Dosage And administration of the control intervention : Placebo to match Methotrexate capsule orally once per week

Bristol-Myers Squibb K.K.

NULL

complete

BOTH

1000

Phase 3

NULL

848

NCT02797769
(ClinicalTrials.gov)

August 2015

8/6/2016

A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)

Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases

Rheumatoid Arthritis

Drug: Other Biologics;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Not yet recruiting

18 Years

N/A

Both

75000

N/A

NULL

849

NCT02481180
(ClinicalTrials.gov)

July 31, 2015

18/6/2015

Tolerance, Pharmacokinetics and Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)

An Open, Dose Escalation, Multiple Dose Study to Assess Tolerance?Pharmacokinetics?Preliminary Efficacy of T0001 in RA (Rheumatoid Arthritis)

Rheumatoid Arthritis

Drug: T0001;Drug: Enbrel

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

NULL

Terminated

18 Years

65 Years

All

Phase 1

China

850

EUCTR2015-000665-30-GB
(EUCTR)

30/07/2015

20/05/2015

Coherus Open-Label Safety Extension Study

An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES

Rheumatoid arthritisChronic Plaque Psoriasis
MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 18.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: BGX-0214

Coherus BioSciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

447

Phase 3

France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

851

EUCTR2012-003876-38-HU
(EUCTR)

28/07/2015

22/05/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

Rheumatoid Arthritis
MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
Product Name: MabThera ®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

852

EUCTR2015-000665-30-IT
(EUCTR)

27/07/2015

28/02/2018

Coherus Open-Label Safety Extension Study

An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES

Rheumatoid arthritisChronic Plaque Psoriasis
MedDRA version: 20.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 20.0;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: etanercept
Product Code: CHS-0214
INN or Proposed INN: ETANERCEPT
Other descriptive name: ETANERCEPT

COHERUS BIOSCIENCES, INC.

NULL

Not Recruiting

Female: yes
Male: yes

447

Phase 3

France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;United Kingdom;Italy

853

EUCTR2015-000665-30-ES
(EUCTR)

24/07/2015

01/06/2015

Coherus Open-Label Safety Extension Study

An Open-Label Safety Extension Study (OLSES) Evaluating the Long term Safety and Durability of Response of CHS 0214 (CHS 0214-05) - OLSES

Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: BGX-0214

Coherus BioSciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

447

Phase 3

France;Canada;Spain;Australia;Israel;South Africa;Germany;Japan;Italy;United Kingdom

854

NCT02504671
(ClinicalTrials.gov)

July 23, 2015

20/7/2015

Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis

A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination With Methotrexate Therapy, in Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Methotrexate

Arthritis, Rheumatoid

Drug: GSK3196165;Drug: MTX;Drug: Folic acid;Drug: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

N/A

All

222

Phase 2

Bulgaria;Canada;Czechia;Estonia;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic

855

EUCTR2014-003453-34-HU
(EUCTR)

23/07/2015

27/05/2015

Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.

Product Code: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

856

EUCTR2012-002535-28-ES
(EUCTR)

22/07/2015

10/07/2015

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Rheumatoid Arthritis
MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 4

Portugal;Belgium;Spain;Netherlands;Italy;United Kingdom

857

EUCTR2012-003876-38-DE
(EUCTR)

21/07/2015

29/04/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

Rheumatoid Arthritis
MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
Product Name: MabThera ®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

858

EUCTR2015-000833-64-FR
(EUCTR)

17/07/2015

02/07/2015

N/A

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: ORENCIA
Trade Name: MABTHERA
Trade Name: ROACTEMRA

CHU Amiens-Picardie

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 4

France

859

EUCTR2014-003034-42-BG
(EUCTR)

15/07/2015

11/05/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis

A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Moderate to Severe Rheumatoid Arthritis who Have Completed One of the Preceding Phase IIb Studies with ALX-0061

Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 2

Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

860

EUCTR2014-003034-42-BE
(EUCTR)

13/07/2015

18/05/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 2

Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

861

EUCTR2014-003033-26-CZ
(EUCTR)

08/07/2015

05/12/2014

A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis

A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination with Methotrexate, in Subjects with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis (RA)
MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

862

EUCTR2014-000110-61-ES
(EUCTR)

06/07/2015

01/06/2015

Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

863

NCT02518620
(ClinicalTrials.gov)

July 2015

6/8/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis

A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Moderate to Severe Rheumatoid Arthritis Who Have Completed One of the Preceding Phase IIb Studies With ALX-0061

Rheumatoid Arthritis

Biological: ALX-0061

Ablynx

NULL

Completed

18 Years

74 Years

All

406

Phase 2

Belgium;Bulgaria;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Macedonia, The Former Yugoslav Republic of

864

NCT02531178
(ClinicalTrials.gov)

July 2015

14/7/2015

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled Study in Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABBV-257

Rheumatoid Arthritis

Biological: ABBV-257;Biological: Placebo

AbbVie

NULL

Completed

18 Years

75 Years

Both

Phase 1

Germany

865

NCT02242474
(ClinicalTrials.gov)

July 2015

15/9/2014

Anti-TNFa Use During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis

Prospective Randomized Multicentric Trial on Anti-TNFa Treatment and Infection Risk in the Perioperative Period During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: Anti-TNF suspended perioperatively;Drug: Anti-TNFa continued perioperatively

CHU de Quebec-Universite Laval

NULL

Unknown status

18 Years

N/A

All

660

Phase 4

Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

866

NCT02598466
(ClinicalTrials.gov)

July 2015

4/11/2015

Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa

Patient-Reported Efficacy of Subcutaneous Abatacept in Rheumatoid Arthritis: An Evaluation Of Patients In a Compassionate Use Programme in South Africa

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

Hexor, South Africa

Completed

18 Years

N/A

Both

N/A

NULL

867

EUCTR2014-003034-42-DE
(EUCTR)

29/06/2015

18/03/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 2

Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

868

NCT02480153
(ClinicalTrials.gov)

June 25, 2015

19/6/2015

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Rheumatoid Arthritis

Biological: PF-06410293;Biological: Adalimumab

Pfizer

NULL

Completed

18 Years

N/A

All

597

Phase 3

United States;Australia;Brazil;Bulgaria;Colombia;Czechia;Estonia;Georgia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Russian Federation;Serbia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Canada;Czech Republic

869

EUCTR2014-003034-42-ES
(EUCTR)

19/06/2015

14/04/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 2

Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

870

EUCTR2014-003012-36-BG
(EUCTR)

19/06/2015

12/03/2015

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: not available
Other descriptive name: ALX-0061
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

871

EUCTR2014-003453-34-EE
(EUCTR)

18/06/2015

14/05/2015

Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.

Product Code: GSK3196165
INN or Proposed INN: INN not available
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany

872

EUCTR2014-003012-36-CZ
(EUCTR)

10/06/2015

05/01/2015

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

873

NCT02405780
(ClinicalTrials.gov)

June 10, 2015

17/3/2015

A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients

An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients With Rheumatoid Arthritis on Concomitant Methotrexate

Arthritis, Rheumatoid

Drug: FKB327;Drug: Humira ®

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Completed

18 Years

N/A

All

645

Phase 3

United States;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Bulgaria;Czech Republic

874

EUCTR2014-000358-13-HR
(EUCTR)

08/06/2015

10/11/2015

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1080

Phase 3b;Phase 4

United States;Serbia;Philippines;Estonia;Taiwan;Spain;Thailand;Israel;Chile;Russian Federation;Australia;Peru;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria

875

EUCTR2014-001471-31-DE
(EUCTR)

02/06/2015

04/02/2015

This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.

Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

876

EUCTR2015-000538-31-DE
(EUCTR)

01/06/2015

07/04/2015

Application into the joint of opioids in chronic arthritis of the knee joint

NEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint - Neuroimpa - knee joint

chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA.
MedDRA version: 18.0;Level: LLT;Classification code 10067624;Term: Knee arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Morphine Hexal
INN or Proposed INN: Morphinsulfat
Other descriptive name: MORPHINE SULFATE
Trade Name: Triam 40 mg Lichtenstein
INN or Proposed INN: TRIAMCINOLONACETONID
Other descriptive name: TRIAMCINOLONACETONID EP

Charité University medicine Berlin

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

877

JPRN-UMIN000017495

2015/06/01

26/11/2015

Establish the suitable strategy of maintenance therapy for rheumatoid arthritis patient with methotrexate and adalimumab

rheumatoid arthritis(RA)

dose maintain group: no change of treatment

MTX reducing group: reduce 2mg/week of MTX at ever 8 weeks. If remission is maintained at MTX 2mg/week, MTX will be stopped.

ADA spacing group: space the intervals of ADA for 1week at ever 8 weeks. If remission is maitained at the 6 weeks-intervals of ADA, ADA is stopped.

Keio University School of Medicine, Japan.

NULL

Recruiting

Not applicable

Male and Female

Not selected

Japan

878

NCT02552082
(ClinicalTrials.gov)

June 2015

10/8/2015

Scorpio Non Restricted Geometry (NRG) Study in Japan

The Verification Study on the Effectiveness of Rotational Tolerance of Scorpio NRG Study in TKA

Osteoarthritis;Rheumatoid Arthritis

Device: Scorpio NRG posterior stabilized (PS)

Stryker Japan K.K.

NULL

Completed

20 Years

N/A

All

150

Japan

879

EUCTR2014-003012-36-ES
(EUCTR)

27/05/2015

02/02/2015

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

880

EUCTR2010-021184-32-BG
(EUCTR)

27/05/2015

14/04/2015

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs andone or up to three anti-TNF therapies

Refractory rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: NA
Product Code: GP2013
INN or Proposed INN: rituximab
Other descriptive name: NA
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 1;Phase 2

United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

881

EUCTR2014-003033-26-DE
(EUCTR)

21/05/2015

18/12/2014

A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

882

EUCTR2014-003012-36-DE
(EUCTR)

21/05/2015

29/12/2014

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

883

NCT02402686
(ClinicalTrials.gov)

May 20, 2015

25/3/2015

Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)

Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

353

Hungary

884

EUCTR2014-004904-31-NL
(EUCTR)

19/05/2015

26/01/2015

Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remsima (infliximab)

Mundipharma Pharmaceuticals B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

885

JPRN-UMIN000017440

2015/05/18

07/05/2015

In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study.

In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study. - RAXEL study

Rheumatoid arthritis

for 3 months Tofacitinib 5mg BID everyday
for 3 months Tofacitinib 5mg BID everyday
for 3 months Methotrexate6mg-16mg/week

Graduate School of Medicine and School of Medicine, Chiba Universitythe department of allergy and clinical immunology

NULL

Complete: follow-up complete

18years-old

90years-old

Male and Female

134

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

886

EUCTR2013-004019-37-DK
(EUCTR)

13/05/2015

24/02/2015

A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Australia;Denmark;Bulgaria;Germany;New Zealand

887

EUCTR2014-000110-61-CZ
(EUCTR)

11/05/2015

04/05/2015

Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

Product Code: FKB327 PFS
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Code: FKB327 AI
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3

Bulgaria;Germany;United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru

888

EUCTR2014-003034-42-HU
(EUCTR)

08/05/2015

03/03/2015

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects with Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 2

Serbia;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

889

EUCTR2013-004569-16-DE
(EUCTR)

07/05/2015

26/11/2014

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany;Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy

890

EUCTR2011-004720-35-NO
(EUCTR)

04/05/2015

26/01/2015

Rheumatoid arthritis (RA)
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: RoActemra
Other descriptive name: TOCILIZUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Metex
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Imurel
INN or Proposed INN: IMUREL
Other descriptive name: AZATHIOPRINE
Trade Name: Arava
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Salazopyrin EN
INN or Proposed INN: Salazopyrin EN
Other descriptive name: SULFASALAZINE
Trade Name: Plaquenil
Product Name: Plaquenil
INN or Proposed INN: Plaquenil
Other descriptive name: HYDROXYCHLOROQUINE SULFATE

Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Finland;Denmark;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

891

JPRN-UMIN000024143

2015/05/01

23/09/2016

efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis

atherosclerosis efficacy of tofacitinib in RA

RA patients with moderate to severe active disease despite MTX treatment (disease activity score: DAS28>3.2)

hiroshima clinic

NULL

Complete: follow-up continuing

18years-old

75years-old

Male and Female

Phase 4

Japan

892

NCT02566967
(ClinicalTrials.gov)

May 2015

1/10/2015

An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve Low Disease Activity (LDA) or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective

An Evaluation of the Optimal Dose of Tofacitinib Needed to Achieve LDA or Clinical Remission in Patients With Active Rheumatoid Arthritis (RA) as Measured From a Clinical and Structural Perspective When Treating to Target

Rheumatoid Arthritis

Drug: tofacitinib

Norman B. Gaylis, MD

NULL

Completed

18 Years

N/A

All

Phase 3

United States

893

NCT02456844
(ClinicalTrials.gov)

May 2015

27/5/2015

Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients

Effects of BMS-986142 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates Montelukast (CYP2C8), Flurbiprofen (CYP2C9), Midazolam (CYP3A4), Digoxin (P-gp), and Pravastatin (OATP1B1) in Healthy Subjects

Rheumatoid Arthritis

Drug: Montelukast , Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142;Drug: Methotrexate , Leucovorin and BMS-986142

Bristol-Myers Squibb

NULL

Completed

18 Years

50 Years

Both

Phase 1

NULL

894

NCT02460393
(ClinicalTrials.gov)

May 2015

18/1/2015

A Trial With Humanized TNFa Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects

A Randomized, Double Blind, Placebo Controlled Trial With Humanized TNFa Monoclonal Antibody Injection by Single Dose and Dose Escalation to Explore the Tolerance, Safety and Pharmacokinetic Characteristics in Healthy Subjects

Rheumatoid Arthritis

Drug: Humanized TNFa monoclonal antibody;Other: placebo

Shenyang Sunshine Pharmaceutical Co., LTD.

NULL

Completed

18 Years

45 Years

All

Phase 1

China

895

EUCTR2013-004569-16-GR
(EUCTR)

30/04/2015

29/01/2015

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

896

EUCTR2014-002945-23-ES
(EUCTR)

30/04/2015

09/02/2015

A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who?s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.

A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate - A Phase 2 Study of Namilumab vs Anti-Tumor Necrosis Factor in Patients With Rhematoid Arthritis.

Rheumatoid Arthritis (RA)
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Estonia;Czech Republic;Spain;Russian Federation;Latvia;United Kingdom

897

EUCTR2014-001471-31-BG
(EUCTR)

29/04/2015

21/04/2015

Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand

898

EUCTR2014-003033-26-BG
(EUCTR)

29/04/2015

19/02/2015

A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 2

Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Serbia;United States;Spain;Czech Republic;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

899

EUCTR2010-021184-32-PL
(EUCTR)

21/04/2015

06/02/2015

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 1;Phase 2

United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

900

EUCTR2014-003307-30-SK
(EUCTR)

16/04/2015

02/02/2015

Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis

Product Name: BUMEKIZUMAB
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Celltech, UK Registered Branch of UCB Pharma SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

901

EUCTR2014-003307-30-HU
(EUCTR)

16/04/2015

22/01/2015

Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis

Product Name: BIMEKIZUMAB
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Celltech, UK Registered Branch of UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of

902

EUCTR2014-001471-31-RO
(EUCTR)

08/04/2015

05/10/2015

Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Canada;Poland;Turkey;Romania;Australia;Bulgaria;Germany;New Zealand

903

NCT02393378
(ClinicalTrials.gov)

April 8, 2015

15/3/2015

Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate

Rheumatoid Arthritis

Drug: Namilumab;Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid

Takeda

NULL

Terminated

18 Years

N/A

All

Phase 2

Czechia;Estonia;Russian Federation;Spain;United Kingdom;Czech Republic

904

EUCTR2014-002541-22-DE
(EUCTR)

02/04/2015

09/12/2014

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Humira , 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 3

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

905

JPRN-UMIN000016606

2015/04/01

01/04/2015

Efficacy and safety of electroporation and MTX combination therapy for the patients with RA

rheumatoid arthritis

* Evaluate the articular synovitis by gray and power dopplar scale using ultrasound (US).
* Injection MTX (5mg/ml, 1ml) into MP or PIP joint using guide of US. After three minutes, perform electroporation for four angles with US gel.
* Condition of electroporation is 50V/cm 250ms 4puluse.
* Single intervention of injection MTX or combination of MTX and electroporation. Evaluation is performed at 2, 4, 12, and 26 weeks after baseline.
* Evaluate the articular synovitis by gray and power dopplar scale using ultrasound (US).
* Injection MTX (5mg/ml, 1ml) into MP or PIP joint using guide of US.
* Single intervention of injection MTX or combination of MTX and electroporation. Evaluation is performed at 2, 4, 12, and 26 weeks after baseline.

Osaka City University Medical School, Department of Orthopedic Surgery

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

906

NCT02800811
(ClinicalTrials.gov)

April 2015

20/5/2016

Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104

Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Intravenous Doses of FR104 in Healthy Subjects

Rheumatoid Arthritis;Complication of Transplant

Drug: FR104;Drug: Placebo

OSE Immunotherapeutics

NULL

Completed

18 Years

60 Years

Both

Phase 1

Belgium

907

NCT02423538
(ClinicalTrials.gov)

April 2015

7/4/2015

First-in-Human Single Ascending Dose of SHR0302

A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers

Rheumatoid Arthritis

Drug: SHR0302;Drug: SHR0302 placebo comparator

Jiangsu HengRui Medicine Co., Ltd.

NULL

Active, not recruiting

18 Years

45 Years

Both

Phase 1

China

908

NCT02387762
(ClinicalTrials.gov)

April 2015

1/3/2015

ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate

A Phase 2a, 4-Week, Double-Blind, Proof-of-Concept Efficacy and Safety Study of ACP-196 Versus Placebo in Subjects With Active Rheumatoid Arthritis on Background Methotrexate

Rheumatoid Arthritis

Drug: acalabrutinib;Drug: Placebo

Acerta Pharma BV

NULL

Completed

18 Years

75 Years

All

Phase 2

United States

909

NCT02499315
(ClinicalTrials.gov)

April 2015

10/4/2015

Study to Evaluate the Safety, Tolerability, and Action of AMG 357 in Females With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMG 357 in Female Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AMG 357;Drug: Placebo

Amgen

NULL

Terminated

25 Years

70 Years

Female

Phase 1

United States

910

NCT02433340
(ClinicalTrials.gov)

April 2015

2/4/2015

Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study

Phase 2, Multicenter, Open-Label Extension (OLE) Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Rheumatoid Arthritis

Drug: ABT-122

AbbVie

NULL

Completed

18 Years

99 Years

All

158

Phase 2

Australia;Bulgaria;Canada;Czech Republic;Germany;Hungary;New Zealand;Poland;Romania;Turkey

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

911

NCT02378506
(ClinicalTrials.gov)

April 2015

13/2/2015

Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: etanercept

Pfizer

NULL

Completed

18 Years

N/A

All

188

Phase 3

Bulgaria;Croatia;Germany;Greece;Hungary;Poland;Serbia;Slovakia;South Africa;Russian Federation

912

EUCTR2014-003307-30-CZ
(EUCTR)

31/03/2015

03/02/2015

Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis

Product Name: BIMEKIZUMAB
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Celltech, UK Registered Branch of UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Czech Republic;Moldova, Republic of

913

ChiCTR-IPR-15006107

2015-03-30

2015-03-18

The clinical trial of tolerance of Ginsenoside compound K

To study the pharmacokinetics and tolerance of Ginsenoside compound K tablet in healthy volunteers after multiple dosing administration

rheumatoid arthritis

three groups:Ginsenoside compound K is administrated after single dose or multiple doses;

Institute of Clinical Pharmacology, Central South University

NULL

Pending

Male

three groups:12;

I (Phase 1 study)

China

914

JPRN-UMIN000016950

2015/03/27

03/04/2015

Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept

rheumatoid arthritis

Infliximab or adalimumab or golimumab

Osaka Medical College

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

915

EUCTR2015-000089-72-IT
(EUCTR)

26/03/2015

06/02/2015

abatacept in obese and overweight RA patiens

FAT GENE EXPRESSION IN OVERWEIGHT AND OBESE PATIENTS WITH PERSISTENTLY ACTIVE RHEUMATOID ARTHRITIS TREATED WITH ABATACEPT AND CLINICAL RESPONSE

MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: ORENCIA
Product Name: Orencia abatacept

Policlinico Gemelli-CIC- UCSC

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

916

EUCTR2010-021184-32-GB
(EUCTR)

25/03/2015

12/06/2015

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Refractory rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 1;Phase 2

United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

917

NCT02486302
(ClinicalTrials.gov)

March 24, 2015

28/6/2015

A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.

A PROSPECTIVE, MULTICENTER NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFICACY OF ENBREL (REGISTERED) (ETANERCEPT) OVER A PERIOD OF 12 MONTHS IN THE ROUTINE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, OR PLAQUE PSORIASIS WITH PARTICULAR FOCUS ON THE CLINICAL STATUS IMPROVEMENTS STILL OBSERVABLE AFTER 12 WEEKS OF TREATMENT

Rheumatoid Arthritis;Psoriatic Arthritis;Axial Spondyloarthritis;Plaque Psoriasis

Drug: Etanercept

Pfizer

NULL

Completed

18 Years

N/A

All

1534

Germany

918

EUCTR2014-003033-26-BE
(EUCTR)

23/03/2015

25/11/2014

A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

919

EUCTR2014-001471-31-HU
(EUCTR)

23/03/2015

23/01/2015

This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.

Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;New Zealand

920

EUCTR2014-003012-36-BE
(EUCTR)

23/03/2015

18/12/2014

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

921

EUCTR2014-002541-22-GB
(EUCTR)

18/03/2015

09/01/2015

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

340

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

922

EUCTR2013-004569-16-BG
(EUCTR)

18/03/2015

05/01/2015

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;Bulgaria;South Africa;Germany

923

EUCTR2013-004569-16-HR
(EUCTR)

16/03/2015

29/04/2015

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany

924

EUCTR2014-000352-29-FR
(EUCTR)

16/03/2015

18/06/2015

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB -EU

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

925

EUCTR2012-001176-10-BG
(EUCTR)

16/03/2015

04/11/2014

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE

Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

926

EUCTR2013-005524-42-NL
(EUCTR)

10/03/2015

27/03/2014

STAtins to Prevent Rheumatoid Arthritis (STAPRA)

Prevention of rheumatoid arthritis by atorvastatin in seropositive arthralgia patients: a multi-center doubleblind randomized placebo-controlled trial - STAtins to Prevent Rheumatoid Arthritis (STAPRA)

Rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039080;Term: Rheumatoid factor positive;System Organ Class: 10022891 - Investigations;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Atorvastatin
Product Name: Atorvastatin
Product Code: C10AA05
INN or Proposed INN: ATORVASTATIN

Reade

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 4

Netherlands

927

EUCTR2014-003012-36-HU
(EUCTR)

10/03/2015

30/12/2014

A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

928

NCT02304354
(ClinicalTrials.gov)

March 9, 2015

4/11/2014

Relationship Between T LYmphocytes Depletion and Clinical Response to RITUXimab in Rheumatoid Arthritis (LYRITUX)

Rheumatoid Arthritis

Drug: Rituximab

University Hospital, Tours

NULL

Active, not recruiting

18 Years

N/A

All

Phase 3

France

929

EUCTR2014-001471-31-CZ
(EUCTR)

04/03/2015

27/01/2015

This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.

Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;New Zealand

930

JPRN-UMIN000015433

2015/03/01

01/11/2014

Safety study of methotrexate low-dose once daily administration in rheumatoid arthritis patients

rheumatoid arthritis

methotrexate

Department of Medical Pharmaceutics , Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama

NULL

Recruiting

20years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

931

NCT02287922
(ClinicalTrials.gov)

March 2015

5/11/2014

A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis

A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate

Rheumatoid Arthritis

Biological: ALX-0061;Biological: Placebo;Biological: Tocilizumab

Ablynx

NULL

Completed

18 Years

74 Years

All

251

Phase 2

United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of

932

NCT02414984
(ClinicalTrials.gov)

March 2015

8/4/2015

Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab

Registry of Patients With Rheumatoid Arthritis Exposed to Golimumab (Go-Compl-Ar): Review and Analysis of Compliance in Colombia

Rheumatoid Arthritis

Biological: Golimumab

Janssen-Cilag, S.A.

NULL

Terminated

18 Years

N/A

All

N/A

Colombia

933

NCT02620189
(ClinicalTrials.gov)

March 2015

12/10/2015

Th17 Responses Evaluated in RA Patients on Inhibitors of TNFa

A Study to Investigate the Role of IL-17 and Th17 Pathway Activation in RA Patients With Inadequate Response to Anti-TNFa Therapies

Rheumatoid Arthritis

Drug: Anti-TNF Biologics Therapy

Queen Mary University of London

NULL

Recruiting

18 Years

N/A

Both

N/A

United Kingdom

934

EUCTR2013-004148-49-FR
(EUCTR)

23/02/2015

18/06/2015

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

Product Name: Infliximab -Pfizer
Product Code: PF-06438179
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab -Pfizer
Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Other descriptive name: Infliximab -EU

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany;Japan

935

NCT02638259
(ClinicalTrials.gov)

February 21, 2015

16/12/2015

Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: GP2015

Sandoz

NULL

Completed

18 Years

N/A

All

376

Phase 3

United States;Bulgaria;Czechia;Estonia;Germany;Hungary;Italy;Latvia;Lithuania;Mexico;Poland;Russian Federation;Serbia;Slovakia;Spain;United Kingdom;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

936

EUCTR2013-002805-76-BG
(EUCTR)

20/02/2015

10/10/2014

A 24-week placebo-controlled clinical study to evaluate the adequate dose,efficacy and safety of 3 doses of namilumab combined with methotrexatein subjects with moderate to severe rheumatoid arthritis.

A 24-week randomized, double-blind, placebo-controlled, phase 2 dose finding study to evaluate the efficacy and safety of 3 doses of namilumab (20 mg, 80 mg and 150 mg) in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA) NEXUS.

Rheumatoid Arthritis (RA)
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB
Product Name: Namilumab
Product Code: MT203
INN or Proposed INN: namilumab
Other descriptive name: NAMILUMAB

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

108

Phase 2

Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom

937

EUCTR2014-003033-26-ES
(EUCTR)

20/02/2015

07/01/2015

A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 2

Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

938

NCT02373813
(ClinicalTrials.gov)

February 20, 2015

12/1/2015

Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: etanercept pre-filled syringe sq injection;Drug: Oral methotrexate;Drug: Placebo for etanercept sq injection;Drug: Placebo for methotrexate

Amgen

NULL

Completed

18 Years

N/A

All

371

Phase 3

United States;Argentina;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;South Africa;Spain;Czech Republic

939

EUCTR2014-002945-23-GB
(EUCTR)

18/02/2015

04/11/2014

A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.

Rheumatoid Arthritis (RA)
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Estonia;Czech Republic;Spain;Russian Federation;United Kingdom

940

EUCTR2014-001114-26-SE
(EUCTR)

18/02/2015

26/08/2014

A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects may lose disease control upon reducing their adalimumab dose

A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) subjects (PREDICTRA)

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

941

EUCTR2014-002945-23-CZ
(EUCTR)

18/02/2015

21/11/2014

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Estonia;Czech Republic;Spain;Russian Federation;United Kingdom

942

EUCTR2014-003033-26-HU
(EUCTR)

17/02/2015

26/11/2014

A clinical trial testing different doses of investigational drug ALX-0061 combined with Methotrexate to treat patients with Moderate to Severe Rheumatoid Arthritis

Product Name: ALX-0061
Product Code: ALX-0061
INN or Proposed INN: Not available
Other descriptive name: ALX-0061

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 2

Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

943

EUCTR2014-002541-22-ES
(EUCTR)

16/02/2015

22/12/2014

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

340

Phase 3

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

944

EUCTR2014-001114-26-NL
(EUCTR)

13/02/2015

24/09/2014

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Netherlands;Germany;Sweden

945

EUCTR2014-002541-22-HU
(EUCTR)

11/02/2015

15/12/2014

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

340

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Hungary;Czech Republic;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

946

EUCTR2013-005418-37-DE
(EUCTR)

05/02/2015

24/07/2014

A multicenter, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate.

A multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 (Dekavil) administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate.

Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to at least one anti-TNF treatment.
MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Dekavil
Product Code: F8IL10
INN or Proposed INN: dekavil
Other descriptive name: F8IL10

Philogen S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany;Italy;Switzerland

947

NCT02466581
(ClinicalTrials.gov)

February 3, 2015

29/5/2015

Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity

A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity

Rheumatoid Arthritis

Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone;Biological: Cimzia;Biological: Orencia;Biological: RoActemra

Karolinska Institutet

NULL

Active, not recruiting

18 Years

N/A

All

Phase 4

Sweden

948

EUCTR2013-004569-16-HU
(EUCTR)

03/02/2015

18/11/2014

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany

949

EUCTR2013-003530-33-GB
(EUCTR)

02/02/2015

22/05/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)

Product Name: Upadacitinib 3mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 12mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 30mg
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib 15mg
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

494

Phase 2

United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand

950

JPRN-JapicCTI-152979

01/2/2015

Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Intervention name : Namilumab
Dosage And administration of the intervention : Namilumab 20 mg, 80 mg or 150 mg subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study.
Control intervention name : Placebo
Dosage And administration of the control intervention : Namilumab placebo-matching SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study.

TAKEDA PHARMACEUTICAL COMPANY LTD.

NULL

BOTH

108

Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

951

NCT02390700
(ClinicalTrials.gov)

February 2015

11/3/2015

Observational Study of Golimumab Intravenous Infusion

Golimumab Intravenous Infusion Registry (GO-IV)

Rheumatoid Arthritis

Biological: Golimumab Intravenous

Janssen Inc.

NULL

Terminated

18 Years

N/A

Both

Canada

952

NCT02633332
(ClinicalTrials.gov)

February 2015

30/11/2015

Use of Well Known Drugs for New Destination - RA Improvement (RANT)

Observational Retrospective Study About the Use of Well Known Drugs in Combination to Obtain a New Drug to Improve Quality of Life/Health in Patient With Diagnosed Rheumatoid Arthritis Not Responding to Commonly Used Treatments

Rheumatoid Arthritis;Autoimmune Diseases;Disorder of Synovium;Sjogren's Syndrome;Acute and Chronic Inflammation;Disorder of Pleura and Pleural Cavity;Felty's Syndrome;Rheumatoid Nodules

Drug: Vitamin D3;Drug: Lipitor®;Drug: Acycloguanosine;Drug: Tetracycline;Drug: methotrexate;Drug: etanercept

Università Popolare Homo & Natura

NULL

Completed

18 Years

75 Years

Both

Phase 1

Italy

953

NCT02330445
(ClinicalTrials.gov)

February 2015

18/12/2014

6-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera Collection

Phase I/II Open Label Evaluation of Safety and Feasibility of 6 Months IV PRTX-100 Administrations in Previous Rheumatoid Arthritis Study Participants and Development of Immunological Samples for Assay Development From Normal Volunteers

Arthritis, Rheumatoid

Drug: PRTX-100

Protalex, Inc.

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

954

EUCTR2013-004019-37-BG
(EUCTR)

26/01/2015

02/09/2014

A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122
Trade Name: Adalimumab , Solution for Injection 40 mg/ (0.8 ml) Pre-filled Syringe
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand

955

NCT02137226
(ClinicalTrials.gov)

January 26, 2015

12/5/2014

BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis

Efficacy, Safety and Immunogenicity of BI 695501 Versus Adalimumab in Patients With Active Rheumatoid Arthritis: a Randomized, Double-blind,Parallel Arm, Multiple Dose, Active Comparator Trial

Arthritis, Rheumatoid

Drug: BI 695501;Drug: US-licensed Humira®

Boehringer Ingelheim

NULL

Completed

18 Years

80 Years

All

645

Phase 3

United States;Bulgaria;Chile;Estonia;Germany;Hungary;Korea, Republic of;Malaysia;New Zealand;Poland;Russian Federation;Serbia;Spain;Thailand;Ukraine;Argentina;Colombia;Mexico;Philippines;South Africa

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

956

EUCTR2014-002541-22-CZ
(EUCTR)

26/01/2015

09/12/2014

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 3

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Puerto Rico;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

957

EUCTR2014-000109-11-DE
(EUCTR)

22/01/2015

08/10/2014

Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC

Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

730

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

958

EUCTR2014-003255-54-CZ
(EUCTR)

21/01/2015

24/10/2014

A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid Arthritis

A Double-blind, Randomised, Comparative Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Evaluation of RGB-03 and MabThera® Combined with Methotrexate in Rheumatoid Arthritis Patients

Product Name: RGB-03
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB

Gedeon Richter Plc

NULL

Not Recruiting

Female: yes
Male: yes

142

Phase 1;Phase 3

Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany

959

EUCTR2014-000109-11-BG
(EUCTR)

21/01/2015

10/10/2014

Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC

Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

730

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

960

NCT03719469
(ClinicalTrials.gov)

January 20, 2015

6/9/2018

Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis

Circulating microRNAs Expression as Predictors of Clinical Response in Rheumatoid Arthritis Patients Treated With Green Tea

Rh Disease

Dietary Supplement: Green tea group

King Saud University

NULL

Completed

18 Years

85 Years

All

150

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

961

EUCTR2013-004019-37-DE
(EUCTR)

19/01/2015

24/07/2014

A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand

962

EUCTR2012-002535-28-IT
(EUCTR)

16/01/2015

04/11/2014

Not applicable

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Rheumatoid Arthritis
MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Portugal;Belgium;United Kingdom;Italy

963

EUCTR2013-003530-33-BE
(EUCTR)

15/01/2015

19/09/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

494

Phase 2

United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;South Africa;Bulgaria;Latvia;Netherlands;New Zealand

964

ChiCTR-IPR-15005787

2015-01-15

2015-01-06

The effect of food on the pharmacokinetics of Ginsenoside C-K

To study the effect of food on pharmacokinetics of Ginsenoside C-K tablet in healthy volunteers

rheumatoid arthritis

Two groups:Ginsenoside compound K is administrated after taking food versus fasting;

Institute of Clinical Pharmacology, Central South University

NULL

Pending

Both

Two groups:24;

I (Phase 1 study)

China

965

EUCTR2013-004569-16-SK
(EUCTR)

14/01/2015

21/11/2014

A Single-Arm, Open-Label Study to Assess the Immunogenicity, Safety, and Efficacy of Etanercept Manufactured Using the High Capacity Process Administered to Subjects with Rheumatoid Arthritis

Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

Serbia;Slovakia;Greece;Russian Federation;Colombia;Italy;Hungary;Mexico;Poland;Croatia;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

966

EUCTR2014-000358-13-ES
(EUCTR)

13/01/2015

22/09/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Bulgaria;Germany

967

EUCTR2011-002067-20-FR
(EUCTR)

13/01/2015

23/08/2012

Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis that are not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the European Union, and a number of other countries worldwide.

A multicenter, single blind, randomized parallel group study to assess the short and long term efficacy of certolizumab pegol plus methotrexate compared with adalimumab plus methotrexate in subjects with moderate to severe rheumatoid arthritis responding inadequately to methotrexate. - -

Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany

968

EUCTR2010-021184-32-HU
(EUCTR)

09/01/2015

27/10/2014

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Refractory rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 1;Phase 2

United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

969

EUCTR2013-003530-33-BG
(EUCTR)

09/01/2015

06/11/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

494

Phase 2

United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand

970

EUCTR2013-005543-90-BG
(EUCTR)

06/01/2015

22/10/2014

This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: rituximab
Other descriptive name: ABP 798 - Biosimilar to rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

971

NCT02198651
(ClinicalTrials.gov)

January 5, 2015

22/7/2014

A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects

Rheumatoid Arthritis;Musculoskeletal and Connective Tissue Diseases

Biological: Adalimumab;Other: Placebo

AbbVie

NULL

Completed

18 Years

N/A

All

149

Phase 4

United States;Australia;Austria;Canada;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom

972

EUCTR2014-000352-29-EE
(EUCTR)

05/01/2015

07/08/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB -EU

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand;Colombia

973

ChiCTR-INR-16009274

2015-01-01

2016-09-25

The multi-center clinical research in TCM diagnosis and treatment norms on Rheumatoid arthritis of piweikuixu-shirezuluo symptoms

Rheumatoid arthritis

RA No.1+fengshi mud:RA No.1+fengshi mud;MTX+LEF Group:MTX+LEF;RA No.1+fengshi mud+MTX+LEF Group:RA No.1+fengshi mud+MTX+LEF;

Zhejiang Chinese Medical University

NULL

Recruiting

Both

RA No.1+fengshi mud:150;MTX+LEF Group:150;RA No.1+fengshi mud+MTX+LEF Group:150;

China

974

NCT02927535
(ClinicalTrials.gov)

January 2015

16/9/2016

Evaluation of TNFa Blockers Monotherapy in Early Rheumatoid Arthritis in France

Rheumatoid Arthritis

Drug: TNF blockers monotherapy

Centre Hospitalier Universitaire de Nimes

Pfizer;Pfizer

Completed

18 Years

70 Years

Both

813

N/A

NULL

975

NCT02309359
(ClinicalTrials.gov)

January 2015

27/11/2014

A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis

A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination With Methotrexate, in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Biological: ALX-0061;Other: Placebo;Drug: Methotrexate

Ablynx

NULL

Completed

18 Years

74 Years

All

345

Phase 2

United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

976

NCT02837978
(ClinicalTrials.gov)

January 2015

13/7/2016

The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment

Prospective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in China

Arthritis, Rheumatoid

Drug: Tacrolimus;Drug: MTX

Qiang Shu

NULL

Recruiting

18 Years

80 Years

All

150

Phase 4

China

977

NCT02744196
(ClinicalTrials.gov)

January 2015

4/4/2016

Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC BIOCAD) With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis

Multicenter Comparative Randomised Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC BIOCAD) With Methotrexate in First Line of Biological Therapy of Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Acellbia;Drug: Placebo;Drug: Methotrexate

Biocad

NULL

Completed

18 Years

80 Years

All

159

Phase 3

NULL

978

NCT02371096
(ClinicalTrials.gov)

January 2015

5/2/2015

Comparative Pharmacokinetic Trial of RGB-03 and MabThera

Rheumatoid Arthritis

Drug: MabThera (rituximab);Drug: RGB-03

Gedeon Richter Plc.

NULL

Not yet recruiting

18 Years

75 Years

Both

Phase 1

NULL

979

JPRN-UMIN000012650

2014/12/31

21/12/2013

In vivo kinematic analysis of total knee arthroplasty with 3-dimensional registration technique.

osteoarthritis or rheumatoid arthritis of the knee joint

Fluoroscopy was performed to continuously
capture the knee from the lateral direction in a weight-bearing
position and knee bending position.

Dept. of orthopedic surgery, Osaka Medical College

NULL

Recruiting

20years-old

90years-old

Male and Female

Not selected

Japan

980

NCT04192617
(ClinicalTrials.gov)

December 31, 2014

5/12/2019

A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate

A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase II Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severe Active Rheumatoid Arthritis Receiving Methotrexate

Rheumatoid Arthritis

Drug: SM03;Drug: Placebo;Drug: Methotrexate

SinoMab Pty Ltd

NULL

Completed

18 Years

75 Years

All

156

Phase 2

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

981

EUCTR2014-000443-33-DE
(EUCTR)

18/12/2014

07/07/2014

Coherus RA Study

A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate (CHS-0214-02) (RApsody) - ETA 302

Rheumatoid arthritis
MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: CHS-0214
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Coherus Biosciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

620

Phase 3

United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan

982

EUCTR2014-000109-11-CZ
(EUCTR)

18/12/2014

09/10/2014

Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC

Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

983

NCT02379091
(ClinicalTrials.gov)

December 17, 2014

28/11/2014

Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Namilumab;Drug: Placebo;Drug: Methotrexate;Drug: Folic/folinic acid

Takeda

NULL

Completed

18 Years

N/A

All

108

Phase 2

Bulgaria;Czechia;Japan;Korea, Republic of;Poland;Russian Federation;Spain;United Kingdom;Argentina;Brazil;Colombia;Czech Republic;Germany;Mexico

984

EUCTR2014-003529-16-GB
(EUCTR)

16/12/2014

22/06/2015

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

Stratification of Biologic Therapies for RA by Pathobiology (STRAP): A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP

Trade Name: MabThera
Product Name: MabThera
Trade Name: RoActmera
Product Name: RoActmera
Trade Name: Enbrel
Product Name: Enbrel

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

219

Phase 3

United Kingdom

985

EUCTR2014-002945-23-EE
(EUCTR)

16/12/2014

27/11/2014

Rheumatoid Arthritis (RA)
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Estonia;Spain;Russian Federation;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

986

JPRN-UMIN000020663

2014/12/16

21/01/2016

A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib.

Rheumatoid arthritis

Period :12 months
Patients take Tofacitinib 5mg twice a day.

Kyusyu University Hospital Medicine and biosystemic science

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not applicable

Japan

987

JPRN-UMIN000015794

2014/12/15

10/12/2014

Efficacy of monthly sodium risedronate for the treatment of corticosteroid induced osteoporosis in patients with rheumatoid arthritis (multicenter, double-blind, randomized, placebo-controlled, parallel-group study )

osteoporosis, rheumatoid arthritis

monthly risedronate sodium 75mg for 6 months
monthly placebo for 6 months

Division of rheumatology, endcrinology and nephrology, Hokkaido University Graduate School of Medicine

NULL

Complete: follow-up continuing

20years-old

Not applicable

Male and Female

165

Phase 4

Japan

988

EUCTR2014-001114-26-GR
(EUCTR)

12/12/2014

02/12/2014

A study of subjects with rheumatoid arthritis who are in clinical remission to investigate patient and disease characteristics that could help identify which subjects could reduce their adalimumab dose without flaring

Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

334

Phase 4

Hungary;Canada;Greece;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden

989

EUCTR2014-001114-26-IE
(EUCTR)

11/12/2014

14/08/2014

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

990

EUCTR2013-003530-33-NL
(EUCTR)

11/12/2014

22/05/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

520

Phase 2

Serbia;United States;Spain;Ukraine;Turkey;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Canada;Australia;Bulgaria;South Africa;Latvia;Netherlands;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

991

EUCTR2014-000352-29-DE
(EUCTR)

11/12/2014

13/10/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB -EU
Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

992

NCT02328027
(ClinicalTrials.gov)

December 11, 2014

18/12/2014

99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)

A Phase I-IIa Study of Safety, Tolerance, Pharmacokinetics, Dosimetry and Benefice of Early Nuclear Medicine Imaging of 99mTc-rhAnnexin V-128 in Patients With Rheumatoid Arthritis or Ankylosing Spondylitis

Rheumatoid Arthritis;Ankylosing Spondylitis

Drug: 99mTc-rhAnnexin V-128

Advanced Accelerator Applications

NULL

Terminated

18 Years

N/A

All

Phase 1;Phase 2

Switzerland

993

EUCTR2014-000109-11-ES
(EUCTR)

09/12/2014

04/11/2014

Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate.

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

994

EUCTR2014-000352-29-HU
(EUCTR)

05/12/2014

09/10/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB -EU

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

Serbia;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Bulgaria;Georgia;Germany;Japan;New Zealand

995

EUCTR2014-000993-20-SE
(EUCTR)

04/12/2014

02/09/2014

Dosing of glucocorticoid (triamcinolone hexacetonid) when injecting knee joints of rheumatic diseases

Dosing of intraarticular triamcinolone hexacetonid for knee synovitis in chronic polyarthritis

Psoriatic arthritis and rheumatoid arthritis with synovitis of the knee;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: triamcinolone hexacetonide (Lederspan)
Product Name: triamcinolone hexacetonid (Lederspan)
Product Code: 9512
Trade Name: triamcinolone hexacetonide (Lederspan)
Product Name: triamcinolone hexacetonid (Lederspan)
Product Code: 9512

Center for Research and Development Uppsala University/County Council of Gävleborg

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 4

Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

996

EUCTR2014-000358-13-CZ
(EUCTR)

04/12/2014

04/08/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

997

EUCTR2014-000358-13-PL
(EUCTR)

03/12/2014

24/09/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

998

ChiCTR1800014846

2014-12-01

2018-02-09

Effect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplasty

Effect of preemptive analgesia with parecoxib sodium on multimodal analgesia in primary unilateral total hip arthroplasty: A prospective randomized double-blind controlled trial

osteonecrosis of the femoral head, femoral neck fracture, developmental dysplasia of hip, osteoarthritis, rheumatoid arthritis or ankylosing spondylitis

Experiment group:preoperative intravenous parecoxib sodium and postoperative intravenous parecoxib sodium and patient-controlled analgesia;Control Group:preoperative intravenous pure 0.9% saline and postoperative intravenous parecoxib sodium and patient-controlled analgesia;

Peking Union Medical College Hospital

NULL

Completed

Both

Experiment group:50;Control Group:50;

China

999

NCT02260791
(ClinicalTrials.gov)

December 2014

29/7/2014

A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients

A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate

Arthritis, Rheumatoid

Drug: FKB327;Drug: Humira ®

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Completed

18 Years

N/A

All

728

Phase 3

United States;Bulgaria;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Czech Republic;Serbia

1000

NCT02876874
(ClinicalTrials.gov)

December 2014

3/2/2015

Relationship Between the Activity of Rheumatoid Arthritis and Lymph Node Morphology and Lymphatics Drainage

the Relationship Between the Activity of Rheumatoid Arthritis(RA) and Popliteal/Epitrochlear Lymph Node Morphology and the Drainage of Hand/Foot Superficial Lymphatic Vessels

Rheumatoid Arthritis;Lymph Node Mass;Lymphatic Vessel; Dilatation

Drug: indocyanine green (ICG)

Shanghai University of Traditional Chinese Medicine

NULL

Recruiting

18 Years

65 Years

Both

N/A

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1001

EUCTR2013-001417-32-BG
(EUCTR)

27/11/2014

16/09/2014

A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis - SIRROUND-H

Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: CNTO 136
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;South Africa;Germany;Moldova, Republic of

1002

EUCTR2014-001114-26-GB
(EUCTR)

25/11/2014

14/08/2014

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

1003

EUCTR2013-003530-33-CZ
(EUCTR)

24/11/2014

09/05/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

494

Phase 2

United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Belgium;South Africa;Bulgaria;Latvia;Netherlands;New Zealand

1004

EUCTR2013-003984-72-CZ
(EUCTR)

24/11/2014

14/04/2014

A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 with Background Methotrexate (MTX) in Subjects with Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone.

Rheumatoid Arthritis (RA)
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;South Africa;Latvia

1005

EUCTR2013-002622-23-GR
(EUCTR)

20/11/2014

23/10/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1006

EUCTR2013-005543-90-DE
(EUCTR)

19/11/2014

16/06/2014

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: RITUXIMAB
Other descriptive name: ABP 798 - Biosimilar to rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

1007

EUCTR2014-002374-36-SE
(EUCTR)

19/11/2014

27/08/2014

A study with dose de-escalation of coventional or biologic treatments in early rheeumatoid arthritis in patients with low disease activity.

A multicenter, randomized, open-label, blinded-assessor, follow-up, phase 4 study in patients with rheumatoid arthritis who have completed the initial treatment part (active conventional therapy versus three biologic treatments) in the NORD-STAR study and have reached stable low disease activity - CO-STAR

Rheumatoid arthritis (RA)
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
Trade Name: Methotrexate
Trade Name: Metoject
Trade Name: Azathioprine
Trade Name: Leflunomide

The Karolinska Institutet, ClinTRID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 4

Sweden

1008

NCT02281552
(ClinicalTrials.gov)

November 18, 2014

30/10/2014

A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis

A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Study To Demonstrate Non-inferiority For The Efficacy Of A Once Daily Dose Of Tofacitinib Modified Release Tablet To A Twice Daily Dose Of The Immediate Release Tablet In Adult Patients With Rheumatoid Arthritis On Background Methotrexate

Rheumatoid Arthritis

Drug: Tofacitinib

Pfizer

NULL

Completed

20 Years

N/A

All

209

Phase 3

Japan

1009

EUCTR2014-001114-26-ES
(EUCTR)

17/11/2014

01/09/2014

Rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

334

Phase 4

Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden

1010

EUCTR2014-000358-13-EE
(EUCTR)

13/11/2014

07/08/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1011

EUCTR2014-001114-26-FR
(EUCTR)

13/11/2014

18/06/2015

Rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

334

Phase 4

Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Australia;Germany;Netherlands;Sweden

1012

EUCTR2014-000358-13-GB
(EUCTR)

12/11/2014

12/09/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Moderately to severely active Rheumatoid Arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

1013

EUCTR2014-001114-26-DE
(EUCTR)

10/11/2014

08/08/2014

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

1014

EUCTR2014-000358-13-RO
(EUCTR)

10/11/2014

10/03/2015

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1080

Phase 3b;Phase 4

1015

EUCTR2013-002805-76-ES
(EUCTR)

06/11/2014

19/08/2014

A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis followed by a 48-week active extension study.

Rheumatoid Arthritis (RA)
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

324

Phase 2

United States;Spain;Russian Federation;Colombia;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1016

EUCTR2014-000352-29-LT
(EUCTR)

06/11/2014

08/10/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

1017

EUCTR2014-000358-13-BG
(EUCTR)

06/11/2014

28/10/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

1018

EUCTR2014-001114-26-AT
(EUCTR)

05/11/2014

10/10/2014

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

1019

EUCTR2013-004019-37-HU
(EUCTR)

04/11/2014

31/07/2014

A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand;Poland;Czech Republic;Hungary;Canada

1020

EUCTR2014-001114-26-HU
(EUCTR)

04/11/2014

10/09/2014

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1021

JPRN-UMIN000015616

2014/11/04

10/11/2014

Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction

rheumatoid arthritis

Adalimumab plus Methotrexate
Tocilizumab plus Methotrexate

Biologic Mate Study Group

NULL

Complete: follow-up complete

20years-old

75years-old

Male and Female

300

Not selected

Japan

1022

NCT02551575
(ClinicalTrials.gov)

November 2014

26/8/2015

Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis

Efficacy and Safety of Qingre Huoxue Comprehensive Therapy in the Treatment of Rheumatoid Arthritis (RA): A Randomized, Double-blind, Double-dummy, Multi-center Trial

Rheumatoid Arthritis

Drug: Treatment of MTX and HCQ;Drug: Treatment of TCM;Drug: Integrative Medicine

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

NULL

Active, not recruiting

18 Years

65 Years

Both

468

Phase 2;Phase 3

China

1023

NCT02287610
(ClinicalTrials.gov)

November 2014

6/11/2014

A Non-Interventional Study of RAYOS in Adult Patients With Rheumatoid Arthritis

A Non-Interventional Study to Evaluate the Effectiveness of Delayed-Release Prednisone (RAYOS) on Clinical Assessments and Serologic Disease Activity in Patients With Active Rheumatoid Arthritis in the Clinical Practice Setting

Rheumatoid Arthritis

Drug: RAYOS (delayed-release prednisone)

Horizon Pharma Ireland, Ltd., Dublin Ireland

NULL

Completed

18 Years

N/A

All

N/A

NULL

1024

NCT02296775
(ClinicalTrials.gov)

November 2014

18/11/2014

Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: DRL_RI;Biological: Rituxan;Biological: MabThera

Dr. Reddy's Laboratories Limited

NULL

Completed

18 Years

65 Years

All

276

Phase 1;Phase 2

India;Ukraine

1025

EUCTR2014-000443-33-PL
(EUCTR)

29/10/2014

21/07/2014

Coherus RA Study

Rheumatoid arthritis
MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: CHS-0214
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Coherus BioSciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

620

Phase 3

United States;Belarus;Spain;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;South Africa;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1026

EUCTR2014-000352-29-GB
(EUCTR)

29/10/2014

09/10/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

RHEUMATOID ARTHRITIS
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

1027

EUCTR2014-000352-29-CZ
(EUCTR)

27/10/2014

05/08/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

RHEUMATOID ARTHRITIS
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

1028

EUCTR2014-000443-33-ES
(EUCTR)

24/10/2014

04/07/2014

Coherus RA Study

Rheumatoid arthritis
MedDRA version: 17.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: CHS-0214
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Coherus Biosciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Belarus;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Brazil;South Africa;Germany;Japan

1029

EUCTR2014-000443-33-IT
(EUCTR)

24/10/2014

24/06/2014

Coherus RA Study

Rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: CHS-0214
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Coherus Biosciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Belarus;Spain;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Brazil;South Africa;Germany;Japan

1030

EUCTR2014-000352-29-ES
(EUCTR)

23/10/2014

29/10/2014

A Study of PF-06410293 (Adalimumab-Pfizer) and Adalimumab (Humira) in Combination with Methotrexate in Subjects with Active Rheumatoid Arthritis (REFLECTIONS B538-02).

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELYTO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD ANINADEQUATE RESPONSE TO METHOTREXATE

RHEUMATOID ARTHRITIS
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Adalimumab -Pfizer
Product Code: PF-06410293
INN or Proposed INN: ADALIMUMAB
Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB -EU

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

560

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1031

EUCTR2013-004019-37-RO
(EUCTR)

22/10/2014

05/03/2015

A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

Hungary;Czech Republic;Canada;Poland;Turkey;Romania;Denmark;Australia;Bulgaria;Germany;New Zealand

1032

EUCTR2013-004148-49-PL
(EUCTR)

21/10/2014

27/08/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

1033

EUCTR2014-000443-33-GB
(EUCTR)

20/10/2014

26/06/2014

Coherus RA Study

Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: CHS-0214
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Coherus BioSciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

620

Phase 3

United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan

1034

EUCTR2014-001114-26-IT
(EUCTR)

20/10/2014

16/09/2014

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

334

Phase 4

Hungary;Greece;Canada;Spain;Ireland;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden

1035

EUCTR2013-004148-49-BG
(EUCTR)

20/10/2014

01/09/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

Japan;Bulgaria;Germany;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Georgia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1036

EUCTR2013-004019-37-CZ
(EUCTR)

15/10/2014

05/09/2014

A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 2

Hungary;Czech Republic;Canada;Poland;Romania;Turkey;Denmark;Australia;Bulgaria;Germany;New Zealand

1037

EUCTR2013-002805-76-GB
(EUCTR)

09/10/2014

30/12/2013

A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis.

Rheumatoid Arthritis (RA)
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

108

Phase 2

Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Germany;Japan;United Kingdom

1038

EUCTR2014-001299-79-DK
(EUCTR)

06/10/2014

07/07/2014

Pnemococcal vaccination of rheumatoid arthritis patients in biological treatment

Pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy - Immunovax_RA

Immunoresponse on pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy
MedDRA version: 18.0;Level: LLT;Classification code 10069594;Term: Pneumococcal immunization;System Organ Class: 100000004865;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Trade Name: Prevenar 13
INN or Proposed INN: pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE
Trade Name: Pneumovax
INN or Proposed INN: pneumococcal polysaccharide serotype 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT)

Department of Infectious Diseases, Odense University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Denmark

1039

EUCTR2014-000706-34-GB
(EUCTR)

06/10/2014

18/07/2014

A Study to Determine the Body's Immune Response To a Vaccination for Herpes Zoster In Subjects Who Have Rheumatoid Arthritis and Receive Tofacitinib (CP-690,550) (the drug being tested) or Placebo

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE IMMUNE RESPONSE FOLLOWING ADMINISTRATION OF ZOSTER VACCINE TO SUBJECTS WITH RHEUMATOID ARTHRITIS RECEIVING TOFACITINIB (CP-690,550) OR PLACEBO WITH BACKGROUND METHOTREXATE TREATMENT

Product Name: tofacitinib citrate
Product Code: CP -690,550 – 10
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 2

United States;Hungary;Germany;United Kingdom

1040

EUCTR2013-002805-76-DE
(EUCTR)

06/10/2014

27/01/2014

A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis followed by a 48-week active extension study.

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

324

Phase 2

Czech Republic;Mexico;Argentina;Poland;Brazil;Spain;Russian Federation;Bulgaria;Colombia;Germany;United Kingdom;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1041

EUCTR2014-000358-13-LT
(EUCTR)

03/10/2014

11/09/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

Serbia;United States;Philippines;Taiwan;Estonia;Thailand;Spain;Russian Federation;Chile;Israel;Australia;Peru;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Germany

1042

EUCTR2014-000859-91-FR
(EUCTR)

03/10/2014

18/06/2015

Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde.

Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde. - LYRITUX

Cette étude portera donc sur une population de patients atteints de polyarthrite rhumatoïde (PR) actives et ayant présenté un échec ou une contre-indication à au moins un anti-TNFa, et n’ayant jamais reçu de rituximab.
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MABTHERA
INN or Proposed INN: RITUXIMAB

CHRU de TOURS

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

France

1043

JPRN-UMIN000015462

2014/10/01

17/10/2014

Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study)

Rheumatoid arthritis

Continue current treatment
Tofacitinib discontinuation
MTX discontinuation

School of Medicine, University of Occupational and Environmental Health, Japan

NULL

Recruiting

18years-old

Not applicable

Male and Female

400

Not selected

Japan

1044

JPRN-UMIN000015217

2014/10/01

01/10/2014

Identification of Antibodies Involved in Atherosclerosis Progression and Evaluation of Orencia`s Efficacy on Antibodies, Atherosclerosis Biomarkers and Structural Markers in Orencia-Treated Patients with Rheumatoid Arthritis Complicated by Atherosclerosis

RA patients aged 20 years or older and have never been treated with biological products or molecular targeted drug therapy.

Abatacept

Yokohama City University Graduate School of Medicine

NULL

Recruiting

20years-old

Not applicable

Male and Female

Not applicable

Japan

1045

NCT02500498
(ClinicalTrials.gov)

October 2014

15/7/2015

Safety Profile of Nulojix in Home Infusion Settings

Rheumatoid Arthritis

Drug: Nulojix

Bristol-Myers Squibb

BiologicTx, LLC

Completed

18 Years

N/A

Both

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1046

NCT02270632
(ClinicalTrials.gov)

October 2014

16/10/2014

A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Clinical Efficacy of Two Different Doses of F8IL10 (Dekavil) Administered Subcutaneously to Patients With Active Rheumatoid Arthritis Receiving Methotrexate.

Rheumatoid Arthritis

Drug: F8IL10;Drug: MTX;Drug: Placebo

Philogen S.p.A.

NULL

Recruiting

18 Years

74 Years

Both

Phase 2

Germany;Italy;Switzerland

1047

NCT02265705
(ClinicalTrials.gov)

October 2014

13/10/2014

A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

Rheumatoid Arthritis

Drug: Baricitinib;Drug: Placebo

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

290

Phase 3

Argentina;Brazil;China

1048

NCT02221258
(ClinicalTrials.gov)

October 2014

18/8/2014

Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis(RA)

Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: FURESTEM-RA Inj.

Kang Stem Biotech Co., Ltd.

NULL

Completed

19 Years

80 Years

Both

Phase 1

Korea, Republic of

1049

NCT02257047
(ClinicalTrials.gov)

October 2014

2/10/2014

Red Yeast Rice and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Dietary Supplement: Tea;Dietary Supplement: RYR

Chengdu PLA General Hospital

NULL

Enrolling by invitation

18 Years

75 Years

All

120

N/A

China

1050

EUCTR2014-000358-13-LV
(EUCTR)

26/09/2014

11/09/2014

A clinical trial to assess a novel medicine in the treatment of patients with moderately to severely active rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

1080

Phase 3;Phase 4

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1051

EUCTR2011-005689-39-SK
(EUCTR)

24/09/2014

07/07/2014

A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Ankylosing Spondylitis (AS)
MedDRA version: 17.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Other descriptive name: TOFACITINIB CITRATE

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 2

United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of

1052

NCT02139345
(ClinicalTrials.gov)

September 23, 2014

7/5/2014

TC-A Registration Study

A Prospective, Randomized, Multicenter Clinical Study to Compare the Safety and Efficacy of TC-A PS Total Knee System With TC-PLUS Solution PS Total Knee System in Chinese Subjects

Primary Osteoarthritis;Rheumatoid Arthritis;Post-traumatic Arthritis;Avascular Necrosis

Device: TC-A PS Total Knee Replacement System;Device: TC-PLUS Solution PS Total Knee Replacement System

Smith & Nephew Medical (Shanghai) Ltd

NULL

Completed

50 Years

75 Years

All

162

N/A

China

1053

EUCTR2012-002945-40-DE
(EUCTR)

22/09/2014

01/04/2014

BI695501 compared to adalimumab in patients with active rheumatoid arthritis

Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 3

United States;Serbia;Estonia;Thailand;Spain;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of

1054

EUCTR2013-004555-21-GR
(EUCTR)

22/09/2014

21/03/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: CT- P10
Product Code: CT- P10
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina

1055

EUCTR2013-002358-57-BE
(EUCTR)

18/09/2014

15/07/2014

A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Spain;Belgium;Australia;Netherlands;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1056

EUCTR2013-005418-37-IT
(EUCTR)

15/09/2014

06/03/2014

Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to at least one anti-TNF treatment.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Dekavil
Product Code: F8IL10
INN or Proposed INN: dekavil
Other descriptive name: F8IL10

Philogen S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany;Italy

1057

EUCTR2013-002805-76-CZ
(EUCTR)

11/09/2014

17/07/2014

A 24-week placebo-controlled clinical study to evaluate the adequate dose, efficacy and safety of 3 doses of namilumab combined with methotrexate in subjects with moderate to severe rheumatoid arthritis.

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

108

Phase 2

Czech Republic;Poland;Spain;Russian Federation;Bulgaria;Japan;United Kingdom

1058

EUCTR2011-004720-35-FI
(EUCTR)

10/09/2014

09/09/2014

Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: RoActemra
Other descriptive name: TOCILIZUMAB
INN or Proposed INN: METHOTREXATE
Trade Name: Metoject
Other descriptive name: METHOTREXATE DISODIUM
Other descriptive name: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Salazopyrin EN
Other descriptive name: SULFASALAZINE
Trade Name: Oxiklorin
Product Code: 118-42-3
Other descriptive name: HYDROXYCHLOROQUINE SULFATE

Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Finland;Denmark;Sweden

1059

EUCTR2014-000443-33-HU
(EUCTR)

09/09/2014

06/06/2014

Coherus RA Study

Product Code: CHS-0214
INN or Proposed INN: Etanercept
Other descriptive name: CHS-0214
Trade Name: Enbrel
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT

Coherus Biosciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

620

Phase 3

United States;Belarus;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;South Africa;Germany;Japan

1060

EUCTR2013-003177-99-NL
(EUCTR)

09/09/2014

25/02/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1061

EUCTR2013-005543-90-PL
(EUCTR)

09/09/2014

11/07/2014

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

1062

EUCTR2012-003654-86-BG
(EUCTR)

04/09/2014

21/05/2014

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks as monotherapy to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone

moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: Propsoed INN - FILGOTINIB
Other descriptive name: GLPG0634

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

1063

JPRN-UMIN000014624

2014/09/01

23/07/2014

Effects of postoperative administration of celecoxib on postoperative pain management in patients after total knee arthroplasty. A randomized controlled study.

Osteoarthritis, Rheumatoid arthritis

Administration of celecoxib from 2 hours after TKA surgery
Administration of celecoxib from 2 days after TKA surgery

Mito medical center, Mito Kyodo General Hospital, University of Tsukuba

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

120

Phase 4

Japan

1064

EUCTR2011-005689-39-NL
(EUCTR)

01/09/2014

23/06/2014

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Netherlands;Korea, Republic of

1065

NCT02246257
(ClinicalTrials.gov)

September 2014

17/9/2014

Early Rheumatoid Arthritis COR Intervention

Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis;Cardiovascular Diseases

Other: Simvastatin;Other: Losartan;Other: Metformin;Other: Outpatient rheumatology department;Other: Refered to general practice

MD, PhD, Annemarie Lyng Svensson

NULL

Unknown status

18 Years

N/A

All

300

N/A

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1066

NCT02097264
(ClinicalTrials.gov)

September 2014

24/3/2014

A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

A Randomised, Active Comparator, Double-blind, Multi Centre, Parallel, Phase 2a Trial, Investigating the Mechanism of Action, of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Inflammation;Rheumatoid Arthritis

Drug: NNC0109-0012;Drug: Adalimumab;Drug: placebo

Novo Nordisk A/S

NULL

Withdrawn

18 Years

75 Years

Both

Phase 2

Ireland;Portugal;Spain;United Kingdom

1067

NCT02222493
(ClinicalTrials.gov)

August 26, 2014

19/8/2014

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate

Rheumatoid Arthritis

Biological: PF-06438179;Biological: Infliximab

Pfizer

NULL

Completed

18 Years

N/A

All

650

Phase 3

United States;Australia;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Czechia;Georgia;Germany;Guatemala;Hungary;Israel;Japan;Jordan;Korea, Republic of;Lithuania;Mexico;Morocco;Peru;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Tunisia;Ukraine;United Kingdom;Colombia;Czech Republic;France

1068

EUCTR2013-005543-90-HU
(EUCTR)

26/08/2014

13/05/2014

This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body, and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany

1069

EUCTR2012-003655-11-CZ
(EUCTR)

21/08/2014

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

moderately to severely active rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: filgotinib
Product Code: GLPG0634
INN or Proposed INN: INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

739

Phase 2

Spain;Ukraine;Guatemala;Austria;Russian Federation;Chile;Israel;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of;United States

1070

EUCTR2012-002945-40-BG
(EUCTR)

21/08/2014

05/08/2014

BI695501 compared to adalimumab in patients with active rheumatoid arthritis

Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Russian Federation;Chile;Hungary;Poland;Malaysia;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1071

EUCTR2013-004148-49-HU
(EUCTR)

13/08/2014

06/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

1072

EUCTR2014-002056-40-NO
(EUCTR)

12/08/2014

13/06/2014

A study to evaluate the safety and efficacy of switching from regular infliximab to biosimilar infliximab in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and psoriasis

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN’S DISEASEAND CHRONIC PLAQUE PSORIASISTHE NOR-SWITCH STUDY - NOR_SWITCH

Rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn’s disease and chronic plaque psoriasis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Level: LLT;Classification code 10071117;Term: Plaque psoriasis;System Organ Class: 100000004858
MedDRA version: 18.0;Classification code 10037160;Term: Psoriatic arthritis;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10002556;Term: Ankylosing spondylitis;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning
Trade Name: Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning

Diakonhjemmet Hospital AS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Norway

1073

NCT02202837
(ClinicalTrials.gov)

August 12, 2014

15/7/2014

Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice

Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Rheumatoid Arthritis Patients Treated With Etanercept (Enbrel (Registered))

Rheumatoid Arthritis

Drug: etanercept

Pfizer

NULL

Completed

18 Years

N/A

All

157

Belgium

1074

NCT02308163
(ClinicalTrials.gov)

August 8, 2014

2/12/2014

A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs

Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs

Rheumatoid Arthritis

Drug: Peficitinib;Drug: Placebo;Biological: Etanercept

Astellas Pharma Inc

NULL

Completed

20 Years

N/A

All

509

Phase 3

Japan;Korea, Republic of;Taiwan

1075

EUCTR2013-004604-19-DE
(EUCTR)

06/08/2014

03/06/2014

Effect of Adalimumab plus Methortrexat (MTX) versus Placebo plus MTX on cartilage in early RA patients

Delayed Gadolinium-enhanced Magnetic resonance Imaging (MRI) of Cartilage - A pilot study to measure the effect of Adalimumab plus Methotrexat (MTX) versus Placebo plus MTX on cartilage in early rheumatoid arthritis (RA) patients

patients with early progressive rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Trade Name: Humira 40mg Injektionslösung
Product Name: Humira

Heinrich-Heine-Universität Düsseldorf

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1076

EUCTR2013-002622-23-DE
(EUCTR)

06/08/2014

27/03/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

1077

JPRN-UMIN000014737

2014/08/01

01/08/2014

The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity.

rheumatoid arthritis

Denosumab group: Denosumab 60mg is administered by subcutaneous injections every 6 months (at baseline, at 6 months and at 12 months). All patients are to take vitamin D.
BP group: Patients take BP continuously. All patients are to take vitamin D.

Yokohama City University Medical Center

NULL

Complete: follow-up complete

50years-old

90years-old

Male and Female

286

Not selected

Japan

1078

ChiCTR-RNC-14004887

2014-08-01

2014-06-30

The pharmacogenomics study on Methotrexate in treating rheumatoid arthritis

rheumatoid arthritis

Case series:Methotrexate;

The people's hospital, Yichun City

NULL

Recruiting

Case series:400;

China

1079

NCT02219191
(ClinicalTrials.gov)

August 2014

16/7/2014

Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases

The Effect of Puerarin Tablets in Treating Metabolism Syndrome in Patients With Chronic Rheumatic Diseases

Rheumatoid Arthritis

Drug: puerarin tablet 50 mg;Drug: Atorvastatin tablet 20 mg

Chengdu PLA General Hospital

NULL

Active, not recruiting

18 Years

75 Years

All

150

N/A

China

1080

NCT02176876
(ClinicalTrials.gov)

August 2014

25/6/2014

Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis

A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: GS-5745;Drug: Placebo to match GS-5745

Gilead Sciences

NULL

Completed

18 Years

70 Years

Both

Phase 1

Czech Republic;Hungary

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1081

NCT02187055
(ClinicalTrials.gov)

August 2014

8/7/2014

An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis

Rhematoid Arthritis

Drug: Tofacitinib with methotrexate;Drug: Tofacitinib without methotrexate;Biological: Adalimumab with methotrexate

Pfizer

NULL

Completed

18 Years

N/A

All

1152

Phase 4

United States;Argentina;Australia;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Czechia;Estonia;Israel;Korea, Republic of;Latvia;Lithuania;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Croatia;Czech Republic;France

1082

NCT02264301
(ClinicalTrials.gov)

August 2014

3/10/2014

Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis

The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Puerarin injection 400 mg;Drug: Qingkailing injection 40 ml

Chengdu PLA General Hospital

NULL

Enrolling by invitation

18 Years

75 Years

All

150

N/A

China

1083

NCT02211469
(ClinicalTrials.gov)

August 2014

6/8/2014

A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects

Rheumatoid Arthritis

Drug: BMS-986104;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

49 Years

Male

Phase 1

United States

1084

NCT02149121
(ClinicalTrials.gov)

August 2014

23/5/2014

PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety Between CT-P10, Rituxan and MabThera in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: CT-P10;Drug: Rituxan;Drug: MabThera

Celltrion

NULL

Completed

18 Years

75 Years

All

384

Phase 3

Austria;Korea, Republic of

1085

NCT02234960
(ClinicalTrials.gov)

August 2014

5/9/2014

Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)

TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL)

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

102

N/A

Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1086

EUCTR2013-002358-57-NL
(EUCTR)

30/07/2014

24/02/2014

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom

1087

EUCTR2013-002622-23-ES
(EUCTR)

29/07/2014

25/04/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Product Code: Bi 695500
INN or Proposed INN: Not applicable

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

1088

EUCTR2013-004148-49-DE
(EUCTR)

28/07/2014

06/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Georgia;Germany

1089

EUCTR2013-003530-33-LV
(EUCTR)

28/07/2014

17/06/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
Product Name: ABT-494 30mg
INN or Proposed INN: ABT-494
Product Name: ABT-494 15mg
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

494

Phase 2

United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;South Africa;Bulgaria;Netherlands;Latvia;New Zealand

1090

NCT02305849
(ClinicalTrials.gov)

July 25, 2014

1/12/2014

A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment

Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to MTX

Rheumatoid Arthritis

Drug: Peficitinib;Drug: Placebo;Drug: Methotrexate

Astellas Pharma Inc

NULL

Completed

20 Years

N/A

All

519

Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1091

EUCTR2013-005362-19-DE
(EUCTR)

17/07/2014

18/12/2013

Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB)

Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) - TAVAB

Myasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Charité - Universitätsmedizin Berlin

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany

1092

EUCTR2013-003177-99-GB
(EUCTR)

17/07/2014

11/03/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden

1093

EUCTR2013-004148-49-LT
(EUCTR)

14/07/2014

23/05/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

Poland;Brazil;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Philippines;Morocco;Ukraine;Israel;Russian Federation;Colombia;France;Australia;Peru;South Africa;Tunisia;Bosnia and Herzegovina;Korea, Republic of;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina

1094

EUCTR2013-003177-99-CZ
(EUCTR)

10/07/2014

05/02/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

Portugal;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden

1095

EUCTR2012-002945-40-ES
(EUCTR)

07/07/2014

29/04/2014

BI695501 compared to adalimumab in patients with active rheumatoid arthritis

Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Colombia;France;Hungary;Mexico;Argentina;Poland;Malaysia;Belgium;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1096

EUCTR2013-004148-49-GB
(EUCTR)

03/07/2014

06/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

1097

JPRN-UMIN000016928

2014/07/03

26/03/2015

Targeted Ultrasound in Rheumatoid Arthritis

Rheumatoid arthritis

If DAS28 increased by >0.6 from baseline, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week.
If DAS28 increased by >0.6 from baseline or total PD score is 4 or greater, treatment with biweekly Adalimumab 40mg s.c. is commenced and continued until 96 week.

Leeds University

NULL

Recruiting

18years-old

Not applicable

Male and Female

400

Not selected

Japan,Europe

1098

JPRN-UMIN000015175

2014/07/01

17/09/2014

Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial.

Rheumatoid Arthritis

Subcutaneous Tocilizumab 162mg every other week.
Subcutaneous Abatacept 125mg every week.

St.Marianna University School of Medicine

NULL

Recruiting

20years-old

Not applicable

Male and Female

120

Not selected

Japan

1099

NCT02011334
(ClinicalTrials.gov)

July 2014

4/12/2013

A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.

A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICA

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

285

Phase 3

Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay

1100

NCT02053727
(ClinicalTrials.gov)

July 2014

6/11/2013

Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background

Pilot Study to Evaluate Subcutaneous Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background- a Pilot, Double-blind, Placebo-controlled, Randomized, Controlled Trial.

Rheumatoid Arthritis;Chronic Hepatitis B

Drug: Abatacept;Drug: Placebo

University of California, Los Angeles

NULL

Withdrawn

18 Years

N/A

All

N/A

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1101

NCT02141997
(ClinicalTrials.gov)

July 2014

16/5/2014

A Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given With Methotrexate in Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Biological: adalimumab;Biological: ABT-122

AbbVie

NULL

Completed

18 Years

99 Years

All

222

Phase 2

Australia;Bulgaria;Canada;Czech Republic;Germany;Hungary;New Zealand;Poland;Romania;Turkey;United States

1102

EUCTR2013-001417-32-ES
(EUCTR)

30/06/2014

22/05/2014

A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Chile;Colombia;United Kingdom;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of;Sweden

1103

EUCTR2013-003984-72-ES
(EUCTR)

30/06/2014

09/05/2014

A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Inc.

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia

1104

EUCTR2013-004654-13-RO
(EUCTR)

27/06/2014

30/05/2014

The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: ABP 501

Amgen Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

425

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

1105

EUCTR2013-005013-13-PL
(EUCTR)

25/06/2014

31/03/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1106

JPRN-UMIN000014311

2014/06/24

24/06/2014

Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis

rheumatoid arthritis

The quantity of Infliximab is increased.

Institute of Health Biosciences,The University of Tokushima Graduate School

NULL

Pending

20years-old

75years-old

Male and Female

Not selected

Japan

1107

EUCTR2013-002622-23-NL
(EUCTR)

24/06/2014

17/02/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Product Code: Bi 695500
INN or Proposed INN: Rituximab

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

1108

EUCTR2013-003984-72-SK
(EUCTR)

23/06/2014

15/04/2014

A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia

1109

ChiCTR-TRC-14004824

2014-06-23

2014-06-19

Clinical studies on Ginsenoside C-K

Study on tolerability and pharmacokinetics of Ginsenoside C-K tablet in healthy volunteers after a single dose

rheumatoid arthritis

7 groups:Seven different doses with ginsenoside compound K;

Institute of Clinical Pharmacology, Central South University

NULL

Completed

Both

7 groups:77;

I (Phase 1 study)

China

1110

EUCTR2010-019262-86-BE
(EUCTR)

20/06/2014

04/03/2014

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Portugal;United States;Belarus;Philippines;Taiwan;Estonia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1111

EUCTR2013-004148-49-CZ
(EUCTR)

20/06/2014

05/06/2014

RANDOMIZED STUDY OF PF-06438179 AND INFLIXIMAB IN COMBINATIONWITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELYACTIVE RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

614

Phase 3

1112

EUCTR2013-001417-32-LT
(EUCTR)

19/06/2014

07/04/2014

A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of

1113

EUCTR2013-003530-33-HU
(EUCTR)

18/06/2014

26/03/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

494

Phase 2

United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand

1114

EUCTR2012-003686-17-SI
(EUCTR)

17/06/2014

03/04/2014

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3350

Phase 3

Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden

1115

ChiCTR-BOC-16008925

2014-06-10

2016-07-27

Circulating Tfh subpopulation in very early rheumatoid arthritis

Circulating Bcl-6+ICOS+ Tfh subpopulation correlates with disease activity in very early rheumatoid arthritis

Rheumatoid Arthritis

RA patients:methotrexate;Healthy control (HC) individuals:Nil;

The First Hospital, Jilin University, Changchun

NULL

Completed

Both

RA patients:22;Healthy control (HC) individuals:15;

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1116

JPRN-JapicCTI-142621

09/6/2014

CHS-0214 Phase III trial

A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate

Rheumatoid Arthritis

Intervention name : CHS-0214
Dosage And administration of the intervention : subcutaneous injection
Control intervention name : Enbrel
INN of the control intervention : Etanercept
Dosage And administration of the control intervention : subcutaneous injection

DAIICHISANKYO Co.,Ltd.

Coherus Biosciences, Inc.

BOTH

620

Phase 3

NULL

1117

EUCTR2012-002535-28-PT
(EUCTR)

06/06/2014

25/02/2014

Not applicable

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 4

Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom

1118

EUCTR2013-002622-23-HU
(EUCTR)

03/06/2014

02/04/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

1119

EUCTR2013-001417-32-DE
(EUCTR)

02/06/2014

18/02/2014

A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

1120

EUCTR2013-002790-22-HU
(EUCTR)

02/06/2014

03/04/2014

To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)

An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE

Rheumatoid Arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

120

United States;Estonia;Czech Republic;Hungary;Argentina;Poland;Russian Federation;Chile

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1121

ChiCTR1900026116

2014-06-01

2019-09-22

The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial

rheumatoid arthritis

Experimental group:Prednisone+methotrexate+Hydrochloroquine;control group:placebo+methotrexate+Hydrochloroquine;

Central Hospital of Jinhua

NULL

Completed

Both

Experimental group:40;control group:40;

Phase 4

China

1122

JPRN-UMIN000013546

2014/06/01

31/03/2014

The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus

rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis

take a glass of grapefruit juice every day
do not take grapefruit juice

Department of Rheumatology and Clinical Immunology, Kyoto University Hospital

NULL

Pending

16years-old

80years-old

Male and Female

Not applicable

Japan

1123

NCT02147587
(ClinicalTrials.gov)

June 2014

22/5/2014

A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate

A Randomized, Double-blind, Placebo-controlled, Phase 2 Study To Assess The Immune Response Following Administration Of Zoster Vaccine To Subjects With Rheumatoid Arthritis Receiving Tofacitinib (Cp-690,550) Or Placebo With Background Methotrexate Treatment

Rheumatoid Arthritis

Drug: Tofacitinib;Drug: Placebo

Pfizer

NULL

Completed

50 Years

N/A

All

112

Phase 2

United States;United Kingdom

1124

NCT02202395
(ClinicalTrials.gov)

June 2014

23/7/2014

Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

A Radomized, Double-blind, and Placebo-controlled Multicenter Clinical Trial of Hydroxytriptolide, in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: LTS 0.25mg;Drug: LTS 0.5mg;Drug: LTS 1.0mg;Drug: Placebo

Shanghai Pharmaceuticals Holding Co., Ltd

NULL

Completed

35 Years

65 Years

Female

120

Phase 1;Phase 2

China

1125

EUCTR2012-001176-10-PL
(EUCTR)

31/05/2014

28/04/2014

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1126

EUCTR2013-002790-22-EE
(EUCTR)

30/05/2014

07/05/2014

To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)

An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

120

United States;Hungary;Czech Republic;Estonia;Argentina;Poland;Russian Federation;Chile

1127

EUCTR2013-003984-72-LV
(EUCTR)

30/05/2014

28/03/2014

A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.

Rheumatoid Arthritis (RA)
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia

1128

NCT02046616
(ClinicalTrials.gov)

May 28, 2014

24/1/2014

A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Tocilizumab SC in Patients With Active Rheumatoid Arthritis and Inadequate Response to DMARDs. A Single-Arm, Open-Label Study to Evaluate Safety, Tolerability and Efficacy. In a Subgroup of Patients Inflammation Will Be Measured by Ultrasound.

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Methotrexate;Drug: Non-Biologic DMARDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

133

Phase 3

Denmark;Finland;Norway;Sweden

1129

EUCTR2011-004720-35-DK
(EUCTR)

28/05/2014

24/02/2014

Trade Name: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
Trade Name: Metoject
Other descriptive name: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE

Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Finland;Denmark;Netherlands;Norway;Iceland;Sweden

1130

EUCTR2013-001417-32-HU
(EUCTR)

27/05/2014

17/03/2014

A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

Serbia;United States;Spain;Ukraine;Lithuania;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1131

EUCTR2013-003493-27-GR
(EUCTR)

27/05/2014

16/04/2014

Study with the aim to evaluate the safety, tolerability and efficacy of QAL964 in patients with Rheumatoid Arthritis who are treated with anti-rheumatic drug methotrexate but where the treatment does not sufficiently work.

A randomized, double-blind, placebo-controlled study toinvestigate the safety, tolerability and efficacy of orallyadministered QAL964 in patients with active rheumatoidarthritis on stable doses of methotrexate and withinadequate response to methotrexate - CQAL964B2201

Product Code: QAL964
Other descriptive name: QAL964

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Greece;Ukraine;Romania;Russian Federation

1132

EUCTR2012-002945-40-HU
(EUCTR)

27/05/2014

04/04/2014

BI695501 compared to adalimumab in patients with active rheumatoid arthritis

Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 3

United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;South Africa;Bulgaria;Germany;New Zealand;Korea, Republic of

1133

NCT02196558
(ClinicalTrials.gov)

May 26, 2014

16/7/2014

A Study of E6011 in Japanese Subjects With Rheumatoid Arthritis

A Phase 1/2 Study of Repeated Subcutaneous E6011 Administration in Japanese Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: E6011

Eisai Co., Ltd.

NULL

Completed

20 Years

64 Years

All

Phase 1;Phase 2

Japan

1134

EUCTR2012-003654-86-LV
(EUCTR)

26/05/2014

24/04/2014

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone.

moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Serbia;Spain;Ukraine;Guatemala;Lithuania;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Australia;Peru;Bulgaria;Germany;Latvia;New Zealand

1135

EUCTR2012-004339-21-PL
(EUCTR)

25/05/2014

23/04/2014

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy - SARIL-RA-EASY

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: sarilumab

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

France;United States;Mexico;Poland;Russian Federation;Chile;South Africa

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1136

EUCTR2013-004654-13-DE
(EUCTR)

22/05/2014

03/02/2014

The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: ABP 501

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

425

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

1137

EUCTR2013-002790-22-CZ
(EUCTR)

21/05/2014

08/04/2014

To evaluate the immunogenicity and safety of sarilumab administered as monotherapy in patients with rheumatoid arthritis (RA)

An open-label, randomized, parallel group study assessing the immunogenicity and safety of sarilumab administered as monotherapy in patients with active rheumatoid arthritis - SARIL-RA-ONE

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 3

United States;Hungary;Estonia;Czech Republic;Argentina;Poland;Russian Federation;Chile

1138

EUCTR2013-003984-72-HU
(EUCTR)

20/05/2014

04/04/2014

A Study Investigating the Efficacy and Safety of ABT-494 given with Methotrexate in Subjects with Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone.

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Deutschland GmbH & Co.KG

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Chile;Israel;Russian Federation;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;South Africa;Latvia

1139

EUCTR2012-002945-40-EE
(EUCTR)

09/05/2014

10/04/2014

BI695501 compared to adalimumab in patients with active rheumatoid arthritis

Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 3

United States;Serbia;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;New Zealand;Korea, Republic of

1140

EUCTR2010-019262-86-SE
(EUCTR)

09/05/2014

24/03/2014

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 3

Portugal;Belarus;United States;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1141

EUCTR2013-002622-23-PT
(EUCTR)

09/05/2014

28/02/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

Serbia;United States;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden

1142

EUCTR2012-001176-10-HR
(EUCTR)

08/05/2014

05/09/2014

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

1143

EUCTR2013-003177-99-ES
(EUCTR)

07/05/2014

17/03/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

4000

Phase 3B;Phase 4

Portugal;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden

1144

ChiCTR-TRC-14004520

2014-05-01

2014-04-13

To study the signal pathways of Rheumatoid Arthritis Syndrome of Accumulated Dampness and intervention mechanism of Sanhuang Yilong Decoction based the theory that lung, spleen and kidney regulate water

rheumatoid arthritis

two:Methotrexate, hydroxychloroquine sulfate pills and NSAIDs in both groups; Sanhuang Yinong decoction will be give in the experimental group;RA patients:NA;

General Hospital of Chengdu Military Region

NULL

Recruiting

Both

two:240;RA patients:40;

I (Phase 1 study)

China

1145

NCT02123264
(ClinicalTrials.gov)

May 2014

23/4/2014

Zoledronic Acid in Rheumatoid Arthritis

Randomized Clinical Trial on the Prevention of Radiographic Progression With Zoledronic Acid in Patients With Early Rheumatoid Arthritis and Low Disease Activity

Arthritis, Rheumatoid

Drug: Zoledronic acid

Carmen Gómez-Vaquero

NULL

Terminated

18 Years

N/A

All

Phase 3

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1146

NCT02105129
(ClinicalTrials.gov)

May 2014

19/3/2014

A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523

A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL-523

Rheumatoid Arthritis (RA)

Drug: HMPL-523;Drug: Placebo

Hutchison Medipharma Limited

NULL

Completed

18 Years

45 Years

Male

118

Phase 1

Australia

1147

NCT02927509
(ClinicalTrials.gov)

May 2014

15/9/2016

Evaluation of Tumour Necrosis Factor Alpha (TNFa) Blockers in Early Rheumatoid Arthritis in France

Rheumatoid Arthritis

Drug: TNF alpha blockers

Centre Hospitalier Universitaire de Nimes

Pfizer;Pfizer

Completed

18 Years

70 Years

Both

813

N/A

NULL

1148

NCT02151474
(ClinicalTrials.gov)

May 2014

28/5/2014

INCB047986 in Rheumatoid Arthritis

A Double-Blind, Placebo-Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28-Day Course of INCB047986 in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: INCB047986;Drug: Placebo

Incyte Corporation

NULL

Recruiting

18 Years

N/A

Both

Phase 2

United States

1149

NCT02167139
(ClinicalTrials.gov)

May 2014

16/6/2014

A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Drug: Humira (adalimumab);Drug: SB5 (proposed biosimilar to adalimumab)

Samsung Bioepis Co., Ltd.

NULL

Completed

18 Years

75 Years

All

544

Phase 3

Lithuania;Poland

1150

EUCTR2013-005013-13-BG
(EUCTR)

28/04/2014

23/04/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Phase 3

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1151

EUCTR2013-003177-99-SK
(EUCTR)

28/04/2014

10/03/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden

1152

EUCTR2012-002535-28-BE
(EUCTR)

28/04/2014

28/03/2014

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Rheumatoid Arthritis
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 4

Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom

1153

EUCTR2012-001176-10-NL
(EUCTR)

18/04/2014

28/12/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China

1154

EUCTR2013-004654-13-BG
(EUCTR)

14/04/2014

18/03/2014

The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: ABP 501

Amgen Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

425

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

1155

EUCTR2013-004654-13-PL
(EUCTR)

13/04/2014

03/04/2014

The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: ABP 501

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

425

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1156

EUCTR2013-003177-99-SE
(EUCTR)

11/04/2014

05/02/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden

1157

EUCTR2013-003493-27-HU
(EUCTR)

08/04/2014

30/01/2014

Product Code: QAL964
Other descriptive name: QAL964

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;Ukraine;Russian Federation

1158

EUCTR2013-005013-13-LT
(EUCTR)

08/04/2014

13/02/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

1159

EUCTR2013-004555-21-AT
(EUCTR)

07/04/2014

02/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of

1160

EUCTR2013-004555-21-SK
(EUCTR)

07/04/2014

23/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1161

NCT04582084
(ClinicalTrials.gov)

April 4, 2014

3/10/2020

Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis

Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance Study

Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis

Drug: Etanercept

AryoGen Pharmed Co.

NULL

Completed

18 Years

N/A

All

583

Iran, Islamic Republic of

1162

EUCTR2013-002358-57-CZ
(EUCTR)

04/04/2014

11/12/2013

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Hungary;Czech Republic;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom

1163

EUCTR2013-005013-13-CZ
(EUCTR)

03/04/2014

13/02/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina

1164

EUCTR2013-004555-21-HU
(EUCTR)

02/04/2014

23/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 18.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Korea, Republic of;Bosnia and Herzegovina;Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Latvia;Germany

1165

EUCTR2013-002622-23-BE
(EUCTR)

02/04/2014

26/03/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1166

JPRN-UMIN000013440

2014/04/01

18/03/2014

To evaluate the efficacy and safety of subcutaneous and intravenous abatacept.

Rheumatoid arthritis

SC abatacept
IV abatacept
Extension of SC abatacept

Osaka Medical College

NULL

Complete: follow-up complete

20years-old

80years-old

Male and Female

Not selected

Japan

1167

NCT02109289
(ClinicalTrials.gov)

April 2014

3/4/2014

Etanercept in Rheumatoid Arthritis and Vascular Inflammation

Pilot Open-label Study of the Effect of Etanercept on Vascular Inflammation in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis;Vascular Inflammation

Drug: etanercept

Innovaderm Research Inc.

NULL

Terminated

18 Years

80 Years

All

Phase 4

Canada

1168

NCT02114931
(ClinicalTrials.gov)

April 2014

11/4/2014

Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: ABP 501

Amgen

NULL

Completed

18 Years

81 Years

All

467

Phase 3

United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Poland;Romania;Russian Federation;Spain;United Kingdom

1169

NCT02101073
(ClinicalTrials.gov)

March 31, 2014

27/3/2014

ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

A Phase I, Open-Label Study Evaluating the Bioavailability of ALX-0061 After Subcutaneous and Intravenous Administration in Healthy Volunteers.

Rheumatoid Arthritis

Biological: ALX-0061

Ablynx

NULL

Completed

18 Years

55 Years

All

Phase 1

Netherlands

1170

EUCTR2013-004555-21-DE
(EUCTR)

31/03/2014

17/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1171

EUCTR2013-002622-23-BG
(EUCTR)

27/03/2014

21/03/2014

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Product Code: Bi 695500

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

250

1172

EUCTR2012-003655-11-BG
(EUCTR)

27/03/2014

19/02/2014

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

moderately to severely active rheumatoid arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: filgotinib
Product Code: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

739

Phase 2

United States;Spain;Ukraine;Guatemala;Austria;Russian Federation;Chile;Israel;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of

1173

NCT02066389
(ClinicalTrials.gov)

March 26, 2014

17/2/2014

A Study Investigating the Efficacy and Safety of Upadacitinib (ABT-494) Given With Methotrexate (MTX) in Adults With Rheumatoid Arthritis Who Have Had an Inadequate Response to MTX Alone

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 With Background Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone

Rheumatoid Arthritis

Drug: Placebo;Drug: Upadacitinib

AbbVie

NULL

Completed

18 Years

100 Years

All

300

Phase 2

United States;Bulgaria;Chile;Czechia;Hungary;Israel;Latvia;Mexico;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Turkey;Ukraine;Czech Republic;Romania;Serbia

1174

EUCTR2010-020992-21-DE
(EUCTR)

25/03/2014

08/07/2011

Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis

A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 2b;Phase 3

Serbia;United States;Philippines;Taiwan;Morocco;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Monaco;India;Czech Republic;Mexico;Argentina;Poland;Romania;South Africa;Germany;Tunisia;Bosnia and Herzegovina

1175

EUCTR2013-004654-13-ES
(EUCTR)

25/03/2014

28/01/2014

The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

An Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: ABP 501
Other descriptive name: ABP 501

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

425

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1176

EUCTR2013-005001-31-ES
(EUCTR)

25/03/2014

07/02/2014

Study on the ability of zoledronic acid to prevent worsening of radiographs of hands and feet of patients with rheumatoid arthritis diagnosed less than 2 years ago and who have few symptoms in their joints by making treatment with the drugs commonly used for the management of disease.

Randomized clinical trial on the prevention of radiographic progression with zoledronic acid in patients with early rheumatoid arthritis and low disease activity - Prevention of radiographic progression in rheumatoid arthritis with zoledronic acid

Trade Name: Zoledronic acid
Product Name: Zoledronic acid
INN or Proposed INN: ZOLEDRONIC ACID

Dra. Carmen Gómez Vaquero (Servicio de Reumatología del Hospital Universiari de Bellvitge - Idibell)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Spain

1177

EUCTR2013-003780-65-IT
(EUCTR)

24/03/2014

03/12/2013

Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitors

Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 14.1;Classification code 10060732;Term: Rheumatoid arthritis flare up;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2B

France;United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Australia;South Africa;Japan;Italy

1178

EUCTR2013-004555-21-PT
(EUCTR)

24/03/2014

07/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina

1179

EUCTR2013-000525-31-RO
(EUCTR)

24/03/2014

12/02/2015

The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

1180

EUCTR2010-019262-86-NO
(EUCTR)

24/03/2014

08/10/2010

Long term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1940

United States;Portugal;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Norway;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1181

EUCTR2013-003780-65-HU
(EUCTR)

19/03/2014

21/01/2014

Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 17.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859
MedDRA version: 17.1;Classification code 10060732;Term: Rheumatoid arthritis flare up;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2B

France;United States;Hungary;Mexico;Canada;Argentina;Australia;South Africa;Japan;Italy

1182

EUCTR2012-003686-17-GR
(EUCTR)

18/03/2014

16/01/2014

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3350

Phase 3

Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden;United Kingdom;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria

1183

EUCTR2012-003194-25-HR
(EUCTR)

17/03/2014

03/09/2014

Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Mabion S.A.

NULL

Not Recruiting

Female: yes
Male: yes

863

Phase 3

Serbia;Poland;Ukraine;Romania;Lithuania;Croatia;Russian Federation;Georgia

1184

JPRN-UMIN000013362

2014/03/15

06/03/2014

Examination of the remission maintenance effect by low dose etanercept after clinical remission in the rheumatoid arthritis.

Rheumatoid Arthritis

Methotrexate
Etanercept

Takarazuka city hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

1185

NCT02092467
(ClinicalTrials.gov)

March 14, 2014

3/3/2014

Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Arthritis, Rheumatoid

Drug: tofacitinib;Biological: adalimumab;Biological: etanercept

Pfizer

NULL

Completed

50 Years

N/A

All

4368

Phase 4

United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;China;Colombia;Czechia;Finland;Hong Kong;Israel;Jordan;Lebanon;Malaysia;Mexico;Netherlands;New Zealand;Peru;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Taiwan;Thailand;Turkey;United Kingdom;Austria;Czech Republic;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1186

EUCTR2013-002358-57-ES
(EUCTR)

11/03/2014

05/12/2013

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Hungary;Czech Republic;Puerto Rico;Canada;Belgium;Poland;Spain;Australia;Netherlands;United Kingdom

1187

EUCTR2013-001492-20-PT
(EUCTR)

05/03/2014

24/01/2014

A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate

A randomised, active comparator, double-blind, multi centre, parallel, phase 2a trial, investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate

Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Other descriptive name: NNC0109-0012
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Portugal;Spain;Ireland;United Kingdom

1188

NCT02046603
(ClinicalTrials.gov)

March 4, 2014

24/1/2014

A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent

Open-Label, Phase IIIb Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic Agent

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

162

Phase 3

United Kingdom

1189

ChiCTR-TCS-14004252

2014-03-04

2014-02-12

A multicenter study for the evaluation of efficacy & safety of buprenorphine transdermal patch (Norspan or Sovenor transdermal patch) in patients with non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, when an opioid

osteoarthritis, rheumatoid arthritis, lower back pain, joint/muscle pain

case series:Norspan 5mg patch (1 patch per week), and the dose can be titrated up to maximum 40mg patch in the titration period (maximun 42 days). Patient will then be using the optimum dosage for 11 weeks, and follow-up for another 2 weeks after treatment period, maximum 19 weeks;

The Chinese University of Hong Kong

NULL

Pending

Both

case series:15;

I (Phase 1 study)

NULL

1190

EUCTR2013-004555-21-LV
(EUCTR)

03/03/2014

02/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Korea, Republic of;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1191

NCT02029599
(ClinicalTrials.gov)

March 2014

26/12/2013

The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis

A Phase 2 Randomised, Double-blind, Placebo-controlled Multiple Ascending Dose Study Evaluate the Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Fang yi qing feng shi granule;Drug: placebo;Drug: Methotrexate;Drug: Acetaminophen tablets

Maoxiang Group Jilin Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

65 Years

Both

240

Phase 2

China

1192

EUCTR2013-004051-20-ES
(EUCTR)

26/02/2014

27/12/2013

NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY

RHEUMATOID ARTHRITIS;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: RoActemra 20 mg/ml concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: ROACTEMRA

FUNDACIÓN ESPAÑOLA DE REUMATOLOGIA

NULL

Not Recruiting

Female: yes
Male: yes

122

Phase 4

Spain

1193

EUCTR2012-003635-31-AT
(EUCTR)

26/02/2014

02/07/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Randomized, double-blind, placebo-controlled, multicenter, phase IIb dose finding study of GLPG0634 administered for 24 weeks in combination with methotrexate to subjects with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate alone.

Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: GLPG0634

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

595

Phase 2b

United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

1194

EUCTR2012-003654-86-AT
(EUCTR)

26/02/2014

08/07/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

moderately to severely active rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

Serbia;United States;Spain;Guatemala;Ukraine;Lithuania;Austria;Israel;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;New Zealand

1195

EUCTR2012-003655-11-HU
(EUCTR)

24/02/2014

11/11/2013

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

Gilead Sciences Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 2

United States;Spain;Guatemala;Ukraine;Austria;Russian Federation;Israel;Chile;Colombia;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1196

EUCTR2012-001176-10-DE
(EUCTR)

24/02/2014

05/12/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

1197

EUCTR2013-004654-13-HU
(EUCTR)

24/02/2014

14/01/2014

The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: ABP 501

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

425

Bulgaria;Germany;United States;Spain;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania

1198

EUCTR2013-002007-34-SE
(EUCTR)

20/02/2014

23/01/2014

Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.

Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA

Trade Name: RoActemra
Product Name: Tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R

Roche a/s

NULL

Not Recruiting

Female: yes
Male: yes

137

Phase 3

Finland;Denmark;Sweden

1199

EUCTR2012-001176-10-PT
(EUCTR)

18/02/2014

09/12/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

Serbia;United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

1200

EUCTR2013-004654-13-CZ
(EUCTR)

12/02/2014

03/01/2014

The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: ABP 501

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

425

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1201

EUCTR2013-004654-13-GB
(EUCTR)

12/02/2014

17/01/2014

The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

An Open-Label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: ABP 501

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

425

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

1202

EUCTR2013-002007-34-FI
(EUCTR)

10/02/2014

14/11/2013

Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.

Product Name: Tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: Tocilizumab
Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R

Roche a/s

NULL

Not Recruiting

Female: yes
Male: yes

137

Phase 3

Finland;Denmark;Sweden

1203

JPRN-UMIN000016844

2014/02/07

20/03/2015

The clinical study for seeking strategy how to treat rheumatoid arthritis by TNF Inhibitors

Rheumatoid arthritis

infliximab: standard strategy
infliximab: aggressive strategy
golimumab: standard strategy
golimumab: aggressive strategy

Takarazuka city hospital

NULL

Recruiting

20years-old

90years-old

Male and Female

Not applicable

Japan

1204

EUCTR2013-002358-57-HU
(EUCTR)

05/02/2014

21/12/2013

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Czech Republic;Hungary;Puerto Rico;Canada;Poland;Belgium;Spain;Australia;Netherlands;United Kingdom

1205

JPRN-JapicCTI-142505

01/2/2014

Phase III study of MRA-SC 162 mg/week

A Randomized, Double-blind, Parallel-group, Phase III Study of MRA-SC in Rheumatoid Arthritis Patients with Inadequate Response to Tocilizumab Subcutaneous Injection 162 mg every 2 weeks

Rheumatoid arthritis

Intervention name : MRA-SC
INN of the intervention : tocilizumab
Dosage And administration of the intervention : 162 mg QW
Control intervention name : MRA-SC
INN of the control intervention : tocilizumab
Dosage And administration of the control intervention : 162 mg Q2W

Chugai Pharmaceutical Co., Ltd.

NULL

BOTH

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1206

EUCTR2013-002777-22-DK
(EUCTR)

31/01/2014

11/12/2013

Targeted Ultrasound in Rheumatoid Arthritis (TURA)

Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA

Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

230

Phase 4

France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom

1207

NCT02169544
(ClinicalTrials.gov)

January 31, 2014

14/5/2014

Post-marketing Study Assessing the Long-Term Safety of Abatacept

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

100000

N/A

NULL

1208

EUCTR2013-002777-22-ES
(EUCTR)

31/01/2014

02/12/2013

Targeted Ultrasound in Rheumatoid Arthritis (TURA)

Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 4

France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom

1209

EUCTR2013-001492-20-ES
(EUCTR)

31/01/2014

16/01/2014

A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate

Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Other descriptive name: NNC0109-0012
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Portugal;Spain;Ireland;United Kingdom

1210

NCT01987479
(ClinicalTrials.gov)

January 30, 2014

8/11/2013

A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis

Multi-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCAR

Rheumatoid Arthritis

Drug: Non-Biologic DMARDs;Drug: Tocilizumab;Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

150

Phase 3

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1211

EUCTR2013-002777-22-HU
(EUCTR)

28/01/2014

28/11/2013

Targeted Ultrasound in Rheumatoid Arthritis (TURA)

Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA

Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 4

France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom

1212

NCT02049138
(ClinicalTrials.gov)

January 24, 2014

28/1/2014

An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Rheumatoid Arthritis Subjects

A Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) With Upadacitinib (ABT-494)

Rheumatoid Arthritis

Drug: ABT-494

AbbVie

NULL

Active, not recruiting

18 Years

100 Years

All

494

Phase 2

United States;Belgium;Bulgaria;Chile;Czechia;Hungary;Israel;Latvia;Mexico;New Zealand;Poland;Puerto Rico;Russian Federation;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Australia;Czech Republic

1213

EUCTR2012-003655-11-BE
(EUCTR)

23/01/2014

15/10/2013

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

Product Name: filgotinib
Product Code: GLPG0634
INN or Proposed INN: INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

739

Phase 2

1214

EUCTR2012-001176-10-IT
(EUCTR)

22/01/2014

28/10/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2165

United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand

1215

EUCTR2011-005689-39-DE
(EUCTR)

20/01/2014

24/05/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Not Recruiting

Female: yes
Male: yes

208

Phase 2

United States;Taiwan;Slovakia;Spain;Russian Federation;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1216

EUCTR2012-001176-10-BE
(EUCTR)

14/01/2014

23/12/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

1217

EUCTR2012-001176-10-AT
(EUCTR)

13/01/2014

13/12/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia

1218

EUCTR2010-019262-86-GB
(EUCTR)

13/01/2014

16/10/2013

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 3

Portugal;Belarus;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

1219

EUCTR2013-000525-31-DE
(EUCTR)

10/01/2014

06/08/2013

The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

1220

EUCTR2012-001176-10-GB
(EUCTR)

10/01/2014

20/12/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Rheumatoid Arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1221

JPRN-UMIN000012364

2014/01/10

25/11/2013

Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis.

rheumatoid arthritis

Tramadol / acetaminophen combination tablets will be administrated by 1 tablets / time/ qid and every 4 hours for pain relief.
Step by step dose up administration schedule over 4weeks will be applied at beginning of treatment as bellows;
*Day1-Day7(1 tablet/day, after night meal)
*Day8-Day14(1 tabletX2 times /day, after morning and night meal)
*Day15-Day21(1 tabletX3 times /day, after morning, afternoon and night meal
*Day22-Day30(1 tabletX4 times /day, after morning, night meal and before bedtime)
Once dose reached to 1 tabletX4 times /day, then treatment will be continue up to 24 weeks.

Osaka City University Medical School, Department of Orthopedic Surgery

NULL

Complete: follow-up complete

25years-old

75years-old

Male and Female

Not applicable

Japan

1222

ChiCTR1800019290

2014-01-01

2018-11-03

The Zoledronic Acidameliorate theSecondary Osteoporosis in Rheumatoid Arthritis patients

Rheumatoid Arthritis

Control group:MTX;Treatment group 1:ZA;Treatment group 2:MTX+ZA;

Xiao Lianbo

NULL

Completed

Both

Control group:22;Treatment group 1:22;Treatment group 2:22;

2 (Phase 2 study)

China

1223

JPRN-JapicCTI-142497

01/1/2014

Phase 2b, Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects who have Experienced an Inadequate Response to TNF inhibitors.

A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitors.

Rheumatoid Arthritis

Intervention name : Clazakizumab
Dosage And administration of the intervention : Injection, 1 mg, 5 mg, 25 mg
Control intervention name : null

Bristol-Myers K.K.

NULL

BOTH

140

Phase 2

NULL

1224

NCT02001987
(ClinicalTrials.gov)

January 2014

29/11/2013

A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy

A Multi-Center Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic Therapy

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Methotrexate;Drug: csDMARDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

139

Phase 3

France

1225

NCT02031471
(ClinicalTrials.gov)

January 2014

16/12/2013

TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment

TOSCARA: An Open-label, Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of Tocilizumab (TCZ) Subcutaneous in TCZ-naïve Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Belgium;Luxembourg

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1226

NCT01988012
(ClinicalTrials.gov)

January 2014

31/10/2013

A Study of the Efficacy and Safety of Tocilizumab in Adults With Rheumatoid Arthritis.

An Open-label, Multicenter Study to Evaluate Disease Activity and Safety of Treatment With Actemra (Tocilizumab) Administered as Subcutaneous Injection in Adult RA Patients.

Rheumatoid Arthritis

Biological: tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

100

Phase 3

Israel

1227

EUCTR2012-003686-17-LT
(EUCTR)

31/12/2013

21/11/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3350

Phase 3

United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden

1228

JPRN-UMIN000012690

2013/12/28

27/12/2013

Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment

Rheumatoid Arthritis

tocilizumab+tacrolimus+Bucillamine
tocilizumab

National hospital organization Chiba east national hospital Clinical Research Center

NULL

Complete: follow-up complete

20years-old

99years-old

Male and Female

Not applicable

Japan

1229

EUCTR2013-001492-20-GB
(EUCTR)

24/12/2013

18/10/2013

A trial investigating the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis and an inadequate response to Methotrexate

Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Other descriptive name: NNC0109-0012
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Portugal;Hungary;Czech Republic;Spain;Belgium;Poland;Ireland;Germany;Netherlands;Italy;United Kingdom

1230

EUCTR2013-004006-26-DK
(EUCTR)

18/12/2013

OPAL

Optical images for monitoring treatment changes in rheumatoid arthritis – a longitudinal study with Rheumascan

Detection of synovitis and tenosynovitis in the hands of patients with rheumatoid arthritis; Diagnostic performance of optical imaging in comparison with ultrasound and magnetic resonance imaging.
MedDRA version: 16.1;Level: LLT;Classification code 10067132;Term: Synovitis wrist;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: ICG-Pulsion
INN or Proposed INN: 2-{7-[1,1-dimethyl-3-(4-sulfobutyl)-benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl}-1,1-dimethyl-3-(sulfobutyl)-1H-benz[e]-indolium hydroxide,inner salt
Other descriptive name: INDOCYANINE GREEN

Knowledge Centre for Rheumatology and Back Diseases

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1231

EUCTR2012-003655-11-LV
(EUCTR)

18/12/2013

08/11/2013

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

Product Name: GLPG0634
Product Code: GLPG0634
INN or Proposed INN: INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: GLPG0634
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: GLPG0634

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

1232

EUCTR2013-002777-22-DE
(EUCTR)

17/12/2013

22/11/2013

Targeted Ultrasound in Rheumatoid Arthritis (TURA)

Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA

Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 4

France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom

1233

EUCTR2013-002150-79-BE
(EUCTR)

16/12/2013

24/10/2013

A study to evaluate the efficacy and safety of tocilizumab subcutaneous in RA patients

TOSCARA: An open-label, single-arm study to evaluate the efficacy, safety and tolerability of tocilizumab (TCZ) subcutaneous in TCZ-naïve patients with active rheumatoid arthritis - TOSCARA

Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-02
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB

N.V. Roche S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Belgium

1234

EUCTR2011-004720-35-IS
(EUCTR)

13/12/2013

06/12/2013

NORD-STAR

A multicenter, randomized, single-blinded, phase 4 study in patients with early rheumatoid arthritis to compare 1) active conventional therapy versus three biologic treatments, and 2) two de-escalation strategies in patients who respond to treatment. - NORD-STAR

Rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
Trade Name: Metoject

The Karolinska Instutute, ClinTRID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Finland;Denmark;Norway;Iceland;Sweden

1235

EUCTR2013-000525-31-BG
(EUCTR)

13/12/2013

21/11/2013

The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1236

NCT01668966
(ClinicalTrials.gov)

December 9, 2013

16/8/2012

A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)

A Multicenter, Open-Label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Months

N/A

All

Phase 3

Brazil

1237

EUCTR2013-002007-34-DK
(EUCTR)

09/12/2013

Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.

Roche a/s

NULL

Not Recruiting

Female: yes
Male: yes

137

Phase 3

Finland;Denmark;Sweden

1238

EUCTR2012-003686-17-HR
(EUCTR)

05/12/2013

01/09/2014

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3350

Phase 3

1239

EUCTR2012-003686-17-SE
(EUCTR)

02/12/2013

05/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3350

Phase 3

1240

JPRN-UMIN000012073

2013/12/01

21/10/2013

Effects of Subcutaneous Actemura and MTX Blending in RA

rheumatoid arthritis

Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to continue methotrexate with the addition of tocilizumab (MTX+TCZ) 162mg/body every other week for 52 weeks.
Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to switch to tocilizumab (TCZ) 162mg/body every other week for 52 weeks.

Department of Orthopaedic Surgery,Graduate School of Medicine, Osaka City University Medical School

NULL

Complete: follow-up complete

20years-old

85years-old

Male and Female

100

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1241

NCT02047604
(ClinicalTrials.gov)

December 2013

22/1/2014

(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).

Rheumatoid Arthritis

Drug: SAN-300;Drug: Placebo

Valeant Pharmaceuticals International, Inc.

NULL

Completed

18 Years

75 Years

All

Phase 2

United States

1242

EUCTR2013-000114-38-DE
(EUCTR)

29/11/2013

29/05/2013

A 24-week, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an insufficient response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)

A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b) - T cell REgulating Arthritis Trial 2b (TREAT 2b)

Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Other descriptive name: A
INN or Proposed INN: Tregalizumab
Other descriptive name: B
INN or Proposed INN: Tregalizumab
Other descriptive name: C
INN or Proposed INN: Tregalizumab
Other descriptive name: D
INN or Proposed INN: Tregalizumab
Other descriptive name: E

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

304

Phase 2b

Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden

1243

NCT03736044
(ClinicalTrials.gov)

November 25, 2013

11/10/2018

Reconstitution of CD4+CD25highCD127low/-Tcell

Analysis of T Cell Population to Obtain a Free-drug Remission in Patients Affected by Rheumatoid Athritis in Remission Phase Induced by TNF-blocker Therapy

Rheumatoid Arthritis

Drug: TNF-blockers suspension in patients with rheumatoid arthritis

University Hospital of Ferrara

NULL

Completed

18 Years

N/A

All

Phase 1

NULL

1244

NCT01941095
(ClinicalTrials.gov)

November 20, 2013

30/8/2013

A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

Multicenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

100

Phase 3

Greece

1245

EUCTR2013-000525-31-PL
(EUCTR)

17/11/2013

10/10/2013

The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1246

EUCTR2013-001999-38-PL
(EUCTR)

17/11/2013

11/10/2013

A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs’ TNF-Kinoid in Adult Subjects with Active Rheumatoid Arthritis despite Methotrexate Therapy - Phase II study of TNF-K in Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 2

Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of

1247

EUCTR2013-002777-22-GB
(EUCTR)

14/11/2013

07/10/2013

Targeted Ultrasound in Rheumatoid Arthritis (TURA)

Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA

Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine

NULL

Not Recruiting

Female: yes
Male: yes

310

Phase 4

France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom

1248

EUCTR2013-003658-26-NL
(EUCTR)

13/11/2013

18/10/2013

Individualised treatment strategy based on disease activity for early RA patients in usual clinical practice: The COBRA Cohort Study

Treat-to-target strategy for early RA patients in usual clinical practice: The COBRA Cohort Study - COBRA Cohort Study

Early Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

VU University Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 4

Netherlands

1249

JPRN-UMIN000012257

2013/11/12

11/11/2013

Impact of corticosteroid on periarticular injection for pain control following total knee arthroplasty: a double-blind randomized trial

osteoarthritis, rheumatoid arthritis, avascular necrosis of femoral condyle

A periarticular injection including methylprednisolone, ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty
A periarticular injection including ropivacaine, morphine, bosmin, and ketoprofen for pain after total knee arthroplasty

Nekoyama Miyao Hospital

NULL

Complete: follow-up complete

18years-old

Not applicable

Male and Female

Not selected

Japan

1250

EUCTR2013-003486-34-DK
(EUCTR)

04/11/2013

Treatment of Tenosynovitis among rheumatoid arthritis patients

Systemic versus ultrasound-guided local glucocorticoid treatment, among rheumatoid arthritis patients with tenosynovitis - a randomized double blind study - SULTAN

MedDRA version: 16.0;Level: LLT;Classification code 10042869;Term: Synovitis and tenosynovitis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Diprofos Depot
INN or Proposed INN: BETAMETHASONE ACIBUTATE
Other descriptive name: Binyrebarkhormon
Trade Name: Natriumklorid 9mg/ml
INN or Proposed INN: SODIUM CHLORIDE
Other descriptive name: SODIUM CHLORIDE

Knowledge Centre for Rheumatology and Back Diseases

NULL

Not Recruiting

Female: yes
Male: yes

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1251

NCT01980836
(ClinicalTrials.gov)

November 2013

4/11/2013

Effect of Tocilizumab to the Cellular Immune Response to Influenza Vaccine

The Effect of Tocilizumab on the Cellular Immune Response to Seasonal Influnza Vaccine in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis;Cellular Immune Response

Biological: Seasonal influenza vaccine

Tel-Aviv Sourasky Medical Center

NULL

Not yet recruiting

18 Years

N/A

Both

Phase 4

Israel

1252

NCT02254655
(ClinicalTrials.gov)

November 2013

18/11/2013

The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis

The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial

Rheumatoid Arthritis

Drug: Puerarin injection 400 mg;Drug: Control

Chengdu PLA General Hospital

NULL

Completed

18 Years

75 Years

All

119

Phase 2

China

1253

NCT02005757
(ClinicalTrials.gov)

November 2013

4/12/2013

Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED)

Open Label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Mizoribine in Active Rheumatoid Arthritis Patients Unsuccessfully Treated With Disease-modifying Antirheumatic Drug

Rheumatoid Arthritis

Drug: Bredinin tablet 150mg;Drug: Bredinin tablet 50mg

Chong Kun Dang Pharmaceutical

NULL

Recruiting

20 Years

80 Years

Both

Phase 2

Korea, Republic of

1254

NCT01951170
(ClinicalTrials.gov)

November 2013

23/9/2013

An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

An Open-Label Study to Evaluate Non-Progression Of Structural Joint Damage Of Subcutaneous Tocilizumab In Patients With Moderate To Severe Active Rheumatoid Arthritis (Ac-Cute)

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Australia

1255

NCT01855789
(ClinicalTrials.gov)

November 2013

14/5/2013

A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate in Participants With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Placebo;Drug: Tocilizumab;Drug: methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

718

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1256

NCT01990157
(ClinicalTrials.gov)

November 2013

5/11/2013

Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis

Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis in Which Methotrexate (MTX) Treatment is Not Effective

Rheumatoid Arthritis

Drug: TAB08

Theramab LLC

NULL

Completed

18 Years

65 Years

All

Phase 1;Phase 2

Russian Federation

1257

EUCTR2012-001176-10-ES
(EUCTR)

31/10/2013

05/09/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand

1258

EUCTR2012-004074-25-DE
(EUCTR)

30/10/2013

29/07/2013

Comparison of the effectiveness and safety of two different starting dosages of cortisone, compared to each other and to placebo, in early active rheumatoid arthritis

Comparison of the efficacy and safety of two different starting dosages of prednisolone in early active rheumatoid arthritis: a randomized, placebo controlled trial - CORRA

Early rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: PredniHEXAL ® 5mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL ® 5mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL ® 10mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL ® 5mg Tabletten , PredniHEXAL® 10mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL ® 20mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon
Other descriptive name: PREDNISOLONE
Trade Name: PredniHEXAL ® 5mg Tabletten , PredniHEXAL® 20mg Tabletten
Product Name: PredniHEXAL
INN or Proposed INN: Prednisolon

Ruhr-Universität Bochum

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Germany

1259

EUCTR2013-001999-38-HU
(EUCTR)

30/10/2013

16/07/2013

A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid

Neovacs SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 2

Serbia;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of

1260

EUCTR2013-001999-38-CZ
(EUCTR)

30/10/2013

24/07/2013

A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 2

Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1261

EUCTR2013-002341-11-GB
(EUCTR)

25/10/2013

26/07/2013

This is a study in healthy subjects to look at the effect of tocilizumab (RoActemra) on a type of white blood cell

A SINGLE BLIND PHASE IV PHARMACODYNAMIC STUDY TO EVALUATE NEUTROPHIL DISTRIBUTION KINETICS AND FUNCTION FOLLOWING SINGLE-DOSE TOCILIZUMAB TREATMENT IN HEALTHY SUBJECTS

healthy volunteers (intended indication: Rheumatoid Arthritis)
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: no
Male: yes

Phase 4

United Kingdom

1262

EUCTR2012-003686-17-GB
(EUCTR)

24/10/2013

06/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3350

Phase 3

1263

EUCTR2013-000342-19-NL
(EUCTR)

24/10/2013

08/10/2013

A clinical trial where patients with Rheumatoid Arthritis are treated with the study drug tocilizumab, subcutaneous (injection in the skin), with or without other non-biological anti-rhematic drugs, to study the safety and efficacy of the drug.

MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS - OSCAR

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB

Roche Nederland B.V.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Netherlands

1264

EUCTR2013-000114-38-BG
(EUCTR)

23/10/2013

09/09/2013

Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

304

Phase 2b

Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden

1265

EUCTR2013-002429-52-IE
(EUCTR)

23/10/2013

15/08/2013

STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS

A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab SC
Other descriptive name: TOCILIZUMAB SC

Roche Farma S.A

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

Portugal;Spain;Ireland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1266

EUCTR2013-002429-52-PT
(EUCTR)

21/10/2013

08/08/2013

STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB

Roche Farma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

Portugal;Spain;Ireland

1267

EUCTR2013-000525-31-CZ
(EUCTR)

21/10/2013

17/07/2013

The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

1268

EUCTR2012-003724-20-RO
(EUCTR)

14/10/2013

28/07/2014

A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.

A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone

Rheumatoid Arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: IPI 145
INN or Proposed INN: -
Other descriptive name: IPI-145
Product Code: IPI 145
INN or Proposed INN: -
Other descriptive name: IPI-145
Product Code: IPI 145
INN or Proposed INN: -
Other descriptive name: IPI-145

Infinity Pharmaceuticals, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

316

Phase 2

Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand

1269

EUCTR2013-000525-31-ES
(EUCTR)

12/10/2013

01/08/2013

The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: ABP 501
Other descriptive name: Biosimilar product to adalimumab
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

1270

NCT01894516
(ClinicalTrials.gov)

October 8, 2013

4/7/2013

Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone

Rheumatoid Arthritis

Drug: GLPG0634;Drug: Placebo

Galapagos NV

NULL

Completed

18 Years

N/A

All

287

Phase 2

United States;Argentina;Australia;Austria;Bulgaria;Chile;Colombia;Germany;Guatemala;Hungary;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1271

EUCTR2013-001999-38-BE
(EUCTR)

07/10/2013

11/07/2013

A clinical study to test the efficacy of a new product (TNF-Kinoid) in patients with Rheumatoid Arthritis in whom treatment with methotrexate is not working anymore

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: not assigned yet
Other descriptive name: TNF-Kinoid

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 2

Serbia;Hungary;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Ukraine;Lebanon;Georgia;Russian Federation;Moldova, Republic of

1272

EUCTR2013-000054-22-GB
(EUCTR)

01/10/2013

07/08/2013

OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanised anti-human monoclonal antibody directed against the IL-6R

Roche Products Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United Kingdom

1273

JPRN-JapicCTI-132277

01/10/2013

AMG 162 Phase III study (DESIRABLE study)

A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III)

rheumatoid arthritis

Intervention name : AMG 162
INN of the intervention : Denosumab
Dosage And administration of the intervention : Administer 60 mg every 6 months or every 3 months as a subcutaneous injection
Control intervention name : Placebo
Dosage And administration of the control intervention : Administer placebo as a subcutaneous injection

DAIICHISANKYO Co.,Ltd.

NULL

BOTH

642

Phase 3

NULL

1274

JPRN-UMIN000011891

2013/10/01

01/10/2013

Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis.

Rheumatoid Arthritis

Golimumab

St.Marianna University School of Medicine

NULL

Complete: follow-up complete

20years-old

70years-old

Male and Female

Not selected

Japan

1275

NCT01960855
(ClinicalTrials.gov)

October 2013

9/10/2013

A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 Given With Methotrexate (MTX) in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy

Rheumatoid Arthritis

Drug: ABT-494;Drug: Placebo

AbbVie

NULL

Completed

18 Years

N/A

All

276

Phase 2

Australia;Belgium;Canada;Czech Republic;Hungary;Netherlands;New Zealand;Poland;Puerto Rico;Spain;United Kingdom;United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1276

NCT01973569
(ClinicalTrials.gov)

October 2013

25/10/2013

AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment

A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III)

Rheumatoid Arthritis

Drug: denosumab;Drug: placebo

Daiichi Sankyo, Inc.

NULL

Completed

20 Years

N/A

All

679

Phase 3

Japan

1277

NCT01970475
(ClinicalTrials.gov)

October 2013

23/10/2013

Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Biological: ABP 501;Biological: Adalimumab

Amgen

NULL

Completed

18 Years

80 Years

All

526

Phase 3

United States;Canada;Germany;United Kingdom;Bulgaria;Czech Republic;Hungary;Mexico;Poland;Romania;Russian Federation;Spain

1278

NCT01773681
(ClinicalTrials.gov)

October 2013

16/1/2013

Novel Imaging Markers for Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Cimzia;Device: Magnetic Resonance Imaging (MRI);Device: High-resolution peripheral quantitative computed tomography (HR-pQCT)

University of California, San Francisco

NULL

Completed

18 Years

N/A

All

United States

1279

NCT01975610
(ClinicalTrials.gov)

October 2013

29/10/2013

Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis

A Phase 2a, 4-Week Double-Blind, Proof-of-Concept Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CC -292;Drug: Placebo

Celgene

NULL

Completed

18 Years

80 Years

Female

Phase 2

United States

1280

NCT01962337
(ClinicalTrials.gov)

October 2013

10/10/2013

Phase 1 Single and Multiple Dose Study of FPA008 in Healthy Volunteers and Rheumatoid Arthritis Subjects

A Phase 1, Randomized, Double Blind, Placebo Controlled, Single and Multiple Ascending Dose Study of FPA008 in Healthy Volunteers and Subjects With Rheumatoid Arthritis

Healthy;Rheumatoid Arthritis

Drug: FPA008;Drug: Placebo

Five Prime Therapeutics, Inc.

NULL

Terminated

21 Years

70 Years

All

Phase 1

Hungary;Netherlands;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1281

NCT01985464
(ClinicalTrials.gov)

October 2013

31/10/2013

Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis

Feasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Umbilical cord mesenchymal stem cells

Translational Biosciences

NULL

Unknown status

18 Years

N/A

All

Phase 1;Phase 2

Panama

1282

NCT01962974
(ClinicalTrials.gov)

October 2013

11/10/2013

A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)

Arthritis, Rheumatoid

Biological: Golimumab 2 mg/kg IV

Janssen Biotech, Inc.

NULL

Terminated

18 Years

76 Years

All

Phase 3

United States;Canada;Argentina;Brazil;Colombia;Mexico

1283

NCT01966718
(ClinicalTrials.gov)

October 2013

14/10/2013

Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.

Repository Corticotropin Injection As Adjunctive Therapy In Patients With Rheumatoid Arthritis Who Have Failed At Least Three Biologic Therapies With Different Modes Of Action

Rheumatoid Arthritis

Drug: Repository corticotropin injection

Arthritis Treatment Center, Maryland

NULL

Completed

18 Years

80 Years

All

Phase 4

United States

1284

EUCTR2012-003635-31-BG
(EUCTR)

27/09/2013

25/09/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

595

Phase 2b

1285

EUCTR2013-000525-31-HU
(EUCTR)

26/09/2013

30/09/2013

The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Spain;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1286

EUCTR2012-003654-86-DE
(EUCTR)

26/09/2013

03/06/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Serbia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

1287

EUCTR2013-000114-38-SK
(EUCTR)

25/09/2013

03/07/2013

Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

304

Phase 2b

Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden

1288

EUCTR2013-000114-38-HU
(EUCTR)

19/09/2013

12/06/2013

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

304

Phase 2b

Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Sweden

1289

EUCTR2013-000944-25-HU
(EUCTR)

19/09/2013

16/07/2013

Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritis

A three year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in subjects with active rheumatoid arthritis - REASSURE-1 Extension

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

454

Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan

1290

EUCTR2012-005733-37-GB
(EUCTR)

18/09/2013

23/07/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Rheumatoid Arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade ®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1291

EUCTR2012-005674-61-LV
(EUCTR)

13/09/2013

Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritis

A double-blind, randomized, placebo-controlled, multi-center, dose escalation study of a single intravenous infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in the treatment of biologic-naïve patients with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Allogeneic Mesenchymal Precursor Cells
Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS

Mesoblast, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;Hungary;Estonia;Czech Republic;Belgium;Poland;Croatia;Latvia

1292

EUCTR2013-000359-42-GR
(EUCTR)

12/09/2013

27/08/2013

Not applicable

Multicenter, open label, phase IIIb study to evaluate the safety and tolerability of subcutaneous tocilizumab as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs in patients with Rheumatoid Arthritis

Product Name: Tocilizumab SC
Product Code: Ro 487-7533/F10-04

ROCHE HELLAS S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Greece

1293

EUCTR2012-005674-61-EE
(EUCTR)

12/09/2013

02/09/2013

Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Allogeneic Mesenchymal Precursor Cells
Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS

Mesoblast, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Hungary;Czech Republic;Estonia;Belgium;Poland;Croatia;Latvia

1294

EUCTR2012-005674-61-BE
(EUCTR)

11/09/2013

30/08/2013

Mesenchymal Precursor Cells (MPCs) for treatment of rheumatoid arthritis

Product Name: Allogeneic Mesenchymal Precursor Cells
Other descriptive name: ALLOGENEIC MESENCHYMAL PRECURSOR CELLS

Mesoblast, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Hungary;Estonia;Czech Republic;Poland;Belgium;Croatia;Latvia

1295

EUCTR2012-001984-66-NO
(EUCTR)

11/09/2013

17/10/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

5910

United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Germany;Norway;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1296

NCT01907230
(ClinicalTrials.gov)

September 10, 2013

14/7/2013

Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients

Propylactic Use of Entecavir for Biological Agents Associated Hepatitis B Virus Reactivation in Inflammatory Arthritis Patients: a Randomized Controlled Trial

Rheumatoid Arthritis;Hepatitis B Reactivation;Exposure to Hepatitis B Virus

Drug: Entecavir

Taipei Veterans General Hospital, Taiwan

NULL

Active, not recruiting

20 Years

90 Years

All

115

Phase 4

Taiwan

1297

EUCTR2012-001176-10-LT
(EUCTR)

09/09/2013

20/06/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

1298

EUCTR2013-000114-38-LT
(EUCTR)

09/09/2013

02/07/2013

Subjects with active rheumatoid arthritis incompletely controlled on stable MTX doses
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab
Product Name: Tregalizumab
Product Code: BT061
INN or Proposed INN: Tregalizumab

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

304

Phase 2b

United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden

1299

NCT01941940
(ClinicalTrials.gov)

September 5, 2013

2/9/2013

A Study to Evaluate Efficacy of Tocilizumab Administered as Monotherapy or in Combination With Methotrexate and/or Other Disease Modifying Antirheumatic Drugs (DMARDs) in Rheumatoid Arthritis (RA) Participants

A National, Open-Label, Single-Arm, Phase IIIb Study to Evaluate the Efficacy of Weekly Tocilizumab Subcutaneous, Administered as Monotherapy or in Combination With Methotrexate and/or Other DMARDs in Rheumatoid Arthritis (RA) Patients

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: DMARDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

227

Phase 3

Italy

1300

EUCTR2012-003635-31-DE
(EUCTR)

05/09/2013

30/04/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

moderately to severely active rheumatoid arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

595

Phase 2b

United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1301

EUCTR2013-000114-38-CZ
(EUCTR)

04/09/2013

12/06/2013

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

304

Phase 2

United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Sweden

1302

EUCTR2012-003654-86-ES
(EUCTR)

03/09/2013

12/07/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Serbia;Spain;Ukraine;Guatemala;Lithuania;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Germany;Latvia;New Zealand

1303

EUCTR2012-003635-31-LV
(EUCTR)

02/09/2013

06/08/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

595

Phase 2b

United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

1304

JPRN-JapicCTI-132209

01/9/2013

Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA (REASSURE-E)

A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : AIN457
INN of the intervention : Secukinumab
Dosage And administration of the intervention : Subjects will receive 150 mg secukinumab s.c.
Control intervention name : null

Novartis Pharma K.K.

NULL

BOTH

454

Phase 3

NULL

1305

ChiCTR-ONRC-13003578

2013-09-01

2013-09-09

Agkistrodon different formulations inflammatory and analgesic effects on rheumatoid arthritis clinical study

Rheumatoid arthritis

The water decoction group of Agkistrodon:Taking the water decoction of Agkistrodon;Agkistrodon liquor:Taking Agkistrodon liquor agents;Agkistrodon pulvis:Taking the Agkistrodon pulvis;Control group:Taking placebo;

Zhejiang Chinese Medical University

NULL

Completed

Both

The water decoction group of Agkistrodon:30;Agkistrodon liquor:30;Agkistrodon pulvis:30;Control group:30;

I (Phase 1 study)

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1306

NCT01911234
(ClinicalTrials.gov)

September 2013

23/7/2013

Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy of Neovacs' TNF-Kinoid in Adult Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Biological: TNF-Kinoid;Other: Placebo

Neovacs

NULL

Completed

18 Years

75 Years

All

143

Phase 2

Belgium;Georgia;Hungary;Lebanon;Macedonia, The Former Yugoslav Republic of;Moldova, Republic of;Poland;Russian Federation;Serbia;Ukraine;Czech Republic

1307

NCT01948388
(ClinicalTrials.gov)

September 2013

9/9/2013

The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients

Study of The Effect of Corticotrophin in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients From a Clinical and Structural Perspective As Measured by a Clinical Disease Activity Index Score and Bone Edema, Synovitis and Erosions on Magnetic Resonance Imaging

Rheumatoid Arthritis

Drug: corticotrophin 80 units

Gaylis, Norman B., M.D.

NULL

Completed

18 Years

N/A

All

Phase 4

United States

1308

NCT01901900
(ClinicalTrials.gov)

September 2013

10/7/2013

Safety and Efficacy of Extended Treatment With Secukinumab in Anti-TNF Inadequate Responders in RA.

A Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Secukinumab (AIN457)

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

196

Phase 3

United States;Argentina;Canada;Guatemala;Hungary;India;Italy;Japan;Mexico;Thailand;Colombia;Panama;Puerto Rico

1309

NCT01995201
(ClinicalTrials.gov)

September 2013

1/11/2013

A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis

A Phase IIIb Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous (SC) Tocilizumab (TCZ) Given as Monotherapy or in Combination With Methotrexate (MTX) or Other Non Biologics DMARDs in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Active, not recruiting

18 Years

N/A

Both

401

Phase 3

Ireland;Portugal;Spain

1310

NCT01783015
(ClinicalTrials.gov)

September 2013

31/1/2013

Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate

A Randomized, Double-blind, Placebo-controlled Study Of The Safety And Efficacy Of Etanercept In Subjects With Rheumatoid Arthritis Who Have Had An Inadequate Response To Adalimumab Or Infliximab Plus Methotrexate

Rheumatoid Arthritis

Drug: Etanercept;Drug: Placebo

Pfizer

NULL

Terminated

18 Years

79 Years

All

Phase 4

Australia;Belgium;France;Hong Kong;Israel;Russian Federation;Spain;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1311

NCT02275299
(ClinicalTrials.gov)

September 2013

23/10/2014

Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Iguratimod;Drug: Leflunomide;Drug: Methotrexate

Jiangsu Simcere Pharmaceutical Co., Ltd.

NULL

Recruiting

18 Years

70 Years

Both

240

Phase 4

China

1312

NCT02072200
(ClinicalTrials.gov)

September 2013

14/2/2014

Efficacy of Lodotra®(Prednisone) in Reduction of Morning Stiffness Duration(K-IMPROvE)

A New Modified-Release Tablet Formulation of Prednisone in Patients With Rheumatoid Arthritis- Multicenter, Phase IV, Interventional Study to Assess Reduction of Morning Stiffness

Rheumatoid Arthritis

Drug: Lodotra®

Mundipharma Korea Ltd

NULL

Completed

20 Years

80 Years

All

147

Phase 4

Korea, Republic of

1313

NCT01955603
(ClinicalTrials.gov)

September 2013

24/9/2013

A Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered to Subjects With Moderate to Severe Rheumatoid Arthritis

A Randomised, Placebo-controlled, Double-blind Within Cohort, Dose Escalation, Multiple-dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0215-0384 Administered Subcutaneously to Subjects With Moderate to Severe Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC0215-0384;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

75 Years

Both

Phase 1

Germany;Hungary;Poland;Russian Federation

1314

NCT01787149
(ClinicalTrials.gov)

September 2013

6/2/2013

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis

Combination With DMARDs

Drug: DMARDs

Mycenax Biotech Inc.

NULL

Unknown status

20 Years

N/A

All

Phase 3

Taiwan

1315

NCT02600468
(ClinicalTrials.gov)

September 2013

6/11/2015

Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg

Outline of Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg

Rheumatoid Arthritis

Drug: Orencia

Bristol-Myers Squibb

Ono Pharmaceutical Co. Ltd

Completed

18 Years

N/A

All

671

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1316

EUCTR2012-003635-31-CZ
(EUCTR)

28/08/2013

31/05/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

595

Phase 2b

United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

1317

EUCTR2012-004342-14-DK
(EUCTR)

27/08/2013

19/04/2013

A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

A Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

Product Name: VX-509
Product Code: VX-509
INN or Proposed INN: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2;Phase 3

United States;Estonia;Lithuania;Denmark;South Africa;Netherlands

1318

EUCTR2013-000525-31-GB
(EUCTR)

27/08/2013

02/07/2013

The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

1319

EUCTR2013-002429-52-ES
(EUCTR)

23/08/2013

12/07/2013

STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB

Roche Farma S.A

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

Portugal;Spain;Ireland

1320

EUCTR2012-004090-16-NL
(EUCTR)

20/08/2013

02/05/2013

Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy.

A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 655064

Boehringer Ingelheim B.V

NULL

Not Recruiting

Female: yes
Male: yes

106

Czech Republic;Poland;Spain;Germany;Netherlands;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1321

EUCTR2012-002181-12-SE
(EUCTR)

19/08/2013

09/07/2012

A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

Active rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: None
Other descriptive name: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2a

United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden

1322

EUCTR2011-005649-10-DE
(EUCTR)

19/08/2013

18/07/2012

An exploratory clinical study to investigate mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints versus a different antibody whose mechanism works by inhibiting tumor necrosis factor.

A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany

1323

EUCTR2012-005733-37-CZ
(EUCTR)

16/08/2013

15/05/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade ®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

1324

EUCTR2012-003654-86-HU
(EUCTR)

15/08/2013

17/05/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Serbia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

1325

EUCTR2012-005026-30-HU
(EUCTR)

15/08/2013

20/02/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Trade Name: Enbrel ®
Product Name: Enbrel ®
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc

Samsung Bioepis Co., Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

498

Czech Republic;Hungary;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1326

EUCTR2012-002181-12-AT
(EUCTR)

08/08/2013

25/06/2013

A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

Product Name: MK-8457
Product Code: MK-8457
Other descriptive name: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as the SPONSOR or Merck)

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2a

United States;Greece;Spain;Austria;Colombia;United Kingdom;Italy;France;Hungary;Brazil;Poland;Australia;Denmark;Peru;South Africa;New Zealand;Sweden

1327

EUCTR2011-005689-39-CZ
(EUCTR)

07/08/2013

23/05/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Ankylosing Spondylitis (AS)
MedDRA version: 17.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Taiwan;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of

1328

EUCTR2013-000114-38-EE
(EUCTR)

06/08/2013

13/06/2013

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

304

Phase 2b

Serbia;United States;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;Hungary;Czech Republic;Mexico;Canada;Poland;Bulgaria;Germany;Sweden

1329

EUCTR2010-020892-22-NL
(EUCTR)

03/08/2013

10/08/2011

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Latvia;Netherlands;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

1330

EUCTR2012-005733-37-LV
(EUCTR)

02/08/2013

22/05/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade ®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1331

EUCTR2013-000944-25-IT
(EUCTR)

02/08/2013

06/06/2013

Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with rheumatoid arthritis

A three year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in subjects with active rheumatoid arthritis - REASSURE-1 Extension

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Farma S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

454

Panama;United States;Thailand;Guatemala;Colombia;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Japan

1332

EUCTR2012-000439-17-LV
(EUCTR)

02/08/2013

05/06/2013

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy

active rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: MK-8457
Product Code: MK-8457

MERCK SHARP & DOHME CORP.

NULL

Not Recruiting

Female: yes
Male: yes

434

Phase 2

United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Peru;Denmark;South Africa;Latvia;Germany;Moldova, Republic of;Japan

1333

EUCTR2013-001569-17-IT
(EUCTR)

02/08/2013

04/06/2013

A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients.

A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients.

Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB

Roche S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3B

Italy

1334

NCT01936181
(ClinicalTrials.gov)

August 2013

2/9/2013

A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Drug: Remicade (infliximab);Drug: SB2 (proposed biosimilar to infliximab)

Samsung Bioepis Co., Ltd.

NULL

Completed

18 Years

75 Years

All

584

Phase 3

Bulgaria;Lithuania

1335

NCT01394913
(ClinicalTrials.gov)

August 2013

12/7/2011

Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis

A Prospective, Double-blind, Randomized Study to Compare Efficacy of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Reumatocept (etanercept);Drug: Enbrel (etanercept)

EMS

NULL

Suspended

18 Years

70 Years

Both

216

Phase 3

Brazil

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1336

NCT01925157
(ClinicalTrials.gov)

August 2013

15/8/2013

A Study of LY3090106 in Healthy Participants and Participants With Rheumatoid Arthritis (RA)

A Single-Dose, Multicenter, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3090106 in Healthy Subjects and Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: LY3090106 - SQ;Biological: LY3090106 - IV;Biological: Placebo - SQ

Eli Lilly and Company

NULL

Completed

18 Years

80 Years

Both

Phase 1

Bulgaria;Moldova, Republic of;Poland;Romania;Hungary;United States

1337

NCT01905735
(ClinicalTrials.gov)

August 2013

19/7/2013

A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis

A Multicentric,Double-blind,Placebo Controlled,Phase-2 Study to Assess the Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis .

Rheumatoid Arthritis.

Drug: Rhustoxicodendron 30;Drug: placebo

Healthcare Homoeo Charitable Society

NULL

Recruiting

25 Years

60 Years

Both

Phase 2

India

1338

NCT01932372
(ClinicalTrials.gov)

July 26, 2013

30/7/2013

Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)

Rheumatoid Arthritis

Drug: Tofacitinib (Xeljanz);Drug: Etanercept , other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc

Pfizer

NULL

Active, not recruiting

N/A

All

9968

Japan

1339

EUCTR2012-003686-17-PL
(EUCTR)

24/07/2013

04/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3350

Phase 3

1340

EUCTR2012-003686-17-LV
(EUCTR)

24/07/2013

05/07/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3350

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1341

EUCTR2012-003635-31-ES
(EUCTR)

23/07/2013

10/06/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

595

Phase 2b

Latvia;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand;Serbia;United States;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru

1342

EUCTR2012-003686-17-BE
(EUCTR)

18/07/2013

31/05/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3350

Phase 3

Germany;Japan;Sweden;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania

1343

EUCTR2012-002323-15-HR
(EUCTR)

17/07/2013

30/03/2015

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON

Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of

1344

NCT01888874
(ClinicalTrials.gov)

July 17, 2013

26/6/2013

Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

Rheumatoid Arthritis

Drug: GLPG0634;Drug: Placebo

Galapagos NV

NULL

Completed

18 Years

N/A

All

599

Phase 2

United States;Argentina;Australia;Austria;Belgium;Bulgaria;Chile;Colombia;Czechia;France;Germany;Guatemala;Hungary;Israel;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Russian Federation;Spain;Ukraine;Czech Republic;Peru;Puerto Rico

1345

EUCTR2011-005648-93-GB
(EUCTR)

12/07/2013

30/05/2013

A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis Protocol Ref: CD-IA-CAM-3001-1109 - An Open-label of Mavrilimumab in Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 2

Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1346

EUCTR2012-003686-17-HU
(EUCTR)

11/07/2013

07/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3350

Phase 3

1347

EUCTR2012-005733-37-LT
(EUCTR)

11/07/2013

20/05/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade ®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

1348

EUCTR2012-005733-37-BG
(EUCTR)

10/07/2013

21/05/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade ®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

1349

EUCTR2012-003635-31-HU
(EUCTR)

09/07/2013

22/04/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Product Name: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

595

Phase 2b

1350

EUCTR2012-003644-71-BE
(EUCTR)

08/07/2013

06/02/2013

Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Etanercept in Subjects with Rheumatoid Arthritis Who Have Had and Inadequate Response to Adalimumab or Infliximab Plus Methotrexate.

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 4

France;Hong Kong;Spain;Poland;Belgium;Australia;Russian Federation;Israel;Chile;Netherlands;Colombia;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1351

EUCTR2011-005648-93-PT
(EUCTR)

05/07/2013

03/04/2013

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

400

Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany

1352

EUCTR2011-005649-10-GB
(EUCTR)

05/07/2013

11/03/2013

A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis Protocol:CD-IA-CAM-3001-1107 - Mavrilimumab versus Anti tumor Necrosis Factor in Rheumatoid Arthritis

MedImmune Limited

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany

1353

EUCTR2012-003686-17-DE
(EUCTR)

04/07/2013

13/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3350

Phase 3

1354

EUCTR2012-003686-17-ES
(EUCTR)

04/07/2013

26/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib

Lilly S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

Portugal;United States;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden

1355

EUCTR2012-003686-17-DK
(EUCTR)

04/07/2013

07/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3350

Phase 3

United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1356

EUCTR2012-001984-66-LV
(EUCTR)

03/07/2013

25/04/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand

1357

EUCTR2012-001984-66-IT
(EUCTR)

02/07/2013

07/05/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

1358

JPRN-JapicCTI-153073

01/7/2013

18/11/2015

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Rheumatoid arthritis

Intervention name : Sirukumab
Dosage And administration of the intervention : 100 mg
Intervention name : Sirukuma
Dosage And administration of the intervention : 50mg
Control intervention name : null

Janssen Pharmaceutical K.K.

NULL

BOTH

280

Phase 3

NULL

1359

EUCTR2012-003223-38-DE
(EUCTR)

01/07/2013

08/04/2013

Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04

RHEUMATOID ARTHRITIS
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Rituximab -Pfizer
Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

157

Phase 2

United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

1360

NCT01890473
(ClinicalTrials.gov)

July 2013

27/6/2013

Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe

Phase Ib, Multicenter, Randomized, Open-Label, Parallel-Group Study to Characterize the Pharmacokinetics of a Single Dose of Abatacept 125 mg Administered Subcutaneously Using the BD Physioject™ Autoinjector or the UltraSafe Passive Needle Guard Prefilled Syringe

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

356

Phase 1

United States;Argentina;Mexico;Peru;South Africa

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1361

NCT01927263
(ClinicalTrials.gov)

July 2013

9/8/2013

A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis

A Phase 3 Clinical Study of NI-071 in Patients With Rheumatoid Arthritis ?A Double-blind, Active Drug-controlled Study and Long-term Study?

Rheumatoid Arthritis

Biological: NI-071;Biological: Infliximab

Nichi-Iko Pharmaceutical Co.,Ltd.

NULL

Completed

20 Years

75 Years

Both

242

Phase 3

Japan

1362

NCT01853033
(ClinicalTrials.gov)

July 2013

10/5/2013

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis

A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122

Rheumatoid Arthritis

Biological: ABT-122;Biological: Placebo

AbbVie

NULL

Completed

18 Years

75 Years

All

Phase 1

United States

1363

NCT02236481
(ClinicalTrials.gov)

July 2013

8/9/2014

Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes

No-profit Study to Ensure Normal Clinical Practice, to Evaluate the Efficacy of Anakinra in Reducing the Glycated Haemoglobin in Patients Affected by Rheumatoid Arthritis and Diabetes; Randomized, Open Label, Parallel Group,Controlled Clinical Study

Diabetes Mellitus, Type 2;Arthritis, Rheumatoid

Drug: Anakinra;Drug: TNF alpha inhibitors

Prof. Roberto Giacomelli

NULL

Terminated

18 Years

N/A

All

Phase 4

Italy

1364

NCT01862224
(ClinicalTrials.gov)

July 2013

2/5/2013

A Synovial Biopsy Study of JNJ-38518168 in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Synovial Biopsy Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Drug: JNJ-38518168;Drug: Placebo;Drug: Placebo / JNJ-38518168

Janssen Research & Development, LLC

NULL

Terminated

18 Years

65 Years

Both

Phase 2

United States;Moldova, Republic of

1365

NCT02519387
(ClinicalTrials.gov)

July 2013

15/7/2015

Efficacy and Safety of Buprenorphine Transdermal Patch in Non-cancer Pain of Moderate Intensity

Multicentre Study for Evaluation of the Efficacy and Safety of Buprenorphine Transdermal Patch (SOVENOR®) 5mg and 10mg in Patients With Non-malignant Pain of Moderate Intensity Due to Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain and Joint/Muscle Pain, When an Opioid is Necessary for Obtaining Adequate Analgesia

Osteoarthritis;Rheumatoid Arthritis;Lower Back Pain;Joint Pain;Muscle Pain

Drug: Buprenorphine Transdermal Patch

Mundipharma Pharmaceuticals Sdn. Bhd.

NULL

Completed

40 Years

N/A

All

Phase 4

Malaysia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1366

NCT01864265
(ClinicalTrials.gov)

July 2013

21/5/2013

Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain

Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain. A Multi-center, Randomized Double-blind Controlled Study Prediction of Response to Certolizumab-Pegol in RA (PreCePRA)

Rheumatoid Arthritis

Drug: Certolizumab Pegol;Drug: Placebo

University of Erlangen-Nürnberg Medical School

NULL

Completed

18 Years

N/A

All

156

Phase 3

Germany;Portugal;Serbia;Belgium;United Kingdom;United States

1367

NCT02894047
(ClinicalTrials.gov)

July 2013

5/9/2016

Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two Years

Arthritis, Rheumatoid

Biological: blood

Centre Hospitalier Universitaire, Amiens

NULL

Completed

18 Years

N/A

Both

N/A

France

1368

EUCTR2011-005689-39-HU
(EUCTR)

27/06/2013

22/05/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Pfizer Inc, 235 East 42nd Street, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Germany;Korea, Republic of

1369

EUCTR2012-004090-16-CZ
(EUCTR)

27/06/2013

14/02/2013

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 655064
INN or Proposed INN: BI 655064

Boehringer Ingelheim RCV GmbH & Co KG

NULL

Not Recruiting

Female: yes
Male: yes

106

Phase 1;Phase 2

Czech Republic;Poland;Spain;Netherlands;Germany;New Zealand

1370

NCT01885078
(ClinicalTrials.gov)

June 27, 2013

19/6/2013

An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Baricitinib;Drug: Placebo

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

2089

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;United Kingdom;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1371

EUCTR2012-001984-66-DE
(EUCTR)

26/06/2013

06/03/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Poland;Romania;Germany;Norway;New Zealand

1372

EUCTR2012-003635-31-BE
(EUCTR)

26/06/2013

03/04/2013

Evaluation of different oral doses and regimens of GLPG0634 given for 24 weeks in patients with active rheumatoid arthritis and an insufficient response to methotrexate alone

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

595

Phase 2b

United States;Serbia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Australia;Peru;Latvia;Moldova, Republic of;Guatemala;Lithuania;Austria;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand

1373

EUCTR2012-003686-17-NL
(EUCTR)

26/06/2013

25/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3000

Phase 3

Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland

1374

EUCTR2011-005689-39-ES
(EUCTR)

26/06/2013

24/06/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Ankylosing Spondylitis (AS)
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc. 235 East 42nd Street, New York, 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Korea, Republic of

1375

EUCTR2012-001984-66-LT
(EUCTR)

20/06/2013

23/04/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1376

EUCTR2012-004482-40-ES
(EUCTR)

18/06/2013

16/05/2013

Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapies

Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized.

Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: HUMIRA
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: ENBREL
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Trade Name: CIMZIA
Product Name: Certolizumab Pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: SIMPONI
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB
Trade Name: ORENCIA
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
Trade Name: RoActemra
Product Name: Tocilizumab
INN or Proposed INN: TOCILIZUMAB
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB

FRANCISCO J. BLANCO GARCÍA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

1377

EUCTR2012-003686-17-CZ
(EUCTR)

17/06/2013

31/05/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3350

Phase 3

1378

EUCTR2012-003724-20-DE
(EUCTR)

13/06/2013

04/02/2013

A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.

Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145

Infinity Pharmaceuticals, Inc

NULL

Not Recruiting

Female: yes
Male: yes

316

Phase 2

Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Colombia;Germany;New Zealand

1379

EUCTR2012-003686-17-PT
(EUCTR)

12/06/2013

14/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3350

Phase 3

United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden

1380

EUCTR2012-003686-17-AT
(EUCTR)

11/06/2013

07/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3350

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1381

NCT01901185
(ClinicalTrials.gov)

June 11, 2013

17/5/2013

Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Autoinjector to Self-inject Etanercept

A Single-arm, Multicenter Study to Evaluate the Ability of Subjects With Rheumatoid Arthritis or Psoriatic Arthritis to Effectively Use a Reusable Electromechanical Autoinjector to Self-inject Etanercept

Rheumatoid Arthritis;Psoriatic Arthritis

Drug: Etanercept / Autoinjector A

Amgen

NULL

Completed

18 Years

N/A

All

Phase 3

United States

1382

EUCTR2012-003686-17-FR
(EUCTR)

07/06/2013

21/09/2015

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3000

Phase 3

United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden

1383

EUCTR2012-001984-66-HU
(EUCTR)

06/06/2013

14/03/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

1384

NCT01875991
(ClinicalTrials.gov)

June 5, 2013

10/6/2013

Preference Between Two Autoinjectors in Patients With Rheumatoid Arthritis and Plaque Psoriasis Treated With Etanercept

An Open-label, Randomized, Crossover Study to Assess the Preference for Autoinjector A Versus Autoinjector B in Rheumatoid Arthritis and Plaque Psoriasis Subjects Treated With Etanercept

Rheumatoid Arthritis;Plaque Psoriasis

Drug: Etanercept via Autoinjector A;Drug: Etanercept via Autoinjector B

Amgen

NULL

Completed

18 Years

N/A

All

217

Phase 4

United States;Canada

1385

EUCTR2012-003686-17-SK
(EUCTR)

05/06/2013

02/05/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1386

EUCTR2012-003536-23-PL
(EUCTR)

05/06/2013

22/04/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden

1387

NCT01885819
(ClinicalTrials.gov)

June 2013

18/6/2013

Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis

Feasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Autologous stromal vascular fraction cells

Translational Biosciences

NULL

Withdrawn

18 Years

N/A

All

Phase 1;Phase 2

Panama

1388

NCT01861782
(ClinicalTrials.gov)

June 2013

12/5/2013

Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With RA

Comparison Between Dead Sea Solar and Water Treatment to Sulfur Pool and Medicinal Mud Treatment in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Other: Dead Sea Solar and Water Treatment;Other: Sulfur Pool & Medicinal Mud

Soroka University Medical Center

NULL

Active, not recruiting

18 Years

N/A

Both

N/A

Israel

1389

NCT01909427
(ClinicalTrials.gov)

June 2013

10/7/2013

An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO 6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Drug: Placebo;Drug: CNTO 6785 200 mg;Drug: CNTO 6785 100 mg;Drug: CNTO 6785 50 mg;Drug: CNTO 6785 15 mg

Janssen Research & Development, LLC

NULL

Completed

18 Years

80 Years

Both

257

Phase 2

Argentina;Colombia;Czech Republic;Philippines;Poland;Russian Federation;Thailand

1390

NCT01895309
(ClinicalTrials.gov)

June 2013

3/7/2013

A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Drug: Enbrel (etanercept);Drug: SB4 (proposed biosimilar to etanercept)

Samsung Bioepis Co., Ltd.

NULL

Completed

18 Years

75 Years

All

596

Phase 3

Poland;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1391

NCT01878318
(ClinicalTrials.gov)

June 2013

6/6/2013

A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs

Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs

Rheumatoid Arthritis

Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Withdrawn

18 Years

N/A

Both

Phase 4

Venezuela

1392

NCT01955733
(ClinicalTrials.gov)

May 31, 2013

30/9/2013

Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis

Safety and Efficacy of BI 695500 in Patients With Moderately to Severely Active Rheumatoid Arthritis: an Open-label Extension Trial

Arthritis, Rheumatoid

Drug: BI 695500

Boehringer Ingelheim

NULL

Terminated

18 Years

82 Years

All

Phase 3

United States;Belgium;Bulgaria;Germany;Greece;Netherlands;Poland;Portugal;Spain;Argentina;Brazil;Canada;Chile;Hungary;Ireland;Mexico;United Kingdom

1393

EUCTR2012-003686-17-IT
(EUCTR)

29/05/2013

04/04/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

Portugal;United States;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden

1394

JPRN-UMIN000014485

2013/05/24

01/12/2014

Golimumab study for development of tight control and biologics-free condition.

Golimumab study for development of tight control and biologics-free condition. - Go-sunrising study

rheumatoid arthritis

Treatment with Golimumab for patients with rheumatoid arthritis

Rheumatology, Internal MedicineJuntendo University School of Medicine, Juntendo Koshigaya Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

1395

EUCTR2012-000610-11-CZ
(EUCTR)

22/05/2013

20/06/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate

A randomised, double blind, placebo-controlled, multiple dose, phase 2b, 24 week trial followed by an open label extension of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate

Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

298

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1396

EUCTR2012-000609-58-CZ
(EUCTR)

22/05/2013

21/06/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics

Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany

1397

EUCTR2012-003536-23-GB
(EUCTR)

21/05/2013

15/03/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden

1398

EUCTR2012-003724-20-BG
(EUCTR)

20/05/2013

20/03/2013

A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.

Rheumatoid Arthritis
MedDRA version: 17.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145

Infinity Pharmaceuticals, Inc

NULL

Not Recruiting

Female: yes
Male: yes

316

Phase 2

Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand

1399

EUCTR2012-001984-66-FI
(EUCTR)

17/05/2013

24/04/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand

1400

EUCTR2012-005026-30-PL
(EUCTR)

17/05/2013

08/03/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

596

Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1401

EUCTR2012-002339-27-ES
(EUCTR)

16/05/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD

Moderately to severely active rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib

Lilly S.A.

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of

1402

EUCTR2012-001984-66-GR
(EUCTR)

15/05/2013

23/04/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand

1403

EUCTR2012-005026-30-CZ
(EUCTR)

15/05/2013

22/02/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

596

Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India

1404

EUCTR2012-003223-38-GB
(EUCTR)

14/05/2013

12/02/2013

Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04

RHEUMATOID ARTHRITIS
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

157

Phase 2

United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

1405

EUCTR2012-003439-41-NL
(EUCTR)

14/05/2013

27/03/2013

A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX 509 using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects with Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs

Rheumatoid Arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Estonia;Lithuania;Denmark;South Africa;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1406

EUCTR2013-000337-13-DE
(EUCTR)

13/05/2013

12/02/2013

Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA)

Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled studyPrediction of response to Certolizumab-Pegol in RA (PreCePRA)

Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL

Universitätsklinikum Erlangen

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 3

Serbia;Portugal;Germany

1407

EUCTR2012-001984-66-CZ
(EUCTR)

13/05/2013

27/03/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

United States;Taiwan;Greece;Ecuador;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Australia;Peru;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Poland;Romania;Germany;Norway;New Zealand

1408

EUCTR2012-005026-30-LT
(EUCTR)

10/05/2013

21/02/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Rheumatoid Arthritis (RA)
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

498

Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India

1409

NCT01927757
(ClinicalTrials.gov)

May 6, 2013

5/6/2013

Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab

A Single Arm Trial to Evaluate the Efficacy of Etanercept in Moderate to Severe Rheumatoid Arthritis Patients Who Failed to Respond or Lost a Satisfactory Response to Treatment With Adalimumab When Used as Their First Biologic Agent

Moderate to Severe Rheumatoid Arthritis

Biological: Etanercept;Drug: Methotrexate

Amgen

NULL

Terminated

18 Years

N/A

All

Phase 4

United States;Canada;Puerto Rico

1410

EUCTR2010-019262-86-SK
(EUCTR)

02/05/2013

04/03/2013

Long term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

2100

Phase 3

Portugal;United States;Belarus;Philippines;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Germany;Norway;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1411

EUCTR2012-003536-23-NL
(EUCTR)

01/05/2013

22/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

Mexico;Argentina;Poland;Belgium;Brazil;Romania;Norway;Netherlands;Sweden;United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary

1412

NCT01357759
(ClinicalTrials.gov)

May 2013

18/5/2011

Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Trial of MORAb-022 in Healthy Subjects and Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MORAb-022

Morphotek

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States;Netherlands

1413

NCT02350881
(ClinicalTrials.gov)

May 2013

19/1/2015

Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.

A Post-Market Observational Study to Evaluate Safety and Performance of Primus™ FGT Implant at a Minimum of 5 Years Follow-up

Hallux Limitus of Left Great Toe;Rheumatoid Arthritis;Arthritis of 1st Metatarsophalangeal Joint;Osteoarthritis;Bunion;Hallux Limitus of Right Great Toe

Device: Primus FGTI (Flexible Great toe Implant)

Tornier, Inc.

NULL

Completed

18 Years

N/A

All

N/A

Italy

1414

NCT01873443
(ClinicalTrials.gov)

May 2013

22/5/2013

Long-Term Efficacy and Safety of CT-P10 in Patients With RA

An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1

Rheumatoid Arthritis

Drug: Rituximab , MTX, folic acid

Celltrion

NULL

Completed

18 Years

75 Years

Both

Phase 1

Korea, Republic of

1415

NCT02468791
(ClinicalTrials.gov)

May 2013

9/6/2015

MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rituximab

Mabion SA

NULL

Completed

18 Years

80 Years

All

709

Phase 3

Bosnia and Herzegovina;Georgia;Poland;Serbia;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1416

EUCTR2012-001984-66-GB
(EUCTR)

25/04/2013

04/03/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

Rheumatoid Arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

Phase 3

United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand

1417

EUCTR2012-001984-66-ES
(EUCTR)

25/04/2013

09/04/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

United States;Taiwan;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;South Africa;Latvia;Korea, Republic of;Finland;Guatemala;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Norway;Germany;New Zealand

1418

EUCTR2011-003538-16-PL
(EUCTR)

23/04/2013

08/03/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To Non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand

1419

EUCTR2012-004090-16-DE
(EUCTR)

23/04/2013

06/11/2012

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 655064

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

106

Czech Republic;Poland;Spain;Netherlands;Germany;New Zealand

1420

EUCTR2010-022243-38-NL
(EUCTR)

23/04/2013

13/12/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy - SIRROUND-T

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

840

United States;Serbia;Portugal;Taiwan;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1421

EUCTR2012-002322-73-LT
(EUCTR)

16/04/2013

28/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan

1422

EUCTR2012-002323-15-GR
(EUCTR)

15/04/2013

29/03/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Phase 3Study Evaluating the Efficacy and Safety of Baricitinib(LY3009104) in Patients with Moderately to Severely ActiveRheumatoid Arthritis Who Have Had an InadequateResponse to Tumor Necrosis Factor Inhibitors - RA - BEACON

Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;Korea, Republic of

1423

EUCTR2012-003439-41-LT
(EUCTR)

11/04/2013

31/12/2012

A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Estonia;Lithuania;Denmark;South Africa;Netherlands

1424

EUCTR2011-002894-48-NO
(EUCTR)

11/04/2013

06/09/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695500
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden

1425

EUCTR2012-004342-14-LT
(EUCTR)

11/04/2013

29/01/2013

A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

Product Name: VX-509
Product Code: VX-509
INN or Proposed INN: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2;Phase 3

United States;Estonia;Lithuania;Denmark;South Africa;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1426

EUCTR2012-005026-30-BG
(EUCTR)

10/04/2013

05/03/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

596

Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India

1427

EUCTR2012-003536-23-NO
(EUCTR)

09/04/2013

12/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden

1428

EUCTR2012-003881-42-RO
(EUCTR)

09/04/2013

23/07/2014

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2b

United States;Puerto Rico;Romania;Germany

1429

EUCTR2011-004017-17-GB
(EUCTR)

08/04/2013

11/01/2013

Tocilizumab and Remission in early rheumatoid arthritis

Prospective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the changes in expression of JAK-STAT and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients with Early Rheumatoid Arthritis (TREMERA). - TREMERA

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

The University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

1430

EUCTR2012-003536-23-SE
(EUCTR)

08/04/2013

07/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1431

EUCTR2012-003439-41-DK
(EUCTR)

04/04/2013

22/03/2013

A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Estonia;Lithuania;Denmark;South Africa;Netherlands

1432

EUCTR2012-003536-23-BE
(EUCTR)

04/04/2013

07/01/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Netherlands;Germany;Norway;Sweden

1433

EUCTR2012-003057-29-CZ
(EUCTR)

02/04/2013

12/09/2012

A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.

A RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED, ASCENDING MULTIPLE DOSE STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF XMAB®5871 IN PATIENTS WITH RHEUMATOID ARTHRITIS - XmAb®5871 Phase IIa, Ascending Multiple Dose Study in Rheumatoid Arthritis Patients

XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis.
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: XmAb5871_10.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)
Product Name: XmAb5871_3.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)
Product Name: XmAb5871_1.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)
Product Name: XmAb5871_0.3MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody. Lot Numbers: 1-FIN-1588 (9.6mg/ml)

Xencor Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Czech Republic;Slovakia

1434

EUCTR2012-003536-23-ES
(EUCTR)

01/04/2013

04/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden

1435

JPRN-UMIN000009887

2013/04/01

01/04/2013

Associations between the initial concentration of serum TNF alpha and effects due to increasing a dose of Infliximab, and between effects of infliximab and the concentration of serum IL-6

Rheumatoid Arthritis

When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is less than 1.1 pg/ml, we will raise the dose of infliximab to 6 mg/kg.
When 3mg/kg of infliximab brings poor results to RA patients, we will change a dose of infliximab according to the initial concentration of serum TNF alpha.
If the initial concentration of serum TNF alpha is more than 1.1 pg/ml, we will raise the dose of infliximab to 10 mg/kg.

Department of Orthopaedic surgery, Tohoku University Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

100

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1436

JPRN-JapicCTI-132121

01/4/2013

Abatacept Post-marketing Clinical Study in Japan

A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Intervention name : Abatacept
Dosage And administration of the intervention : 10 mg/kg IV / month
Control intervention name : Placebo
Dosage And administration of the control intervention : 0 mg/kg IV / month

Bristol-Myers Squibb K.K.

Ono Pharmaceutical Co.,LTD.

BOTH

400

Phase 4

NULL

1437

NCT01844895
(ClinicalTrials.gov)

April 2013

5/4/2013

Methotrexate-Inadequate Response Autoinjector Device Sub Study

Substudy-A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

120

Phase 3

NULL

1438

NCT01547091
(ClinicalTrials.gov)

April 2013

22/2/2012

Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis

Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II

Rheumatoid Arthritis

Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs);Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs);Biological: UC-MSC+DMARDS

Alliancells Bioscience Corporation Limited

NULL

Recruiting

18 Years

70 Years

Both

200

Phase 1;Phase 2

China

1439

NCT01851707
(ClinicalTrials.gov)

April 2013

8/5/2013

A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone

A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of Duvelisib With Background Methotrexate in Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone

Rheumatoid Arthritis

Drug: IPI-145;Drug: Placebo

Verastem, Inc.

NULL

Completed

18 Years

70 Years

All

322

Phase 2

Bulgaria;Colombia;Germany;Hungary;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Ukraine

1440

NCT01830985
(ClinicalTrials.gov)

April 2013

10/4/2013

A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis

A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

Rheumatoid Arthritis

Drug: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Completed

18 Years

65 Years

Both

Phase 2;Phase 3

United States;Estonia;Lithuania;South Africa

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1441

EUCTR2012-003536-23-IT
(EUCTR)

29/03/2013

05/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden

1442

EUCTR2011-002896-40-PL
(EUCTR)

29/03/2013

11/02/2013

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01

RHEUMATOID ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

1443

EUCTR2011-003538-16-CZ
(EUCTR)

29/03/2013

08/11/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand

1444

EUCTR2012-002324-32-SE
(EUCTR)

27/03/2013

20/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden

1445

EUCTR2012-002322-73-SI
(EUCTR)

26/03/2013

19/03/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Moderately to severely active rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1446

EUCTR2011-003538-16-DE
(EUCTR)

26/03/2013

10/12/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

1447

EUCTR2010-019262-86-CZ
(EUCTR)

26/03/2013

30/03/2011

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

2025

Phase 3

United States;Portugal;Belarus;Philippines;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Norway;Germany;New Zealand;Sweden

1448

EUCTR2011-002840-29-RO
(EUCTR)

25/03/2013

16/06/2016

A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate

A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ–38518168 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available

Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2

United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of

1449

EUCTR2012-002339-27-GB
(EUCTR)

21/03/2013

04/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Romania;Germany;Japan;Korea, Republic of

1450

EUCTR2012-002339-27-DE
(EUCTR)

21/03/2013

21/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

Portugal;Taiwan;Slovakia;Spain;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1451

EUCTR2012-002323-15-GB
(EUCTR)

21/03/2013

21/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Moderately to severely active rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

United States;Greece;Spain;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of

1452

JPRN-UMIN000010286

2013/03/21

21/03/2013

Maintenance Trial by Orencia in Rheumatoid Arthritis

Rheumatoid Arthritis

Patients whose RA status is in low disease activity after 24 weeks of treatment with abatacept receive the reduced dosage of abatacept.

Hokkaido University Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

150

Not selected

Japan

1453

EUCTR2012-002322-73-DE
(EUCTR)

21/03/2013

21/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

1454

EUCTR2012-005275-14-NO
(EUCTR)

19/03/2013

04/02/2013

Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs

Remission in rheumatoid arthritis – assessing withdrawal of disease-modifying antirheumatic drugs in a non-inferiority design - ARCTIC REWIND

Rheumatoid arthritis (RA)
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Methotrexate Pfizer 2,5 mg tabletter
Trade Name: Methotrexate Pfizer 2,5 mg tabletter
Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Trade Name: Metex 50 mg/ml injeksjonsvæske, oppløsning i ferdigfylt sprøyte
Trade Name: Salazopyrin EN 500 mg enterotabletter
Trade Name: Salazopyrin EN 500 mg enterotabletter
Trade Name: Plaquenil 200 mg filmdrasjerte tabletter
Trade Name: Plaquenil 200 mg filmdrasjerte tabletter
Trade Name: Arava 20 mg filmdrasjerte tabletter
Trade Name: Arava 20 mg filmdrasjerte tabletter
Trade Name: ENBREL 25 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.
Trade Name: Cimzia 200 mg injeksjonsvæske, oppløsning
Trade Name: Simponi 50 mg injeksjonsvæske, oppløsning i ferdigfylt sprøyte.
Trade Name: Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning.
Trade Name: Humira 40 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte

Diakonhjemmet Hospital AS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Norway

1455

EUCTR2011-003538-16-PT
(EUCTR)

14/03/2013

13/12/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

United States;Portugal;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1456

EUCTR2012-003881-42-DE
(EUCTR)

13/03/2013

09/01/2013

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2b

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Romania;Germany

1457

EUCTR2012-003536-23-FI
(EUCTR)

13/03/2013

19/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden

1458

EUCTR2012-003536-23-EE
(EUCTR)

13/03/2013

12/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Netherlands;Norway;Sweden

1459

EUCTR2012-003644-71-ES
(EUCTR)

12/03/2013

21/12/2012

Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

168

France;Hong Kong;Czech Republic;Spain;Australia;Israel;Chile;Russian Federation;Netherlands;Germany;Colombia

1460

EUCTR2012-002324-32-GR
(EUCTR)

12/03/2013

26/02/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Portugal;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Sweden;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1461

EUCTR2011-005648-93-SK
(EUCTR)

11/03/2013

06/02/2013

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany

1462

EUCTR2012-002339-27-BE
(EUCTR)

11/03/2013

19/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany;Japan;Korea, Republic of

1463

EUCTR2012-003629-40-CZ
(EUCTR)

11/03/2013

23/11/2012

An Efficacy And Safety Study of CNTO6785 In Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: CNTO6785
Product Code: CNTO6785
INN or Proposed INN: CNTO6785

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

Philippines;Czech Republic;Argentina;Thailand;Poland;Russian Federation;Colombia;China;India

1464

EUCTR2011-005649-10-SK
(EUCTR)

11/03/2013

06/02/2013

A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany

1465

EUCTR2011-003538-16-IT
(EUCTR)

08/03/2013

14/01/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: SARILUMAB
Product Code: SAR153191
INN or Proposed INN: sarilumab
Product Name: SARILUMAB
Product Code: SAR153191
INN or Proposed INN: sarilumab

SANOFI- AVENTIS RECHERCHE ET DÃ‰VELOPPEMENT

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Colombia;Italy;Switzerland;India;Australia;Peru;Korea, Republic of;Korea, Democratic People's Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1466

EUCTR2012-003536-23-HU
(EUCTR)

07/03/2013

16/01/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden

1467

EUCTR2011-006021-23-PL
(EUCTR)

05/03/2013

04/01/2013

A Phase 2, Open-Label, Non-Comparative, Multi-Center Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone
MedDRA version: 18.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ASP015K
INN or Proposed INN: ASP015K
Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
INN or Proposed INN: ASP015K
Other descriptive name: 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide

Astellas Pharma Global Development Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 2

Hungary;Czech Republic;Mexico;Belgium;Poland;Bulgaria;Germany

1468

EUCTR2011-006020-20-PL
(EUCTR)

05/03/2013

19/11/2012

A Phase 2b, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Finding, Multi-Center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects

Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Other descriptive name: ASP015K hydrobromide, AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2b

United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria

1469

EUCTR2011-006058-94-DE
(EUCTR)

04/03/2013

27/08/2012

Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

A Phase III randomized, double-blind, placebo-controlled multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - REASSURE 2

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

234

Phase 3

United States;Portugal;Panama;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of

1470

EUCTR2011-006018-15-PL
(EUCTR)

01/03/2013

16/11/2012

Astellas Pharma Global Development, Inc. (APGD)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2b

United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1471

NCT02036931
(ClinicalTrials.gov)

March 2013

14/1/2014

A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System

Noninflammatory Degenerative Joint Disease;Rheumatoid Arthritis

Device: Metal on Polyethylene articulation;Drug: Ceramic on Polyethylene articulation;Device: Ceramic on Ceramic articulation

Zimmer Biomet

NULL

Active, not recruiting

18 Years

N/A

All

315

United States;France;Germany;Ireland;Netherlands;Spain

1472

NCT01558089
(ClinicalTrials.gov)

March 2013

15/2/2012

Good EULAR Response In Patients With Early Rheumatoid Arthritis

Ability To Achieve A Good Eular Response In Patients With Moderate-to-severe Active Early Rheumatoid Arthritis Who Satisfy The New Acr/Eular Classification Criteria Receiving Etanercept + Mtx In Real World Clinical Practice In Greece

Rheumatoid Arthritis

Drug: etanercept;Drug: methotrexate

Pfizer

NULL

Completed

18 Years

N/A

All

N/A

Greece

1473

NCT01715896
(ClinicalTrials.gov)

March 2013

16/10/2012

A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Golimumab 50 mg;Biological: Mavrilimumab 100 mg

MedImmune LLC

NULL

Completed

18 Years

80 Years

All

215

Phase 2

Argentina;Colombia;Czech Republic;France;Greece;Hungary;Israel;Mexico;Portugal;Russian Federation;Serbia;Slovakia;Spain;United Kingdom;Turkey

1474

NCT02843789
(ClinicalTrials.gov)

March 2013

19/7/2016

Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy

Arthritis, Rheumatoid

Drug: Tocilizumab

Centre Hospitalier Universitaire de Besancon

NULL

Completed

18 Years

80 Years

All

109

Phase 4

France

1475

EUCTR2012-003223-38-ES
(EUCTR)

27/02/2013

04/03/2013

Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

157

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1476

EUCTR2012-004342-14-EE
(EUCTR)

26/02/2013

31/01/2013

A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

Product Name: VX-509
Product Code: VX-509
INN or Proposed INN: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2;Phase 3

United States;Estonia;Lithuania;Denmark;South Africa;Netherlands

1477

JPRN-UMIN000010126

2013/02/25

26/02/2013

Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease

Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD

Interstitial lung disease related to rheumatoid arthritis

In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on.
In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases.

Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not applicable

Japan

1478

EUCTR2012-002324-32-BE
(EUCTR)

25/02/2013

19/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden

1479

EUCTR2012-003536-23-CZ
(EUCTR)

20/02/2013

03/01/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden

1480

EUCTR2012-002322-73-ES
(EUCTR)

20/02/2013

06/03/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Lilly S.A.

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

United States;Portugal;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1481

EUCTR2012-000610-11-BE
(EUCTR)

20/02/2013

14/06/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate

Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany

1482

EUCTR2012-000609-58-BE
(EUCTR)

20/02/2013

14/06/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics

Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Germany

1483

EUCTR2011-003538-16-AT
(EUCTR)

19/02/2013

14/01/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand

1484

EUCTR2012-004090-16-ES
(EUCTR)

19/02/2013

29/11/2012

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 655064
INN or Proposed INN: BI 655064

Boehringer Ingelheim España, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

130

Czech Republic;Spain;Australia;Netherlands;Germany;New Zealand

1485

EUCTR2012-003724-20-HU
(EUCTR)

19/02/2013

20/12/2012

A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.

Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145

Infinity Pharmaceuticals, Inc

NULL

Not Recruiting

Female: yes
Male: yes

316

Phase 2

Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1486

EUCTR2011-003538-16-GR
(EUCTR)

18/02/2013

14/01/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;Japan;New Zealand

1487

EUCTR2011-005649-10-CZ
(EUCTR)

18/02/2013

11/12/2012

A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Brazil;Germany

1488

EUCTR2012-005370-62-IT
(EUCTR)

18/02/2013

11/01/2013

clinical study to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes.

No-profit” clinical study for the improvement of clinical practice, to evaluate the efficacy of anakinra in reducing the glycated haemoglobin in patients affected by rheumatoid arthritis and diabetes; randomized, open label, parallel group, controlled clinical study.

rheumatoid arthritis and type 2 diabetes mellitus as comorbidity.
MedDRA version: 14.1;Level: LLT;Classification code 10037740;Term: RA;System Organ Class: 100000004859
MedDRA version: 14.1;Level: PT;Classification code 10012601;Term: Diabetes mellitus;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: KINERET *SC 7SIR 100MG 0,67ML
INN or Proposed INN: ANAKINRA

OSPEDALE CIVILE SAN SALVATORE, ASL 04, L'AQUILA

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Italy

1489

EUCTR2012-002322-73-GB
(EUCTR)

15/02/2013

21/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan

1490

JPRN-UMIN000010033

2013/02/14

14/02/2013

To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy

Rheumatoid Arthritis

Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks.

Daihei Kida

NULL

Complete: follow-up complete

20years-old

75years-old

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1491

EUCTR2011-003538-16-HU
(EUCTR)

14/02/2013

14/11/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand

1492

EUCTR2012-002339-27-CZ
(EUCTR)

13/02/2013

04/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

Portugal;Taiwan;Slovakia;Spain;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of

1493

EUCTR2012-002339-27-SK
(EUCTR)

12/02/2013

05/02/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of

1494

EUCTR2012-002322-73-SK
(EUCTR)

12/02/2013

05/02/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

1495

EUCTR2012-002323-15-DK
(EUCTR)

08/02/2013

08/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1496

EUCTR2011-006344-71-DE
(EUCTR)

08/02/2013

25/04/2012

Treatment with eggs of pig whipworm for patients with rheumatoid arthritis, who are insufficiently treated with methotrexate

Trichuris suis ova (TSO) as a additional therapy for rheumatoid arthritis patients with insufficient response to methotrexate. A prospective, double-blind, randomized, controlled monocenter study.

Trade Name: Trichuris suis ova
Product Name: Trichuris suis ova
Product Code: TSO
INN or Proposed INN: Trichuris suis ova
Other descriptive name: Pig whipworm eggs

Immanuel Krankenhaus Berlin

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany

1497

EUCTR2010-022242-24-BG
(EUCTR)

07/02/2013

11/12/2012

A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;Bulgaria;South Africa;Japan;Korea, Republic of

1498

EUCTR2011-006018-15-HU
(EUCTR)

06/02/2013

30/11/2012

Rheumatoid Arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2b

United States;Czech Republic;Hungary;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia

1499

EUCTR2012-002324-32-IT
(EUCTR)

06/02/2013

11/01/2013

A phase 3 study in moderate to severe rheumatoid arthritis

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN

Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Trade Name: Maxtrex
INN or Proposed INN: METHOTREXATE
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Trade Name: Maxtrex
INN or Proposed INN: METHOTREXATE

ELI LILLY AND COMPANY

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden

1500

EUCTR2011-002894-48-BG
(EUCTR)

06/02/2013

20/11/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1501

EUCTR2011-005649-10-HU
(EUCTR)

05/02/2013

27/11/2012

A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany

1502

EUCTR2012-000439-17-HU
(EUCTR)

05/02/2013

20/11/2012

active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MK-8457
Product Code: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Peru;South Africa;Latvia;Germany;Japan;Moldova, Republic of

1503

EUCTR2011-003538-16-LT
(EUCTR)

04/02/2013

05/11/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To non-biologic DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-a Antagonists - SARIL-RA-TARGET

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

United States;Portugal;Hong Kong;Taiwan;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand

1504

EUCTR2012-003194-25-LT
(EUCTR)

04/02/2013

24/09/2012

Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MabionCD20
INN or Proposed INN: Rituximab
Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB

Mabion S.A.

NULL

Not Recruiting

Female: yes
Male: yes

863

Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia

1505

EUCTR2012-002339-27-PT
(EUCTR)

01/02/2013

02/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1506

EUCTR2011-006021-23-CZ
(EUCTR)

01/02/2013

06/12/2012

Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone
MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Astellas Pharma Global Development

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 2

Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany

1507

NCT01724931
(ClinicalTrials.gov)

February 2013

7/11/2012

Aminopterin Dose Finding Treatment for Methotrexate-Naïve Rheumatoid Arthritis

A Phase 2 Double-Blind, Placebo-Controlled, Randomized Dose Finding Study For The Efficacy And Safety Of Aminopterin In Methotrexate-Naive Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: LD-aminopterin;Drug: placebo

Syntrix Biosystems, Inc.

NULL

Completed

18 Years

N/A

Both

175

Phase 2

Ukraine

1508

NCT02087449
(ClinicalTrials.gov)

February 2013

5/3/2014

Evaluate E1 Wear, Clinical Performance of E1 Liner in THA in Korean Patient Population

A Prospective Multi-center Study on E1 Acetabular Liner in THA

Osteoarthritis;Avascular Necrosis;Traumatic Arthritis;Rheumatoid Arthritis;Legg-perthes Disease

Device: E1-Hip Bearing

Zimmer Biomet

NULL

Active, not recruiting

20 Years

65 Years

All

100

Korea, Republic of

1509

EUCTR2012-002324-32-GB
(EUCTR)

31/01/2013

21/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Portugal;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Brazil;Belgium;South Africa;Germany;Japan;Korea, Republic of;Sweden

1510

EUCTR2011-003538-16-SK
(EUCTR)

29/01/2013

08/03/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1511

EUCTR2012-002323-15-BE
(EUCTR)

28/01/2013

20/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of

1512

NCT01712399
(ClinicalTrials.gov)

January 28, 2013

19/10/2012

A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Mavrilimumab 100 mg

MedImmune LLC

NULL

Terminated

19 Years

79 Years

All

409

Phase 2

Argentina;Bulgaria;Chile;Colombia;Czechia;Estonia;Germany;Greece;Hungary;Israel;Mexico;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Czech Republic

1513

EUCTR2011-002894-48-DE
(EUCTR)

25/01/2013

24/07/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

1514

EUCTR2011-006021-23-BG
(EUCTR)

25/01/2013

13/12/2012

A two-year, open-label clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) who completed a previous study of ASP015K

Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone
MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Astellas Pharma Global Development

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 2

Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany;Colombia

1515

EUCTR2012-002323-15-PL
(EUCTR)

25/01/2013

19/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1516

EUCTR2012-003881-42-BE
(EUCTR)

24/01/2013

18/12/2012

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Slovakia;Puerto Rico;Belgium;Romania;Germany

1517

EUCTR2012-003439-41-EE
(EUCTR)

24/01/2013

02/01/2013

A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Estonia;Lithuania;Denmark;South Africa;Netherlands

1518

EUCTR2012-002322-73-GR
(EUCTR)

24/01/2013

13/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Switzerland;France;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan

1519

EUCTR2012-003881-42-SK
(EUCTR)

23/01/2013

27/04/2016

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects who Completed Preceding Study M13-390 with Adalimumab

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Slovakia;Puerto Rico;Belgium;Romania;Germany

1520

EUCTR2012-002324-32-DE
(EUCTR)

23/01/2013

21/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1521

EUCTR2012-002322-73-CZ
(EUCTR)

22/01/2013

04/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

1522

EUCTR2012-002535-28-GB
(EUCTR)

21/01/2013

14/12/2012

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Trade Name: MabThera
Product Name: MabThera
Trade Name: RoActemra
Product Name: RoActemra

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 4

Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom

1523

EUCTR2012-002760-27-BG
(EUCTR)

21/01/2013

09/11/2012

Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

345

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

1524

EUCTR2012-002322-73-BE
(EUCTR)

21/01/2013

19/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

1525

EUCTR2011-002894-48-ES
(EUCTR)

18/01/2013

29/10/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Product Code: BI 695500
INN or Proposed INN: Not applicable
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1526

EUCTR2011-001122-18-BG
(EUCTR)

18/01/2013

28/08/2012

A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy

Rheumatoid Arthritis
MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: CNTO 1959
Other descriptive name: CNTO 1959 IgG
Product Code: CNTO 1959
Other descriptive name: CNTO 1959 IgG
Product Name: Ustekinumab
Product Code: CNTO1275
Other descriptive name: Ustekinumab

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Singapore;Peru;Bulgaria

1527

EUCTR2012-002322-73-PT
(EUCTR)

18/01/2013

02/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

1528

EUCTR2012-002324-32-PT
(EUCTR)

18/01/2013

02/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden

1529

EUCTR2012-002323-15-NL
(EUCTR)

17/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

1530

EUCTR2012-002322-73-NL
(EUCTR)

17/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1531

EUCTR2011-003538-16-ES
(EUCTR)

16/01/2013

29/11/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand

1532

NCT01715831
(ClinicalTrials.gov)

January 15, 2013

25/10/2012

A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488

A Multicenter, Open-Label, Single-Arm Extension Study to Describe the Safety of Tocilizumab Treatment In Brazilian Patients With DMARDs Refractory Rheumatoid Arthritis Which Completed Studies ML21530 and MA21488 and Presenting an Indication of Maintaining the Tocilizumab Treatment

Arthritis, Rheumatoid

Drug: DMARDs;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Brazil

1533

EUCTR2012-004631-22-BE
(EUCTR)

15/01/2013

11/12/2012

TapERA:Tapering Etanercept in Reumatoid Artritis.

TapERA:Maintaining remission in RA while tapering Etanercept. - TapERA

reumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Enbrel
Product Name: Enbrel
Product Code: EMEA/H/C000262

University Hospitals Leuven

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

1534

EUCTR2012-002339-27-HU
(EUCTR)

14/01/2013

22/11/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of

1535

EUCTR2012-002181-12-HU
(EUCTR)

14/01/2013

28/11/2012

A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

Active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MK-8457
Product Code: MK-8457
Other descriptive name: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2a

United States;Greece;Spain;Austria;Colombia;United Kingdom;Italy;France;Hungary;Brazil;Poland;Australia;Denmark;Peru;South Africa;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1536

EUCTR2012-002324-32-AT
(EUCTR)

14/01/2013

09/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden

1537

EUCTR2012-002323-15-AT
(EUCTR)

14/01/2013

08/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

1538

EUCTR2012-002322-73-HU
(EUCTR)

14/01/2013

27/11/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan

1539

EUCTR2011-006020-20-BG
(EUCTR)

11/01/2013

04/01/2013

A clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA)

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2b

United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria

1540

EUCTR2012-002322-73-LV
(EUCTR)

11/01/2013

21/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1541

EUCTR2012-002181-12-IT
(EUCTR)

10/01/2013

06/11/2012

A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti- TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2a

United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;Hungary;Brazil;Australia;Peru;Denmark;South Africa;New Zealand;Sweden

1542

EUCTR2011-006018-15-BG
(EUCTR)

10/01/2013

28/12/2012

A clinical study of ASP015K in patients with moderate to severe rheumatoid arthritis (RA) who are having insufficient relief from methotrexate

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2b

United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia

1543

EUCTR2011-002067-20-GR
(EUCTR)

10/01/2013

13/12/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

1544

EUCTR2012-000439-17-PL
(EUCTR)

10/01/2013

13/11/2012

Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: MK-8457 (free acid)
Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: MK-8457 (free acid)

Merck Sharpe & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

1545

EUCTR2012-002323-15-ES
(EUCTR)

09/01/2013

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Lilly S.A.

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1546

EUCTR2012-000609-58-IT
(EUCTR)

07/01/2013

25/09/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics

Rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: NA
Product Code: 0109-0012A 100 mg/ml
Product Name: NA
Product Code: 0109-0012A 50 mg/ml
Product Name: NA
Product Code: 0109-0012A 25 mg/ml

NOVO NORDISK

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany

1547

EUCTR2012-000610-11-IT
(EUCTR)

07/01/2013

25/09/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate

Product Name: NA
Product Code: 0109-0012A 100 mg/ml
Product Name: NA
Product Code: 0109-0012A 50 mg/ml
Product Name: NA
Product Code: 0109-0012A 25 mg/ml

NOVO NORDISK

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany

1548

EUCTR2012-003644-71-NL
(EUCTR)

07/01/2013

Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 EAst 42nd Street, New York, NY 10017, United States

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

France;Hong Kong;Spain;Belgium;Australia;Russian Federation;Israel;Chile;Colombia;Netherlands

1549

NCT02089087
(ClinicalTrials.gov)

January 7, 2013

13/3/2014

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis Patients

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CFZ533 in Healthy Subjects and Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Biological: CFZ533;Drug: Placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

55 Years

All

Phase 1

United States;Taiwan

1550

ChiCTR-TRC-13002981

2013-01-07

Effectiveness and safety of Chinese herbal medicine in low responders in patient population of rheumatoid arthritis under MTX-based conventional therapy

rheumatoid arthritis;M06.991

A:GTT tablets, 10 mg 3 times a day after meals. Yi Shen Juan Bi (YSJB) ,1 pocket (8 g) 3 times a day after meals;B:Methotrexate (MTX)10 mg/week and Sulfasalazine (SSZ),at an initial dose of 0.5 g three times a day in the first week, from the second week the dose was 1.0g twice a day;

Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences

NULL

Completed

Both

A:110;B:110;

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1551

EUCTR2012-002339-27-IT
(EUCTR)

07/01/2013

21/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib

ELI LILLY AND COMPANY

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

Portugal;Taiwan;Slovakia;Spain;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Croatia;Germany;Japan;Korea, Republic of

1552

EUCTR2011-006021-23-HU
(EUCTR)

04/01/2013

24/10/2012

Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone
MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Astellas Pharma Global Development

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 2

Czech Republic;Hungary;Mexico;Poland;Belgium;Bulgaria;Germany

1553

EUCTR2012-001618-40-PL
(EUCTR)

04/01/2013

31/10/2012

Evaluation of the blood concentration of Tabalumab after the administration of Tabalumab using prefilled syringe or auto-injector in patients with Rheumathoid Arthritis that have not responded correctly to treatment with Methotrexate.

Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate.

Product Name: tabalumab
Product Code: LY2127399
Other descriptive name: TABALUMAB

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

180

United States;Czech Republic;Argentina;Poland;Russian Federation

1554

EUCTR2011-005649-10-PT
(EUCTR)

04/01/2013

10/09/2012

A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany

1555

JPRN-UMIN000007404

2013/01/01

01/03/2012

Open-label, multicenter, randomized controlled trials, for comparing remission induction rate of a dose-escalation therapy of methotrexate and an additional combination therapy with bucillamine for naive patients to over 8 mg/weekly of methotrexate.

Rheumatoid arthritis

Dose escalation of methotrexate
Concomitant therapy of methotrexate and bucillamine

KONAMON Study Group

NULL

Recruiting

Not applicable

Male and Female

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1556

ChiCTR-TRC-13003948

2013-01-01

2013-12-05

The evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney pattern

rheumatoid arthritis

Control:Methotrexate 10mg qw PO + Leflunomide 10mg qd PO ;EA combined with medicine group:M+L+SEA+ZJSM ;

Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine

NULL

Completed

Both

Control:60;EA combined with medicine group:60;

China

1557

NCT01965132
(ClinicalTrials.gov)

January 1, 2013

11/10/2013

Korean College of Rheumatology Biologics Registry

Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis

Drug: Biologic DMARD

Seoul National University Hospital

NULL

Recruiting

18 Years

N/A

All

7000

Korea, Republic of

1558

NCT01721044
(ClinicalTrials.gov)

January 2013

1/11/2012

A Moderate to Severe Rheumatoid Arthritis Study

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

Rheumatoid Arthritis

Drug: Placebo;Drug: Baricitinib;Drug: cDMARD

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

527

Phase 3

United States;Argentina;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Spain;Switzerland;Turkey;United Kingdom;Croatia;India

1559

NCT01765478
(ClinicalTrials.gov)

January 2013

7/1/2013

Safety,PK/PD, Food Effect Study of Orally Administered HM71224 in Healthy Adult Male Volunteers

A Phase1 Study, to Determine the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Doses of Orally Administered HM71224 in Healthy, Adult Male Volunteers

Rheumatoid Arthritis

Drug: HM71224 single ascending dose;Drug: HM71224 food effect;Drug: HM71224 Multiple ascending dose

Hanmi Pharmaceutical Company Limited

NULL

Completed

18 Years

65 Years

Male

Phase 1

Netherlands

1560

NCT01389388
(ClinicalTrials.gov)

January 2013

16/4/2010

Effects of Rosuvastatin on Carotid Artery Plaques in Patients With Inflammatory Joint Disease

Cholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint Diseases

Carotid Artery Plaque;Ankylosing Spondylitis;Rheumatoid Arthritis

Drug: Rosuvastatin

Diakonhjemmet Hospital

NULL

Completed

35 Years

80 Years

Both

114

N/A

Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1561

NCT01754935
(ClinicalTrials.gov)

January 2013

18/12/2012

A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of VX-509 Using Magnetic Resonance Imaging and Arthroscopic Biopsies in Subjects With Active Rheumatoid Arthritis on Stable Disease-Modifying Antirheumatic Drugs

Rheumatoid Arthritis

Drug: VX-509;Drug: VX-509 matching placebo

Vertex Pharmaceuticals Incorporated

NULL

Completed

18 Years

65 Years

Both

Phase 2

United States;Denmark;Estonia;Lithuania;Netherlands;South Africa

1562

NCT01767844
(ClinicalTrials.gov)

January 2013

8/1/2013

Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients?

Can Creatine Supplementation Improve Body Composition and Physical Function in Rheumatoid Arthritis Patients? A Randomised Controlled Pilot Trial

Rheumatoid Arthritis

Dietary Supplement: Creatine;Dietary Supplement: Placebo

Bangor University

NULL

Active, not recruiting

18 Years

N/A

Both

N/A

United Kingdom

1563

EUCTR2012-002323-15-IT
(EUCTR)

18/12/2012

19/12/2012

A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis

Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib

ELI LILLY AND COMPANY

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Australia;Netherlands;Japan;Korea, Republic of

1564

NCT01491815
(ClinicalTrials.gov)

December 14, 2012

8/12/2011

Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction

A Multicenter, Randomized, Open-label, Blinded-assessor, Phase 4 Study in Patients With Early Rheumatoid Arthritis to Compare Active Conventional Therapy Versus Three Biologic Treatments, and Two De-escalation Strategies in Patients Who Respond to Treatment

Rheumatoid Arthritis

Drug: Non-biological DMARD's;Biological: Cimzia;Biological: Orencia;Biological: RoActemra

Karolinska Institutet

NULL

Active, not recruiting

18 Years

N/A

All

812

Phase 4

Denmark;Finland;Iceland;Netherlands;Norway;Sweden

1565

EUCTR2011-006020-20-CZ
(EUCTR)

12/12/2012

03/08/2012

Rheumatoid Arthritis
MedDRA version: 16.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2b

United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1566

EUCTR2011-006018-15-CZ
(EUCTR)

12/12/2012

03/08/2012

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2b

United States;Hungary;Czech Republic;Mexico;Belgium;Poland;Ukraine;Bulgaria;Colombia

1567

EUCTR2010-020992-21-GR
(EUCTR)

11/12/2012

06/12/2012

Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis

A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4,5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.

Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Czech Republic;Slovakia;Greece;Thailand;Spain;Poland;Turkey;Romania;Monaco;Germany;India

1568

EUCTR2011-006058-94-PT
(EUCTR)

11/12/2012

23/10/2012

Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

234

Phase 3

Panama;Portugal;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of

1569

EUCTR2011-005634-19-PL
(EUCTR)

11/12/2012

06/11/2012

A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2b

Serbia;Estonia;Spain;Ukraine;Chile;Russian Federation;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany

1570

JPRN-UMIN000009425

2012/12/06

01/12/2012

A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient

Rheumatoid Arthritis

The dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity.
Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year.
Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year.

Osaka City University Medical School

NULL

Recruiting

20years-old

Not applicable

Male and Female

150

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1571

EUCTR2010-022243-38-BE
(EUCTR)

04/12/2012

06/09/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

840

Portugal;Serbia;United States;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand

1572

EUCTR2011-006058-94-GR
(EUCTR)

04/12/2012

23/10/2012

Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

234

Phase 3

Panama;Portugal;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of

1573

EUCTR2011-005376-42-BG
(EUCTR)

03/12/2012

28/08/2012

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis

Product Code: 0114-0006B
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;Hungary;Spain;Poland;Russian Federation;Bulgaria;Latvia

1574

ChiCTR-DDT-12002658

2012-12-01

2012-11-04

Validation of early rheumatoid arthritis classification criteria

rheumatoid arthritis

Gold Standard:;Index test:;

Peking University People's Hospital

NULL

Completed

100

Both

Target condition:0;Difficult condition:0

China

1575

JPRN-UMIN000013885

2012/12/01

05/05/2014

Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study

rheumatoid arthiritis

RA patients were scheduled to receive TCZ once a month after 24 weeks. Serum NT-pro BNP concentrations were measured simultaneously on stored baseline and 24 week samples.

Itabashi Chuo Medical Center

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

100

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1576

NCT01770106
(ClinicalTrials.gov)

December 2012

3/1/2013

RA Denosumab on Bone Microstructure Study

Comparison of the Effect of Denosumab and Alendronate on Bone Density and Microarchitecture in Rheumatoid Arthritis Females With Low Bone Mass: A Randomized Controlled Trial

Rheumatoid Arthritis

Drug: Denosumab;Drug: Alendronate

Chinese University of Hong Kong

NULL

Completed

18 Years

80 Years

Female

Phase 4

Hong Kong

1577

NCT01721057
(ClinicalTrials.gov)

December 2012

1/11/2012

A Study in Moderate to Severe Rheumatoid Arthritis Participants

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Placebo;Drug: Baricitinib;Drug: cDMARD

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

684

Phase 3

United States;Argentina;Australia;Belgium;Canada;Croatia;Czechia;Germany;Hungary;India;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Taiwan;United Kingdom;Czech Republic

1578

NCT01752855
(ClinicalTrials.gov)

December 2012

17/12/2012

Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab

Rheumatoid Arthritis

Biological: New formulation adalimumab

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

N/A

All

Phase 2

United States;Belgium;Czech Republic;Germany;Puerto Rico;Romania;Slovakia

1579

NCT01759030
(ClinicalTrials.gov)

December 2012

20/12/2012

Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid Arthritis

Double Blind Randomized Clinical Study Evaluating Efficacy and Safety of BCD-020 and MabThera in Patients With Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Other DMARDs Including One or More TNF Inhibitor Therapies

Rheumatoid Arthritis

Drug: Rituximab

Biocad

NULL

Completed

18 Years

80 Years

All

181

Phase 3

Belarus;India;Russian Federation;Ukraine;Colombia

1580

NCT01751776
(ClinicalTrials.gov)

December 2012

14/12/2012

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy

A Randomised, Double-blind, Placebo-controlled Trial for Establishing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of Multiple Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy

Arthritis, Rheumatoid;Healthy

Drug: BI 655064 medium dose;Drug: BI 655064 high dose;Drug: Placebo;Drug: BI 655064 low dose

Boehringer Ingelheim

NULL

Completed

18 Years

70 Years

Both

107

Phase 1

Czech Republic;Germany;Netherlands;New Zealand;Poland;Spain;Romania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1581

NCT01772316
(ClinicalTrials.gov)

December 2012

17/1/2013

A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

A Multicenter, Open-label, Long-term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Spain

1582

EUCTR2012-002181-12-ES
(EUCTR)

27/11/2012

23/08/2012

A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-alpha Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: MK8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2a

United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden

1583

EUCTR2010-022243-38-GB
(EUCTR)

21/11/2012

29/06/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 3

United States;Portugal;Serbia;Taiwan;Spain;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Germany;Japan;New Zealand

1584

EUCTR2011-006021-23-BE
(EUCTR)

19/11/2012

25/10/2012

Rheumatoid arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues [O’Dell, 2004]. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone
MedDRA version: 18.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Astellas Pharma Global Development

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 2

Hungary;Czech Republic;Mexico;Poland;Belgium;Bulgaria;Germany

1585

JPRN-UMIN000011181

2012/11/19

12/07/2013

Continuous epidural infusion versus periarticular multimodal drug injection in bilateral simultaneous total knee arthroplasty: a randomized controlled trial

Osteoarthritis of knee, rheumatoid arthritis

A continuous epidural infusion containing ropivacaine and morphine for pain after simultaneous bilateral total knee arthroplasty
A periarticular multimodal drug injection including ropivacaine, morphine, bosmin, methylprednisolone, and ketoprofen for pain after simultaneous bilateral total knee arthroplasty

Nekoyama miyao hospital

NULL

Complete: follow-up complete

18years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1586

EUCTR2011-002894-48-GR
(EUCTR)

16/11/2012

19/10/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden

1587

EUCTR2012-002181-12-GR
(EUCTR)

16/11/2012

08/10/2012

A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

Active rheumatoid arthritis
MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MK-8457
Product Code: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2a

United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden

1588

EUCTR2011-001122-18-CZ
(EUCTR)

15/11/2012

10/07/2012

A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Korea, Democratic People's Republic of;Turkey;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Argentina;Singapore;Peru;Bulgaria

1589

EUCTR2010-022243-38-IT
(EUCTR)

14/11/2012

11/12/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

JANSSEN-CILAG INTERNATIONAL N.V.

NULL

Not Recruiting

Female: yes
Male: yes

990

Portugal;United States;Taiwan;Spain;Lithuania;Austria;United Kingdom;Italy;Canada;Argentina;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China;Japan;Korea, Republic of

1590

EUCTR2012-002760-27-ES
(EUCTR)

14/11/2012

23/01/2013

Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Farmaceutica, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

345

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1591

EUCTR2012-003057-29-HU
(EUCTR)

13/11/2012

19/09/2012

A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.

Product Name: XmAb5871_10.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.
Product Name: XmAb5871_3.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.
Product Name: XmAb5871_1.0MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.
Product Name: XmAb5871_0.3MG
Product Code: XENP5871
INN or Proposed INN: XmAb®5871
Other descriptive name: Engineered humanized monoclonal anti-human CD19 antibody.

Xencor Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary;Slovakia

1592

EUCTR2012-002760-27-SK
(EUCTR)

12/11/2012

11/10/2012

Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

345

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

1593

EUCTR2012-002181-12-GB
(EUCTR)

12/11/2012

21/08/2012

A Phase IIa Proof Of Concept study to evaluate Safety, Tolerability and Efficacy in Subjects with Rheumatoid Arthritis

Product Name: MK-8457
Product Code: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2a

United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden

1594

EUCTR2012-003057-29-SK
(EUCTR)

12/11/2012

19/09/2012

A multi-centre, randomised, double-blind multiple dose study of increasing doses of XmAb5871 in patients with Rheumatoid Arthritis.

XmAb5871 is a humanized Fc engineered monoclonal antibody that binds to the human B cell restricted cell surface antigen CD19. It has already entered Phase 1 clinical development. The available evidence suggests that XmAb5871 is a potentially useful immunomodulatory antibody for therapy of B cell mediated human disease states such as rheumatoid arthritis.
MedDRA version: 15.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Xencor Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Czech Republic;Slovakia

1595

EUCTR2010-019262-86-PT
(EUCTR)

09/11/2012

09/08/2012

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 3

United States;Portugal;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1596

EUCTR2011-002894-48-PT
(EUCTR)

09/11/2012

09/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 15.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: BI 695500
INN or Proposed INN: No Active Name Specified
Trade Name: MabThera 500 mg concentrate for solution for infusion
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden

1597

EUCTR2011-005648-93-BG
(EUCTR)

09/11/2012

16/08/2012

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 2

Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany

1598

EUCTR2012-002760-27-IT
(EUCTR)

08/11/2012

30/10/2012

A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis.

A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 15.0;Level: LLT;Classification code 10037738;Term: R arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

345

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany

1599

EUCTR2012-002760-27-DE
(EUCTR)

06/11/2012

25/09/2012

Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

345

Romania;Bulgaria;Germany;United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil

1600

EUCTR2012-001760-30-IT
(EUCTR)

05/11/2012

25/07/2012

Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent.

Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent.

Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB

OSSERVATORIO EPIDEMIOLOGICO GISEA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1601

EUCTR2012-001618-40-CZ
(EUCTR)

05/11/2012

03/08/2012

Product Name: tabalumab
Product Code: LY2127399
Other descriptive name: TABALUMAB

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

180

United States;Czech Republic;Argentina;Poland;Russian Federation

1602

JPRN-UMIN000009088

2012/11/01

12/10/2012

Bio Logic MateTM clinical performance test for IFX Efficacy prediction

rheumatoid arthritis

IFX plus methotrexate

Bio Logic Mate Study Group

NULL

Complete: follow-up complete

20years-old

75years-old

Male and Female

150

Not selected

Japan

1603

EUCTR2012-000609-58-GB
(EUCTR)

01/11/2012

20/06/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2

United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Germany

1604

NCT01709760
(ClinicalTrials.gov)

November 2012

16/10/2012

A Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With RA

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate;Drug: ENIA11;Drug: Placebo

Mycenax Biotech Inc.

NULL

Unknown status

20 Years

N/A

All

Phase 3

Taiwan

1605

NCT01711359
(ClinicalTrials.gov)

November 2012

18/10/2012

A Study in Participants With Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs

Rheumatoid Arthritis

Drug: Baricitinib;Drug: Methotrexate;Drug: Baricitinib Placebo;Drug: MTX Placebo;Drug: Folic Acid

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

588

Phase 3

United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Greece;India;Italy;Japan;Korea, Republic of;Mexico;Portugal;Puerto Rico;Russian Federation;South Africa;Sweden;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1606

NCT01749787
(ClinicalTrials.gov)

November 2012

6/12/2012

Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis

A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: PRTX-100 at 1.5 mcg/kg;Drug: PRTX-100 at 3.0 mcg/kg;Drug: PRTX-100 at 6.0 mcg/kg;Drug: PRTX-100 at 12.0 mcg/kg;Drug: PRTX-100 at 240 mcg;Drug: Placebo;Drug: PRTX-100 at 420 mcg

Protalex, Inc.

NULL

Completed

18 Years

N/A

Both

Phase 1

United States

1607

NCT01741493
(ClinicalTrials.gov)

November 2012

3/12/2012

A Study in Healthy Adults and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Doses of ABT-494

A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494

Rheumatoid Arthritis

Drug: ABT-494;Drug: Placebo;Drug: Tofacitinib

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

75 Years

All

Phase 1

United States

1608

NCT01725230
(ClinicalTrials.gov)

November 2012

7/11/2012

Assess the Pharmacokinetics of Rosuvastatin and Simvastatin When Administered Alone or in Combination With Fostamatinib

An Open-label, Non-randomized, 2-Period, Fixed Sequence, Single-center Study to Assess the Pharmacokinetics of Rosuvastatin and Simvastatin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily

Rheumatoid Arthritis

Drug: Fostamatinib;Drug: Rosuvastatin;Drug: Simvastatin

AstraZeneca

NULL

Completed

18 Years

55 Years

Both

Phase 1

United States

1609

NCT01679951
(ClinicalTrials.gov)

October 31, 2012

3/9/2012

A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate

A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Dose Range Finding Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy

Rheumatoid Arthritis

Drug: Placebo;Drug: JNJ-38518168 (3 mg);Drug: JNJ-38518168 (10 mg);Drug: JNJ-38518168 (30 mg);Drug: Methotrexate

Janssen Research & Development, LLC

NULL

Terminated

18 Years

80 Years

All

272

Phase 2

United States;Argentina;Chile;Colombia;Czechia;Hungary;Japan;Korea, Republic of;Latvia;Mexico;Poland;Romania;Russian Federation;Taiwan;Thailand;Ukraine;Czech Republic

1610

EUCTR2011-002840-29-CZ
(EUCTR)

31/10/2012

05/09/2012

A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate

Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1611

NCT01636843
(ClinicalTrials.gov)

October 30, 2012

6/7/2012

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

Inflammation;Rheumatoid Arthritis

Drug: NNC0109-0012;Drug: placebo

Novo Nordisk A/S

NULL

Terminated

18 Years

75 Years

All

298

Phase 2

United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Spain;Ukraine;Czech Republic

1612

NCT01741688
(ClinicalTrials.gov)

October 26, 2012

30/11/2012

An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis

A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Rheumatoid Arthritis

Biological: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

N/A

Peru

1613

EUCTR2011-002840-29-HU
(EUCTR)

25/10/2012

04/09/2012

A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate

Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of

1614

EUCTR2011-005634-19-BG
(EUCTR)

24/10/2012

19/10/2012

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany

1615

EUCTR2010-021146-22-GB
(EUCTR)

23/10/2012

25/10/2012

Alemtuzumab and rheumatoid arthritis - a study to look at the function of the immune system

Alemtuzumab and rheumatoid arthritis - an immunisation study - Alemtuzumab and rheumatoid arthritis - an immunisation study

Trade Name: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994; manufacturerd by Cambridge Therapeutic Antibody Centre, Burroughs Wellcome, Glaxo Wellcome)
Product Name: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994 )

The Newcastle upon Tyne Hospitals NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1616

EUCTR2011-002896-40-DE
(EUCTR)

23/10/2012

02/07/2012

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

RHEUMATOID ARTHRITIS
MedDRA version: 16.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017 US

NULL

Not Recruiting

Female: yes
Male: yes

195

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany

1617

EUCTR2011-005649-10-ES
(EUCTR)

22/10/2012

19/07/2012

A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;Brazil;Germany

1618

EUCTR2011-002840-29-LV
(EUCTR)

22/10/2012

25/10/2012

A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate

Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of

1619

EUCTR2010-022243-38-ES
(EUCTR)

22/10/2012

21/08/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

990

United States;Serbia;Portugal;Taiwan;Spain;Lithuania;Austria;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of

1620

EUCTR2012-000535-36-PL
(EUCTR)

18/10/2012

13/09/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1621

EUCTR2012-000610-11-ES
(EUCTR)

17/10/2012

09/07/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate

Product Code: 0109-0012A 100 mg/ml
Product Code: 0109-0012A 50 mg/ml
Product Code: 0109-0012A 25 mg/ml

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany

1622

EUCTR2011-002894-48-HU
(EUCTR)

16/10/2012

16/08/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

1623

EUCTR2010-022243-38-PT
(EUCTR)

15/10/2012

27/08/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

840

1624

EUCTR2012-002573-62-SE
(EUCTR)

12/10/2012

14/08/2012

Doppler quantitative evaluation and follow-up over 12 months in RA patients with moderate and high disease activity who are candidates for biologic add-on therapy with Adalimumab

Rheumatoid arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Humira

The Karolinska Institute, ClinTRID

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 4

Sweden

1625

NCT01636557
(ClinicalTrials.gov)

October 11, 2012

6/7/2012

A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis

A Phase I, Open-label, Drug Interaction Study to Evaluate the Effect of a Single-dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Sirukumab;Drug: Midazolam;Drug: Warfarin;Drug: Vitamin K;Drug: Omeprazole;Drug: Caffeine

Janssen Research & Development, LLC

NULL

Completed

18 Years

65 Years

All

Phase 1

Germany;Korea, Republic of;Moldova, Republic of;South Africa

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1626

NCT01736189
(ClinicalTrials.gov)

October 11, 2012

27/11/2012

Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice

Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice (Combo Study; Adalimumab With High Dose MTX)

Rheumatoid Arthritis

Drug: Adalimumab

AbbVie (prior sponsor, Abbott)

NULL

Completed

16 Years

99 Years

All

346

Japan

1627

EUCTR2007-002066-35-SK
(EUCTR)

10/10/2012

15/04/2008

A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THETREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - not applicable

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Other descriptive name: CP -690,550 -10
Product Name: CP -690,550
Other descriptive name: CP -690,550 -10
Trade Name: Humira ® 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: Humira ®

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

Czech Republic;Hungary;Slovakia;Greece;Bulgaria;Germany;Italy

1628

EUCTR2011-005648-93-HU
(EUCTR)

09/10/2012

17/04/2012

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

400

Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany

1629

EUCTR2012-002760-27-HU
(EUCTR)

09/10/2012

03/09/2012

Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

345

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

1630

EUCTR2011-002894-48-EE
(EUCTR)

08/10/2012

08/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1631

EUCTR2011-005648-93-GR
(EUCTR)

03/10/2012

05/10/2012

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 2

Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany

1632

EUCTR2011-005649-10-GR
(EUCTR)

03/10/2012

05/10/2012

A Phase 2 Exploratory Study of Mavrilimumab versus Anti tumor Necrosis Factor in Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Trade Name: Simponi
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Czech Republic;Mexico;Argentina;Brazil;Germany;Hungary;Portugal;Slovakia;Greece;Spain;Russian Federation;Israel;United Kingdom;France

1633

JPRN-UMIN000018101

2012/10/01

26/06/2015

Venous thromboembolism after total knee arthroplasty and high tibial osteotomy with / without edxaban: a prospective study

Osteoarthritis, rheumatoid arthritis, osteonecrosis

To determine whether postoperative VTE is present and to evaluate the efficacy and safety of edoxaban for the prevention of patients undergoing TKA, OWHTO, or CWHTO, angiography of the pulmonary artery and deep veins of the lower limbs is performed in all patients on postoperative day 7.
Levels of coagulation and fibrinolysis markers are evaluated on the preoperative day and on postoperative days 1, 3, 7, and 14.

Yokohama City University School of Medicine

NULL

Recruiting

Not applicable

Male and Female

100

Not selected

Japan

1634

JPRN-UMIN000008812

2012/10/01

01/10/2012

Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR)

Rheumatoid arthritis

tocilizumab monotherapy

Department of Rheumatology & Clinical ImmunologySaitama Medical Center, Saitama Medical Universitity

NULL

Complete: follow-up complete

16years-old

80years-old

Male and Female

Not selected

Japan

1635

JPRN-JapicCTI-132091

01/10/2012

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents

Rheumatoid Arthritis

Intervention name : AIN457
INN of the intervention : secukinumab
Dosage And administration of the intervention : subcutaneously 75mg, 150mg
Control intervention name : null

Novartis Pharma K.K.

NULL

BOTH

234

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1636

NCT01734993
(ClinicalTrials.gov)

October 2012

19/11/2012

A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).

A Multicenter, Open-Label Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

France

1637

NCT02915094
(ClinicalTrials.gov)

October 2012

23/9/2016

Kineret in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Anakinra

Swedish Orphan Biovitrum

NULL

Completed

18 Years

N/A

All

N/A

Germany

1638

NCT01710358
(ClinicalTrials.gov)

October 2012

17/10/2012

A Study in Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

Rheumatoid Arthritis

Drug: Adalimumab;Drug: Baricitinib;Drug: Methotrexate;Drug: Adalimumab Placebo;Drug: Baricitinib Placebo

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

1307

Phase 3

United States;Argentina;Belgium;Canada;China;Croatia;Czechia;France;Germany;Greece;Hungary;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;United Kingdom;Czech Republic;Netherlands

1639

NCT01730456
(ClinicalTrials.gov)

October 2012

15/11/2012

A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926

A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

Phase 3

Macedonia, The Former Yugoslav Republic of

1640

NCT01770379
(ClinicalTrials.gov)

October 2012

16/10/2012

Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFa Agents.

Rheumatoid Arthritis

Biological: Secukinumab (AIN457);Biological: Placebo

Novartis Pharmaceuticals

NULL

Terminated

18 Years

N/A

All

242

Phase 3

United States;Argentina;Brazil;Colombia;Czech Republic;Dominican Republic;Germany;Greece;Guatemala;India;Italy;Japan;Korea, Republic of;Panama;Portugal;South Africa;Ecuador;Puerto Rico

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1641

EUCTR2011-004419-22-BG
(EUCTR)

29/09/2012

22/06/2012

Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate

A 24-week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Phase 2 Study of Different Doses of VX-509 in Adult Subjects With Active Rheumatoid Arthritis on Stable Methotrexate Therapy with 104-Week Open Label Extension

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany

1642

JPRN-jRCTs032180245

28/09/2012

12/03/2019

Wear of 32mm OXINIUM head on XLPE: Multicenter RCT Study

Wear of 32mm Oxidized Zirconium (OXINIUM) head on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 32mmOX multicenter study

Hip osteoarthritis, Rheumatoid arthritis
Hip osteoarthritis, Rheumatoid arthritis

Arm A: Oxidized zirconium alloy (OXINIUM) femoral head
Arm B: Standard cobalt chromium alloy head
Random allocation is registered automatically at the UMIN Internet Medical Research Data Center (INDICE)

Kume Shinichiro

NULL

Not Recruiting

>= 20age old

<= 75age old

Both

352

Phase 4

Japan

1643

EUCTR2012-002760-27-CZ
(EUCTR)

27/09/2012

13/08/2012

Extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

345

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

1644

EUCTR2011-006058-94-CZ
(EUCTR)

26/09/2012

19/07/2012

Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

234

Phase 3

Portugal;Panama;United States;Ecuador;Greece;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Japan;Korea, Republic of

1645

EUCTR2012-000609-58-DE
(EUCTR)

25/09/2012

27/06/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics

Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1646

EUCTR2012-000610-11-DE
(EUCTR)

25/09/2012

03/07/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate

Product Code: 0109-0012A 100 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 50 mg/ml
INN or Proposed INN: N/A
Product Code: 0109-0012A 25 mg/ml
INN or Proposed INN: N/A

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany

1647

EUCTR2012-002181-12-DK
(EUCTR)

24/09/2012

A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA

Product Name: MK-8457
Product Code: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2a

United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Denmark;Peru;Australia;South Africa;New Zealand;Sweden

1648

EUCTR2011-005648-93-DE
(EUCTR)

19/09/2012

11/05/2012

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 2

Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany

1649

EUCTR2011-005634-19-DE
(EUCTR)

19/09/2012

02/05/2012

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany

1650

JPRN-UMIN000015297

2012/09/19

01/10/2014

The feasibility study of accelated infliximab infusion from initial administration

The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)

Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.

Chiba University Hospital

NULL

Recruiting

20years-old

70years-old

Male and Female

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1651

EUCTR2011-002894-48-GB
(EUCTR)

14/09/2012

06/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

1652

JPRN-JapicCTI-152782

12/9/2012

29/01/2015

Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis

Rheumatoid Arthritis

Intervention name : Kolbet
INN of the intervention : Iguratimod
Dosage And administration of the intervention : Oral

Toyama Chemical Co., Ltd. (Current FUJIFILM Toyama Chemical Co., Ltd.)

NULL

BOTH

2000

NULL

1653

NCT01850966
(ClinicalTrials.gov)

September 12, 2012

8/5/2013

Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Iguratimod

Eisai Co., Ltd.

NULL

Completed

N/A

All

2747

Japan

1654

JPRN-JapicCTI-132051

12/9/2012

23/01/2013

Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis

Rheumatoid Arthritis

Intervention name : iguratimod (Careram)
Dosage And administration of the intervention : Oral

Eisai Co., Ltd.

NULL

BOTH

2000

NULL

1655

EUCTR2011-002894-48-NL
(EUCTR)

10/09/2012

14/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1656

EUCTR2011-005648-93-ES
(EUCTR)

10/09/2012

24/05/2012

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis -

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Hungary;Germany;Bulgaria;Chile;France;South Africa;Czech Republic;Russian Federation;Ukraine;Serbia;Argentina;Mexico;Estonia;Spain

1657

EUCTR2011-006020-20-HU
(EUCTR)

07/09/2012

29/06/2012

Rheumatoid Arthritis
MedDRA version: 15.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ASP015K
Product Code: ASP015K
INN or Proposed INN: ASP015K hydrobromide
Other descriptive name: ASP015K hydrobromide , AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Product Code: ASP015K
INN or Proposed INN: ASP015K hydrobromide
Other descriptive name: ASP015K hydrobromide , AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide
Product Name: ASP015K
Product Code: ASP015K
INN or Proposed INN: ASP015K hydrobromide
Other descriptive name: ASP015K hydrobromide , AS1940150-BR, JKT-201A, 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H-pyrrolo[2,3-b]pyridine-5-carboxamide monohydrobromide

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2b

United States;Czech Republic;Hungary;Mexico;Poland;Ukraine;Bulgaria

1658

EUCTR2010-022243-38-DE
(EUCTR)

05/09/2012

21/06/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

840

1659

NCT01682512
(ClinicalTrials.gov)

September 5, 2012

10/8/2012

Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis

Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial.

Arthritis, Rheumatoid

Drug: BI 695500;Drug: Rituxan ®;Drug: MabThera ®

Boehringer Ingelheim

NULL

Terminated

18 Years

80 Years

All

294

Phase 3

United States;Argentina;Belgium;Bulgaria;Canada;Chile;Germany;Greece;Hungary;Ireland;Mexico;Netherlands;Poland;Portugal;Spain;Ukraine;United Kingdom;Brazil;Estonia;France;Guatemala;Italy;New Zealand;Norway;Peru;Russian Federation;Serbia;South Africa;Sweden

1660

EUCTR2012-000535-36-DE
(EUCTR)

05/09/2012

15/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1661

EUCTR2010-022243-38-AT
(EUCTR)

04/09/2012

01/08/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

840

1662

EUCTR2011-006058-94-IT
(EUCTR)

04/09/2012

13/09/2012

Secukinumab efficacy and safety study in patients with active Rheumatoid Arthritis (RA) and an Inadequate response to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB
Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: SECUKINUMAB

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

234

Phase 3

Portugal;Panama;United States;Greece;Ecuador;Guatemala;Colombia;Italy;India;Czech Republic;Argentina;Brazil;Dominican Republic;South Africa;Germany;Korea, Republic of

1663

NCT01647451
(ClinicalTrials.gov)

September 2012

19/7/2012

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC0114-0006;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

75 Years

All

Phase 2

Bulgaria;Hungary;Latvia;Poland;Russian Federation;Serbia;Spain

1664

NCT01635686
(ClinicalTrials.gov)

September 2012

4/7/2012

Comparison the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers

A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of DWP422 25 mg With Those of ENBREL 25MG PFS INJ. After Subcutaneous Injection in Healthy Male Volunteers

Rheumatoid Arthritis

Drug: DWP422 25mg;Drug: ENBREL 25MG PFS INJ.

Daewoong Pharmaceutical Co. LTD.

NULL

Not yet recruiting

20 Years

45 Years

Male

Phase 1

Korea, Republic of

1665

NCT01661140
(ClinicalTrials.gov)

September 2012

7/8/2012

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage

Randomized, Phase IV, Placebo-controlled, Comparative Study to Evaluate the Efficacy and Safety of Tapering Methotrexate (MTX) Dosage Versus Maintaining the Dosage in Patients With Severe Active Rheumatoid Arthritis (RA) Who Have Demonstrated an Inadequate Response (IR) to Prior Disease-modifying Anti-rheumatic Drugs (DMARDs) Treatment and Have Initiated RoActemra (RoActemra, TCZ) in Combination With MTX

Rheumatoid Arthritis

Drug: Methotrexate (stable dose);Drug: Tocilizumab;Drug: Methotrexate (tapering dose)

Hoffmann-La Roche

NULL

Terminated

18 Years

N/A

All

427

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1666

NCT01640938
(ClinicalTrials.gov)

September 2012

12/7/2012

Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis

A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Secukinumab (AIN457)

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

259

Phase 3

United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Russian Federation;Slovakia;Spain;Romania

1667

NCT01676701
(ClinicalTrials.gov)

September 2012

29/8/2012

Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA)

Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Tabalumab Auto-Injector;Drug: Tabalumab Prefilled Syringe

Eli Lilly and Company

NULL

Terminated

18 Years

N/A

All

Phase 3

United States;Argentina;Czechia;Poland;Puerto Rico;Russian Federation;Czech Republic

1668

EUCTR2012-000535-36-BE
(EUCTR)

28/08/2012

05/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Czech Republic;Slovakia;Puerto Rico;Poland;Belgium;Romania;Germany

1669

EUCTR2011-006070-73-DE
(EUCTR)

28/08/2012

24/02/2012

Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis

A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM

Product Name: Fostamatinib 50 mg blue film-coated tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

130

United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany

1670

EUCTR2011-002067-20-IT
(EUCTR)

23/08/2012

13/09/2012

Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the EU and a n. of other countries worldwide

Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

UCB PHARMA SA/NV.

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1671

EUCTR2012-000535-36-SK
(EUCTR)

23/08/2012

14/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany

1672

NCT01643928
(ClinicalTrials.gov)

August 16, 2012

6/7/2012

Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS

Rheumatoid Arthritis

Biological: Rituximab -Pfizer (PF-05280586) x 3 courses;Biological: Rituximab -EU+ Rituximab-Pfizer x 2 Courses;Biological: Rituximab -US + Rituximab-Pfizer x 2 Courses

Pfizer

NULL

Completed

18 Years

N/A

All

185

N/A

United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Switzerland;Ukraine

1673

EUCTR2012-000439-17-DE
(EUCTR)

15/08/2012

10/04/2012

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis

active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: NA
Other descriptive name: MK-8457
Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: NA
Other descriptive name: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

434

Phase 2

1674

EUCTR2011-002896-40-GB
(EUCTR)

14/08/2012

11/06/2012

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

RHEUMATOID ARTHRITIS
MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

195

Phase 2

United States;Taiwan;Spain;Korea, Democratic People's Republic of;Russian Federation;Israel;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany

1675

EUCTR2012-000610-11-HU
(EUCTR)

13/08/2012

18/06/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate

Product Code: 0109-0012A 100 mg/ml
Product Code: 0109-0012A 50 mg/ml
Product Code: 0109-0012A 25 mg/ml

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1676

EUCTR2012-000609-58-HU
(EUCTR)

13/08/2012

18/06/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNFa biologics

Product Code: 0109-0012A 100 mg/ml
Product Code: 0109-0012A 50 mg/ml
Product Code: 0109-0012A 25 mg/ml

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany

1677

EUCTR2012-000535-36-CZ
(EUCTR)

02/08/2012

18/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany

1678

EUCTR2011-002894-48-BE
(EUCTR)

02/08/2012

18/07/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

Phase 1;Phase 3

1679

EUCTR2011-005634-19-CZ
(EUCTR)

01/08/2012

24/04/2012

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany

1680

EUCTR2011-005648-93-CZ
(EUCTR)

01/08/2012

24/04/2012

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

400

Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1681

NCT01652937
(ClinicalTrials.gov)

August 2012

19/7/2012

BIIB057 in Subjects With Rheumatoid Arthritis and Inadequate Response to Disease-Modifying Antirheumatic Drugs

A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BIIB057 in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs

Rheumatoid Arthritis

Drug: BIIB057;Drug: Placebo

Biogen Idec

NULL

Withdrawn

18 Years

N/A

Female

Phase 2

Canada

1682

NCT01645280
(ClinicalTrials.gov)

August 2012

6/6/2012

A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy

Arthritis, Rheumatoid

Drug: Placebo + methotrexate (MTX) (Group 1);Drug: Ustekinumab + MTX (Group 2);Drug: Ustekinumab + MTX (Group 3);Drug: CNTO 1959 + MTX (Group 4);Drug: CNTO 1959 + MTX (Group 5)

Janssen Research & Development, LLC

NULL

Completed

18 Years

80 Years

All

274

Phase 2

United States;Argentina;Bulgaria;Chile;Colombia;Czech Republic;Hungary;Poland;Russian Federation;Singapore;Ukraine;Korea, Republic of;Mexico;Peru;Turkey

1683

NCT01636817
(ClinicalTrials.gov)

August 2012

6/7/2012

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics

Inflammation;Rheumatoid Arthritis

Drug: NNC0109-0012;Drug: placebo

Novo Nordisk A/S

NULL

Terminated

18 Years

75 Years

All

239

Phase 2

United States;Argentina;Belgium;Brazil;Czechia;France;Germany;Hungary;Italy;Mexico;Poland;Spain;United Kingdom;Czech Republic

1684

NCT01651936
(ClinicalTrials.gov)

August 2012

25/7/2012

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010)

A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects With Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy

Rheumatoid Arthritis

Drug: MK-8457 100 mg;Drug: Methotrexate;Drug: Dose-match placebo

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

N/A

All

Phase 2

Australia;Colombia;Denmark;France;Greece;Hungary;Italy;Korea, Republic of;New Zealand;Poland;South Africa;Spain;United Kingdom;United States

1685

NCT01746680
(ClinicalTrials.gov)

August 2012

4/12/2012

Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis

Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tacrolimus with Methotrexate

Chong Kun Dang Pharmaceutical

NULL

Completed

20 Years

N/A

Both

111

Phase 4

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1686

NCT01662063
(ClinicalTrials.gov)

August 2012

30/7/2012

A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)

A Multicenter Open-Label, Long-Term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab

Genentech, Inc.

NULL

Completed

18 Years

N/A

All

218

Phase 3

United States;Puerto Rico

1687

NCT01870908
(ClinicalTrials.gov)

August 2012

4/6/2013

Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients

Drug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical Settings

Rheumatoid Arthritis

Drug: tacrolimus;Drug: biological agents

Astellas Pharma Inc

NULL

Completed

N/A

Both

664

N/A

Japan

1688

NCT01705730
(ClinicalTrials.gov)

July 31, 2012

10/10/2012

A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy

Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy

Rheumatoid Arthritis

Drug: tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Belgium

1689

EUCTR2011-006018-15-BE
(EUCTR)

28/07/2012

02/07/2012

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2

United States;Hungary;Czech Republic;Mexico;Poland;Belgium;Ukraine;Bulgaria;Colombia

1690

EUCTR2011-005634-19-ES
(EUCTR)

27/07/2012

24/04/2012

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1691

EUCTR2011-004529-28-CZ
(EUCTR)

25/07/2012

03/04/2012

A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis

A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available

Product Name: JNJ-40346527 -AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Czech Republic;Argentina;Poland;Malaysia;Bulgaria;Chile;Russian Federation;Korea, Republic of

1692

EUCTR2011-002067-20-GB
(EUCTR)

23/07/2012

13/03/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

Phase 4

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany

1693

EUCTR2011-005648-93-EE
(EUCTR)

19/07/2012

16/04/2012

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

400

Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Argentina;South Africa;Bulgaria;Germany

1694

EUCTR2012-000439-17-GB
(EUCTR)

17/07/2012

16/04/2012

active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MK-8457
Product Code: MK-8457

Merck, Sharpe & Dohme Corp., a subsidiary of Merck & Co. Inc (hereafter referred to as Merck)

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

1695

EUCTR2010-019262-86-AT
(EUCTR)

12/07/2012

06/06/2012

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - SARIL-RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Other descriptive name: SAR153191

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

2000

Phase 3

Mexico;Canada;Argentina;Poland;Portugal;Belarus;United States;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1696

EUCTR2010-022243-38-LT
(EUCTR)

11/07/2012

29/05/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

840

1697

JPRN-UMIN000010902

2012/07/11

07/06/2013

A randomized controlled trial comparing epidural anesthesia and periarticular multimodal drug injection for total knee arthroplasty

Osteoarthritis of knee, rheumatoid arthritis, avascular necrosis

An epidural anesthesia containing 2mg/ml ropivacaine 100ml and 10mg/ml morphine 0.8ml for pain after total knee arthroplasty
A periarticular multimodal drug injection including 7.5mg/ml ropivacaine, 10mg/ml morphine 0.8ml, bosmin 0.3mg, methylprednisolone 40mg, and ketoprofen 50mg for pain after total knee arthroplasty

Nekoyama miyao hospital

NULL

Complete: follow-up complete

18years-old

Not applicable

Male and Female

100

Not selected

Japan

1698

EUCTR2010-022242-24-LT
(EUCTR)

11/07/2012

29/05/2012

A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

1650

Phase 3

1699

EUCTR2011-005376-42-LV
(EUCTR)

06/07/2012

13/03/2012

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis

Product Code: 0114-0006B

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia

1700

NCT01554696
(ClinicalTrials.gov)

July 6, 2012

13/3/2012

A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects Who Have Had an Inadequate Response to Methotrexate

A Phase 2b, Randomized, Double-blind, Parallel-group, Placebo Controlled, Dose-finding, Multi-center Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis in Patients Who Have Had an Inadequate Response to Methotrexate

Arthritis, Rheumatoid

Drug: peficitinib;Drug: Placebo;Drug: methotrexate

Astellas Pharma Inc

NULL

Completed

18 Years

N/A

All

379

Phase 2

United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1701

EUCTR2011-002067-20-PT
(EUCTR)

06/07/2012

21/03/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

Phase 4

Portugal;United States;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

1702

JPRN-UMIN000008404

2012/07/01

12/07/2012

Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria.

rheumatoid arthritis

Extension of Tocilizumab Dose Intervals

Japan Labour Health and Welfare Organization,Yokohama Rosai Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

1703

JPRN-UMIN000033222

2012/07/01

02/07/2018

Clinical Results of Prophylactic Iodine-supported Primary TKA for Compromised Cases

Osteoarthritis, Rheumatoid arthritis of knee joint

prophylactic iodine-suported primaru TKA

Fukui General Hospital

NULL

Complete: follow-up complete

50years-old

90years-old

Male and Female

Not selected

Japan

1704

NCT01893151
(ClinicalTrials.gov)

July 2012

2/7/2013

Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRI

A Randomized, Double-blind Study to Evaluate the Efficacy of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI)

Rheumatoid Arthritis

Drug: Iguratimod;Drug: Iguratimod placebo

Jiangsu Simcere Pharmaceutical Co., Ltd.

NULL

Recruiting

18 Years

65 Years

Both

200

Phase 4

China

1705

NCT01597739
(ClinicalTrials.gov)

July 2012

10/5/2012

A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy

A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy

Arthritis, Rheumatoid

Drug: JNJ-40346527;Drug: Placebo

Janssen Research & Development, LLC

NULL

Completed

18 Years

80 Years

Both

Phase 2

Argentina;Bulgaria;Chile;Czech Republic;Hungary;Korea, Republic of;Poland;Russian Federation;Singapore;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1706

NCT01578850
(ClinicalTrials.gov)

July 2012

12/4/2012

Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)

Rheumatoid Arthritis

Drug: Etanercept;Drug: placebo

Pfizer

NULL

Completed

18 Years

70 Years

All

491

Phase 4

Brazil;China;Colombia;Czech Republic;Egypt;Hungary;Jordan;Lebanon;Malaysia;Mexico;Philippines;Qatar;Romania;Russian Federation;South Africa;Taiwan;Thailand;Ukraine;United Arab Emirates;Saudi Arabia

1707

NCT01665430
(ClinicalTrials.gov)

July 2012

13/8/2012

A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis

A Multicenter, Open-Label, Single Arm, Long-Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Terminated

18 Years

N/A

All

Phase 3

Poland

1708

NCT01640054
(ClinicalTrials.gov)

July 2012

2/7/2012

A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis

(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Rheumatoid Arthritis

Drug: Fostamatinib

AstraZeneca

NULL

Terminated

18 Years

N/A

All

115

Phase 2

Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam

1709

NCT01649804
(ClinicalTrials.gov)

July 2012

23/7/2012

A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis

A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG-TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Hungary

1710

NCT01793259
(ClinicalTrials.gov)

July 2012

14/2/2013

Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)

An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: methotrexate prefilled pen;Drug: methotrexate prefilled syringe

medac GmbH

NULL

Completed

18 Years

75 Years

Both

120

Phase 3

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1711

NCT01659242
(ClinicalTrials.gov)

July 2012

3/8/2012

Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis:an Ultrasound/Magnetic Resonance Imaging Study

Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis Patients With Active Disease Despite Methotrexate: an Ultrasound and Magnetic Resonance Imaging Study

Rheumatoid Arthritis

Drug: Methotrexate plus sulfasalazine;Drug: Leflunomide

Singapore General Hospital

NULL

Terminated

21 Years

65 Years

Both

Phase 4

Singapore

1712

EUCTR2010-018485-24-HU
(EUCTR)

29/06/2012

02/05/2012

To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis

A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA

Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

216

Czech Republic;Hungary;Spain;Latvia;Germany

1713

EUCTR2011-002067-20-BG
(EUCTR)

28/06/2012

11/05/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

Phase 4

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

1714

EUCTR2011-005260-20-GB
(EUCTR)

28/06/2012

10/05/2012

RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor.

Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER

Adult Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Roche Products Limited

NULL

Not Recruiting

Female: yes
Male: yes

618

Phase 4

United Kingdom

1715

EUCTR2011-002067-20-ES
(EUCTR)

26/06/2012

10/05/2012

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1716

EUCTR2011-002067-20-AT
(EUCTR)

26/06/2012

27/03/2012

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

1717

EUCTR2011-005204-15-AT
(EUCTR)

20/06/2012

15/05/2012

Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?

Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop

biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy.
MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Orncia
INN or Proposed INN: ABATACEPT
Trade Name: Roactemra
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Orncia
INN or Proposed INN: ABATACEPT

Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 4

Austria

1718

EUCTR2011-002067-20-CZ
(EUCTR)

19/06/2012

25/04/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

Phase 4

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany

1719

NCT01565655
(ClinicalTrials.gov)

June 19, 2012

27/3/2012

A Study to Evaluate the Safety and Efficacy of ASP015K in Moderate to Severe Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: peficitinib;Drug: Placebo

Astellas Pharma Global Development, Inc.

NULL

Completed

18 Years

N/A

All

289

Phase 2

United States;Bulgaria;Czechia;Hungary;Mexico;Poland;Czech Republic

1720

EUCTR2011-005376-42-ES
(EUCTR)

18/06/2012

29/03/2012

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis

Product Code: 0114-0006B

Novo Nordisk A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;Russian Federation;Serbia;Bulgaria;Spain;Latvia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1721

EUCTR2010-018485-24-LV
(EUCTR)

15/06/2012

14/05/2012

To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis

Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal

Biotest AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

176

Hungary;Germany;Czech Republic;Spain;Latvia

1722

EUCTR2011-002067-20-DE
(EUCTR)

13/06/2012

16/02/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 18.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

1723

EUCTR2011-001122-18-HU
(EUCTR)

13/06/2012

02/05/2012

A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Colombia;Hungary;Czech Republic;Mexico;Argentina;Singapore;Peru;Bulgaria

1724

NCT01638013
(ClinicalTrials.gov)

June 13, 2012

9/7/2012

A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K

Open-label Extension Study in Rheumatoid Arthritis Patients Who Have Completed Phase 2b Study or Phase 3 Study of ASP015K

Arthritis, Rheumatoid

Drug: Peficitinib

Astellas Pharma Inc

NULL

Completed

20 Years

N/A

All

843

Phase 3

Japan;Korea, Republic of;Taiwan

1725

EUCTR2011-005634-19-EE
(EUCTR)

13/06/2012

16/04/2012

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1726

EUCTR2011-005448-87-CZ
(EUCTR)

11/06/2012

12/04/2012

A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S)

A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S)

Trade Name: Enbrel ® 50 mg Solution for Injection in Pre-filled Syringe
INN or Proposed INN: ETANERCEPT

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

320

United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Hungary;Czech Republic;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China

1727

EUCTR2011-001729-25-NL
(EUCTR)

11/06/2012

05/03/2012

Study designed to demonstrate the efficacy and safety of Certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis.

A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of certolizumab pegol in combination with methotrexate for inducing and sustaining clinical response in the treatment of dmard-naïve adults with early active rheumatoid arthritis. - -

Early active rheumatoid arthritis
MedDRA version: 15.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

800

United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden

1728

EUCTR2009-017998-37-BE
(EUCTR)

08/06/2012

11/04/2012

Scintigraphic detection of tumor necrosis factor with radioactive labeled TNFa-blocker in patients with active rheumatoid arthritis and active axial and peripheric spondyloarthropathy.

Patients with an active spondyloarthropathy and with an active rheumatoid arthritis; who were diagnosed according to the classic ACR-criteria (American College of Rheumatology) for rheumatoid arthritis and according the ASAS-criteria (Assessment of SpondyloArthritis international Society) for spondylarthropathy. Patients with an active rheumatoid arthritis or with an active axial and peripheral spondyloarthropathy. Patients with erosive hand arthrosis. Patients with an active Crohn's disease.
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Level: HLT;Classification code 10052775;Term: Spondyloarthropathies;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10039078;Term: Rheumatoid arthropathies;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Ghent University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Belgium

1729

EUCTR2011-005021-48-NL
(EUCTR)

07/06/2012

05/06/2012

A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)

A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO

adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland

1730

EUCTR2011-004419-22-SK
(EUCTR)

06/06/2012

12/04/2012

Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1731

EUCTR2011-004419-22-HU
(EUCTR)

06/06/2012

21/03/2012

Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany

1732

EUCTR2011-004419-22-CZ
(EUCTR)

06/06/2012

13/03/2012

Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany

1733

NCT01611688
(ClinicalTrials.gov)

June 4, 2012

1/6/2012

First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC0215-0384;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

75 Years

All

Phase 1

Germany

1734

EUCTR2011-004529-28-BG
(EUCTR)

01/06/2012

07/05/2012

A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis

Product Name: JNJ-40346527 -AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Poland;Bulgaria

1735

JPRN-UMIN000008281

2012/06/01

28/06/2012

Dose-escalation study of infliximab or methotrexate based on the disease activity in patients with rheumatoid arthritis treated with infliximab

rheumatoid arthritis

Dose-escalation of MTX or IFX

Department of Internal Medicien and Rheumatology, Juntendo University School of Medicine

NULL

Recruiting

20years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1736

JPRN-UMIN000007806

2012/06/01

01/05/2012

The feasibility study of accelated infliximab infusion during maintenance phase

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)

Chiba University Hospital

NULL

Complete: follow-up complete

Not applicable

Male and Female

Phase 2

Japan

1737

EUCTR2011-001729-25-GB
(EUCTR)

01/06/2012

19/04/2012

Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

United States;Spain;Ireland;Austria;Colombia;Italy;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden

1738

EUCTR2011-002067-20-IE
(EUCTR)

01/06/2012

10/04/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

Phase 4

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany

1739

NCT01712178
(ClinicalTrials.gov)

June 2012

14/6/2012

A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety

Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of a New Adalimumab Formulation in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Adalimumab , current formulation;Biological: Adalimumab , new formulation

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

N/A

All

100

Phase 2

United States;Belgium;Czech Republic;Germany;Puerto Rico;Romania;Slovakia

1740

NCT01602302
(ClinicalTrials.gov)

June 2012

16/5/2012

Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis

Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)

Medical University of Graz

NULL

Terminated

18 Years

90 Years

All

Phase 4

Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1741

NCT01664104
(ClinicalTrials.gov)

June 2012

7/8/2012

A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting

CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

151

N/A

Italy

1742

NCT02015520
(ClinicalTrials.gov)

June 2012

6/12/2013

Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis

A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects With Moderate to Severe Active Rheumatoid Arthritis Who Have Experienced an Inadequate Response to TNF Inhibitors

Rheumatoid Arthritis

Drug: Clazakizumab;Drug: Placebo (Matching with Clazakizumab)

CSL Behring

NULL

Completed

18 Years

N/A

All

143

Phase 2

United States;Argentina;Canada;France;Hungary;Italy;Japan;Mexico;South Africa;Australia

1743

NCT02052375
(ClinicalTrials.gov)

June 2012

30/1/2014

A Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Multiple Dose Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study To Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP2408 After Subcutaneous Injections in Patients With Rheumatoid Arthritis on Methotrexate

Rheumatoid Arthritis;Pharmacokinetics of ASP2408

Drug: ASP2408;Drug: Placebo

Astellas Pharma Global Development, Inc.

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States

1744

EUCTR2012-000222-21-DE
(EUCTR)

31/05/2012

16/03/2012

Comparison of the patient's experience with the methotrexate pre-filled syringe and with the methrotexate pre-filled pen and preference of the patient for subcutaneous methotrexate injection.

An open-label, randomized, two-period cross-over study of repeated subcutaneous injections of methotrexate 50mg/ml solution either by a pre-filled syringe (reference) or by a disposable pre-filled pen (test) to assess patient’s preference and self-injection experience and to compare the local tolerability in patients with active rheumatoid arthritis - Preference MTX pre-filled syringe vs pre-filled pen in RA

Trade Name: metex® 50 mg/ml Injektionslösung, Fertigspritze
Product Name: metex® 50 mg/ml Injektionslösung, Fertigspritze
Product Code: 70930.00.00
INN or Proposed INN: Methotrexate disodium
Product Name: methotrexate pre-filled pen
INN or Proposed INN: Methotrexate disodium

medac Gesellschaft für klinische Spezialpräparate mbH

NULL

Not Recruiting

Female: yes
Male: yes

Germany

1745

EUCTR2011-005376-42-HU
(EUCTR)

30/05/2012

11/04/2012

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis

Product Code: 0114-0006B

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Serbia;Hungary;Spain;Poland;Bulgaria;Russian Federation;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1746

EUCTR2011-002067-20-HU
(EUCTR)

30/05/2012

20/03/2012

Moderate to severe rheumatoid arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

1747

EUCTR2011-005634-19-HU
(EUCTR)

30/05/2012

11/04/2012

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2b

Serbia;Estonia;Spain;Ukraine;Chile;Russian Federation;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany

1748

EUCTR2011-004720-35-SE
(EUCTR)

28/05/2012

22/12/2011

Trade Name: Cimzia
Trade Name: Orencia
Trade Name: RoActemra
INN or Proposed INN: METHOTREXATE
Trade Name: Metoject
Other descriptive name: AZATHIOPRINE
INN or Proposed INN: LEFLUNOMIDE

The Karolinska Institute, ClinTRID

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Sweden

1749

EUCTR2011-006040-79-DK
(EUCTR)

25/05/2012

A clinical trial with the aim to explore the efficacy and safety of adding tocilizumab to standard of care in patients withearly rheumatoid arth

The efficacy and safety of adding tocilizumab to methotrexate and intra-articular glucocorticosteroid treatment in early rheumatoid arthritis.A randomized, double-blinded, placebo-controlled trial. - DanACT Early

Adult Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: RoActemra ®

Aarhus University Hospital, Department of Rheumatology U

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 4

Denmark

1750

EUCTR2011-004419-22-DE
(EUCTR)

23/05/2012

01/03/2012

Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1751

EUCTR2011-005021-48-CZ
(EUCTR)

23/05/2012

15/02/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands

1752

EUCTR2011-001729-25-IT
(EUCTR)

23/05/2012

19/03/2012

Study designed to demonstrate the efficacy and safety of certolizumab pegol in combination with Methotrexate in the treatment of subjects suffering from early, progressive active rheumatoid arthritis

Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
INN or Proposed INN: METHOTREXATE

UCB PHARMA SA/NV.

NULL

Not Recruiting

Female: yes
Male: yes

800

United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden

1753

EUCTR2011-006070-73-BG
(EUCTR)

22/05/2012

07/05/2012

Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis

Product Name: Fostamatinib 50 mg blue film-coated tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

130

United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;South Africa;Bulgaria;Germany

1754

NCT01569152
(ClinicalTrials.gov)

May 22, 2012

30/3/2012

Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Dose-Ranging Clinical Trial With a Proof-of-Concept Lead Cohort to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis (RA)

Drug: MK-8457 100 mg;Drug: Dose-Matched Placebo;Drug: Methotrexate

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

N/A

All

Phase 2

Canada;Chile;Denmark;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Moldova, Republic of;Peru;Poland;South Africa;Taiwan;United Kingdom;United States

1755

EUCTR2011-001729-25-SE
(EUCTR)

22/05/2012

22/02/2012

Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1756

EUCTR2011-006070-73-CZ
(EUCTR)

16/05/2012

29/02/2012

Evaluation of the Effect of Fostamatinib Dosed at 100mg twice a Day on Blood Pressure when Walking, Moving Around and Living Normal Daily Life in Patients with Rheumatoid Arthritis

Product Name: Fostamatinib 50 mg blue film-coated tablet
Product Code: R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: R788 sodium hexahydrate, RIG2-01, RIG-G

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

130

United States;Czech Republic;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Bulgaria;South Africa;Germany

1757

EUCTR2011-005021-48-ES
(EUCTR)

14/05/2012

21/02/2012

A study to investigate and compare the efficacy, safety, tolerability andpharmacodynamic (biochemical and physiological effects of the drug) ofTL011 and MabThera® (rituximab) in patients with severe, activerheumatoid arthritis treated with methotrexate (MTX)

A multicenter, double-blind, randomized, active controlled, parallelgroupstudy to evaluate the efficacy, safety, tolerability andpharmacodynamic profiles of TL011 infusions compared with MabThera®(rituximab) in subjects with severe, active rheumatoid arthritis treatedwith methotrexate (MTX) - ALTO

Sujetos adultos con artritis reumatoide (AR) activa de grado severo tratados con MTX
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg Concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland

1758

EUCTR2012-000139-21-AT
(EUCTR)

14/05/2012

23/04/2012

Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action

A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Other descriptive name: TOCILIZUMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Other descriptive name: TOCILIZUMAB

Medizinische Universität Wien, Universitätsklinik für Innere Medizin III

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic;Slovakia;Austria;Russian Federation;Switzerland

1759

EUCTR2011-005448-87-HU
(EUCTR)

14/05/2012

21/03/2012

A STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S)

A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S)

Trade Name: Enbrel ® 50 mg Solution for Injection in Pre-filled Syringe
INN or Proposed INN: ETANERCEPT

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

320

United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China

1760

EUCTR2011-004529-28-PL
(EUCTR)

14/05/2012

28/03/2012

A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis

Product Name: JNJ-40346527 -AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Poland;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1761

EUCTR2012-000439-17-LT
(EUCTR)

11/05/2012

15/03/2012

active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: None
Other descriptive name: MK-8457
Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: None
Other descriptive name: MK-8457

MERCK SHARP & DOHME CORP.

NULL

Not Recruiting

Female: yes
Male: yes

342

Phase 2

1762

EUCTR2011-005008-14-HU
(EUCTR)

10/05/2012

28/02/2012

Not applicable

Randomized, Double blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis who have an Inadequate Response to Methotrexate Alone

Product Name: GLPG0634
Product Name: GLPG0634
Product Name: GLPG0634
Product Name: GLPG0634

Galapagos SASU

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;European Union;Ukraine;Russian Federation;Moldova, Republic of

1763

EUCTR2011-005021-48-BG
(EUCTR)

09/05/2012

20/04/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands

1764

EUCTR2011-006125-14-HU
(EUCTR)

04/05/2012

08/03/2012

A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS - FUNCTION LTE

Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: RoActemra
Product Code: RO4877533

Roche (Magyarország) Kft.

NULL

Not Recruiting

Female: yes
Male: yes

241

Hungary

1765

EUCTR2011-005021-48-HU
(EUCTR)

04/05/2012

15/02/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1766

EUCTR2011-004419-22-EE
(EUCTR)

02/05/2012

21/03/2012

Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

United States;Serbia;Estonia;Slovakia;Ukraine;Russian Federation;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany

1767

JPRN-UMIN000014484

2012/05/01

01/12/2014

Saitama Actemra study for QOL in patients with Rheumatoid arthritis

rheumatoid arthritis

Treatment with Tocilizumab

Juntendo University, Juntendo Koshigaya Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

1768

JPRN-UMIN000007786

2012/05/01

19/04/2012

"Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis "

Rheumatoid Arthritis

infliximab plus methotrexate

Saitama Medical Center. Saitama Medical University

NULL

Complete: follow-up complete

20years-old

75years-old

Male and Female

Not applicable

Japan

1769

NCT01554917
(ClinicalTrials.gov)

May 2012

12/3/2012

A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Iguratimod

Jiangsu Simcere Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

N/A

All

1759

Phase 4

China

1770

NCT01548001
(ClinicalTrials.gov)

May 2012

5/3/2012

Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis

A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Iguratimod;Drug: Methotrexate

Jiangsu Simcere Pharmaceutical Co., Ltd.

NULL

Active, not recruiting

18 Years

65 Years

Both

910

Phase 4

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1771

NCT01664598
(ClinicalTrials.gov)

May 2012

10/8/2012

An Extension Study of WA19926 of the Long-Term Safety of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis

A Multicenter, Open-label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

Phase 3

Russian Federation

1772

NCT01668641
(ClinicalTrials.gov)

May 2012

14/8/2012

Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II Study to Compare Four Dose Regimens of GLPG0634 Versus Placebo, in Combination With Methotrexate, Administered for 4 Weeks in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

Rheumatoid Arthritis

Drug: GLPG0634;Drug: Placebo

Galapagos NV

NULL

Completed

18 Years

70 Years

Both

Phase 2

Hungary;Moldova, Republic of;Russian Federation;Ukraine

1773

NCT01617590
(ClinicalTrials.gov)

May 2012

28/5/2012

Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

A 48-week, Multi-center, Randomized, Open-lable, Controlled Study to Assess the Response (ACR20) Using Different Disease-Modifying Antirheumatic Drugs Cycle Combination Regimen in Adult Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: leflunomide;Drug: methotrexate

Shanxi Medical University

NULL

Recruiting

18 Years

75 Years

Both

500

N/A

China

1774

NCT01618968
(ClinicalTrials.gov)

May 2012

4/6/2012

Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device

Exposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis (RA)

Drug: MTX

Antares Pharma Inc.

NULL

Completed

18 Years

N/A

All

Phase 2

United States

1775

NCT01617005
(ClinicalTrials.gov)

May 2012

8/6/2012

A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

N/A

Montenegro

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1776

NCT01559103
(ClinicalTrials.gov)

May 2012

19/3/2012

Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients

A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6)

Rheumatoid Arthritis

Biological: MEDI5117;Biological: MEDI5117 Placebo

AstraZeneca

NULL

Terminated

20 Years

75 Years

Both

Phase 1

United States;Germany;United Kingdom

1777

NCT01618955
(ClinicalTrials.gov)

May 2012

4/6/2012

Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device

Phase 2, Multi-Center, Open-Label, Single-Dose, Single Arm, In-Clinic Study to Evaluate the Actual Human Use of Methotrexate Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device in Adult Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis (RA)

Device: VIBEX MTX

Antares Pharma Inc.

NULL

Completed

18 Years

N/A

All

101

Phase 2

United States

1778

NCT01724268
(ClinicalTrials.gov)

May 2012

7/11/2012

Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient

Randomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot Study

RHEUMATOID ARTHRITIS

Drug: Pred + Meth;Drug: Anti TNF + Meth

Hamad Medical Corporation

NULL

Recruiting

18 Years

N/A

Both

Phase 3

Qatar

1779

NCT01638715
(ClinicalTrials.gov)

May 2012

3/7/2012

A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action

Rheumatoid Arthritis

Drug: Remicade;Drug: Orencia;Drug: Ro-Actemra;Drug: Mabthera

Medical University of Vienna

NULL

Completed

18 Years

75 Years

All

115

Phase 4

Austria;Czechia;Russian Federation;Switzerland;Czech Republic;Saudi Arabia

1780

NCT01576549
(ClinicalTrials.gov)

May 2012

10/4/2012

A Study of LY2127399 in Rheumatoid Arthritis

An Exploratory Open-Label Biomarker Study of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Synovial Biopsies

Rheumatoid Arthritis

Drug: LY2127399

Eli Lilly and Company

NULL

Terminated

18 Years

N/A

All

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1781

NCT01613079
(ClinicalTrials.gov)

May 2012

4/6/2012

Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

Evaluation of Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of RA Patients With Clinical Efficacy and Safety.

Arthritis, Rheumatoid

Drug: Tripterygium wilfordii Hook F;Drug: Methotrexate

Peking Union Medical College Hospital

NULL

Completed

18 Years

65 Years

Both

201

Phase 2;Phase 3

China

1782

JPRN-UMIN000009535

2012/04/25

12/12/2012

Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate

Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate - SCRUM study

rheumatoid arthritis

We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation .
MTX increase group was increased to 16mg, it will continue to increase as much as possible.
We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation .
MTX increase group was increased to 16mg, it will continue to increase as much as possible.
We observe the patients if there is no positive joint power Doppler signal.

Osaka City University Medical School

NULL

Complete: follow-up complete

20years-old

100years-old

Male and Female

120

Not selected

Japan

1783

JPRN-UMIN000018017

2012/04/23

22/06/2015

Analysis for the reactivation of hepatitis B virus (HBV) in rheumatoid arthritis or psoriasis patients with past HBV infection treated with anti-tumor necrosis factor-alpha therapy

rheumatoid arthritis or psoriasis patients with past hepatitis B virus infection

The effect of preventive lamivudine, adefovir or entecavir on de novo HBV hepatitis.

Department of general internal medicine, Kyushu-University hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

1784

EUCTR2011-004529-28-HU
(EUCTR)

18/04/2012

01/03/2012

A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis

Product Name: JNJ-40346527 -AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Czech Republic;Hungary;Argentina;Poland;Ukraine;Singapore;Chile;Bulgaria;Russian Federation;Korea, Republic of

1785

JPRN-UMIN000011087

2012/04/11

01/07/2013

Efficacy of monthly minodronate for the treatment of osteoporosis associated with rheumatoid arthritis after previous treatment with bisphosphonates

Osteoporosis

Minodronic acid (50mg/month or 1mg/day)

Osaka University Graduate School of Medicine

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

100

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1786

EUCTR2011-001729-25-DE
(EUCTR)

11/04/2012

10/01/2012

Early active rheumatoid arthritis
MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

800

United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden

1787

EUCTR2011-005021-48-PL
(EUCTR)

10/04/2012

14/03/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Poland;Macedonia, the former Yugoslav Republic of

1788

EUCTR2011-002392-41-BG
(EUCTR)

09/04/2012

07/02/2012

A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.

A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Treatment of patients with moderate to severe rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Z102
Product Code: Z102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
Product Name: Prednisone
INN or Proposed INN: PREDNISONE

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria

1789

EUCTR2011-001729-25-CZ
(EUCTR)

03/04/2012

03/02/2012

Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

800

United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden

1790

JPRN-UMIN000007380

2012/04/01

01/05/2012

Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis

rheumatoid arthritis

tocilizumab + methotrexate (10mg/week)
high-dose methotrexate (stepwisely increased to 16mg/week)

Kinki University Faculty of Medicine, Division of Hematology and Rheumatology

NULL

Complete: follow-up complete

20years-old

80years-old

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1791

JPRN-UMIN000007432

2012/04/01

02/03/2012

Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody.

rheumatoid arthritis

Infliximab and Methotrexate.
Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks (indispensable), and if SDAI Score 3.3 or more, it will change into of 3mg/kg 4week or 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. If not remission(SDAI Score 3.3 or more), after change into of 3mg/kg 4week interval medication, it will change into of 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks.

Keio University

NULL

Complete: follow-up continuing

20years-old

75years-old

Male and Female

100

Not selected

Japan

1792

NCT01655381
(ClinicalTrials.gov)

April 2012

30/7/2012

A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis

A Multicenter, Open-label, Single Arm, Long-term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

France

1793

NCT01590459
(ClinicalTrials.gov)

April 2012

27/4/2012

24-week Study With Open Label Extension of VX-509, an Oral JAK3 Inhibitor, in Subjects Taking Methotrexate

Rheumatoid Arthritis

Drug: VX-509;Drug: VX-509 matching placebo

Vertex Pharmaceuticals Incorporated

NULL

Completed

18 Years

80 Years

Both

359

Phase 2

United States;Argentina;Bulgaria;Czech Republic;Estonia;Germany;Hungary;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine

1794

NCT01583959
(ClinicalTrials.gov)

April 2012

15/3/2012

Study of Different Doses of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis

Randomized Trial of 10 mg Versus 30 mg Per Week of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Folic Acid;Drug: Placebo

Postgraduate Institute of Medical Education and Research

NULL

Completed

18 Years

75 Years

Both

100

Phase 4

India

1795

NCT01579890
(ClinicalTrials.gov)

April 2012

16/4/2012

Compassionate Use of Pennsaid Topical Lotion (Diclofenac) in Osteo or Rheumatoid Arthritis

A Non-blinded, Non-placebo Controlled, Compassionate Use, Open Treatment, Open-ended Program of the Safety of Pennsaid Topical Lotion (Diclofenac) in the Treatment of Osteo or Rheumatoid Arthritis

Osteoarthritis of the Hand

Drug: Diclofenac

Mallinckrodt

Nuvo Research Inc.

Approved for marketing

N/A

Both

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1796

NCT02818361
(ClinicalTrials.gov)

April 2012

15/6/2016

Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Topical tripterygium gel;Drug: Placebo gel

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

NULL

Completed

18 Years

65 Years

All

N/A

China

1797

NCT01484561
(ClinicalTrials.gov)

April 2012

30/11/2011

A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis

A Phase 1, Randomized, Placebo-Controlled, Two-Period, Fixed Sequence Study To Evaluate The Effect Of CP-690,550 On Measured Glomerular Filtration Rate In Patients With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: CP -690,550 or Placebo;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

148

Phase 1

United States;Czech Republic;Germany;Korea, Republic of;Mexico;Poland;Russian Federation;Spain

1798

NCT02171143
(ClinicalTrials.gov)

April 2012

18/6/2014

A Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate

Rheumatoid Arthritis;Pharmacokinetics of ASP2409

Drug: ASP2409;Drug: Placebo

Astellas Pharma Global Development, Inc.

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States

1799

NCT01569074
(ClinicalTrials.gov)

April 2012

30/3/2012

Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis

(OSKIRA-Asia-1): A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy

Rheumatoid Arthritis

Drug: Fostamatinib;Drug: Placebo

AstraZeneca

NULL

Terminated

18 Years

N/A

All

163

Phase 2

Hong Kong;Japan;Korea, Republic of;Taiwan;Thailand;Vietnam

1800

NCT01563978
(ClinicalTrials.gov)

April 2012

23/3/2012

Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis

OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: fostamatinib;Drug: placebo

AstraZeneca

NULL

Completed

18 Years

N/A

All

266

Phase 2

United States;Bulgaria;Czech Republic;Germany;Poland;South Africa;Ukraine;Argentina;Mexico;Peru

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1801

EUCTR2011-004171-36-ES
(EUCTR)

30/03/2012

30/01/2012

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: SAIT101
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody
Trade Name: MabThera ®
Product Name: MabThera ®
INN or Proposed INN: RITUXIMAB

Samsung Electronics Co. Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

616

Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of

1802

EUCTR2011-004171-36-PL
(EUCTR)

29/03/2012

22/02/2012

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

1803

EUCTR2011-002392-41-HU
(EUCTR)

28/03/2012

16/12/2011

A trial to compare Z102 against Prednisone in patients with rheumatoid arthritis.

A PHASE II, DOUBLE-BLIND, CONTROLLED, MULTI-CENTER, RANDOMIZED, LONG TERM SAFETY TRIAL OF Z102 AND PREDNISONE (5 MG OR 7.5 MG) IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Product Name: Z102
Product Code: Z102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
Product Name: Prednisone
INN or Proposed INN: PREDNISONE

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Serbia;United States;Ukraine;Chile;Russian Federation;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Peru;Bulgaria

1804

EUCTR2010-021184-32-EE
(EUCTR)

23/03/2012

08/03/2012

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Hexal AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

164

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Germany

1805

EUCTR2011-001729-25-HU
(EUCTR)

22/03/2012

26/01/2012

Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

800

United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1806

NCT01526057
(ClinicalTrials.gov)

March 20, 2012

1/2/2012

A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)

Rheumatoid Arthritis

Biological: PF-05280586;Biological: MabThera;Biological: Rituxan

Pfizer

NULL

Completed

18 Years

N/A

All

220

Phase 2

United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Taiwan

1807

EUCTR2011-006001-10-IT
(EUCTR)

19/03/2012

14/03/2012

Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response

Rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MABTHERA *EV 1FL 50ML 500MG
INN or Proposed INN: RITUXIMAB
Other descriptive name: NA
Trade Name: MABTHERA *EV 1FL 50ML 500MG
INN or Proposed INN: RITUXIMAB
Other descriptive name: NA

A.O. UNIVERSITARIA INTEGRATA DI VERONA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

1808

EUCTR2011-001729-25-ES
(EUCTR)

16/03/2012

27/01/2012

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

800

United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden

1809

EUCTR2011-002275-41-CZ
(EUCTR)

15/03/2012

28/12/2011

A Study of Two Different Adalimumab Formulations in Adults withRheumatoid Arthritis.

A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis.

Rheumatoid Arthritis.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Belgium

1810

EUCTR2011-004468-31-LT
(EUCTR)

14/03/2012

05/01/2012

Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis

An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1811

EUCTR2009-011791-30-HU
(EUCTR)

14/03/2012

19/01/2012

A multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis

A randomised, double-blind, placebo-controlled, multiple dose trial of NNC0151-0000-0000 in subjects with rheumatoid arthritis

Product Name: NNC151-0000
Product Code: NNC0151-0000-0000
Other descriptive name: Anti-C5aR

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Hungary;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom

1812

EUCTR2011-003953-25-DE
(EUCTR)

13/03/2012

04/01/2012

A Study of Two Different Adalimumab Formulations in Adults with Rheumatoid Arthritis.

A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
Product Code: L04 AB04
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Canada;Australia;Germany

1813

EUCTR2011-001729-25-IE
(EUCTR)

09/03/2012

12/01/2012

Early active rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden

1814

EUCTR2011-001729-25-AT
(EUCTR)

08/03/2012

08/02/2012

Early active rheumatoid arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Cimzia
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Trexan
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

800

United States;Spain;Ireland;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden

1815

NCT01649999
(ClinicalTrials.gov)

March 1, 2012

23/7/2012

A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects

Phase 2b Study of ASP015K - A Double-Blind, Placebo-Controlled, Dose-Finding Study in Moderate to Severe Rheumatoid Arthritis Patients

Arthritis, Rheumatoid

Drug: peficitinib;Drug: Placebo

Astellas Pharma Inc

NULL

Completed

20 Years

75 Years

All

281

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1816

JPRN-UMIN000017230

2012/03/01

22/04/2015

Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)

Rheumatoid arthritis

Biologic treatment (tocilizumab)

Kyushu University

NULL

Recruiting

20years-old

Not applicable

Male and Female

Not selected

Japan

1817

NCT01626573
(ClinicalTrials.gov)

March 2012

3/5/2012

A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis

A Double- Blind, Placebo Controlled Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Itacitinib;Drug: Itacitinib Placebo

Incyte Corporation

NULL

Completed

18 Years

75 Years

All

106

Phase 2

United States;Puerto Rico

1818

NCT01561313
(ClinicalTrials.gov)

March 2012

21/3/2012

Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab.

A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis.

Rheumatoid Arthritis

Biological: Adalimumab

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

N/A

All

Phase 2

Belgium;Czech Republic

1819

NCT01571219
(ClinicalTrials.gov)

March 2012

23/3/2012

An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-Administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab(Remicade or CP-P13) in Study CT-P13 3.1

Rheumatoid Arthritis

Biological: Infliximab

Celltrion

NULL

Completed

18 Years

75 Years

All

302

Phase 3

Korea, Republic of;United Kingdom

1820

NCT01670045
(ClinicalTrials.gov)

March 2012

17/8/2012

A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

N/A

Indonesia;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1821

NCT01542580
(ClinicalTrials.gov)

March 2012

27/2/2012

A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

Osteoarthritis;Rheumatoid Arthritis;Traumatic Arthritis;Post Traumatic Deformity;Complications; Arthroplasty;Deformity of Limb

Device: Vanguard SSK 360 with PS Bearing;Device: Vanguard SSK 360 with PSC bearing;Device: Vanguard DA 360;Device: Vanguard 360 TiNbN Femur with PS bearing;Device: Vanguard 360 TiNbN Femur with PSC bearing

Zimmer Biomet

NULL

Enrolling by invitation

18 Years

N/A

All

255

United States;Belgium;Denmark;France;Germany;Italy;Spain;United Kingdom

1822

NCT01582880
(ClinicalTrials.gov)

March 2012

10/4/2012

Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis

The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis

Chemical Injuries;Unspecified Complication of Corneal Transplant;Autoimmune Diseases;Ocular Cicatricial Pemphigoid;Stevens Johnson Syndrome;Lupus Erythematosus, Systemic;Rheumatoid Arthritis;Other Autoimmune Diseases

Drug: Riboflavin

Joseph B. Ciolino, MD

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

1823

NCT01612377
(ClinicalTrials.gov)

March 2012

22/2/2012

Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis

A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Prednisolone -Dipyridamole;Drug: Prednisone;Drug: prednisone

Zalicus

NULL

Terminated

18 Years

N/A

Both

Phase 2

Serbia

1824

NCT01565408
(ClinicalTrials.gov)

March 2012

21/3/2012

Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis

Safety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC0114-0006;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

75 Years

All

Phase 1

Germany;Russian Federation

1825

EUCTR2011-004171-36-GB
(EUCTR)

24/02/2012

15/12/2011

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1826

EUCTR2011-004171-36-HU
(EUCTR)

23/02/2012

16/12/2011

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

1827

EUCTR2011-002024-40-ES
(EUCTR)

16/02/2012

14/10/2011

Proof-of-Concept Study with BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults with Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

Product Name: CCR1 Antagonist
Product Code: BMS-817399

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

172

Russian Federation;Mexico;Argentina;Korea, Republic of;Spain;United States;South Africa

1828

EUCTR2011-004171-36-CZ
(EUCTR)

15/02/2012

30/11/2011

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Samsung Electronics Co. Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

1829

EUCTR2011-004468-31-ES
(EUCTR)

10/02/2012

07/12/2011

Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Portugal;Colombia;Bulgaria;Chile;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Poland;Jordan

1830

EUCTR2011-004468-31-PL
(EUCTR)

07/02/2012

10/02/2012

Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1831

EUCTR2011-004468-31-LV
(EUCTR)

06/02/2012

30/12/2011

Long-term safety and effectivenss CT-P13 together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Portugal;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

1832

EUCTR2011-000311-34-IT
(EUCTR)

03/02/2012

06/12/2011

GO-AHEAD

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects with Active Axial Spondyloarthritis (Phase 3b, Protocol No. P07642, also known as MK-8259-006-00). - GO-AHEAD

Active Axial Spondyloarthritis (SpA)
MedDRA version: 14.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB

SCHERING PLOUGH RESEARCH INSTITUTE, A DIVISION OF SCHERING CORPORATION

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3b

United States;Greece;Canada;Finland;Spain;Turkey;Russian Federation;Germany;United Kingdom;Italy

1833

EUCTR2011-004468-31-IT
(EUCTR)

02/02/2012

02/03/2012

Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Other descriptive name: NA

CELLTRION, INC.

NULL

Not Recruiting

Female: yes
Male: yes

617

Korea, Republic of;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Peru;Latvia;Bosnia and Herzegovina

1834

JPRN-UMIN000007019

2012/02/01

01/02/2012

Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease

Rheumatoid arthritis

tocilizumab monotherapy

Department of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical Universitity

NULL

Complete: follow-up complete

16years-old

70years-old

Male and Female

Not selected

Japan

1835

JPRN-UMIN000007205

2012/02/01

02/02/2012

The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis

Rheumatoid arthritis

1) Tacrolimus
Oral administration of tacrolimus is started usually at a dose of 1.5 mg/day immediately after informed consent is obtained.
The dose can be increased or decreased within the limits of 3 mg/day with taking into account symptoms, adverse reactions and so on.
However, the administration of tacrolimus can be started at a dose of 0.5 or 1.0 mg/day in order to reduce adverse effects.

Juntendo University

NULL

Pending

65years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1836

NCT01567358
(ClinicalTrials.gov)

February 2012

23/3/2012

Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis

A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate

Rheumatoid Arthritis

Biological: Infliximab

Nichi-Iko Pharmaceutical Co.,Ltd.

NULL

Completed

20 Years

75 Years

Both

Phase 1

Japan

1837

NCT01623752
(ClinicalTrials.gov)

February 2012

18/6/2012

Prospective Evaluation of the Radiographic Efficacy of Enbrel

A PROSPECTIVE EVALUATION OF THE RADIOGRAPHIC EFFICACY OF ETANERCEPT IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIATIC ARTHRITIS.

Rheumatoid Arthritis;Psoriasis Arthritis

Drug: Etanercept

Pfizer

NULL

Completed

18 Years

N/A

All

1821

NULL

1838

NCT01587989
(ClinicalTrials.gov)

February 2012

12/3/2012

A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) Versus Tocilizumab Monotherapy in Patients With Mild to Moderate Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 < 4,5 and >2,6)

Rheumatoid Arthritis

Drug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Austria

1839

NCT01613027
(ClinicalTrials.gov)

February 2012

25/5/2012

An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis

A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)

Rheumatoid Arthritis

Biological: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

135

N/A

Greece

1840

NCT01646385
(ClinicalTrials.gov)

February 2012

12/4/2012

Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry

Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data

Rheumatoid Arthritis

Drug: etanercept;Drug: non-biologic anti-rheumatic drugs

Pfizer

NULL

Completed

18 Years

N/A

All

6393

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1841

NCT01438892
(ClinicalTrials.gov)

February 2012

20/9/2011

Impact Of RA Therapy Compliance On Patient-Reported Outcomes

Rheumatoid Arthritis

Drug: tDMARDs;Drug: biodmards

Pfizer

NULL

Completed

18 Years

N/A

Both

396

N/A

United States

1842

NCT01395251
(ClinicalTrials.gov)

February 2012

12/7/2011

Diagnostic Value of Oral Prednisolone Test for Rheumatoid Arthritis

Phase II/III Study of Oral Prednisolone Test in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Prednisolone

Rheumazentrum Ruhrgebiet

NULL

Completed

18 Years

N/A

Both

130

Phase 2;Phase 3

Germany

1843

NCT01534884
(ClinicalTrials.gov)

February 2012

8/2/2012

Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: rituximab

Celltrion

NULL

Completed

18 Years

75 Years

Both

154

Phase 1

Korea, Republic of

1844

NCT01940926
(ClinicalTrials.gov)

February 2012

9/9/2013

68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis

Diagnostic Performance and Evaluation Efficacy of 68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: 68Ga-BNOTA-PRGD2

Peking Union Medical College Hospital

NULL

Unknown status

18 Years

N/A

All

Early Phase 1

China

1845

NCT01562327
(ClinicalTrials.gov)

February 2012

21/3/2012

A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab Actemra

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

N/A

Argentina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1846

EUCTR2011-002275-41-BE
(EUCTR)

31/01/2012

06/01/2012

A Study of Two Different Adalimumab Formulations in Adults withRheumatoid Arthritis.

A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects with Rheumatoid Arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Belgium

1847

EUCTR2011-004468-31-AT
(EUCTR)

26/01/2012

30/11/2011

Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;Colombia;Bulgaria;Chile;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Jordan;Poland

1848

EUCTR2010-023782-22-SK
(EUCTR)

25/01/2012

07/10/2011

A TRIAL TO TEST THE EFFICACY AND SAFETY OF STUDY DRUG PF-04171327(1,5,10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY FOR SUBJECTS WITH RHEUMATOID ARHTRITIS OVER A PERIOD OF 8 WEEKS FOLLOWED BY 4 WEEKS OF TAPERING OF STUDY DRUG

A PHASE 2, RANDOMIZED, DOUBLE-BLIND ASSESSMENT OF EFFICACY AND SAFETY OF PF-04171327(1, 5, 10, 15 MG DOSE, DAILY) COMPARED TO 5 MG AND 10 MG PREDNISONE DAILY AND PLACEBO DAILY IN SUBJECTS WITH RHEUMATOID ARTHRITIS OVER AN 8 WEEK PERIOD FOLLOWED BY A 4 WEEK PERIOD OF TAPERING OF STUDY DRUG

Rheumatoid Arthritis
MedDRA version: 16.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-04171327
INN or Proposed INN: Not available
Product Code: PF-04171327
INN or Proposed INN: Not available
Product Code: PF-04171327
INN or Proposed INN: Not available
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

315

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of

1849

EUCTR2011-002849-36-LV
(EUCTR)

12/01/2012

22/11/2011

A study of multiple different dosages of JNJ 39758979 and placebo in patients with active Rheumatoid Arthritis

A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ-39758979 in Subjects with Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy - not available

Product Name: JNJ-39758979 -AAC - enteric coated tablet - 10 mg
Product Code: JNJ-39758979
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Product Name: JNJ-39758979 -AAC - enteric coated tablet - 30 mg
Product Code: JNJ-39758979
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned
Product Name: JNJ-39758979 -AAC - enteric coated tablet - 100 mg
Product Code: JNJ-39758979
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

325

Phase 2b

United States;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Mexico;Argentina;Poland;Malaysia;Singapore;Romania;Latvia;Japan

1850

EUCTR2011-004468-31-GB
(EUCTR)

06/01/2012

25/11/2011

Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Phase 3

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1851

JPRN-UMIN000012613

2012/01/01

20/12/2013

Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients.

rheumatoid arthritis

etanercept50mg/wk or25mg twice/wk
reduction of etanercept to 25mg/wk arfter 3 months from remission

Dept. of orthopedic surgery, Osaka Medical College

NULL

Complete: follow-up complete

20years-old

70years-old

Male and Female

Not selected

Japan

1852

ChiCTR-TRC-12001859

2012-01-01

2012-01-04

Treatment of coronary heart disease in rheumatoid arthritis with leflunomide combined with ligustrazine in clinical research

coronary heart disease in rheumatoid arthritis

1:leflunomide combined with ligustrazine;2:leflunomide combined with placebo;

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

NULL

Completed

Both

1:30;2:30;

China

1853

NCT01533714
(ClinicalTrials.gov)

January 2012

10/2/2012

The Long-term Safety and Efficacy of Olokizumab (CDP6038) With Active Rheumatoid Arthritis

Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083

Rheumatoid Arthritis

Biological: Olokizumab

UCB Pharma

NULL

Completed

20 Years

N/A

Both

103

Phase 2

Japan;Korea, Republic of;Taiwan

1854

NCT01521923
(ClinicalTrials.gov)

January 2012

19/1/2012

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Certolizumab Pegol + Methotrexate (MTX);Biological: Placebo + Methotrexate (MTX)

UCB Pharma

NULL

Completed

18 Years

N/A

All

359

Phase 3

United States;Argentina;Australia;Austria;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Monaco;Netherlands;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom;Czech Republic

1855

NCT01519791
(ClinicalTrials.gov)

January 2012

19/1/2012

Rheumatoid Arthritis

Biological: Certolizumab Pegol;Other: Placebo;Biological: Methotrexate

UCB Pharma SA

NULL

Completed

18 Years

N/A

All

880

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1856

NCT01506661
(ClinicalTrials.gov)

January 2012

5/1/2012

Safety of Zostavax Vaccination in Rheumatoid Arthritis

Immune Response to Varicella Zoster Vaccination (ZOSTAVAX) in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis;Varicella Zoster

Drug: Zostavax (varicella zoster virus) vaccine

Oklahoma Medical Research Foundation

NULL

Completed

50 Years

80 Years

All

Phase 1

United States

1857

NCT01474291
(ClinicalTrials.gov)

January 2012

15/11/2011

An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice

Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO

Rheumatoid Arthritis

Biological: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

608

N/A

France;Monaco

1858

NCT01502423
(ClinicalTrials.gov)

January 2012

1/12/2011

A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab

A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Adalimumab

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

N/A

All

Phase 2

Australia;Canada;Germany

1859

EUCTR2011-004468-31-SK
(EUCTR)

30/12/2011

04/01/2012

Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

1860

EUCTR2011-002633-19-DE
(EUCTR)

21/12/2011

02/08/2011

Prednisolone test for patients with an inflammatory joint disease

Diagnostic value of oral prednisolone test for rheumatoid arthritis - RZR12011-TryCort

rheumatoid arthritis
MedDRA version: 14.0;Level: LLT;Classification code 10062719;Term: Seronegative rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Product Name: Paracetamol
INN or Proposed INN: PARACETAMOL

Rheumazentrum Ruhrgebiet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1861

EUCTR2010-023782-22-BG
(EUCTR)

21/12/2011

21/05/2012

Rheumatoid Arthritis
MedDRA version: 15.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Hungary;Czech Republic;Mexico;Canada;Malaysia;Poland;Romania;Bulgaria;South Africa;Germany;Korea, Republic of

1862

EUCTR2010-023782-22-ES
(EUCTR)

16/12/2011

20/07/2011

Rheumatoid Arthritis
MedDRA version: 14.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer, S.L.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

315

Phase 2

Hungary;Colombia;Germany;Malaysia;Bulgaria;South Africa;India;Slovakia;Russian Federation;Czech Republic;Ukraine;Serbia;Canada;Mexico;Korea, Republic of;Romania;Spain;United States;Poland

1863

EUCTR2010-023782-22-DE
(EUCTR)

13/12/2011

16/09/2011

Rheumatoid Arthritis
MedDRA version: 16.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-04171327
INN or Proposed INN: na
Product Code: PF-04171327
INN or Proposed INN: na
Product Code: PF-04171327
INN or Proposed INN: na
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of

1864

EUCTR2009-016266-90-PT
(EUCTR)

09/12/2011

29/01/2010

Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients

A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1740

Belarus;United States;Portugal;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand

1865

EUCTR2011-000436-28-PL
(EUCTR)

07/12/2011

20/06/2011

A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Product Name: Z102
Product Code: Z102
INN or Proposed INN: Z102 (Prednisolone and Dipyridamole).
Product Name: Prednisolone
Product Code: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
Product Code: Dipyridamole
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
INN or Proposed INN: PREDNISONE

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1866

EUCTR2010-022208-36-PL
(EUCTR)

05/12/2011

08/04/2011

An Open Label Study for Patients With Rheumatoid Arthritis (FLEX-P)

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) (FLEX-P)

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1505

Phase 3b

Germany;Malaysia;France;Bulgaria;Brazil;Australia;South Africa;New Zealand;Peru;Korea, Republic of;United States;Greece;Croatia;Poland;Hungary;Colombia;Italy;Lithuania;India;Russian Federation;Slovakia;Ukraine;Taiwan;Sri Lanka;Argentina;Mexico;Romania;Spain;Japan

1867

EUCTR2010-020065-24-GR
(EUCTR)

05/12/2011

04/11/2011

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE

Trade Name: RoActemra ®
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody
Trade Name: Enbrel ®
INN or Proposed INN: ETANERCEPT
Other descriptive name: Etanercept

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2800

Phase 4

United States;Serbia;Philippines;Greece;Ecuador;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany

1868

NCT01480388
(ClinicalTrials.gov)

December 2011

23/11/2011

A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate

A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ-39758979 in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy

Active Rheumatoid Arthritis; Rheumatoid Arthritis

Drug: Placebo/JNJ-39758979 (300 mg/d);Drug: JNJ-39758979 (10 mg);Drug: JNJ-39758979 (30 mg);Drug: JNJ-39758979 (100 mg);Drug: JNJ-39758979 (300 mg)

Janssen Research & Development, LLC

NULL

Withdrawn

18 Years

80 Years

Both

Phase 2

United States

1869

NCT01443364
(ClinicalTrials.gov)

December 2011

27/9/2011

Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis

Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Biological: Certolizumab pegol

UCB Italy s.p.a.

NULL

Completed

18 Years

N/A

All

132

Phase 4

Italy

1870

EUCTR2011-001220-38-DE
(EUCTR)

30/11/2011

21/07/2011

A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis

A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

350

United States;Belgium;Russian Federation;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1871

NCT01326962
(ClinicalTrials.gov)

November 30, 2011

7/3/2011

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF

Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Saudi Arabia

1872

EUCTR2011-000275-13-BE
(EUCTR)

29/11/2011

20/10/2011

Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs

A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

630

Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan

1873

EUCTR2010-023956-99-CZ
(EUCTR)

29/11/2011

17/06/2011

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate

A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - site specific (v1.0, dated 11-Jan-2011)Revised Protocol 04 incorporating Protocol Amendment 12 (v1.0, dated 09-Oct-2014)

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 17.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
INN or Proposed INN: CLAZAKIZUMAB

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

677

Phase 2B

Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of;United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil

1874

EUCTR2011-005036-26-GB
(EUCTR)

29/11/2011

31/10/2011

A study to investigate what effects FX125L (taken by mouth) has on adults with chronic inflammatory diseases

An Exploratory Phase IIa Study to Investigate the Biological Activity of Oral FX125L in Adult Patients with Chronic Inflammatory Disease

AsthmaChronic obstructive pulmonary diseaseRheumatoid arthritisPsoriasis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Classification code 10003553;Term: Asthma;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Level: LLT;Classification code 10010952;Term: COPD;Classification code 10037153;Term: Psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: FX125L

Funxional Therapeutics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

United Kingdom

1875

EUCTR2010-023782-22-HU
(EUCTR)

22/11/2011

27/09/2011

Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer Inc.235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1876

ChiCTR-TRC-11001789

2011-11-14

2011-12-12

Effect of TGP combined with MTX and LEF on liver function in RA patients: Clinical study protocol

Rheumatoid Arthritis

Treatment:TGP capsules (TGP) + methotrexate (MTX) + leflunom;Control:methotrexate(MTX) + leflunomide (LEF);

Anhui Provincial Hospital Department of Rheumatism

NULL

Completed

Both

Treatment:140;Control:140;

China

1877

EUCTR2010-024516-34-BG
(EUCTR)

09/11/2011

07/09/2011

Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate

A randomized, double-blind, placebo-controlled regimen finding study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active Rheumatoid Arthritis despite treatment with methotrexate

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

215

United States;Hungary;Slovakia;Canada;Bulgaria;Italy

1878

EUCTR2011-000102-21-BG
(EUCTR)

09/11/2011

01/09/2011

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents

A randomized, double-blind, placebo- and active-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 1 year in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFa agents - NURTURE-1

Rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

1879

JPRN-UMIN000006653

2011/11/01

04/11/2011

Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US-

Trabecular Metal Primary Hip Prosthesis Registry Study -Multicenter clinical research in Japan and US- - TM Stem Registry Study -Multicenter clinical research in Japan and US

Patients who have been diagnosed Osteoarthritis, Rheumatoid Arthritis and Avascular Necrosis, etc.

Trabecular Metal Primary Hip Prosthesis by THA

Shonan Kamakura Joint Reconstruction Center

NULL

Complete: follow-up continuing

18years-old

Not applicable

Male and Female

100

Not applicable

Japan,North America

1880

NCT01468077
(ClinicalTrials.gov)

November 2011

7/11/2011

A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment

Multicenter, Randomized, Parallel Group Study to Compare the Incidence of Tocilizumab Related Infusion Reactions in Patients With Moderate to Severe Active RA, When Infusion is Given Over 31 Minutes Compared to 1 Hour

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 2

Denmark;Iceland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1881

NCT01251120
(ClinicalTrials.gov)

November 2011

30/11/2010

A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis

A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: DMARD

Hoffmann-La Roche

NULL

Terminated

18 Years

N/A

All

Phase 4

Finland

1882

NCT01469013
(ClinicalTrials.gov)

November 2011

8/11/2011

Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of Baricitinib (LY3009104) in Japanese Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy

Arthritis, Rheumatoid

Drug: Placebo;Drug: Baricitinib;Drug: Methotrexate

Eli Lilly and Company

NULL

Completed

20 Years

75 Years

All

145

Phase 2

Japan

1883

NCT01592292
(ClinicalTrials.gov)

November 2011

11/4/2012

An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent

Rheumatoid Arthritis

Drug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: Infliximab

Hoffmann-La Roche

NULL

Completed

20 Years

N/A

All

N/A

Korea, Republic of

1884

EUCTR2010-020992-21-SK
(EUCTR)

26/10/2011

06/12/2011

Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis

A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to methotrexate, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 3

United States;Slovakia;Greece;Spain;Thailand;Turkey;India;France;Czech Republic;Poland;Romania;Tunisia;Germany

1885

EUCTR2009-016266-90-BE
(EUCTR)

25/10/2011

22/08/2011

Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1594

Phase 2;Phase 3

Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Romania;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1886

EUCTR2011-000102-21-DE
(EUCTR)

20/10/2011

09/08/2011

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

1887

EUCTR2010-020992-21-ES
(EUCTR)

17/10/2011

28/05/2012

Comparación de la eficacia de masitinib frente a metotrexato en el tratamiento de la artritis reumatoide

Estudio prospectivo, Fase IIb/III, multicéntrico, randomizado, doble ciego, controlado, de 3 grupos paralelos y 24 semanas de duración con posible extensión, para comparar la eficacia y seguridad de masitinib, a la dosis de 3 y 4,5 mg/kg/día, con metotrexato, con randomización 1:1:1, en el tratamiento de pacientes con artritis reumatoide activa y con una respuesta inadecuada a 1. metotrexato, a 2. cualquier FAME incluido al menos un fármaco biológico si previamente resultó ineficaz en pacientes tratados con metotrexato o a 3. metotrexato en combinación con cualquier FAME incluidos fármacos biológicos - AB1010 en tratamiento de pacientes con artritis reumatoide activa.

Atritis Reumatoide
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: No aplica
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: no aplica
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: no aplica
INN or Proposed INN: METHOTREXATE
Other descriptive name: no aplica
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: No aplica
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: No aplica

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

140

Slovakia;Greece;Thailand;Spain;Turkey;Germany;India;United States;Czech Republic

1888

EUCTR2010-020992-21-CZ
(EUCTR)

12/10/2011

18/07/2011

Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis

A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 2b;Phase 3

United States;Czech Republic;Slovakia;Greece;Spain;Thailand;Turkey;Germany;India

1889

EUCTR2011-000436-28-BG
(EUCTR)

07/10/2011

06/10/2011

A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

Zalicus, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria

1890

EUCTR2010-019912-18-BG
(EUCTR)

03/10/2011

25/08/2011

A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Adult Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody
Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1891

NCT01557322
(ClinicalTrials.gov)

October 2011

8/2/2012

Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

Evaluation of the Clinical Characteristics, Real-world Treatment Pathways, and Outcomes of Patients With Moderate Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: etanercept;Drug: methotrexate (MTX)

Pfizer

NULL

Completed

18 Years

N/A

All

1754

N/A

NULL

1892

NCT01961505
(ClinicalTrials.gov)

October 2011

23/9/2013

Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis

A Randomized Controlled Study to Determine the Effects and Safety of Topical Compound Tripterygium Wilfordii Hook F in Patients With Active Rheumatoid Arthritis.

Active Rheumatoid Arthritis

Drug: Topical compound tripterygium;Drug: Placebo

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

NULL

Completed

18 Years

65 Years

All

N/A

NULL

1893

NCT01641952
(ClinicalTrials.gov)

October 2011

13/7/2012

An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent

Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program

Rheumatoid Arthritis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

505

N/A

Romania

1894

NCT01436370
(ClinicalTrials.gov)

October 2011

15/9/2011

TIV and High Dose TIV in Subjects With Rheumatoid Arthritis

A Phase II Study in Adults With Rheumatoid Arthritis Receiving TNF-alpha-inhibitor Therapy to Assess the Immunogenicity and Safety of Trivalent Inactivated Vaccine (TIV) and High Dose Trivalent Inactivated Vaccine (High-Dose TIV) Administered at Two Dosage Levels

Influenza

Biological: Trivalent inactivated influenza vaccine

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Completed

18 Years

64 Years

All

102

Phase 2

United States

1895

NCT01954381
(ClinicalTrials.gov)

October 2011

13/10/2011

Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Device: transthoracic echocardiographic;Device: Doppler ultrasound.;Biological: blood samples

Assistance Publique Hopitaux De Marseille

NULL

Completed

18 Years

N/A

Both

Phase 3

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1896

NCT01292616
(ClinicalTrials.gov)

October 2011

8/2/2011

Effect of TNF-Inhibition Combined With Conventional DMARDs on Cervical Pannus in Patients With RA and Cervical Spine Involvement

Rheumatoid Arthritis

Drug: therapy with disease-modifying anti rheumatic drugs (DMARD)

University of Zurich

NULL

Recruiting

18 Years

N/A

Both

N/A

Switzerland

1897

NCT01463059
(ClinicalTrials.gov)

October 2011

27/10/2011

Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy

A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy

Rheumatoid Arthritis

Biological: Placebo;Biological: Olokizumab 60 mg;Biological: Olokizumab 120 mg;Biological: Olokizumab 240 mg

UCB Japan Co. Ltd.

NULL

Completed

20 Years

N/A

Both

119

Phase 2

Japan;Korea, Republic of;Taiwan

1898

NCT01439204
(ClinicalTrials.gov)

October 2011

21/9/2011

Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb

A Randomized, Open-label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of Abatacept (BMS-188667) Drug Products Using Active Pharmaceutical Ingredient Manufactured at Devens, MA Site Relative to Active Pharmaceutical Ingredient Manufactured at Lonza, New Hampshire (NH) in Healthy Subjects

Rheumatoid Arthritis

Biological: Abatacept (BMS-188667)

Bristol-Myers Squibb

NULL

Completed

18 Years

55 Years

All

223

Phase 1

United States

1899

NCT01359943
(ClinicalTrials.gov)

October 2011

19/5/2011

Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate

A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered With an Intravenous (i.v.) or Subcutaneous (s.c.) Loading Regimen Compared to Placebo in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate

Rheumatoid Arthritis

Biological: secukinumab (AIN457);Drug: placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

221

Phase 2

United States;Bulgaria;Canada;Hungary;Italy;Poland;Puerto Rico;Slovakia

1900

EUCTR2010-024516-34-SK
(EUCTR)

29/09/2011

13/04/2012

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

215

United States;Hungary;Slovakia;Canada;Bulgaria;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1901

EUCTR2010-020065-24-BE
(EUCTR)

26/09/2011

16/05/2011

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

3080

United States;Serbia;Philippines;Ecuador;Greece;Spain;Russian Federation;Israel;Chile;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany

1902

EUCTR2011-000102-21-SK
(EUCTR)

22/09/2011

28/06/2011

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents

Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany

1903

EUCTR2010-023956-99-DE
(EUCTR)

22/09/2011

01/06/2011

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

677

Phase 2B

United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of

1904

EUCTR2010-023782-22-CZ
(EUCTR)

21/09/2011

01/08/2011

Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Russian Federation;Colombia;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Poland;Romania;South Africa;Bulgaria;Germany;Korea, Republic of

1905

EUCTR2011-001220-38-BE
(EUCTR)

19/09/2011

30/08/2011

A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis

A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

United States;Belgium;Russian Federation;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1906

EUCTR2010-023692-26-SK
(EUCTR)

09/09/2011

13/09/2011

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis - OSKIRA - 4

Product Name: Fostamatinib disodium
Product Code: previously known as R935788
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2

United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands

1907

EUCTR2010-020065-24-DE
(EUCTR)

06/09/2011

30/05/2011

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2800

Phase 4

United States;Serbia;Philippines;Ecuador;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany

1908

EUCTR2010-023587-40-NL
(EUCTR)

06/09/2011

11/05/2011

Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira ®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

700

Germany;Netherlands;Italy;Sweden;Greece;Finland;Spain

1909

NCT02164214
(ClinicalTrials.gov)

September 2011

4/7/2013

Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)?

DOES ETANERCEPT INFLUENCE TWEAK MODULATION OF INFLAMMATION DURING INFLAMMATORY RHEUMATISMS (PSORIATIC ARTHRITIS AND RHEUMATOID ARTHRITIS)?

Inflammatory Rheumatism;Psoriatic Arthritis;Rheumatoid Arthritis

Drug: etanercept Treatment

Assistance Publique Hopitaux De Marseille

NULL

Completed

18 Years

N/A

Both

Phase 3

France

1910

NCT01350804
(ClinicalTrials.gov)

September 2011

9/5/2011

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor a (Anti-TNFa) Agents (CAIN457F2309 and CAIN457F2309E1)

A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)

Rheumatoid Arthritis

Biological: AIN457;Biological: Placebo;Biological: Abatacept

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

551

Phase 3

United States;Brazil;Bulgaria;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Mexico;Romania;Russian Federation;Slovakia;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1911

NCT02076659
(ClinicalTrials.gov)

September 2011

24/2/2014

Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients

A Dose-finding, Pharmacokinetic Phase I Study of the Human Monoclonal Antibody-cytokine Fusion Protein F8IL10 (Dekavil) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: F8IL10;Drug: Methotrexate

Philogen S.p.A.

NULL

Completed

18 Years

75 Years

All

Phase 1

Italy

1912

NCT01446978
(ClinicalTrials.gov)

September 2011

3/10/2011

Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate

Vaccine Response Impaired

Biological: hepatitis A vaccine

Sormland County Council, Sweden

NULL

Active, not recruiting

18 Years

N/A

Both

150

Phase 2

Sweden

1913

NCT01462162
(ClinicalTrials.gov)

September 2011

27/10/2011

A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis

A Prospective Observational Study to Evaluate and Correlate the Impact of Treatment With Tocilizumab (RoActemra®) on Fatigue and Different Factors Influencing Fatigue in Participants With Rheumatoid Arthritis in Routine Clinical Practice

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

122

N/A

Spain

1914

NCT01544101
(ClinicalTrials.gov)

September 2011

27/2/2012

A Nutritional Intervention for Arthritis

Rheumatoid Arthritis

Other: Vegan Diet;Dietary Supplement: dietary supplement omega3 fatty acids aand vitamins

Physicians Committee for Responsible Medicine

NULL

Completed

18 Years

N/A

Both

N/A

United States

1915

NCT01404585
(ClinicalTrials.gov)

September 2011

27/7/2011

Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults With Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Placebo;Drug: BMS-817399

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

Both

123

Phase 2

United States;Argentina;Korea, Republic of;Mexico;Russian Federation;South Africa;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1916

NCT01359150
(ClinicalTrials.gov)

September 2011

11/5/2011

A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo

A Randomized, Double Blind, Placebo Controlled Phase 2 Study To Assess The Immune Response Following Administration Of Influenza And Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving Cp-690,550 Or Placebo Cp-690,550 With And Without Background Methotrexate

Rheumatoid Arthritis

Drug: CP -690,550;Drug: placebo

Pfizer

NULL

Completed

18 Years

N/A

All

223

Phase 2

United States;Poland

1917

NCT01393639
(ClinicalTrials.gov)

September 2011

13/6/2011

Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis

A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of Pf 04171327(1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Week Period Of Tapering Of Study Drug.

Rheumatoid Arthritis

Drug: PF-04171327;Drug: prednisone;Other: prednisone;Other: placebo

Pfizer

NULL

Completed

18 Years

N/A

All

323

Phase 2

United States;Bulgaria;Colombia;Czechia;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;Canada;Czech Republic

1918

NCT01417052
(ClinicalTrials.gov)

September 2011

12/8/2011

A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: 50 mg LX3305 QD;Drug: 100 mg LX3305 QD;Drug: 150 mg LX3305 QD;Drug: 200 mg LX3305 QD;Drug: 250 mg LX3305 QD;Drug: 300 mg LX3305 QD;Drug: 400 mg LX3305 QD;Drug: 250 mg LX3305 BID;Drug: 500 mg LX3305 QD;Drug: Placebo

Lexicon Pharmaceuticals

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States

1919

NCT01399697
(ClinicalTrials.gov)

September 2011

20/7/2011

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With MTX Versus Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 > 3,2)

Rheumatoid Arthritis

Drug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

261

Phase 4

Spain

1920

NCT01245439
(ClinicalTrials.gov)

September 2011

17/11/2010

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Turkey

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1921

EUCTR2010-020745-27-HU
(EUCTR)

31/08/2011

11/07/2011

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist (OSKIRA - 3)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany

1922

EUCTR2010-019912-18-HU
(EUCTR)

31/08/2011

08/06/2011

A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Adult Rheumatoid Arthritis (RA)
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

1923

EUCTR2010-024516-34-HU
(EUCTR)

31/08/2011

29/06/2011

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

215

United States;Hungary;Canada;Bulgaria;Italy

1924

EUCTR2010-020065-24-NL
(EUCTR)

31/08/2011

06/07/2011

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

3080

Phase 4

Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany

1925

NCT01377012
(ClinicalTrials.gov)

August 30, 2011

17/6/2011

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFa Agents

A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFa Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)

Rheumatoid Arthritis

Biological: Secukinumab (AIN457);Biological: Placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

637

Phase 3

United States;Argentina;Belgium;Canada;Colombia;Guatemala;Hungary;India;Italy;Japan;Mexico;Panama;Puerto Rico;Thailand;Turkey;United Kingdom;Peru;Romania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1926

EUCTR2010-020065-24-ES
(EUCTR)

25/08/2011

01/07/2011

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

Trade Name: RoActemra ®
INN or Proposed INN: tocilizumab
Other descriptive name: Anticuerpo monoclonal anti-humano recombinante humanizado, receptor de IL-6R.
Trade Name: Enbrel ®
INN or Proposed INN: ETANERCEPT
Other descriptive name: Etanercept

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2800

Phase 4

1927

EUCTR2011-000385-35-IT
(EUCTR)

19/08/2011

27/02/2012

MULTICENTER, OPEN LABEL STUDY TO EVALUATE THE PREDICTABILITY OF EARLY RESPONSE TO CERTOLIZUMAB PEGOL (IN COMBINATION WITH METHOTREXATE) AS CONFIRMED AT WEEK 52 IN SUBJECTS WITH MODERATE-SEVERE RHEUMATOID ARTHRITIS (RA): THE CZP-SPEED STUDY

Trade Name: CIMZIA
INN or Proposed INN: CERTOLUZIMAB PEGOL
Other descriptive name: NA

UCB PHARMA

NULL

Not Recruiting

Female: yes
Male: yes

Italy

1928

EUCTR2011-000102-21-CZ
(EUCTR)

19/08/2011

27/05/2011

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Czech Republic;Hungary;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

1929

EUCTR2010-022378-15-GB
(EUCTR)

18/08/2011

10/02/2011

A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.

VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET

Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (IMMU-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody

Nycomed GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom

1930

EUCTR2010-023956-99-HU
(EUCTR)

17/08/2011

18/05/2011

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

677

Phase 2B

United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1931

EUCTR2011-002363-15-IS
(EUCTR)

17/08/2011

22/06/2011

A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis.

Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST

Adult Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: RoActemra ®

Roche a/s

NULL

Not Recruiting

Female: yes
Male: yes

Denmark;Iceland

1932

EUCTR2011-000102-21-ES
(EUCTR)

17/08/2011

04/07/2011

Seguridad y Eficacia de secukinumab comparado con placebo y abatacept in pacientes con artritis reumatoide activa que no respodieron a agentes anti- TNFalfa

Estudio aleatorizado, doble ciego, controlado con placebo y con control activo de secukinumab para demostrar la eficacia en 24 semanas y evaluar la seguridad, tolerabilidad y eficacia a largo plazo durante 1 año en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada a anti-TNFalfa

ARTRITIS REUMATOIDE
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: secukinumab
Other descriptive name: NO APLICA
Trade Name: ORENCIA 250 mg polvo para concentrado para sol. para perfusión
INN or Proposed INN: ABATACEPT
Other descriptive name: ABATACEPT

Novartis Farmacéutica S.A.

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany

1933

EUCTR2011-002363-15-DK
(EUCTR)

16/08/2011

27/07/2011

A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis.

Trade Name: RoActemra ®
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody

Roche a/s

NULL

Not Recruiting

Female: yes
Male: yes

Denmark;Iceland

1934

EUCTR2010-020065-24-GB
(EUCTR)

15/08/2011

08/04/2011

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

3080

Phase 4

1935

EUCTR2010-021184-32-IT
(EUCTR)

03/08/2011

02/02/2011

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Refractory rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

164

Phase 2

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1936

NCT01331837
(ClinicalTrials.gov)

August 2, 2011

7/4/2011

A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Etanercept;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

50 Years

N/A

All

3080

Phase 4

United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Canada;Chile;Croatia;Czechia;Ecuador;France;Germany;Greece;Hungary;India;Israel;Italy;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Turkey;United Kingdom;Brazil;China;Czech Republic

1937

EUCTR2011-000436-28-HU
(EUCTR)

02/08/2011

10/08/2011

A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria

1938

NCT01390545
(ClinicalTrials.gov)

August 2011

5/7/2011

VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis

VELVET (Veltuzumab Various Doses Exploratory Trial), a Randomized, Double Blind, Placebo Controlled, Multicentre, Multinational Phase II Dose Range Finding Trial in Subjects With Moderate to Severe Rheumatoid Arthritis Insufficiently Controlled With Either Methotrexate Alone or Methotrexate Plus Anti-tumour Necrosis Factor Biological Treatment, Comparing 3 Different Subcutaneous Dosages of Anti-CD20 Monoclonal Antibody Veltuzumab to Placebo as an add-on Therapy to Methotrexate.

Rheumatoid Arthritis

Drug: Veltuzumab

Takeda

NULL

Terminated

18 Years

N/A

Both

300

Phase 2

United States;Argentina;Canada;Czech Republic;Germany;Hungary;Italy;Mexico;Poland;Spain;United Kingdom

1939

NCT01414101
(ClinicalTrials.gov)

August 2011

21/7/2011

Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 329993 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ISIS CRP Rx or Placebo

Isis Pharmaceuticals

NULL

Completed

18 Years

75 Years

Both

Phase 2

Canada;Russian Federation

1940

NCT01442545
(ClinicalTrials.gov)

August 2011

23/8/2011

A Study to Investigate How JNJ-39758979 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants

A Study to Investigate the Effect of Multiple Doses of JNJ 39758979 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Patients on a Stable Methotrexate Dose

Rheumatoid Arthritis

Drug: JNJ-39758979 / MTX

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1941

NCT01295151
(ClinicalTrials.gov)

August 2011

11/2/2011

SWITCH Clinical Trial for Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug.

Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug

Rheumatoid Arthritis

Drug: Etanercept;Drug: Abatacept;Biological: Rituximab;Drug: Adalimumab;Drug: Certolizumab Pegol;Drug: Infliximab;Drug: Golimumab

Julia Brown

NULL

Completed

18 Years

N/A

Both

122

Phase 4

United Kingdom

1942

NCT01426789
(ClinicalTrials.gov)

August 2011

12/8/2011

A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients

A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension

Rheumatoid Arthritis

Drug: Placebo;Drug: Secukinumab

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

100

Phase 2

United States;Belgium;Germany;Russian Federation;United Kingdom

1943

JPRN-UMIN000013750

2011/07/31

21/04/2014

Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis

Rheumatoid arthritis, Periodontitis

IL-6 receptor inhibition group:
Tocilizumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.

TNF inhibition group:
Infliximab, Etanercept, and Adalimumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.

Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences

NULL

Complete: follow-up complete

Not applicable

Male and Female

Not selected

Japan

1944

EUCTR2011-000275-13-HU
(EUCTR)

29/07/2011

10/06/2011

Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

630

Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan

1945

EUCTR2010-020065-24-AT
(EUCTR)

28/07/2011

17/05/2011

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

3080

Phase 4

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1946

EUCTR2010-023956-99-NL
(EUCTR)

28/07/2011

30/05/2011

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 13.1;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Anti-Interleukin-6 Monoclonal Antibody
Product Code: BMS-945429
INN or Proposed INN: BMS-945429
Other descriptive name: anti-IL-6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

677

Phase 2B

United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of

1947

EUCTR2011-001863-39-AT
(EUCTR)

28/07/2011

15/06/2011

A study of saftey and efficacy of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab Monotherapy in patients with mild to moderate rheumatoid arthritis, who have not adequately responded to their current treatment with MTX.

A multi-center study of the safety and effect on disease activity of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab monotheraphy in patients with mild to moderate rheumatoid arthritis, with inadequate response to MTX (defined as DAS 28 = 4,5 and > 2,6) - OPTIMISE

Mild to moderate rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexat Lederle 2.5mg tablets
Product Name: Methotrexat
Product Code: RO0029893
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium

Roche Austria GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Austria

1948

NCT01382940
(ClinicalTrials.gov)

July 26, 2011

24/6/2011

A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis

A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: rituximab;Drug: methotrexate;Drug: methylprednisolone;Drug: acetaminophen;Drug: antihistamine

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

351

Phase 4

United States

1949

EUCTR2010-022206-40-PL
(EUCTR)

26/07/2011

11/04/2011

A Rheumatoid Arthritis Study in Patients (FLEX-O)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 3

United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of

1950

EUCTR2010-020065-24-CZ
(EUCTR)

26/07/2011

27/05/2011

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

3080

Phase 4

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1951

EUCTR2010-020065-24-LT
(EUCTR)

25/07/2011

25/05/2011

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

3080

1952

EUCTR2010-024516-34-IT
(EUCTR)

25/07/2011

29/12/2011

A randomized, double-blind, placebo-controlled study of efficacy, safety and tolerability of secukinumab at 12 weeks administered with an i.v. or s.c. loading regimen compared to placebo in patients with active rheumatoid arthritis despite treatment with methotrexate

Product Name: Secukinumab
Product Code: AIN457F
Other descriptive name: Secukinumab

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

215

United States;Hungary;Canada;Bulgaria;Italy

1953

EUCTR2010-022207-22-PL
(EUCTR)

22/07/2011

11/04/2011

A Study in Patients With Rheumatoid Arthritis(FLEX-V)

A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors (FLEX-V)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

555

Phase 3

Germany;Colombia;Malaysia;Italy;Australia;Brazil;Russian Federation;New Zealand;Argentina;Mexico;Taiwan;Korea, Republic of;Spain;Japan;Greece;United States;Poland

1954

EUCTR2010-023956-99-BE
(EUCTR)

20/07/2011

24/05/2011

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

677

Phase 2B

United States;Taiwan;Spain;Russian Federation;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of

1955

EUCTR2011-000275-13-GB
(EUCTR)

20/07/2011

18/07/2011

Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

630

Panama;United States;Thailand;Guatemala;Turkey;Colombia;Italy;United Kingdom;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1956

EUCTR2010-023956-99-ES
(EUCTR)

20/07/2011

03/11/2011

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate

A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects with Moderate to Severe Rheumatoid Arthritis with Inadequate Response to MethotrexatePharmacogenetics Blood Sample Amendment 01 - Site Specific (v1.0, dated 11-Jan-2011);Protocol Amendment 03 (v1.0, dated 08-Mar-2011) -

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 14.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

677

Phase 2B

Hungary;Germany;Netherlands;France;Italy;South Africa;Brazil;Russian Federation;Czech Republic;Canada;Peru;Taiwan;Argentina;Belgium;Mexico;Korea, Republic of;Spain;Japan;United States

1957

EUCTR2010-022205-17-PL
(EUCTR)

19/07/2011

08/04/2011

A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate (FLEX-M)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Trade Name: Boostrix ®
Product Name: Boostrix ®
Product Code: -
Other descriptive name: DIPHTHERIA TOXOID
Other descriptive name: TETANUS TOXOID
Other descriptive name: PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE
Other descriptive name: PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE
Trade Name: PNEUMOVAX® 23
Product Name: PNEUMOVAX® 23
Product Code: -
Other descriptive name: pneumococcal serotypes

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

990

Phase 3

Hungary;Colombia;Malaysia;Bulgaria;South Africa;Australia;Brazil;Lithuania;India;Slovakia;Russian Federation;Ukraine;New Zealand;Peru;Taiwan;Sri Lanka;Mexico;Argentina;Romania;Korea, Republic of;Japan;United States;Croatia;Poland

1958

EUCTR2011-000102-21-HU
(EUCTR)

14/07/2011

08/06/2011

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti-TNFa agents

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab
Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: ABATACEPT

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Czech Republic;Mexico;Canada;Brazil;Romania;Bulgaria;Germany

1959

EUCTR2011-001220-38-GB
(EUCTR)

12/07/2011

17/05/2011

A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis

A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

United States;Belgium;Russian Federation;Germany;United Kingdom

1960

JPRN-jRCTs032180273

11/07/2011

14/03/2019

Wear of OXINIUM on XLPE: Multicenter RCT Study

Wear of Oxidized Zirconium (OXINIUM) on Cross-linked Polyethylene in Primary Total Hip Arthroplasty: Multicenter Randomized controlled Trial Study - 28mmOX multicenter study

Hip osteoarthritis, Rheumatoid arthritis
Hip osteoarthritis, Rheumatoid arthritis

Akiyama Haruhiko

NULL

Not Recruiting

>= 20age old

<= 75age old

Both

1308

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1961

EUCTR2010-023956-99-IT
(EUCTR)

11/07/2011

01/03/2012

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Anti-Interleukin-6 Monoclonal
Product Code: BMS-945429
INN or Proposed INN: NA
Other descriptive name: anti IL 6 mAb
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: NA
Trade Name: Methotrexate
INN or Proposed INN: METHOTREXATE

BRISTOL-M.SQUIBB

NULL

Not Recruiting

Female: yes
Male: yes

677

Phase 2B

United States;Taiwan;Spain;Korea, Democratic People's Republic of;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Germany;Netherlands;Japan;Korea, Republic of

1962

EUCTR2009-016266-90-AT
(EUCTR)

06/07/2011

31/05/2011

Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1594

Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand

1963

JPRN-JapicCTI-111628

01/7/2011

Phase IIB Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects Who Are Not Responding to Methotrexate

A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of Clazakizumab Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.

Rheumatoid Arthritis

Intervention name : Clazakizumab
Dosage And administration of the intervention : Injection, 25 mg, 100 mg, 200 mg
Control intervention name : Methotrexate ,Adalimumab
Dosage And administration of the control intervention : Methotrexate:Oral,7.5 mg, Adalimumab:Injection,40mg

Bristol-Myers K.K.

NULL

BOTH

406

Phase 2

NULL

1964

NCT01410695
(ClinicalTrials.gov)

July 2011

4/8/2011

Masitinib in Refractory Active Rheumatoid Arthritis

A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs

Rheumatoid Arthritis (RA)

Drug: masitinib 3 mg;Drug: masitinib 6.0 mg;Drug: methotrexate;Drug: Placebo (methotrexate);Drug: Placebo (masitinib)

AB Science

NULL

Terminated

18 Years

N/A

All

324

Phase 2;Phase 3

Czechia;Czech Republic;France;United States

1965

NCT02433184
(ClinicalTrials.gov)

July 2011

23/4/2015

Very Early Versus Delayed Etanercept in Patients With RA

A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early Versus Delayed Etanercept in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Hydroxychloroquine

University of Leeds

NULL

Completed

18 Years

80 Years

All

120

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1966

NCT01390441
(ClinicalTrials.gov)

July 2011

7/7/2011

A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)

A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed Rituxan® in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Biological: MK-8808;Biological: MabThera ® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Loratadine

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

65 Years

All

100

Phase 1

Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;United States

1967

EUCTR2010-021283-14-HU
(EUCTR)

29/06/2011

27/04/2011

A randomised, double blind, placebo-controlled trial with multiple doses of Anti-IL-20 in subjects with rheumatoid arthritis

A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Anti-IL-20 (109-0012)
Product Code: NNC 0109-0000-0012
Other descriptive name: Anti-IL-20

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Portugal;Hungary;United Kingdom;Spain;Italy

1968

EUCTR2011-000102-21-IT
(EUCTR)

28/06/2011

09/01/2012

Safety and efficacy of secukinumab compared to placebo and abatacept in patients with active rheumatoid arthritis who did not respond to anti- TNFa agents

Product Name: Secukinumab
Product Code: AIN457F
INN or Proposed INN: Secukinumab
Trade Name: ORENCIA *IV 2FL 250MG+2SIR
INN or Proposed INN: ABATACEPT

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

548

United States;Slovakia;Spain;Russian Federation;Colombia;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Bulgaria;Germany

1969

EUCTR2011-000275-13-IT
(EUCTR)

28/06/2011

23/02/2012

Safety and efficacy of secukinumab compared to placebo in patients with active rheumatoid arthritis who did not respond to anti-TNFa drugs.

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

630

Panama;United States;Thailand;Guatemala;Turkey;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Canada;Argentina;Belgium;Peru;Japan

1970

EUCTR2010-019262-86-ES
(EUCTR)

22/06/2011

21/04/2010

Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)

Artritis Reumatoide_______________________Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: SAR153191

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Hungary;Finland;Germany;Netherlands;Estonia;Spain;Greece;Austria;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1971

EUCTR2010-022208-36-GR
(EUCTR)

21/06/2011

16/05/2011

An Open Label Study for Patients With Rheumatoid Arthritis

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1505

Phase 3b

United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Sri Lanka;Italy;India;Malaysia;Australia;Peru;South Africa;Korea, Republic of;Lithuania;Hungary;Mexico;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;New Zealand;Japan

1972

EUCTR2011-000107-40-GB
(EUCTR)

16/06/2011

10/03/2011

A 12 weeks study to evaluate effect of revamilst in addition tomethotrexate in rheumatiod arthritis patients.

A Phase IIb, 12 week Randomized, Double-Blind, Parallel Group, Placebo-Controlled study to evaluate Efficacy, Safety and Tolerability of 2, 4 and 6 mg of Revamilast in patients with Active Rheumatoid Arthritis who have had an inadequate response to Methotrexate.

Product Name: Revamilast
Product Code: GRC 4039
INN or Proposed INN: Revamilast
Product Name: Revamilast
Product Code: GRC 4039
INN or Proposed INN: Revamilast
Product Name: Revamilast
Product Code: GRC 4039
INN or Proposed INN: Revamilast

Glenmark Pharmaceuticals SA

NULL

Not Recruiting

Female: yes
Male: yes

406

Phase 2b

Philippines;Poland;Sri Lanka;United Kingdom;India

1973

EUCTR2010-020065-24-HU
(EUCTR)

15/06/2011

02/05/2011

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

3080

Phase 4

Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany

1974

EUCTR2010-023587-40-DE
(EUCTR)

14/06/2011

02/03/2011

A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor

Adult Rheumatoid Arthritis (RA)
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Humira ®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

700

United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden

1975

ChiCTR-DDT-12002268

2011-06-11

2012-06-11

Early diagnosis of rheumatoid arthritis

Study on the clinical application of imaging in early rheumatoid

rheumatoid arthritis

Gold Standard:;Index test:;

Department of Clinical Immunology, Xijing Hospital, Fourth Military Medical University

NULL

Completed

Both

Target condition:0;Difficult condition:0

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1976

EUCTR2008-001523-57-NO
(EUCTR)

10/06/2011

23/09/2008

Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy

1977

EUCTR2010-021184-32-BE
(EUCTR)

08/06/2011

14/04/2011

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the US
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

164

Phase 2

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

1978

EUCTR2010-022208-36-DE
(EUCTR)

08/06/2011

03/12/2010

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1505

Phase 3b

Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy

1979

EUCTR2010-020065-24-LV
(EUCTR)

08/06/2011

11/05/2011

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

3080

Phase 4

1980

EUCTR2010-022207-22-DE
(EUCTR)

08/06/2011

03/12/2010

A Study in Patients With Rheumatoid Arthritis (FLEX-V)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Other descriptive name: not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Other descriptive name: not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

555

Phase 3

United States;Taiwan;Greece;Spain;Russian Federation;Colombia;Italy;Mexico;Argentina;Poland;Brazil;Malaysia;Australia;Germany;New Zealand;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1981

EUCTR2010-022504-42-GB
(EUCTR)

07/06/2011

16/11/2010

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY3009104
Product Code: LY3009104
INN or Proposed INN: Not available
Other descriptive name: JAK1 / JAK2 Inhibtor
Product Name: LY3009104
Product Code: LY3009104
INN or Proposed INN: Not available
Other descriptive name: JAK1 / JAK2 Inhibtor

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

Hungary;United Kingdom

1982

EUCTR2011-000215-79-FR
(EUCTR)

07/06/2011

24/02/2011

Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA

Polyarthrite rhumatoïde

CHU de Clermont Ferrand

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

France

1983

JPRN-UMIN000005590

2011/06/01

12/05/2011

Maintenance of remission by tocilizumab mono-therapy after remission obtained by combination with methotrexate in patients with rheumatoid arthritis

Rheumatoid arthritis

Cessation of MTX (tocilizumab monotherapy)
Continue MTX with tocilizumab

Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University

NULL

Complete: follow-up complete

20years-old

75years-old

Male and Female

Not selected

Japan

1984

EUCTR2007-000012-90-NL
(EUCTR)

01/06/2011

18/10/2010

The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial

The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure.
MedDRA version: 9.1;Level: LLT;Classification code 10041591;Term: Spinal osteoarthritis
MedDRA version: 9.1;Classification code 10003268;Term: Arthritis rheumatoid

Trade Name: Celebrex
Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses

University of Dundee

NULL

Not Recruiting

Female: yes
Male: yes

Denmark;Netherlands;United Kingdom

1985

JPRN-UMIN000005773

2011/06/01

14/06/2011

Magnetic resonance image analysis for quantification of knee articular cartilage verified response to etanercept(ETN) in subjects with active rheumatoid arthritis

rheumatoid arthritis

ETN+MTX
MTX

22nd Century Medical & Research Center, the University of Tokyo

NULL

Complete: follow-up complete

20years-old

80years-old

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1986

NCT01450982
(ClinicalTrials.gov)

June 2011

13/6/2011

A Study to Investigate How JNJ-38518168 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants

A Study to Investigate the Effects of JNJ-38518168 on Methotrexate Pharmacokinetics in Rheumatoid Arthritis Participants on a Stable Methotrexate Dose

Rheumatoid Arthritis

Drug: JNJ-38518168 / MTX

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States

1987

NCT01384422
(ClinicalTrials.gov)

June 2011

27/6/2011

Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: GLPG0634

Galapagos NV

NULL

Completed

18 Years

70 Years

Both

Phase 2

Moldova, Republic of

1988

NCT01373151
(ClinicalTrials.gov)

June 2011

13/6/2011

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

Rheumatoid Arthritis

Drug: BMS-945429 Placebo;Biological: BMS-945429;Drug: Methotrexate;Drug: Methotrexate Placebo;Drug: Adalimumab Placebo;Drug: Adalimumab

CSL Behring

NULL

Completed

18 Years

N/A

All

418

Phase 2

United States;Argentina;Belgium;Brazil;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;South Africa;Spain;Taiwan;Czech Republic;Peru

1989

NCT01405118
(ClinicalTrials.gov)

June 2011

7/7/2011

Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers

A Phase 1, Open Labeled, Fixed Sequence Study To Estimate The Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers

Rheumatoid Arthritis

Drug: Metformin /CP-690,550

Pfizer

NULL

Completed

18 Years

55 Years

Both

Phase 1

Belgium

1990

NCT01355354
(ClinicalTrials.gov)

June 2011

17/5/2011

Effects of Administration of Fostamatinib on Blood Concentrations of Digoxin in Healthy Subjects

An Open-Label, Non-Randomised, 2-Period, Single Centre Study to Assess the Pharmacokinetics of Digoxin in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily

Healthy Volunteers;Rheumatoid Arthritis

Drug: Digoxin;Drug: Fostamatinib

AstraZeneca

NULL

Completed

18 Years

45 Years

Both

Phase 1

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1991

NCT01369745
(ClinicalTrials.gov)

June 2011

7/6/2011

A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis

A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Prednisolone;Drug: dipyridamole;Drug: Prednisone;Drug: Z102;Other: placebo

Zalicus

NULL

Completed

18 Years

N/A

All

294

Phase 2

United States

1992

NCT01215942
(ClinicalTrials.gov)

June 2011

5/10/2010

An Open Label Study for Participants With Rheumatoid Arthritis

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: LY2127399

Eli Lilly and Company

NULL

Terminated

18 Years

N/A

All

1086

Phase 3

United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;France;Germany;Greece;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sri Lanka;Taiwan;Ukraine;Italy;Peru

1993

EUCTR2010-022378-15-DE
(EUCTR)

25/05/2011

09/02/2011

A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.

Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody

Nycomed GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom

1994

EUCTR2010-022378-15-ES
(EUCTR)

19/05/2011

21/02/2011

A clinical study to explore the therapeutic effects of different doses ofthe new drug veltuzumab, a drug of biologic origin, and placebo, inpatients with rheumatoid arthritis.

Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody

Nycomed GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom

1995

EUCTR2010-018485-24-DE
(EUCTR)

18/05/2011

28/01/2011

To investigate the efficacy and safety of SC BT061 in patients with activerheumatoid arthritis

Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

176

Hungary;Czech Republic;Spain;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1996

EUCTR2010-021283-14-PT
(EUCTR)

13/05/2011

07/12/2010

A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Anti-IL-20 (109-0012)
Product Code: NNC 0109-0000-0012
Other descriptive name: Anti-IL-20

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Portugal;Hungary;Czech Republic;Spain;Italy;United Kingdom

1997

JPRN-UMIN000024507

2011/05/12

21/10/2016

Drug interaction between methotrexate and salazosulfapyridine in Japanese patients with rheumatoid arthritis

rheumatoid arthritis

In these patients, who had received SASP/MTX combination therapy for at least 12 weeks, SASP was discontinued, and the patients received MTX monotherapy for the next 24 weeks.

Japan Community Healthcare Organization

NULL

Complete: follow-up complete

20years-old

100years-old

Male and Female

Not selected

Japan

1998

EUCTR2011-003016-23-IT
(EUCTR)

11/05/2011

07/03/2012

Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy

Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy (DMARDS)of arthritis management - CIDAI STUDY

Rheumatoid Arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Guna-Anti Interleukin 1
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: Guna-Antiinterleukin 1 alfa
INN or Proposed INN: NA
Other descriptive name: Guna-Antiinterleukin 1 beta
Product Name: Interleukin 10
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: Guna-Interleukin 10
Product Name: Interleukin 4
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: Guna-Interleukin 4

GUNA SPA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

1999

EUCTR2010-022224-77-BE
(EUCTR)

10/05/2011

14/01/2011

Open-label study to assess the safety and efficacy of CDP6038 inpatients who completed RA0056

A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057

Product Name: CDP6038
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: Recombinant human Mab of IgG4 subtype

UCB Biosciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

United States;Belgium;United Kingdom

2000

EUCTR2010-020839-39-BE
(EUCTR)

10/05/2011

25/11/2010

Efficacy and safety of CDP6038 in patients with rheumatoid arthritis withan unsuccessful response to anti-TNF therapy

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056

Product Name: CDP6038
Product Code: CDP6038
Other descriptive name: Recombinant human Mab of IgG4 subtype
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: Tocilizumab
INN or Proposed INN: RoActemra ®
Other descriptive name: TOCILIZUMAB

UCB Biosciences, Inc. A Member of the UCB Group of Companies

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

United States;Belgium;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2001

EUCTR2010-019871-31-CZ
(EUCTR)

10/05/2011

01/03/2011

Etoricoxib and placebo in patients with rheumatoid arthritis

A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK- 0663/Etoricoxib in Patients with Rheumatoid ArthritisRandomizovaná dvojite zaslepená placebem kontrolovaná multicentrická studie fáze III složená ze dvou cástí hodnotící relativní úcinnost a toleranci dvou dávek MK-0663/Etoricoxibu u pacientu s revmatoidní artritidou

Rheumatoid Arthritis (RA)
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin
Trade Name: ARCOXIA
Product Name: Etoricoxib
Product Code: MK-0663
INN or Proposed INN: ETORICOXIB
Other descriptive name: 5-Chlor-6'-methyl- 3-[4-(methylsulfonyl)phenyl]- 2,3'-bipyridin

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1250

Phase 3

United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

2002

EUCTR2010-023587-40-GR
(EUCTR)

10/05/2011

16/05/2011

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

700

United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden

2003

EUCTR2009-013758-33-NL
(EUCTR)

10/05/2011

16/09/2010

MULTICENTER STUDY WITH A 16-WEEK DOUBLE-BLIND, PLACEBO-CONTROLLED (DURING THE INITIAL 2 WEEKS) RANDOMIZED PERIOD, FOLLOWED BY A 24-WEEK OPEN LABEL EXTENSION TO ASSESS MAGNETIC RESONANCE IMAGE-VERIFIED EARLY RESPONSE TO CERTOLIZUMAB PEGOL IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

Trade Name: Cimzia ®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Denmark;Netherlands;Sweden

2004

EUCTR2009-015019-42-DE
(EUCTR)

10/05/2011

20/08/2010

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)

A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy - GO KIDS

Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

170

United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Peru;Germany;Netherlands

2005

EUCTR2010-023587-40-SE
(EUCTR)

04/05/2011

14/03/2011

A randomized, open-label, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2006

EUCTR2009-016266-90-ES
(EUCTR)

03/05/2011

16/12/2009

Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato__________________________________________________A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy - MOBILITY

Artritis Reumatoide_____________________________________Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1740

Portugal;Hungary;Finland;Germany;Czech Republic;Netherlands;Estonia;Spain;Greece;Austria;Lithuania

2007

EUCTR2010-019871-31-SK
(EUCTR)

02/05/2011

28/02/2011

Rheumatoid Arthritis (RA)
MedDRA version: 13.0;Level: LLT;Classification code 10039073;Term:

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom

2008

NCT01329991
(ClinicalTrials.gov)

May 2011

4/4/2011

Phase 1b Study of PLX5622 in Rheumatoid Arthritis Patients Who Are Receiving Methotrexate

A Phase 1b Study to Assess Safety, Pharmacokinetics, Pharmacodynamics, and Drug-Drug Interaction of PLX5622 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate

Rheumatoid Arthritis

Drug: PLX5622;Drug: Placebo

Plexxikon

NULL

Completed

18 Years

N/A

Both

Phase 1

United States

2009

NCT01370902
(ClinicalTrials.gov)

May 2011

31/5/2011

Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

A Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC 0141-0000-0100;Drug: placebo

Innate Pharma

NULL

Completed

18 Years

75 Years

Both

Phase 1

Germany

2010

NCT01262118
(ClinicalTrials.gov)

May 2011

15/11/2010

Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis

An Exploratory Phase 1, Fixed Sequence, Open-Label Study To Assess The Effects Of CP-690,550 On The Kinetics Of Cholesterol Flux Through The High Density Lipoprotein/Reverse Cholesterol Transport Pathway In Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CP -690,550 (tasocitinib)

Pfizer

NULL

Completed

18 Years

N/A

All

Phase 1

United States;Hungary

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2011

NCT01283971
(ClinicalTrials.gov)

May 2011

25/1/2011

A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor

A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: adalimumab;Drug: placebo to tocilizumab;Drug: placebo to adalimumab;Drug: methotrexate;Drug: folate

Hoffmann-La Roche

NULL

Terminated

18 Years

N/A

All

Phase 4

United States;Denmark;Finland;France;Germany;Greece;Italy;Netherlands;Puerto Rico;Russian Federation;Spain;Sweden;United Kingdom

2012

NCT01347983
(ClinicalTrials.gov)

May 2011

3/5/2011

Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: Tocilizumab +Methotrexate(MTX)

Chugai Pharma Taiwan

NULL

Completed

20 Years

75 Years

Both

Phase 3

Taiwan

2013

NCT01404429
(ClinicalTrials.gov)

May 2011

26/7/2011

Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis

Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate

Postgraduate Institute of Medical Education and Research

NULL

Completed

18 Years

65 Years

All

100

Phase 4

India

2014

EUCTR2010-020065-24-IT
(EUCTR)

29/04/2011

20/03/2012

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel(etanercept) in Patients With Rheumatoid Arthritis and Increased Riskfor Heart Disease.

A clinical outcomes study to evaluate the effects of IL-6 receptorblockade with tocilizumab (TCZ) in comparison with etanercept (ETA) onthe rate of cardiovascular events in patients with moderate to severerheumatoid arthritis (RA). - ENTRACTE

Trade Name: RoActemra ®
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal
Trade Name: Enbrel ®
INN or Proposed INN: ETANERCEPT
Other descriptive name: Etanercept

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

2800

Phase 4

United States;Philippines;Greece;Ecuador;Spain;Chile;Russian Federation;Israel;Italy;India;Malaysia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany

2015

EUCTR2010-023587-40-DK
(EUCTR)

28/04/2011

12/04/2011

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 4

United States;European Union;Greece;Finland;Spain;Denmark;Russian Federation;Netherlands;Germany;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2016

EUCTR2010-022224-77-GB
(EUCTR)

27/04/2011

21/12/2010

Open-label study to assess the safety and efficacy of CDP6038 in patients who completed RA0056

Product Name: CDP6038
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: Recombinant human Mab of IgG4 subtype

UCB Biosciences Inc

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

United States;Belgium;United Kingdom

2017

EUCTR2010-019262-86-DE
(EUCTR)

26/04/2011

20/08/2010

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

2025

Phase 3

Portugal;United States;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Ecuador;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

2018

EUCTR2010-019514-24-CZ
(EUCTR)

21/04/2011

06/12/2010

Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)

A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO

Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX Goldshield Tablets
INN or Proposed INN: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

380

United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Belgium;Austria;Germany

2019

EUCTR2010-019912-18-GR
(EUCTR)

18/04/2011

01/04/2011

Rheumatoid arthritis (RA)
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: tocilizumab 162mg/0.9ml SC PFS SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6;

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

Hungary;Greece;Spain;Bulgaria

2020

EUCTR2010-023587-40-FI
(EUCTR)

15/04/2011

24/02/2011

A randomized, open-label double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira ®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2021

EUCTR2010-023587-40-ES
(EUCTR)

13/04/2011

17/02/2011

A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF.

Adult Rheumatoid Arthritis (RA)Artritis reumatoide del adulto (AR)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Finland;Germany;Netherlands;Spain;Italy;Greece;Sweden

2022

EUCTR2010-018485-24-ES
(EUCTR)

12/04/2011

04/11/2010

Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal

Biotest AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

176

Hungary;Germany;Czech Republic;Spain;Latvia

2023

EUCTR2010-021020-94-HU
(EUCTR)

08/04/2011

05/10/2010

A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-a) antagonists. - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-a

active rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SAR153191
Product Code: SAR153191
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Czech Republic;Germany;Spain;Italy

2024

EUCTR2010-022378-15-HU
(EUCTR)

08/04/2011

21/02/2011

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody

Nycomed GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Czech Republic;Hungary;Spain;Germany;United Kingdom

2025

EUCTR2010-023692-26-GB
(EUCTR)

07/04/2011

18/11/2010

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2

United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2026

EUCTR2008-007346-63-GB
(EUCTR)

05/04/2011

11/10/2010

Reumap: An Open Label phase II study of Bovine Intestinal Alkaline Phosphatase (bIAP), An Inflammation modulating moiety, in RA patients - REUMAP

Rheumatoid Arthritis

Product Name: bIAP
Product Code: EC 3.1.3.1
INN or Proposed INN: bovine intesastinal alkaline phosphatase (bIAP)
Other descriptive name: bIAP

Alloksys Life Sciences B.V.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

2027

EUCTR2009-015019-42-BE
(EUCTR)

04/04/2011

06/09/2010

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 16.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 3

Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Netherlands;Germany

2028

EUCTR2010-019514-24-DE
(EUCTR)

04/04/2011

08/11/2010

Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)

Rheumatoid Arthritis.
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

380

United States;Czech Republic;Puerto Rico;Canada;Argentina;Spain;Austria;Germany

2029

EUCTR2010-022208-36-LT
(EUCTR)

01/04/2011

28/12/2010

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1505

Phase 3b

Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy

2030

EUCTR2010-022205-17-LT
(EUCTR)

01/04/2011

28/12/2010

A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate(FLEX-M)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: Not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

990

Phase 3

United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2031

EUCTR2010-022206-40-LT
(EUCTR)

01/04/2011

28/12/2010

A Rheumatoid Arthritis Study in Patients(FLEX-O)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 3

United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Australia;Peru;South Africa;Bulgaria;Japan;New Zealand

2032

JPRN-UMIN000005362

2011/04/01

01/04/2011

Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs).

Patients with rheumatoid arthritis with anemia taking NSAIDs

Treatment with mesalazine

Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine

NULL

Complete: follow-up complete

20years-old

70years-old

Male and Female

Not selected

Japan

2033

NCT01336218
(ClinicalTrials.gov)

April 2011

14/4/2011

Effects of Administration of Fostamatinib on Blood Concentrations of Rifampicin in Healthy Subjects.

An Open-Label, Non-Randomized, 2-Period, Single Center Study to Assess the Single Dose Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone and in Combination With Rifampicin

Rheumatoid Arthritis;Healthy Volunteers

Drug: fostamatinib;Drug: rifampicin

AstraZeneca

NULL

Completed

18 Years

55 Years

Both

Phase 1

United States

2034

EUCTR2010-023880-17-GB
(EUCTR)

31/03/2011

25/02/2011

SWITCH Clinical Trial for Patients with Rheumatoid Arthritis who have failed an initial TNF-blocking drug

SWITCH: Randomised-controlled trial of switching to alternative tumour-necrosis factor (TNF)-blocking drugs or abatacept or rituximab in patients with rheumatoid arthritis who have failed an initial TNF-blocking drug. - SWITCH

Rheumatoid arthritis in patients who have failed to respond to an initial TNF-blocking drug
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

477

Phase 4

United Kingdom

2035

EUCTR2010-022206-40-BG
(EUCTR)

30/03/2011

24/02/2011

A Rheumatoid Arthritis Study in Patients (FLEX-O)

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 3

United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2036

EUCTR2010-022205-17-BG
(EUCTR)

29/03/2011

24/02/2011

A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate (FLEX-M)

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Trade Name: Boostrix ®
Product Name: Boostrix ®
Product Code: -
Other descriptive name: DIPHTHERIA TOXOID
Other descriptive name: TETANUS TOXOID
Other descriptive name: PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE
Other descriptive name: PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ADSORBED ON ALUMINIUM HYDROXIDE
Other descriptive name: PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE
Trade Name: PNEUMOVAX® 23
Product Name: PNEUMOVAX® 23
Product Code: -
Other descriptive name: pneumococcal serotypes

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

990

Phase 3

2037

EUCTR2010-021558-21-GB
(EUCTR)

28/03/2011

08/10/2010

A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis

Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616
Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Hungary;Slovakia;Czech Republic;Germany;United Kingdom;Ukraine

2038

EUCTR2010-021577-37-BG
(EUCTR)

24/03/2011

04/02/2011

A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS

Product Name: Anti Lymphotoxin Alpha
Product Code: MLTA3698A
Other descriptive name: Anti lymphotoxin alpha
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

GENENTECH, Inc

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Mexico;Spain;Peru;Chile;Bulgaria;Germany

2039

EUCTR2010-022208-36-BG
(EUCTR)

24/03/2011

24/02/2011

An Open Label Study for Patients With Rheumatoid Arthritis (FLEX-P)

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) (FLEX-P)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: Not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: Not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1505

Phase 3b

United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Sri Lanka;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;Lithuania;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

2040

EUCTR2010-021558-21-SK
(EUCTR)

23/03/2011

26/10/2010

A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Hungary;Czech Republic;Germany;United Kingdom;Slovakia;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2041

EUCTR2010-023910-30-GB
(EUCTR)

23/03/2011

28/02/2011

A Prospective, Single-centre, Randomised Study Evaluating the Clinical, Imaging and Immunological Depth of Remission Achieved by Very Early versus Delayed Etanercept in patients with Rheumatoid Arthritis (VEDERA) - Very Early versus Delayed Etanercept in patients with RA (VEDERA)

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Enbrel 50mg pre-filled pen
Product Name: Etanercept (Enbrel)
Product Code: EU/1/99/126/020
INN or Proposed INN: Etanercept
Other descriptive name: Enbrel
Trade Name: Enbrel 50mg pre-filled syringe
Product Name: Etanercept (Enbrel)
Product Code: EU/1/99/126/017
INN or Proposed INN: Etanercept

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 4

United Kingdom

2042

EUCTR2010-022207-22-ES
(EUCTR)

21/03/2011

29/12/2010

A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacyand Safety of LY2127399 in Patients with Moderateto Severe Rheumatoid Arthritis (RA) who had anInadequate Response to one or more TNF-alphaInhibitorsEstudio de fase 3, multicéntrico, aleatorizado,doble ciego, controlado con placebo de evaluaciónde la eficacia y la seguridad de LY2127399 enpacientes con artritis reumatoide (AR) moderada ointensa que no han obtenido una respuestasuficiente con uno o varios inhibidores del TNF-alfa

Rheumatoid Arthritis Artritis Reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

555

Phase 3

Greece;Poland;Spain;Germany;Italy

2043

EUCTR2010-022208-36-ES
(EUCTR)

21/03/2011

29/12/2010

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)Estudio en fase 3b, multicéntrico y abierto paraevaluar la seguridad y la eficacia a largo plazo deLY2127399 en pacientes con artritis reumatoide(AR)

Rheumatoid ArthritisArtritis Reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1505

Phase 3b

Hungary;Germany;Bulgaria;Spain;Greece;Poland;Lithuania

2044

EUCTR2010-023692-26-BG
(EUCTR)

17/03/2011

24/02/2011

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

370

Phase 2B

Netherlands;United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;Bulgaria;South Africa;Germany

2045

EUCTR2010-021577-37-DE
(EUCTR)

17/03/2011

29/10/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: N/A
Product Code: MLTA3698A
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

GENENTECH, Inc

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Hungary;Spain;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2046

EUCTR2010-022378-15-CZ
(EUCTR)

16/03/2011

21/02/2011

A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.

Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (IMMU-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody

Nycomed GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom

2047

EUCTR2010-022207-22-GR
(EUCTR)

15/03/2011

20/01/2011

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

555

Phase 3

Greece;Poland;Spain;Germany;Italy

2048

EUCTR2010-023587-40-IT
(EUCTR)

10/03/2011

27/04/2011

Rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: RoActemra
INN or Proposed INN: tocilizumab
Trade Name: Humira
INN or Proposed INN: Adalimumab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

700

Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden

2049

EUCTR2010-021020-94-DE
(EUCTR)

10/03/2011

15/09/2010

active rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Code: SAR153191
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Czech Republic;Germany;Spain;Italy

2050

EUCTR2009-016055-22-SE
(EUCTR)

09/03/2011

11/01/2011

Hepatitis A vaccine in patients with immunomodulative drugs

Patients with rheumatoid arthritis treated with immunosuppressive medication
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Classification code 10054980;Term: Immunosuppressant drug therapy
MedDRA version: 12.1;Classification code 10063430;Term: Hepatitis A immunisation

Trade Name: Epaxal
Product Name: Epaxal
Other descriptive name: Inactivated hepatitis A virus
Trade Name: Havrix
Product Name: Havrix
Other descriptive name: inactivated hepatitis A virus

HY, HUS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

380

Finland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2051

EUCTR2010-023469-22-NL
(EUCTR)

09/03/2011

02/12/2010

A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis - ARA 290 in ARA

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: ARA290
Product Code: ARA290

LUMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Netherlands

2052

EUCTR2010-022865-81-CZ
(EUCTR)

02/03/2011

22/12/2010

Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritis

A phase I/II, multi-center, randomized, double-blind, placebo controlled study, with a single ascending dose part followed by a multiple ascending dose part, evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of intravenous ALX-0061 in patients with rheumatoid arthritis - ALX-0061 phase I/II, single ascending dose and multiple ascending dose study in rheumatoid arthritis

Product Name: ALX-0061
Product Code: ALX-0061
Other descriptive name: ALX-0061 Nanobody

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

Hungary;Czech Republic

2053

NCT01313520
(ClinicalTrials.gov)

March 1, 2011

25/2/2011

A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)

A Randomized Clinical Trial to Study the Effects of Infliximab on Clinical Efficacy and Hand and Wrist Magnetic Resonance Imaging (MRI) in Patients With Active Rheumatoid Arthritis (RA)(Protocol No. P08136)

Arthritis, Rheumatoid

Drug: Infliximab;Drug: Placebo

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

Phase 2

Moldova, Republic of;Romania

2054

NCT01299961
(ClinicalTrials.gov)

March 2011

18/2/2011

Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis

Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: abatacept

University of California, Los Angeles

NULL

Completed

18 Years

N/A

All

Phase 3

United States

2055

NCT01566201
(ClinicalTrials.gov)

March 2011

27/3/2012

Effects of Interleukin-1 Inhibition on Vascular and Left Ventricular Function in Rheumatoid Arthritis Patients With Coronary Artery Disease

The Effect of Inhibition of Interleukin-1 Activity on Vascular and Left Ventricular Function in Patients With Coronary Artery Disease and Coexistent Rheumatoid Arthritis

Rheumatoid Arthritis;Coronary Artery Disease;Inflammation

Drug: anakinra;Drug: placebo

University of Athens

NULL

Completed

18 Years

N/A

Both

N/A

Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2056

NCT01317797
(ClinicalTrials.gov)

March 2011

18/2/2011

A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis

A Phase Ib Double-blind, Placebo-controlled, Randomized, Dose-escalating Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Subcutaneous Injections of MT203 in Patients With Mild to Moderate Rheumatoid Arthritis on Treatment With Methotrexate

Rheumatoid Arthritis

Drug: namilumab (MT203);Drug: Placebo

Takeda

NULL

Completed

18 Years

N/A

All

Phase 1

Bulgaria;Netherlands

2057

NCT01353859
(ClinicalTrials.gov)

March 2011

13/5/2011

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Indonesia;Greece

2058

NCT01294397
(ClinicalTrials.gov)

March 2011

13/1/2011

Effects of Denosumab on the Pharmacokinetics of Etanercept

The Effects of Denosumab on the Pharmacokinetics of Etanercept in Postmenopausal Women With Low Bone Mineral Density and Rheumatoid Arthritis

Postmenopausal;Osteopenia;Rheumatoid Arthritis;Osteoporosis

Drug: Etanercept;Drug: Denosumab

Amgen

NULL

Terminated

45 Years

80 Years

Female

Phase 1

United States

2059

NCT01232569
(ClinicalTrials.gov)

March 2011

1/11/2010

A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab 162 mg;Drug: Placebo

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

656

Phase 3

United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;Greece;Guatemala;Hungary;Israel;Malaysia;Mexico;New Zealand;Panama;Philippines;Poland;Russian Federation;South Africa;Spain;Switzerland;Thailand;Peru

2060

NCT01284569
(ClinicalTrials.gov)

March 2011

21/1/2011

Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients

A Phase I/II, Randomised, Double-Blind, Placebo Controlled Study, Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Single and Multiple Intravenous Doses of ALX-0061 in Patients With RA

Rheumatoid Arthritis

Biological: ALX-0061;Biological: Placebo

Ablynx

NULL

Completed

18 Years

80 Years

All

Phase 1;Phase 2

Czechia;Hungary;Poland;Czech Republic;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2061

NCT01313208
(ClinicalTrials.gov)

March 2011

10/3/2011

Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy

Rheumatoid Arthritis

Drug: etanercept;Drug: Placebo;Drug: DMARD Therapy

Amgen

NULL

Completed

18 Years

80 Years

All

210

Phase 4

United States;Canada

2062

NCT01332994
(ClinicalTrials.gov)

March 2011

18/3/2011

A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis

Efficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI)

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

519

Phase 3

Germany

2063

NCT01301703
(ClinicalTrials.gov)

March 2011

21/2/2011

Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis

The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Tetanus Toxoid , Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)

Tel-Aviv Sourasky Medical Center

NULL

Not yet recruiting

18 Years

64 Years

Both

100

Phase 4

Israel

2064

NCT01309854
(ClinicalTrials.gov)

March 2011

21/2/2011

Effects of Administration of Fostamatinib on Blood Concentrations of Pioglitazone in Healthy Subjects

An Open-Label, Single Center Study to Assess the Pharmacokinetics of Pioglitazone in Healthy Subjects When Administered Alone and in Combination With Fostamatinib 100 mg Twice Daily

Rheumatoid Arthritis;Healthy Volunteers;Pharmacokinetics;Pioglitazone;Drug-drug Interaction;Amount of Pioglitazone in Blood

Drug: fostamatinib;Drug: pioglitazone

AstraZeneca

NULL

Completed

18 Years

55 Years

Both

Phase 1

United States

2065

NCT01276262
(ClinicalTrials.gov)

March 2011

12/1/2011

Effects of Administration of Fostamatinib on Blood Concentrations of an Oral Contraceptive in Healthy Female Subjects

A Single-blind, Placebo-controlled, 2-period, Fixed Sequence Study to Determine the Effects of Coadministration of Fostamatinib 100 mg Twice Daily on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects

Scientific Terminology Rheumatoid Arthritis, Healthy Female Volunteers, Pharmacokinetics, Oral Contraceptive, Drug-drug Interaction;Laymen Terminology Level of Oral Contraceptive in Blood, Oral Contraceptive, Rheumatoid Arthritis, Drug -Drug Interaction

Drug: fostamatinib;Drug: Microgynon® 30 (Oral contraceptive);Drug: Placebo

AstraZeneca

NULL

Completed

18 Years

45 Years

Female

Phase 1

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2066

NCT01311622
(ClinicalTrials.gov)

March 2011

21/2/2011

Effects of Administration of Fostamatinib on Blood Concentrations of Warfarin in Healthy Subjects

An Open-Label, Single Centre Study to Assess the Pharmacokinetics and Pharmacodynamics of Warfarin When Co-Administered With Fostamatinib in Healthy Subjects

Rheumatoid Arthritis;Healthy Subjects

Drug: warfarin;Drug: fostamatinib

AstraZeneca

NULL

Completed

18 Years

55 Years

Both

Phase 1

United Kingdom

2067

NCT01296711
(ClinicalTrials.gov)

March 2011

14/2/2011

Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056

A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056

Rheumatoid Arthritis

Biological: CDP6038

UCB BIOSCIENCES, Inc.

NULL

Completed

18 Years

N/A

Both

190

Phase 2

United States;Belgium;United Kingdom

2068

EUCTR2010-020890-18-CZ
(EUCTR)

25/02/2011

02/11/2010

AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF TOFACITINIB (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS

Product Name: Tofacitinib
Product Code: CP -690,550
INN or Proposed INN: tasocitinib citrate
Trade Name: Methotrexate Sodium Tablets 2.5 mg
INN or Proposed INN: Methotrexate Sodium

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic

2069

EUCTR2010-020839-39-GB
(EUCTR)

25/02/2011

12/10/2010

Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with an unsuccessful response to anti-TNF therapy

Product Name: Olikizumab
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: Recombinant human Mab of IgG4 subtype
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: Tocilizumab
INN or Proposed INN: RoActemra ®
Other descriptive name: TOCILIZUMAB

UCB Biosciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

United Kingdom;United States

2070

EUCTR2010-022207-22-IT
(EUCTR)

24/02/2011

03/02/2011

Rheumatoid Arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

555

Phase 3

Greece;Poland;Spain;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2071

EUCTR2010-022206-40-HU
(EUCTR)

23/02/2011

26/11/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 3

Hungary;Poland;Lithuania;Bulgaria

2072

EUCTR2010-022208-36-HU
(EUCTR)

18/02/2011

26/11/2010

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1505

Phase 3b

Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy

2073

EUCTR2010-020744-35-IT
(EUCTR)

18/02/2011

22/12/2010

Patients with active Rheumatoid Arthritis despite current treatment with a DMARD.
MedDRA version: 9.1;Level: PT;Classification code 10039073

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;United Kingdom;Italy

2074

EUCTR2010-020745-27-IT
(EUCTR)

18/02/2011

22/12/2010

Patients with active Rheumatoid Arthritis (RA), despite treatment with methotrexate, who have had an inadequate response to a single TNF-alfa antagonist.
MedDRA version: 9.1;Level: PT;Classification code 10039073

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

France;Portugal;Hungary;Czech Republic;Spain;Germany;United Kingdom;Italy

2075

EUCTR2010-020890-18-HU
(EUCTR)

18/02/2011

16/11/2010

Tofacitinib MRI in Early Rheumatoid Arthritis

AN EXPLORATORY PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO ASSESS THE EFFECTS OF Tofacitinib (CP-690,550) ON MAGNETIC RESONANCE IMAGING ENDPOINTS, IN METHOTREXATE NAÏVE SUBJECTS WITH EARLY ACTIVE RHEUMATOID ARTHRITIS

Product Name: Tofacitinib
Product Code: CP -690,550
INN or Proposed INN: tasocitinib citrate
Trade Name: Methotrexate Sodium Tablets 2.5 mg
INN or Proposed INN: Methotrexate Sodium

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2076

EUCTR2010-022205-17-HU
(EUCTR)

18/02/2011

15/12/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

990

Phase 3

Hungary;Poland;Lithuania;Bulgaria

2077

EUCTR2010-020745-27-DE
(EUCTR)

17/02/2011

21/07/2010

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany

2078

EUCTR2010-020744-35-DE
(EUCTR)

17/02/2011

21/07/2010

Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Disease Modifying Anti-rheumatic Drug (DMARD) But NotResponding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Portugal;Serbia;United States;Spain;Ukraine;Lithuania;Israel;Italy;United Kingdom;India;Czech Republic;Canada;Romania;South Africa;Latvia;Germany

2079

EUCTR2010-020892-22-DE
(EUCTR)

17/02/2011

21/07/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

2080

EUCTR2009-012615-18-FR
(EUCTR)

16/02/2011

05/11/2010

Efficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency - SCORPION

Rheumatoid arthritis (RA)
MedDRA version: 12.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: UVEDOSE
INN or Proposed INN: COLECALCIFEROL

CHU de Clermont-Ferrand

NULL

Not Recruiting

Female: yes
Male: yes

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2081

EUCTR2010-023692-26-CZ
(EUCTR)

16/02/2011

22/12/2010

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2B

United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands

2082

EUCTR2010-021558-21-DE
(EUCTR)

15/02/2011

19/10/2010

A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Czech Republic;Hungary;Slovakia;Germany;United Kingdom

2083

EUCTR2010-020743-12-DE
(EUCTR)

15/02/2011

21/07/2010

Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Estonia;Slovakia;Ukraine;Chile;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany

2084

EUCTR2010-022865-81-HU
(EUCTR)

11/02/2011

15/02/2011

Clinical trial to investigate the safety, efficacy, and absorption, distribution, and elimination of ALX-0061 compared to placebo in patients with rheumatoid arthritis

Product Name: ALX-0061
Product Code: ALX-0061
Other descriptive name: ALX-0061 Nanobody

Ablynx NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

Czech Republic;Hungary

2085

EUCTR2010-020892-22-IT
(EUCTR)

08/02/2011

22/12/2010

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA-X

Patients with active Rheumatoid Arthritis (RA) who have participated in a qualifying study.
MedDRA version: 9.1;Level: PT;Classification code 10039073

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

2000

Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Latvia;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2086

EUCTR2010-021558-21-HU
(EUCTR)

08/02/2011

07/10/2010

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Hungary;Slovakia;Czech Republic;Germany;United Kingdom

2087

EUCTR2010-020499-50-GB
(EUCTR)

07/02/2011

31/12/2010

Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis.

rheumatoid arthritis
MedDRA version: 13;Level: PT;Classification code 10039073;Term: rheumatoid arthritis

Trade Name: MabThera
Product Name: rituximab

South Tees Hospitals NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

2088

EUCTR2010-022504-42-HU
(EUCTR)

04/02/2011

23/11/2010

A study to evaluate the efficacy of different doses of LY3009104 therapy compared to placebo in patients with Rheumatoid Arthritis who are on ongoing methotrexate background therapy.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy

Product Name: LY3009104
Product Code: LY3009104
INN or Proposed INN: Not available
Other descriptive name: JAK1 / JAK2 Inhibitor
Product Name: LY3009104
Product Code: LY3009104
INN or Proposed INN: Not available
Other descriptive name: JAK1 / JAK2 Inhibtor

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2b

United States;Czech Republic;Hungary;Mexico;Argentina;Poland;Ukraine;Croatia;Romania;Peru;United Kingdom;India

2089

EUCTR2010-023692-26-HU
(EUCTR)

04/02/2011

08/02/2011

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2B

United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands

2090

EUCTR2010-019262-86-NL
(EUCTR)

02/02/2011

24/06/2010

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2091

JPRN-UMIN000008164

2011/02/01

13/06/2012

Restart for sustaining remission of rheumatoid arthritis in use of etanercept

Rheumatoid Arthritis

After the administration of etanercept (50mg/week), the dosage of etanercept will be discontinued when the low disease activity (DAS28-ESR<3.2) is achieved. If patients recur from low disease activity, same dose of etanercept will be administered again by the observation of every two months. This strategy will be maintained for two years. We must control the disease activity below the low disease activity using combined medicine except glucocorticoid if patients could not reach low disease activity after the administration of etanercept in three months. It will be considered to be a dropout if patients cannot reach low disease activity within six months.

Osaka City University Medical School

NULL

Recruiting

20years-old

Not applicable

Male and Female

Phase 4

Japan

2092

EUCTR2010-021283-14-IT
(EUCTR)

01/02/2011

23/12/2010

A randomised, double blind, placebo-controlled, multiple dose trial of NNC109-0012 (Anti-IL-20) in subjects with rheumatoid arthritis - NN8226-3875

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073

Product Name: Anti-IL-20 (109-0012)
Product Code: NNC 0109-0000-0012

NOVO NORDISK

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Portugal;United Kingdom;Spain;Italy

2093

NCT01235507
(ClinicalTrials.gov)

February 2011

15/10/2010

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)

Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDs

Rheumatoid Arthritis

Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Bosnia and Herzegovina

2094

NCT01254331
(ClinicalTrials.gov)

February 2011

3/12/2010

An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment

Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Tunisia

2095

NCT01282255
(ClinicalTrials.gov)

February 2011

21/1/2011

Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis

A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC109-0012;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

75 Years

All

Phase 2

Czech Republic;Germany;Italy;Poland;Portugal;Romania;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2096

NCT02092961
(ClinicalTrials.gov)

February 2011

19/3/2014

Randomised Double-Blind, Placebo-Controlled, Parallel Group Study in Patients With Active Rheumatoid Arthritis:Magnetic Resonance Imaging Sub-Study

A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Placebo or Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study

Rheumatoid Arthritis

Drug: Fostamatinib;Drug: Adalimumab;Drug: Placebo of Fostamatinib;Drug: Placebo of Adalimumab

AstraZeneca

NULL

Terminated

18 Years

N/A

All

198

Phase 2

United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;South Africa;United Kingdom

2097

NCT01765374
(ClinicalTrials.gov)

February 2011

12/5/2011

Study of Sonographic Efficacy of Rituximab in Rheumatoid Arthritis

Rheumatoid Arthritis

Device: ESAOTE MyLab60;Drug: Rituximab

University Hospital, Rouen

NULL

Completed

18 Years

N/A

Both

Phase 4

France

2098

NCT01292265
(ClinicalTrials.gov)

February 2011

7/2/2011

A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)

A Phase 3b, Open Label, Multicenter, Exploratory Study to Assess Changes in Joint Inflammation Using Ultrasonography in Subjects With Rheumatoid Arthritis Treated for 12 Weeks With Certolizumab Pegol

Rheumatoid Arthritis

Biological: Certolizumab Pegol

UCB Pharma

NULL

Terminated

18 Years

N/A

All

Phase 3

United States

2099

NCT01285752
(ClinicalTrials.gov)

February 2011

27/1/2011

A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: AK106-001616;Drug: Active comparator

Asahi Kasei Pharma Corporation

NULL

Completed

18 Years

65 Years

Both

240

Phase 2

Czech Republic;Germany;Hungary;Poland;Slovakia;Ukraine;United Kingdom

2100

EUCTR2010-021577-37-ES
(EUCTR)

27/01/2011

23/11/2010

ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS

Artritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: N/A
Product Code: MLTA3698A
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB

GENENTECH, Inc

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Hungary;Germany;Bulgaria;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2101

EUCTR2010-019514-24-ES
(EUCTR)

27/01/2011

30/11/2010

Estudio multicéntrico, doble ciego, aleatorizado, de brazos paralelos para determinar la respuesta a la dosis de metotrexato (MTX) en combinación con adalimumab en sujetos con artritis reumatoide temprana (CONCERTO). A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. - CONCERTO

Rheumatoid Arthritis. Artritis Reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METOTREXATO
Other descriptive name: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: MTX HEXAL Tablets
INN or Proposed INN: METHOTREXATE

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

380

Czech Republic;Spain;Austria;Germany

2102

EUCTR2010-019926-15-CZ
(EUCTR)

27/01/2011

01/12/2010

A Phase 2 placebo-controlled study to compare the effectiveness and safety of two doses of apremilast (CC-10004) in subjects with active rheumatoid arthritis, who have not responded to methotrexate treatment

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY, TO COMPARE THE EFFICACY AND SAFETY OF TWO DOSES OF APREMILAST (CC-10004) IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

Rheumatoid arthritis, a chronic systemic autoimmune inflammatory disease characterized by persisten synovial inflammations.
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: Apremilast
Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: Apremilast

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

United States;Czech Republic

2103

EUCTR2010-019514-24-AT
(EUCTR)

27/01/2011

21/12/2010

Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)

Rheumatoid Arthritis.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

380

United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Austria;Germany

2104

EUCTR2010-019514-24-BE
(EUCTR)

25/01/2011

25/11/2010

Study to determine the effects of different doses of Methotrexate (MTX) when taken with adalimumab in subjects with Early Rheumatoid Arthritis (RA)

Rheumatoid Arthritis.
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 3

United States;Czech Republic;Canada;Puerto Rico;Argentina;Spain;Belgium;Austria;Germany

2105

EUCTR2010-019912-18-ES
(EUCTR)

17/01/2011

19/01/2011

A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.

Rheumatoid arthritis (RA)Artritis Reumatoide (AR)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: tocilizumab 162mg/0.9ml SC PFS SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6;

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Hungary;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2106

EUCTR2010-021283-14-GB
(EUCTR)

14/01/2011

08/10/2010

A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Anti-IL-20 (109-0012)
Product Code: NNC 0109-0000-0012
Other descriptive name: Anti-IL-20

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Portugal;Hungary;Spain;Italy;United Kingdom

2107

EUCTR2010-020892-22-BG
(EUCTR)

13/01/2011

09/11/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

2108

EUCTR2010-020743-12-PL
(EUCTR)

11/01/2011

01/10/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. (OSKIRA - 1)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany

2109

EUCTR2010-019871-31-BE
(EUCTR)

11/01/2011

31/08/2010

Rheumatoid Arthritis (RA)
MedDRA version: 13.0;Level: LLT;Classification code 10039073;Term:

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom

2110

EUCTR2010-022208-36-IT
(EUCTR)

10/01/2011

08/02/2011

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis(RA) - ND

Rheumatoid Arthritis.
MedDRA version: 9.1;Level: PT;Classification code 10039073

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1505

Phase 3b

Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2111

NCT03410940
(ClinicalTrials.gov)

January 7, 2011

19/1/2018

PMCF Study of the CLS Brevius Stem With Kinectiv Technology

Post-Market Clinical Follow-Up (PMCF) Study of the CLS Brevius Stem With Kinectiv Technology

Osteoarthritis;Avascular Necrosis;Rheumatoid Arthritis;Femoral Neck Fractures;Prosthesis Failure

Device: CLS Brevius stem with Kinectiv technology

Zimmer Biomet

NULL

Terminated

18 Years

N/A

All

223

Italy;Poland;Spain

2112

EUCTR2010-021283-14-ES
(EUCTR)

07/01/2011

05/11/2010

A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis.Ensayo de dosis múltiples, aleatorizado, doble ciego y controlado con placebo de anti IL 20 (109 0012) en pacientes con artritis reumatoide.

Rheumatoid arthritisArtritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Anti-IL-20 (109-0012)
Product Code: NNC 0109-0000-0012
Other descriptive name: Anti-IL-20

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Portugal;United Kingdom;Spain;Italy

2113

EUCTR2010-022049-88-DE
(EUCTR)

05/01/2011

11/11/2010

Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI

Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: RoActemra 20 mg/ml Concentrate for solution for infusion
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: Tocilizumab
Trade Name: Mabthera 500 mg Concentrate for solution for infusion
Product Name: Rituximab
Product Code: RO045-2294
INN or Proposed INN: RITUXIMAB

Roche Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany

2114

NCT01274910
(ClinicalTrials.gov)

January 2011

4/1/2011

Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial

Rheumatoid Arthritis

Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA);Dietary Supplement: Capsules (Placebo)

Rabin Medical Center

NULL

Recruiting

50 Years

80 Years

Both

N/A

Israel

2115

NCT01264770
(ClinicalTrials.gov)

January 2011

17/12/2010

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)

(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Fostamatinib and placebo injections;Drug: Adalimumab and placebo of fostamatinib;Drug: Placebo of fostamatinib, fostamatinib, and placebo injections

AstraZeneca

NULL

Terminated

18 Years

N/A

All

644

Phase 2

United States;Bulgaria;Canada;Czech Republic;Germany;Hungary;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2116

NCT01382160
(ClinicalTrials.gov)

January 2011

2/12/2010

Serum Concentration of Adalimumab as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)

Serum Concentration of Adalimumab (Humira) as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)

Rheumatoid Arthritis

Biological: adalimumab

University Hospital, Tours

NULL

Completed

18 Years

N/A

Both

Phase 4

France

2117

NCT01202773
(ClinicalTrials.gov)

January 2011

14/9/2010

A Study in Participants With Rheumatoid Arthritis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-a Inhibitors (FLEX V)

Rheumatoid Arthritis

Drug: LY2127399;Drug: Placebo Q4W;Drug: Placebo Q2W

Eli Lilly and Company

NULL

Terminated

18 Years

N/A

All

456

Phase 3

United States;Argentina;Australia;Brazil;Colombia;France;Germany;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Russian Federation;South Africa;Spain;Taiwan

2118

NCT01223911
(ClinicalTrials.gov)

January 2011

14/10/2010

A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

A Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC 0151-0000-0000;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

75 Years

All

Phase 2

Czech Republic;Denmark;Hungary;Poland;Romania;United Kingdom

2119

NCT01411215
(ClinicalTrials.gov)

January 2011

13/5/2011

A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department

A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department

Rheumatoid Arthritis;Ankylosing Spondylitis

Drug: Enbrel

Pfizer

NULL

Terminated

18 Years

N/A

All

160

N/A

China

2120

NCT01219933
(ClinicalTrials.gov)

January 2011

11/10/2010

A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemra/Actemra (Tocilizumab) (ACT-ALONE)

An Open-label, Single-arm Study to Describe Glucocorticoid Use in Rheumatoid Arthritis Patients Treated With Tocilizumab in Daily Clinical Practice and to Evaluate Systematic Glucocorticoid Dose Reduction Once Low Disease Activity is Reached (ACT-ALONE)

Rheumatoid Arthritis

Drug: methylprednisolone;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2121

NCT01737944
(ClinicalTrials.gov)

January 2011

27/11/2012

Exposure Study Comparing 3 Routes of Methotrexate (MTX) Administration

Exposure, Safety and Local Tolerance Study Comparing 3 Routes of Methotrexate (MTX) Administration: Vibex-MTX Device, Subcutaneous (SC)and Intramuscular (IM) in Adult Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate (MTX)

Antares Pharma Inc.

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

2122

NCT01242514
(ClinicalTrials.gov)

January 2011

10/11/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Fostamatinib

AstraZeneca

NULL

Terminated

18 Years

N/A

All

1917

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;Colombia;Czech Republic;Estonia;France;Germany;Hungary;India;Israel;Italy;Latvia;Lithuania;Mexico;Peru;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Netherlands;Turkey

2123

NCT01202760
(ClinicalTrials.gov)

January 2011

14/9/2010

A Rheumatoid Arthritis Study in Participants

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)

Rheumatoid Arthritis

Drug: LY2127399;Drug: Placebo

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

1004

Phase 3

United States;Argentina;Australia;Bulgaria;Colombia;Croatia;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Sri Lanka;Taiwan;Ukraine;Peru

2124

EUCTR2010-021558-21-CZ
(EUCTR)

23/12/2010

21/10/2010

A Clinical Study of AK106-001616 in Patients With Rheumatoid Arthritis

A Phase IIa, Multi-Centre, Randomised, Double-Blind, Comparator Controlled, Repeated-Dose Study of 2 Dose Levels of AK106 001616 in Patients with Rheumatoid Arthritis

Product Name: AK106-001616
Product Code: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen
Product Name: AK106-001616
Product Code: AK106-001616

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Hungary;Czech Republic;Slovakia;Ukraine;Germany;United Kingdom

2125

EUCTR2010-019134-27-BG
(EUCTR)

23/12/2010

18/10/2010

A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY

Rhuematoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Trade Name: Methotrexate 10 mg tablets
Product Name: Methotrextate
INN or Proposed INN: Methotrexate
Trade Name: Folimet
Product Name: Folic Acid
INN or Proposed INN: Folic Acid

Chelsea Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Czech Republic;Mexico;Argentina;Poland;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2126

EUCTR2010-021020-94-ES
(EUCTR)

21/12/2010

21/10/2010

Estudio aleatorizado, doble ciego, con grupos paralelos, controlado con placebo y control activo para evaluar los efectos clínicos beneficiosos de SAR153191 subcutáneo (s.c.), administrado junto con metotrexato (MTX), en pacientes con artritis reumatoide (AR) activa que no respondieron al tratamiento anterior con antagonistas del factor de necrosis tumoral alfa (TNF-α)._______________A randomized, double-blind, parallel-group, placebo- and active calibrator-controlledstudy assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-?) antagonists - Effect of SAR153191with Methotrexate in patients with active rheumatoid arthritis who failed TNF-?

artritis reumatoide activa
MedDRA version: 12.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: SAR153191
Trade Name: SIMPONI 50 mg solución inyectable en pluma precargada
INN or Proposed INN: GOLIMUMAB
Other descriptive name: GOLIMUMAB

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Czech Republic;Germany;Spain;Italy

2127

NCT02675803
(ClinicalTrials.gov)

December 20, 2010

9/7/2015

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of VAY736 in Rheumatoid Arthritis Patients

A Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VAY736 in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Biological: VAY736;Biological: VAY736 placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

65 Years

All

Phase 1

Germany

2128

EUCTR2010-020745-27-PT
(EUCTR)

17/12/2010

16/09/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

France;Portugal;Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom

2129

EUCTR2010-021020-94-CZ
(EUCTR)

17/12/2010

05/10/2010

active rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Code: SAR153191
Trade Name: Simponi
INN or Proposed INN: GOLIMUMAB

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Germany;Czech Republic;Spain;Italy

2130

EUCTR2010-020744-35-PT
(EUCTR)

17/12/2010

16/09/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2131

EUCTR2010-020892-22-PT
(EUCTR)

17/12/2010

17/09/2010

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Portugal;Estonia;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Latvia;Netherlands

2132

EUCTR2010-021577-37-HU
(EUCTR)

16/12/2010

27/10/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: N/A
Product Code: MLTA3698A
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

GENENTECH, Inc

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Hungary;Spain;Bulgaria;Germany

2133

EUCTR2010-021283-14-CZ
(EUCTR)

15/12/2010

27/09/2010

A randomised, double blind, placebo-controlled, multiple dose trial of Anti-IL-20 (109-0012) in subjects with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Anti-IL-20 (109-0012)
Product Code: NNC 0109-0000-0012
Other descriptive name: Anti-IL-20

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Portugal;Hungary;Czech Republic;Spain;Italy;United Kingdom

2134

EUCTR2010-020745-27-FR
(EUCTR)

14/12/2010

05/10/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Hungary;Portugal;Czech Republic;Germany;United Kingdom;France;Spain;Italy

2135

EUCTR2010-020743-12-FR
(EUCTR)

14/12/2010

05/10/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

Hungary;Germany;United Kingdom;Bulgaria;Estonia;France;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2136

EUCTR2010-020892-22-ES
(EUCTR)

13/12/2010

05/10/2010

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid ArthritisEstudio de extensión a largo plazo para evaluar la seguridad y la eficacia de fostamatinib disódico (FosD) en el tratamiento de la artritisreumatoide - OSKIRA - X

Rheumatoid ArthritisArtritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Netherlands;Latvia;Germany;Italy;United Kingdom

2137

EUCTR2010-020744-35-ES
(EUCTR)

13/12/2010

23/09/2010

A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDsEstudio en fase III, multicéntrico, aleatorizado, dobleciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas defostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficientea los FARME - OSKIRA - 2

Rheumatoid ArthritisArtritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Portugal;Czech Republic;Spain;Lithuania;Latvia;Germany;Italy;United Kingdom

2138

EUCTR2010-022206-40-SK
(EUCTR)

13/12/2010

27/04/2016

A Rheumatoid Arthritis Study in Patients (FLEX-O)

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 3

2139

EUCTR2010-020745-27-ES
(EUCTR)

13/12/2010

30/09/2010

A Phase III, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with Inadequate Response to a TNF-alpha antagonistEstudio en fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar dos pautas posológicas de fostamatinib disódico en pacientes con artritis reumatoide que tienen una respuesta insuficiente a un antagonista del TNF-alfa - OSKIRA - 3

Rheumatoid ArthritisArtritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

France;Portugal;Hungary;Czech Republic;Belgium;Spain;Germany;Italy;United Kingdom

2140

EUCTR2009-015898-12-NL
(EUCTR)

10/12/2010

10/06/2010

Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Patients with active rheumatoid arthritis and an inadequate response to Methotrexate
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259

Galápagos NV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Netherlands;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2141

NCT01285310
(ClinicalTrials.gov)

December 9, 2010

19/11/2010

Study of Apremilast to Evaluate the Safety and Effectiveness for Patients With Rheumatoid Arthritis

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study, To Compare the Efficacy and Safety of Two Doses of Apremilast (CC-10004) in Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Apremilast 30 mg;Drug: Apremilast 20 mg;Drug: Placebo

Amgen

NULL

Terminated

18 Years

N/A

All

237

Phase 2

United States;Czechia;Poland;Spain;Czech Republic

2142

EUCTR2010-021435-14-NL
(EUCTR)

06/12/2010

24/06/2010

Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis

rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667

Academisch Medisch Centrum Amsterdam

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

2143

EUCTR2009-016266-90-RO
(EUCTR)

03/12/2010

26/07/2010

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1740

Portugal;Estonia;Hungary;Czech Republic;Greece;Finland;Spain;Lithuania;Romania;Austria;Netherlands;Germany

2144

EUCTR2010-019262-86-LT
(EUCTR)

01/12/2010

26/10/2010

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 3

Portugal;United States;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

2145

NCT01142726
(ClinicalTrials.gov)

December 2010

3/6/2010

Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis

A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults With Very Early RA

Rheumatoid Arthritis

Drug: Abatacept;Drug: Methotrexate;Drug: Abatacept placebo;Drug: Methotrexate placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

511

Phase 3

United States;Australia;Belgium;Canada;Denmark;Finland;France;Germany;Italy;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Sweden;Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2146

NCT01236118
(ClinicalTrials.gov)

December 2010

4/11/2010

A Study of LY2439821 in Rheumatoid Arthritis

An Open-Label Extension Study to Evaluate Safety and Tolerability of Multiple Subcutaneous Doses of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate

Rheumatoid Arthritis

Drug: LY2439821

Eli Lilly and Company

NULL

Completed

20 Years

N/A

All

Phase 1

Japan

2147

NCT01270997
(ClinicalTrials.gov)

December 2010

2/1/2011

Randomized Double-blind Parallel Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA Patients

A Multicenter Randomized Double-blind Active-controlled Parallel Group Phase ? Trial to Evaluate the Equivalence in Efficacy and Safety of HD203 and Enbrel in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Etanercept

Hanwha Chemical

NULL

Completed

20 Years

N/A

Both

294

Phase 3

Korea, Republic of

2148

NCT01258712
(ClinicalTrials.gov)

December 2010

8/12/2010

Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients

Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients

Rheumatoid Arthritis (RA)

Drug: Tocilizumab + methotrexate(MTX);Drug: Tocilizumab placebo + methotrexate(MTX)

Chugai Pharma Taiwan

NULL

Completed

20 Years

75 Years

Both

Phase 3

Taiwan

2149

NCT01235598
(ClinicalTrials.gov)

December 2010

4/11/2010

Magnetic Resonance Image Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)

A 16-week Double-blind, Placebo-controlled (for Initial 2 Weeks) Randomized Period, Followed by a 24-week Open-label Extension to Assess Magnetic Resonance Image (MRI) - Verified Early Response to Certolizumab Pegol in Subjects With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Other: Placebo;Biological: Certolizumab Pegol (CZP) 200 mg;Biological: Certolizumab Pegol (CZP) 400 mg

UCB Pharma

NULL

Completed

18 Years

N/A

All

Phase 3

Denmark;Netherlands;Poland;Sweden

2150

NCT01481493
(ClinicalTrials.gov)

December 2010

17/10/2011

Dose-finding of Multiple Dose of BT061 in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable Methotrexate (MTX)

A Multi-center, Double-blind, Randomized, Placebo-controlled, Dose-finding Study in Patients With Active Rheumatoid Arthritis Incompletely Controlled on Stable MTX Doses to Investigate Efficacy and Safety of SC BT061

Rheumatoid Arthritis

Biological: BT061;Biological: Placebo

Biotest

NULL

Completed

18 Years

75 Years

Both

127

Phase 2

Czech Republic;Germany;Hungary;Italy;Latvia;Poland;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2151

NCT01198002
(ClinicalTrials.gov)

December 2010

8/9/2010

A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate

Rheumatoid Arthritis

Drug: LY2127399;Drug: Placebo Q2W;Drug: Placebo Q4W;Drug: Methotrexate

Eli Lilly and Company

NULL

Terminated

18 Years

N/A

All

1041

Phase 3

United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Sri Lanka;Taiwan;Ukraine;Peru

2152

EUCTR2010-018646-31-LT
(EUCTR)

30/11/2010

06/08/2010

CT-P13 Compared With Remicade When Co-Administered With Methotrexate

A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;Colombia;Bulgaria;Chile;Indonesia;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Russian Federation;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Poland;Jordan

2153

EUCTR2010-021184-32-DE
(EUCTR)

30/11/2010

30/08/2010

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Refractory rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

164

Phase 2

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

2154

EUCTR2010-018375-22-BG
(EUCTR)

25/11/2010

23/09/2010

A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.

Product Name: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

United States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand

2155

EUCTR2010-020745-27-BE
(EUCTR)

23/11/2010

01/07/2010

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2156

EUCTR2010-020892-22-BE
(EUCTR)

23/11/2010

01/07/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

2157

EUCTR2010-020743-12-BE
(EUCTR)

23/11/2010

07/07/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom

2158

EUCTR2009-017306-36-NL
(EUCTR)

19/11/2010

19/08/2010

ANTI-IGE THERAPY (OMALIZUMAB) IN IGE-ACPA POSITIVE RA. - TIGER

RHEUMATOID ARTHRITIS
MedDRA version: 12.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid

Trade Name: Xolair
Product Name: OMALIZUMAB
INN or Proposed INN: OMALIZUMAB
Other descriptive name: Xolair

Leiden University Medical Center, Department of Rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

2159

EUCTR2009-011791-30-CZ
(EUCTR)

18/11/2010

02/08/2010

A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: NNC151-0000
Product Code: NNC0151-0000-0000
Other descriptive name: Anti-C5aR

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Czech Republic;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom

2160

EUCTR2009-015019-42-FI
(EUCTR)

17/11/2010

27/09/2010

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

170

United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2161

EUCTR2010-021184-32-AT
(EUCTR)

11/11/2010

19/10/2010

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

Refractory rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

288

Phase 2

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

2162

EUCTR2010-020743-12-BG
(EUCTR)

10/11/2010

09/11/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. (OSKIRA - 1)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany

2163

EUCTR2009-012041-35-BG
(EUCTR)

10/11/2010

18/08/2010

A phase II, randomized, double-blind, controlled study to evaluate the immune responses, safety and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis who have relapsed despite anti-TNFa biological therapy

Product Name: TNF-Kinoid
Product Code: TNF-K

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Argentina;Belgium;Croatia;Romania;Chile;Bulgaria

2164

EUCTR2010-018674-20-DK
(EUCTR)

05/11/2010

21/09/2010

Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA)

A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised protocol 01 incorporating protocol amendment 01

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

470

Phase 3b

United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Denmark;Australia;South Africa;Germany;Korea, Republic of;Sweden

2165

EUCTR2010-018674-20-DE
(EUCTR)

05/11/2010

17/08/2010

Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination With Methotrexate in Adults With Very Early Rheumatoid Arthritis (RA)

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

470

Phase 3b

United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2166

EUCTR2010-018646-31-ES
(EUCTR)

05/11/2010

12/08/2010

Estudio de fase 3, aleatorizado, doble ciego y con grupos paralelos para demostrar la equivalencia en eficacia y seguridad de CT-P13 comparado con Remicade cuando se administra con metotrexato a pacientes con artritis reumatoide activa.A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -

Artritis reumatoide.Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: REMICADE 100 mg polvo para concentrado para solución para perfusión
INN or Proposed INN: INFLIXIMAB
Other descriptive name: INFLIXIMAB

CELLTRION, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

584

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

2167

EUCTR2010-019871-31-AT
(EUCTR)

03/11/2010

01/09/2010

Etoricoxib and placebo in patients with rheumatoid arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

2168

EUCTR2010-019871-31-LT
(EUCTR)

02/11/2010

17/09/2010

Etoricoxib and placebo in patients with rheumatoid arthritis

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1250

Phase 3

United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

2169

EUCTR2009-015019-42-LT
(EUCTR)

02/11/2010

17/09/2010

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

170

Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany

2170

EUCTR2009-016266-90-NL
(EUCTR)

01/11/2010

16/04/2010

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1740

Portugal;Hungary;Finland;Germany;Czech Republic;Netherlands;Estonia;Spain;Greece;Austria;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2171

JPRN-UMIN000004412

2010/11/01

20/10/2010

Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid

rheumatoid arthritis

tocilizumab

General Internal Medicine, Tenri Hospital

NULL

Recruiting

16years-old

80years-old

Male and Female

Not applicable

Japan

2172

JPRN-UMIN000008756

2010/11/01

30/08/2012

Abatacept-based approach to cure of RA

Rheumatoid Arthritis

Abatacept treatmentat month 12
MTX treatment at month 12

University of Occupational and Environmental Health, Japan

NULL

Recruiting

15years-old

Not applicable

Female

Not selected

Japan

2173

NCT01618019
(ClinicalTrials.gov)

November 2010

8/6/2012

N-3 PUFA and Rheumatoid Arthritis in Korea

Effect of n-3 Polyunsaturated Fatty Acid Supplementation on Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Dietary Supplement: Omega-3 fatty acid;Dietary Supplement: Placebo

Hanyang University

NULL

Completed

18 Years

80 Years

All

109

N/A

Korea, Republic of

2174

NCT01245790
(ClinicalTrials.gov)

November 2010

19/11/2010

A Study of Fostamatinib in Subjects With Impaired Kidney Function

An Open-label, Phase I Study to Assess the Pharmacokinetics of R406 in Subjects With Renal Impairment Compared to Healthy Subjects Following Administration of a Single Dose of Fostamatinib 150 mg

Rheumatoid Arthritis;Renal Impairment

Drug: fostamatinib

AstraZeneca

NULL

Completed

18 Years

N/A

Both

Phase 1

United States

2175

NCT01255761
(ClinicalTrials.gov)

November 2010

6/12/2010

A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects

Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia

Rheumatoid Arthritis

Biological: Certolizumab Pegol (CZP)

UCB Pharma

NULL

Completed

18 Years

N/A

All

736

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2176

NCT01225393
(ClinicalTrials.gov)

November 2010

18/10/2010

A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MLTA3698A;Drug: adalimumab;Drug: leflunomide;Drug: methotrexate;Drug: placebo

Genentech, Inc.

NULL

Completed

18 Years

75 Years

Both

211

Phase 2

Romania;Spain;Bulgaria;Chile;Germany;Hungary;Mexico;Peru;Poland;United States

2177

NCT01242488
(ClinicalTrials.gov)

November 2010

15/11/2010

Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy

Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy

Rheumatoid Arthritis

Biological: CDP6038;Biological: Tocilizumab (Actemra or RoActemra);Other: Placebo sc;Other: Placebo iv

UCB Pharma

NULL

Completed

18 Years

N/A

Both

221

Phase 2

United States;Belgium;United Kingdom

2178

NCT01287858
(ClinicalTrials.gov)

November 2010

12/1/2011

Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy Subjects

A Phase 1, Randomized, Double Blind, Placebo Controlled, Sequential, Ascending Single-Dose and Multiple-Dose First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AC430 in Healthy Subjects

Rheumatoid Arthritis

Drug: AC430

Daiichi Sankyo Inc.

NULL

Completed

18 Years

45 Years

Both

Phase 1

United States

2179

EUCTR2010-021184-32-FR
(EUCTR)

28/10/2010

13/09/2010

Refractory rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

164

Phase 2

France;Hungary;Estonia;Poland;Belgium;Spain;Austria;Bulgaria;Germany;United Kingdom;Italy

2180

EUCTR2008-006924-68-AT
(EUCTR)

28/10/2010

12/01/2009

Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

France;Portugal;Hungary;Czech Republic;Spain;Austria;Netherlands;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2181

EUCTR2010-020745-27-GB
(EUCTR)

26/10/2010

05/07/2010

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

France;Portugal;United States;Spain;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany

2182

EUCTR2010-020744-35-GB
(EUCTR)

26/10/2010

05/07/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia

2183

EUCTR2010-020743-12-GB
(EUCTR)

26/10/2010

05/07/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

France;Estonia;Hungary;Slovakia;Poland;Belgium;Bulgaria;Germany;United Kingdom

2184

NCT01362062
(ClinicalTrials.gov)

October 26, 2010

26/5/2011

Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy

A Study to Observe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti TNF Therapy.

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

110

N/A

India

2185

EUCTR2010-020892-22-GB
(EUCTR)

26/10/2010

05/07/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2186

EUCTR2010-019871-31-DE
(EUCTR)

25/10/2010

09/12/2010

Etoricoxib and placebo in patients with rheumatoid arthritis

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1250

Phase 3

United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

2187

EUCTR2010-020744-35-LV
(EUCTR)

22/10/2010

13/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;Czech Republic;Canada;Romania;South Africa;Latvia;Germany

2188

EUCTR2010-020892-22-LV
(EUCTR)

22/10/2010

13/08/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

United States;Portugal;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Peru;South Africa;Latvia;Netherlands;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany

2189

EUCTR2010-018674-20-IT
(EUCTR)

21/10/2010

17/12/2010

A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA - ND

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073

Product Name: Abatacept
Product Code: BMS188667
Trade Name: METHOTREXATE HOSPIRA 2.5 mg tablety
INN or Proposed INN: Methotrexate

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

470

Phase 3b

France;Finland;Denmark;Germany;Italy;Sweden

2190

EUCTR2010-018485-24-CZ
(EUCTR)

20/10/2010

24/08/2010

To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis

Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

128

Hungary;Czech Republic;Spain;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2191

EUCTR2010-019134-27-CZ
(EUCTR)

19/10/2010

28/06/2010

Rhuematoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Trade Name: Methotrexate
Product Name: Methotrextate
INN or Proposed INN: Methotrexate
Trade Name: Folic Acid
Product Name: Folic Acid
INN or Proposed INN: Folic Acid

Chelsea Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

Czech Republic;Bulgaria

2192

EUCTR2010-019871-31-FI
(EUCTR)

18/10/2010

30/08/2010

Etoricoxib and placebo in patients with rheumatoid arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

United States;Taiwan;Slovakia;Finland;Lithuania;Austria;Russian Federation;Colombia;United Kingdom;India;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;South Africa;Germany

2193

EUCTR2010-020892-22-HU
(EUCTR)

15/10/2010

11/08/2010

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Latvia;Germany;Italy;United Kingdom

2194

EUCTR2010-021020-94-IT
(EUCTR)

15/10/2010

28/09/2010

A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who have failed previous tumor necrosis factor-alpha (TNF-alpha) antagonists. - ND

active rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073

Product Code: SAR153191
Trade Name: SIMPONI
INN or Proposed INN: GOLIMUMAB

Sanofi-aventis Recherche & D?veloppement

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Czech Republic;Germany;Spain;Italy

2195

EUCTR2010-019964-36-DE
(EUCTR)

14/10/2010

09/06/2010

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects with Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy - CARAT-2

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CCX354 -C
Product Code: CCX354 -C
Other descriptive name: CCX354
Product Name: CCX354 -C
Product Code: CCX354 -C
Other descriptive name: CCX354

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2

Czech Republic;Hungary;Belgium;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2196

EUCTR2008-001523-57-DE
(EUCTR)

14/10/2010

10/06/2010

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;United Kingdom;Germany;Denmark;France;Norway;Spain;Italy

2197

EUCTR2007-006129-29-PL
(EUCTR)

14/10/2010

21/04/2010

A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study

Product Name: MOR103
Product Code: MOR103
Other descriptive name: Human Recombinant IgG1, lambda

MorphoSys AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Ukraine;Netherlands;Belarus;Bulgaria;Poland

2198

EUCTR2010-020743-12-HU
(EUCTR)

14/10/2010

11/08/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

France;Estonia;Hungary;Poland;Bulgaria;Germany;United Kingdom

2199

EUCTR2010-018674-20-FI
(EUCTR)

13/10/2010

23/08/2010

Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA)

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

470

Phase 3b

United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden

2200

EUCTR2010-020738-24-GB
(EUCTR)

12/10/2010

17/08/2010

To see whether for patients with established rheumatoid arthritis that have already achieved a good response to Tumour Necrosis Factor Inhibitor (TNF inhibitor) treatment, whether the treatment be tapered to a minimum dose without affecting the control of disease activity.

Optimising Treatment With Tumour Necrosis Factor Inhibitors In Rheumatoid Arthritis: Is Dose Tapering Practical In Good Responders? A Proof Of Principle” And Exploratory Trial. (OPTTIRA) - OPTTIRA

Patients with established Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

King's College London

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2201

EUCTR2010-020744-35-CZ
(EUCTR)

11/10/2010

30/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia

2202

EUCTR2010-020892-22-CZ
(EUCTR)

11/10/2010

30/08/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

2203

EUCTR2010-018646-31-SK
(EUCTR)

11/10/2010

23/06/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;Slovakia;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom

2204

EUCTR2010-018375-22-LT
(EUCTR)

11/10/2010

16/08/2010

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

United States;Philippines;Hong Kong;Spain;Thailand;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;New Zealand

2205

EUCTR2010-018646-31-LV
(EUCTR)

11/10/2010

29/06/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

633

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2206

EUCTR2010-020892-22-SK
(EUCTR)

11/10/2010

05/08/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

2207

EUCTR2010-020743-12-SK
(EUCTR)

11/10/2010

05/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Peru;Australia;Bulgaria;Germany

2208

EUCTR2010-020892-22-LT
(EUCTR)

11/10/2010

18/08/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

2209

EUCTR2010-020744-35-LT
(EUCTR)

11/10/2010

18/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia

2210

EUCTR2010-020745-27-CZ
(EUCTR)

11/10/2010

30/08/2010

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2211

EUCTR2010-018646-31-BG
(EUCTR)

07/10/2010

07/09/2010

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom

2212

EUCTR2009-016119-38-BG
(EUCTR)

05/10/2010

18/08/2010

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

United Kingdom;Bulgaria;Latvia;Poland

2213

EUCTR2009-015019-42-AT
(EUCTR)

05/10/2010

01/09/2010

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

170

Serbia;United States;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany

2214

EUCTR2010-018375-22-DE
(EUCTR)

05/10/2010

14/07/2010

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1200

2215

EUCTR2009-015845-21-GR
(EUCTR)

04/10/2010

A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis

Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira ®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2216

EUCTR2010-021449-28-FR
(EUCTR)

04/10/2010

09/08/2010

Valeur prédictive de la concentration sérique d’Adalimumab (Humira) sur la réponse clinique dans la polyarthrite rhumatoïde - AFORA

Polyarthrite rhumatoïde
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB

CHRU de TOURS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

2217

EUCTR2010-018646-31-PT
(EUCTR)

01/10/2010

23/07/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;Spain;Lithuania;Austria;Bulgaria;Latvia;Italy;United Kingdom

2218

EUCTR2009-015845-21-PT
(EUCTR)

01/10/2010

22/07/2010

Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira ®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;Portugal;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden

2219

EUCTR2006-005035-19-HU
(EUCTR)

01/10/2010

19/09/2007

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TASOCITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Product Code: CP -690,550
Product Name: CP -690,550
Product Code: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

4000

Hungary;Germany;Bulgaria;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Spain;Greece

2220

NCT01264211
(ClinicalTrials.gov)

October 2010

28/6/2010

Safety and Efficacy of the Combination of Diacerein 100 mg Daily and MTX Versus MTX Alone in the Treatment of Early Rheumatoid Arthritis (RA)

A 6-month Pilot Randomised Double-blind Placebo-controlled Multicentre, Phase 2 Study

Rheumatoid Arthritis

Drug: Diacerein;Drug: Placebo

TRB Chemedica

NULL

Completed

18 Years

65 Years

Both

Phase 2

Thailand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2221

NCT01221636
(ClinicalTrials.gov)

October 2010

13/10/2010

Pharmacokinetic Study to Compare the Blood Levels of Low vs High Metal Manufacture of Abatacept

A Study to Compare the Pharmacokinetics of Abatacept (BMS-188667) Drug Product Using Active Pharmaceutical Ingredient Manufactured With a High Concentration of Metals Relative to the Active Pharmaceutical Ingredient Manufactured With a Low Concentration of Metals

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Withdrawn

18 Years

55 Years

Both

Phase 1

United States

2222

NCT01034306
(ClinicalTrials.gov)

October 2010

16/12/2009

Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis

A Phase IIB Study of the Efficacy and Safety of Daily CF101 in Patients With Active Rheumatoid Arthritis and Elevated Baseline Expression Levels of Peripheral Blood Mononuclear Cell A3 Adenosine Receptors

Rheumatoid Arthritis

Drug: CF101;Drug: Placebo control

Can-Fite BioPharma

NULL

Completed

18 Years

75 Years

All

Phase 2

Bulgaria;Israel

2223

NCT01217086
(ClinicalTrials.gov)

October 2010

4/10/2010

Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)

Randomized, Double-blind, Parallel-group, Phase 3 Study

Rheumatoid Arthritis

Drug: Infliximab

Celltrion

NULL

Completed

18 Years

75 Years

Both

617

Phase 3

Korea, Republic of

2224

NCT01185301
(ClinicalTrials.gov)

October 2010

18/8/2010

Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)

A Double-Blind, Randomized, Parallel-Arm, Multicenter Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy With Adalimumab in Subjects With Early Rheumatoid Arthritis (CONCERTO)

Early Rheumatoid Arthritis

Biological: adalimumab;Drug: methotrexate

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

N/A

All

395

Phase 3

United States;Argentina;Austria;Belgium;Canada;Czech Republic;Germany;Poland;Puerto Rico;Spain

2225

NCT01098201
(ClinicalTrials.gov)

October 2010

30/3/2010

Certolizumab and Lower Extremity Lymph Flow in Rheumatoid Arthritis (RA)

The Effect of Certolizumab on Lower Extremity Lymph Flow in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Certolizumab

University of Rochester

NULL

Completed

18 Years

N/A

Both

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2226

NCT01164579
(ClinicalTrials.gov)

October 2010

15/7/2010

Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tasocitinib plus Methotrexate;Drug: Tofacitinib plus placebo methotrexate;Drug: Placebo tofacitinib plus Methotrexate

Pfizer

NULL

Completed

18 Years

N/A

All

109

Phase 2

United States;Argentina;Chile;Croatia;Czech Republic;Hungary;Mexico;Poland;Puerto Rico

2227

NCT01211249
(ClinicalTrials.gov)

October 2010

28/9/2010

GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis

Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination With Methotrexate, Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: GLPG0259 oral capsule;Drug: Placebo;Drug: GLPG0259 (Part B);Drug: Placebo (Part B)

Galapagos NV

NULL

Completed

18 Years

70 Years

Both

Phase 2

Belgium;Netherlands;Poland;Russian Federation;Ukraine

2228

NCT01781702
(ClinicalTrials.gov)

October 2010

30/1/2013

Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients

A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients

Pelubiprofen;Celebrex;Rheumatoid Arthritis

Drug: Pelubiprofen 30 mg;Drug: Celebrex 200 mg

Daewon Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

80 Years

Both

120

Phase 3

NULL

2229

NCT01214733
(ClinicalTrials.gov)

October 2010

4/10/2010

A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis

An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

Phase 3

South Africa

2230

NCT02528292
(ClinicalTrials.gov)

October 2010

5/8/2011

Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Rheumatoid Arthritis

Phase 4 Study of Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Patients With Rheumatoid Arthritis Undergoing Treatment With Anti-TNF Therapy

Rheumatoid Arthritis

Procedure: Synovial biopsy;Drug: Anti-TNF therapy

Barts & The London NHS Trust

NULL

Active, not recruiting

18 Years

N/A

Both

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2231

ChiCTR1900024107

2010-09-29

2019-06-26

A randomized, controlled, open label, multicenter clinical trial to evaluate the efficacy and safety of recombinant tumor necrosis factor receptor:Fc fusion protein (rhTNFR:Fc) with Methotrexate in active rheumatoid arthritis (ReABLE-II)

Active Rheumatoid Arthritis

A:Treatment of Yisaipu combined with methotrexate for 52 weeks;B:Treatment of Yisaipu combined with methotrexate for the first 24 weeks and followed by methotrexate monotherapy;C:Methotrexate monotherapy for 52 weeks;

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

NULL

Completed

Both

A:30;B:30;C:30;

Phase 4

China

2232

EUCTR2010-018646-31-AT
(EUCTR)

29/09/2010

03/08/2010

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

2233

EUCTR2010-019262-86-GR
(EUCTR)

28/09/2010

23/09/2010

A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: N/A
Product Code: SAR153191

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Hungary;Finland;Germany;Netherlands;Estonia;Spain;Greece;Austria;Lithuania

2234

EUCTR2010-019694-15-BE
(EUCTR)

28/09/2010

28/07/2010

Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached - ACT-Alone

Rheumatoid Arthritis in adult
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Medrol 4 mg tablets
Other descriptive name: METHYLPREDNISOLONE
Trade Name: Medrol A 16 mg tablets
Other descriptive name: METHYLPREDNISOLONE

N.V. Roche S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Belgium

2235

EUCTR2010-020892-22-EE
(EUCTR)

27/09/2010

16/08/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2236

NCT01208181
(ClinicalTrials.gov)

September 27, 2010

22/9/2010

A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)

A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Etoricoxib 60 mg;Drug: Etoricoxib 90 mg;Drug: Placebo to Etoricoxib 60 mg;Drug: Placebo to Etoricoxib 90 mg

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

1404

Phase 3

Argentina;Austria;Canada;Colombia;Czech Republic;Finland;Germany;Guatemala;India;Lithuania;Mexico;Panama;Peru;Poland;Romania;Russian Federation;Slovakia;South Africa;Taiwan;United Kingdom;United States

2237

EUCTR2010-020743-12-EE
(EUCTR)

24/09/2010

16/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Methotrexate But Not Responding. (OSKIRA - 1)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

Astra Zeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Estonia;Slovakia;Ukraine;Russian Federation;Chile;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Peru;Bulgaria;Germany

2238

EUCTR2010-018674-20-BE
(EUCTR)

23/09/2010

19/08/2010

Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination with Methotrexate in Adults with very early Rheumatoid Arthritis (RA)

A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating protocol amendment 01

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

470

Phase 3

United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Belgium;Poland;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden

2239

EUCTR2009-011791-30-DK
(EUCTR)

22/09/2010

12/11/2009

A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: NNC151-0000
Product Code: NNC0151-0000-0000
Other descriptive name: Anti-C5aR

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Czech Republic;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom

2240

JPRN-UMIN000011789

2010/09/21

20/09/2013

Usefulness of intravenous abatacept at an increased dose in rheumatoid arthritis patients with a poor prognosis

Rheumatoid arthritis

Administration of increased dose of abatacept to patients with rheumatoid arthritis previously treated with abatacept.

National Health Organization Nagoya Medical Center

NULL

Complete: follow-up complete

Not applicable

Male and Female

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2241

EUCTR2009-015898-12-BE
(EUCTR)

20/09/2010

14/06/2010

Patients with active rheumatoid arthritis and an inadequate response to Methotrexate
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259

Galápagos NV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Netherlands;Belgium

2242

EUCTR2010-018674-20-SE
(EUCTR)

16/09/2010

20/08/2010

Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA)

A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate in Inducing Clinical Remission Compared to Methotrexate Monotherapy in Adults with Very Early RA.Revised Protocol 01 incorporating amendment 01

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

470

Phase 3b

France;United States;Mexico;Canada;Finland;Denmark;Australia;Russian Federation;Germany;Italy;Korea, Republic of;Sweden

2243

EUCTR2010-019935-37-FI
(EUCTR)

15/09/2010

02/07/2010

A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis

Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term:

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
Other descriptive name: TOCILIZUMAB

Roche Oy

NULL

Not Recruiting

Female: yes
Male: yes

160

Finland

2244

EUCTR2010-018646-31-IT
(EUCTR)

14/09/2010

26/07/2010

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

2245

EUCTR2010-018375-22-GB
(EUCTR)

14/09/2010

29/06/2010

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2246

EUCTR2010-018674-20-FR
(EUCTR)

10/09/2010

16/08/2010

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

470

Phase 3b

Finland;Germany;Denmark;France;Italy;Sweden

2247

EUCTR2010-018646-31-GB
(EUCTR)

09/09/2010

22/07/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

633

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

2248

EUCTR2009-013758-33-DK
(EUCTR)

09/09/2010

09/06/2010

Trade Name: Cimzia ®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Denmark;Netherlands;Sweden

2249

EUCTR2010-019964-36-CZ
(EUCTR)

08/09/2010

09/06/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CCX354 -C
Product Code: CCX354 -C
Other descriptive name: CCX354

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2

Hungary;Czech Republic;Belgium;Germany

2250

EUCTR2009-016266-90-LT
(EUCTR)

06/09/2010

25/01/2010

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: not applicable
Product Code: SAR153191
Product Name: not applicable
Product Code: SAR153191
Product Name: not applicable
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

1740

Portugal;Estonia;Hungary;Czech Republic;Greece;Finland;Spain;Romania;Lithuania;Austria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2251

ChiCTR-TRC-10001014

2010-09-01

2010-08-30

Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Method of Activating Blood Circulation by Removing Blood Stasis

Rheumatoid Arthritis;M06.991

Group A:observation group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po. Ligustrazine Powder-Needle, 0.12g, solubling in 5% GS/NS 100ml, qd, iv, in 30 to 60 minutes. ;Group B:control group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po. ;

Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences

NULL

Completed

Both

Group A:60;Group B:60;

I (Phase 1 study)

China

2252

NCT01197534
(ClinicalTrials.gov)

September 2010

8/9/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.

(OSKIRA-2): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to DMARDs

Rheumatoid Arthritis

Drug: fostamatinib;Drug: placebo, fostamatinib

AstraZeneca

NULL

Completed

18 Years

N/A

All

913

Phase 3

United States;Canada;Czech Republic;Germany;India;Israel;Italy;Latvia;Lithuania;Portugal;Romania;Serbia;South Africa;Spain;Ukraine;United Kingdom

2253

NCT01197755
(ClinicalTrials.gov)

September 2010

8/9/2010

(OSKIRA-3): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With Inadequate Response to a TNF-alpha Antagonist

Rheumatoid Arthritis

Drug: fostamatinib;Drug: placebo

AstraZeneca

NULL

Completed

18 Years

N/A

All

323

Phase 3

United States;Argentina;Belgium;Brazil;Canada;Czech Republic;France;Germany;Hungary;Israel;Italy;Mexico;Portugal;South Africa;Spain;United Kingdom;Australia

2254

NCT01208506
(ClinicalTrials.gov)

September 2010

23/9/2010

First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis

First Human Dose Trial of NNC0114-0000-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis;Healthy

Drug: NNC0114-0000-0005;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

75 Years

All

Phase 1

Germany

2255

NCT01242917
(ClinicalTrials.gov)

September 2010

15/11/2010

A Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy

Rheumatoid Arthritis

Drug: CCX-354 -C;Drug: Placebo;Drug: CCX354 -C

ChemoCentryx

NULL

Completed

18 Years

75 Years

Both

159

Phase 2

Belgium;Czech Republic;Germany;Hungary;Netherlands;Poland;Romania;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2256

NCT01194414
(ClinicalTrials.gov)

September 2010

1/9/2010

A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis

A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab SC;Drug: tocilizumab IV;Drug: placebo to tocilizumab SC;Drug: placebo to tocilizumab IV;Drug: Disease-modifying antirheumatic drugs (DMARDs)

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

1262

Phase 3

United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Guatemala;Hong Kong;Italy;Lithuania;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Singapore;South Africa;Spain;Thailand;United Kingdom

2257

NCT01185288
(ClinicalTrials.gov)

September 2010

18/8/2010

A Study to Determine the Effect of Methotrexate (MTX) Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Treated With Adalimumab (MUSICA)

A Multicenter, Double-Blind, Randomized, Parallel-Arm Study to Determine the Effect of Methotrexate Dose on Clinical Outcome and Ultrasonographic Signs in Subjects With Moderately to Severely Active Rheumatoid Arthritis Treated With Adalimumab (MUSICA)

Rheumatoid Arthritis

Biological: Adalimumab;Drug: Methotrexate

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

N/A

All

309

Phase 4

United States;Puerto Rico

2258

NCT01197521
(ClinicalTrials.gov)

September 2010

8/9/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.

(OSKIRA-1): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: fostamatinib;Drug: placebo, fostamatinib

AstraZeneca

NULL

Completed

18 Years

N/A

All

923

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Chile;Estonia;France;Hungary;India;Mexico;Peru;Poland;Slovakia;Ukraine;United Kingdom;Germany;Russian Federation

2259

NCT01116141
(ClinicalTrials.gov)

September 2010

3/5/2010

A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA)

A Phase II, Multi-center, Randomized, Parallel Group, Double-blind, MTX Controlled Study to Assess the Clinical Efficacy, Safety and Tolerability of CH-4051 in Patients With Active RA Who Have Shown an Inadequate Response to MTX Monotherapy

Rheumatoid Arthritis

Drug: CH-4051;Drug: Methotrexate (MTX);Drug: Folic Acid

Chelsea Therapeutics

NULL

Completed

18 Years

80 Years

Both

250

Phase 2

NULL

2260

NCT01163747
(ClinicalTrials.gov)

September 2010

14/7/2010

A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)

A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

Rheumatoid Arthritis

Biological: tocilizumab;Drug: methotrexate;Biological: 23-Valent Pneumococcal Polysaccharide Vaccine;Biological: Tetanus Toxoid Adsorbed Vaccine

Genentech, Inc.

NULL

Completed

18 Years

64 Years

All

Phase 4

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2261

NCT01184001
(ClinicalTrials.gov)

September 2010

17/8/2010

A Study To Evaluate The Effect Of Food On How Tasocitinib (CP-690,550) Is Absorbed And Moves Through The Body Following Oral Administration Of Tasocitinib (CP-690,550) Tablets To Healthy Subjects

A Phase 1, Randomized, 2-Period, 2-Sequence, Open Label, Single Dose, Cross-Over Study To Evaluate The Effect Of Food On Pharmacokinetics Of Tasocitinib (CP-690,550) Tablets In Healthy Subjects

Rheumatoid Arthritis

Drug: Treatment A;Drug: Treatment B

Pfizer

NULL

Completed

21 Years

55 Years

Both

Phase 1

Singapore

2262

EUCTR2010-019964-36-BE
(EUCTR)

26/08/2010

20/05/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CCX354 -C
Product Code: CCX354 -C
Other descriptive name: CCX354

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2

Czech Republic;Hungary;Belgium;Germany

2263

EUCTR2009-016119-38-LV
(EUCTR)

13/08/2010

28/05/2010

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

United Kingdom;Bulgaria;Latvia;Poland

2264

EUCTR2010-018375-22-ES
(EUCTR)

03/08/2010

04/06/2010

A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.

Rheumatoid arthritisArtritis Reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: tocilizumab 162mg/0.9ml jeringa SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Germany;United Kingdom;Bulgaria;Spain;Italy;Lithuania

2265

JPRN-JapicCTI-101263

01/8/2010

DRIVE

A Dose-response Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on Methotrexate (MTX) to Validate Inhibitory Effect on Bone Erosion (Phase II)

Rheumatoid Arthritis

Intervention name : AMG 162
INN of the intervention : Denosumab
Dosage And administration of the intervention : AMG 162 60 mg administered subcutaneously - Every 6 months/ Every 3 months/ Every 2 months
Control intervention name : Placebo
Dosage And administration of the control intervention : Subcutaneously for placebo

DAIICHISANKYO Co.,Ltd.

NULL

BOTH

320

Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2266

ChiCTR-TRC-10000989

2010-08-01

2010-08-05

A 24 Week Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Chinese Medicines –the Second Trial

A 24 Week Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Chinese Medicines

rheumatoid arthritis;M06.991

observation group:Methotrexate Tablets, once per week, for first tim;observation group:Leigongtengduogan Pian, 10mg per time, 3 times per day, Yishen Juanbi Wan, 8g per time, 3 times per day, for oral administration, after meals ;Total:;

The Ministry of Science and Technology of the People's Republic of China

NULL

Completed

Male

observation group:120;observation group:120;Total:240;

China

2267

NCT01195272
(ClinicalTrials.gov)

August 2010

2/9/2010

A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.

A 52 Week, Single Center, Open-label Study to Evaluate Neutrophil Function and Survival Effects of Tocilizumab (TCZ) in Patients With Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

United Kingdom

2268

NCT01184092
(ClinicalTrials.gov)

August 2010

16/8/2010

A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)

Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted Conditions

Rheumatoid Arthritis

Drug: Treatment A;Drug: Treatment B;Drug: Treatment C

Pfizer

NULL

Completed

21 Years

55 Years

Both

Phase 1

Singapore

2269

NCT01181050
(ClinicalTrials.gov)

August 2010

12/8/2010

Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)

A Randomised, Single-dose, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0142-0002 in Subjects With Active Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC0142-0002;Drug: placebo

Janssen Research & Development, LLC

NULL

Completed

18 Years

75 Years

All

Phase 2

Germany;Russian Federation;Ukraine

2270

NCT01244958
(ClinicalTrials.gov)

August 2010

28/9/2010

Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis

Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis - a Multicenter Randomised Double-blind Clinical Trial

Rheumatoid Arthritis

Biological: Rituximab;Drug: Placebo

Frank Behrens

NULL

Completed

18 Years

75 Years

Both

156

Phase 3

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2271

EUCTR2010-018375-22-IT
(EUCTR)

29/07/2010

05/07/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Trade Name: RoActemra
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy

2272

EUCTR2010-019261-28-DE
(EUCTR)

26/07/2010

16/06/2010

A randomised, single-dose, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC 0142-0000-0002 in subjects with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: NNC 0142-0000-0002
Product Code: NNC 142-0002

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

160

Germany

2273

EUCTR2009-015845-21-DE
(EUCTR)

22/07/2010

18/03/2010

Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira ®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Portugal;Finland;Czech Republic;United Kingdom;Germany;Belgium;Spain;Greece;Sweden

2274

EUCTR2009-016987-34-HU
(EUCTR)

21/07/2010

26/02/2010

PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS

Moderate to severe active Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Czech Republic;Hungary;Poland;Spain;Bulgaria;Germany;Sweden

2275

EUCTR2010-019262-86-HU
(EUCTR)

21/07/2010

27/05/2010

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2025

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2276

EUCTR2009-012759-12-CZ
(EUCTR)

16/07/2010

22/02/2010

A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1128

Phase 3

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Denmark;Germany;Sweden

2277

EUCTR2009-015845-21-CZ
(EUCTR)

16/07/2010

26/03/2010

Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira ®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden

2278

EUCTR2009-016987-34-BG
(EUCTR)

15/07/2010

09/07/2010

Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis

PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS

Moderate to severe active Rheumatoid Arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Not applicable
Product Code: CP -690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM

Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Philippines;Taiwan;Slovakia;Thailand;Spain;Costa Rica;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;Australia;Denmark;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden

2279

EUCTR2010-019964-36-HU
(EUCTR)

14/07/2010

07/06/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CCX354 -C
Product Code: CCX354 -C
Other descriptive name: CCX354

ChemoCentryx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2

Hungary;Czech Republic;Belgium

2280

EUCTR2009-010516-15-GR
(EUCTR)

13/07/2010

21/04/2010

Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate

Rheumatoid arthritis (seropositive)
MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis

Product Name: SBI-087
Product Code: SBI-087
INN or Proposed INN: n/a
Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Hungary;Spain;Greece;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2281

EUCTR2009-017051-10-NL
(EUCTR)

13/07/2010

25/05/2010

Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritis

Patients with rheumatoid arthritis, who suffer from a exacerbation of disease can be included in this study. Exacerbation is defined as a Disease Activity Score of 5.1 or higher.Patients will be excluded if they suffer from diabetes (irrespective of medication) or if they have a contra-indication for dexamethason use.
MedDRA version: 12.0;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up

Trade Name: Dexamethason
Product Name: dexamethason

UMC Utrecht

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

2282

EUCTR2009-016266-90-GR
(EUCTR)

13/07/2010

01/07/2010

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

1740

Portugal;Estonia;Hungary;Czech Republic;Greece;Finland;Spain;Romania;Lithuania;Austria;Netherlands;Germany

2283

EUCTR2009-015845-21-SE
(EUCTR)

06/07/2010

10/05/2010

Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira ®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden

2284

EUCTR2009-017438-32-PL
(EUCTR)

06/07/2010

26/04/2010

A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis

active rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Germany;Poland

2285

EUCTR2009-012041-35-BE
(EUCTR)

02/07/2010

30/09/2009

Product Name: TNF-Kinoid
Product Code: TNF-K
INN or Proposed INN: Not assigned yet
Other descriptive name: N.A.

Neovacs SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;Argentina;Belgium;Croatia;Romania;Chile;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2286

JPRN-UMIN000003807

2010/07/01

01/07/2010

A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis

Rheumatoid Arthritis

Combination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate)
Combination therapy of TNF-bloking biologics and methotrexate

Japan Association of Rheumatologists in Private Practice

NULL

Complete: follow-up complete

Not applicable

Male and Female

160

Not applicable

Japan

2287

EUCTR2010-019262-86-FI
(EUCTR)

01/07/2010

19/05/2010

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 3

Portugal;United States;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

2288

EUCTR2009-016119-38-CZ
(EUCTR)

01/07/2010

02/07/2010

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

Czech Republic;Poland;Bulgaria;Latvia;United Kingdom

2289

EUCTR2009-012055-19-GB
(EUCTR)

24/06/2010

15/03/2010

A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: GSK315234 Injection 100mg/mL
Product Code: GSK315234

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Belgium;France;Ireland

2290

EUCTR2009-012055-19-FR
(EUCTR)

24/06/2010

26/04/2010

A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: GSK315234 Injection 100mg/mL
Product Code: GSK315234

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Belgium;Ireland;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2291

EUCTR2009-016266-90-DE
(EUCTR)

24/06/2010

12/01/2010

Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1594

Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand

2292

EUCTR2009-016119-38-PL
(EUCTR)

23/06/2010

30/04/2010

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

United Kingdom;Bulgaria;Latvia;Poland

2293

EUCTR2010-019262-86-EE
(EUCTR)

18/06/2010

21/05/2010

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 3

Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden;Portugal;United States;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina

2294

EUCTR2009-013758-33-SE
(EUCTR)

17/06/2010

22/03/2010

Trade Name: Cimzia ®
Product Name: certolizumab pegol (CZP)
Product Code: CDP870
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Denmark;Netherlands;Sweden

2295

EUCTR2009-012055-19-IE
(EUCTR)

16/06/2010

12/02/2010

A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: GSK315234 Injection 100mg/mL
Product Code: GSK315234

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Belgium;France;Ireland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2296

EUCTR2009-015845-21-FI
(EUCTR)

16/06/2010

30/04/2010

Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira ®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden

2297

EUCTR2009-012759-12-GR
(EUCTR)

15/06/2010

13/11/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden

2298

EUCTR2009-010582-23-GR
(EUCTR)

15/06/2010

30/12/2009

A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL?) or Adalimumab (HUMIRA?)

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal
Product Name: Golimumab prefilled pen
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3b

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

2299

EUCTR2008-001523-57-HU
(EUCTR)

14/06/2010

27/04/2010

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy

2300

EUCTR2009-015845-21-BE
(EUCTR)

08/06/2010

04/05/2010

Adult Rheumatoid Arthritis (RA)
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira ®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2301

EUCTR2009-014296-40-IT
(EUCTR)

08/06/2010

08/02/2010

Rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073

Product Code: CP -690,550

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

United Kingdom;Germany;Belgium;France;Ireland;Spain;Italy;Austria

2302

EUCTR2010-019873-13-BE
(EUCTR)

07/06/2010

14/04/2010

Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or MethotrexateAddendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA

early rheumatoid arthritis
MedDRA version: 12.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: RoActemra
Product Name: Tocilizumab

UCL Cliniques Universitaires Saint Luc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium

2303

EUCTR2008-005708-18-GB
(EUCTR)

04/06/2010

14/04/2010

Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess

Rheumatoid arthritis, SLE, Polymyalgia rheumatica, Disthyroid eye disease, Cushing's syndrome

Queen Mary University of London

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United Kingdom

2304

NCT01143337
(ClinicalTrials.gov)

June 2010

9/6/2010

Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis

A Multicenter Randomized, Double-blind, Placebo-controlled Study of MP-435 in Combination With MTX in Patients With Rheumatoid Arthritis - Exploratory Study

Rheumatoid Arthritis

Drug: MP-435(dose1) + Methotrexate;Drug: Placebo + Methotrexate

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

20 Years

75 Years

All

112

Phase 2

Japan

2305

EUCTR2008-007185-33-NL
(EUCTR)

20/05/2010

28/09/2009

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 1;Phase 2

Hungary;United Kingdom;Germany;Netherlands;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2306

EUCTR2009-016119-38-GB
(EUCTR)

19/05/2010

17/03/2010

Safety and Efficacy of AMG 827 in Subjects With RA

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

Czech Republic;United Kingdom;Bulgaria;Latvia;Poland;Australia

2307

EUCTR2009-017163-42-SE
(EUCTR)

18/05/2010

23/03/2010

Pain modulation in RA – Influence of adalimumab. A randomized, placebo-controlled study using functional magnetic resonance imaging - PARADE

Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

Karolinska Institute

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Sweden

2308

EUCTR2009-014735-20-BG
(EUCTR)

18/05/2010

23/02/2010

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: CAM-3001
Product Code: CAM-3001
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Czech Republic;Hungary;Estonia;Poland;Lithuania;Bulgaria;Latvia

2309

EUCTR2010-019438-28-SE
(EUCTR)

17/05/2010

18/03/2010

Vaccination against TBE in patients who use immunosuppressive drugs

TBE vaccin in patients using immunosuppressive drugs
MedDRA version: 12.1;Level: LLT;Classification code 10046859;Term: Vaccination
MedDRA version: 12.1;Classification code 10037153;Term: Psoriasis
MedDRA version: 12.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Classification code 10054980;Term: Immunosuppressant drug therapy

Trade Name: FSME-IMMUN
Other descriptive name: TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED)

Mälarsjukhuset Eskilstuna

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Sweden

2310

EUCTR2009-016987-34-PL
(EUCTR)

17/05/2010

19/03/2010

PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS

Moderate to severe active Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Code: CP -690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Czech Republic;Hungary;Spain;Poland;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2311

EUCTR2009-015845-21-GB
(EUCTR)

13/05/2010

17/03/2010

Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden

2312

EUCTR2009-015740-42-DE
(EUCTR)

12/05/2010

12/01/2010

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO

Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Prednisolon
Product Code: Prednisolon
INN or Proposed INN: PREDNISOLONE
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Name: Azathioprin
Other descriptive name: AZATHIOPRINE
Trade Name: Immunosporin
Product Name: Immunosporin
INN or Proposed INN: CICLOSPORIN
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: GOLIMUMAB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Product Name: Quensyl
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Trade Name: REMICADE
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Lantarel
Product Name: Lantarel
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Lantarel
Trade Name: Arava
Product Name: Arava
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Metex 2,5mg
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Metex 2,5mg

Universitätsklinkum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Germany

2313

EUCTR2009-015950-39-DE
(EUCTR)

12/05/2010

28/12/2009

Rituximab-Treatment in Addition to Leflunomide in Patients with active rheumatoid arthritis

Addition of Rituximab to Leflunomide in patients with active rheumatoid arthritis - AMARA

Active rheumatoid arthritis (RA) Patients who have had an inadequate response to disease modifying anti-rheumatic drugs (not more than 3 DMARDs including leflunomide, not more than one anti-TNF failure) and currently have active disease despite at least 3-month treatment with leflunomide. Active disease is defined as DAS 28 > 3.2 and at least swollen joint count (SJC) = 3 and tender joint count (TJC) = 3 included in the 28 joint count.
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera ®
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB

Johann Wolfgang Goethe-Universität Frankfurt/M.

NULL

Not Recruiting

Female: yes
Male: yes

Germany

2314

NCT01101555
(ClinicalTrials.gov)

May 12, 2010

8/4/2010

Repeat Dose Subcutaneous Rhumatoid Arthritis Efficacy Study

A Randomised, Single-blind, Placebo-controlled, Study Toevaluate the Safety, Tolerability, Pharmacodynamics Andpharmacokinetics of Repeat Subcutaneous Administration Ofotelixizumab in Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: subcutanious administration;Other: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

75 Years

All

Phase 1

Russian Federation

2315

EUCTR2010-018331-18-GB
(EUCTR)

12/05/2010

18/03/2010

A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy

Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2316

EUCTR2009-015845-21-ES
(EUCTR)

12/05/2010

12/01/2012

A comparison of tocilizumab and adalimumab in patients withrheumatoid arthritis looking at improvement in joint pain, joint swellingand general disease activity.

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Portugal;Germany;Switzerland;Turkey;Sweden;Australia;Brazil;Finland;United Kingdom;Czech Republic;Mexico;Belgium;Spain;Greece;United States

2317

EUCTR2009-010516-15-ES
(EUCTR)

11/05/2010

29/07/2009

Ensayo aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de SBI-087 en sujetos seropositivos con artritis reumatoide activa en tratamiento de fondo estable con metotrexatoRandomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate

Rheumatoid arthritis (seropositive)Artritis reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis

Product Name: SBI-087
Product Code: SBI-087
INN or Proposed INN: n/a
Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Hungary;Spain;Greece;Poland

2318

EUCTR2007-000896-41-AT
(EUCTR)

06/05/2010

13/05/2008

A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate

Rheumatoid arthritis

Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE

Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA

NULL

Not Recruiting

Female: yes
Male: yes

900

Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

2319

EUCTR2009-016987-34-SK
(EUCTR)

05/05/2010

28/04/2010

Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis

PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS

Product Name: Not applicable
Product Code: CP -690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM

Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

2320

EUCTR2009-012566-32-BG
(EUCTR)

05/05/2010

27/04/2010

A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate theSafety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2321

EUCTR2009-016987-34-DE
(EUCTR)

03/05/2010

17/02/2010

Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis

PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS

Moderate to severe active Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Not applicable
Product Code: CP -690,550
INN or Proposed INN: Tofacitinib
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM

Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Philippines;Taiwan;Slovakia;Thailand;Costa Rica;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Denmark;Australia;Peru;Korea, Republic of;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden

2322

JPRN-UMIN000003615

2010/05/01

14/05/2010

Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA

RA(Rheumatoid Arthritis)

Using 3 DMARDs(Salazosulfapyridine, Bucillamine, and Methotrexate) for 24 months

St Luke's International Hospital

NULL

Recruiting

20years-old

80years-old

Male and Female

Not selected

Japan

2323

ChiCTR-IPR-14005684

2010-05-01

2014-11-14

Compare with methotrexate tablets to evaluate the randomized double-blind, multicenter clinical trial to trial the efficacy and safety of the injection technetium 99Tc methylene diphosphonate treatment for active rheumatoid arthritis.

Rheumatoid arthritis

Yunke group:Yunke 16.5mg (5.5mg*3 sets) / time for each course of treatment, 100ml saline intravenous drip after dissolution and dilution, once a day for 7 successive days;MTX group :Four oral tablets each time, and gradually increase to 6 tablets each time in four weeks or to the maximum tolerated dose of the patients ;Combined treatment group :Yunke group+MTX group ;

Shanghai Renji Hospital

NULL

Completed

Both

Yunke group:60;MTX group :60;Combined treatment group :60;

China

2324

NCT01245452
(ClinicalTrials.gov)

May 2010

19/11/2010

Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate

Comparative Study of the Clinical Response and Cardiorespiratory Endurance in Early Rheumatoid Arthritis Patients Treated With Tocilizumab or Methotrexate Addendum Protocol : Global Gene Expression Profiles in Synovial Biopsies

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Methotrexate

Patrick Durez

NULL

Completed

18 Years

70 Years

Both

N/A

Belgium

2325

NCT01119859
(ClinicalTrials.gov)

May 2010

1/4/2010

A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Adalimumab;Drug: Placebo to tocilizumab;Drug: Placebo to adalimumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

326

Phase 4

United States;Australia;Belgium;Brazil;Czech Republic;Finland;Germany;Greece;Mexico;Portugal;Spain;Sweden;Switzerland;Turkey;United Kingdom;Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2326

NCT01090570
(ClinicalTrials.gov)

May 2010

15/3/2010

Safety, Pharmacokinetic (PK), Pharmcodynamic (PD), and Drug-Drug Interaction of PLX3397 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate

Rheumatoid Arthritis

Drug: PLX3397

Plexxikon

NULL

Withdrawn

18 Years

N/A

Both

Phase 1

United States

2327

NCT01163617
(ClinicalTrials.gov)

May 2010

4/5/2010

The Usability and Injection Time of the Physiolis Syringe and Autoinjector in Rheumatoid Arthritis Patients

A Multicenter, Randomized, Open-Label Study of the Injection Time and Usability of the Physiolis Syringe and Autoinjector in Injection-Experienced Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Device: Adalimumab delivered in current syringe;Device: Adalimumab delivered in Physiolis syringe;Device: Adalimumab delivered in current autoinjector;Device: Adalimumab delivered in Physiolis autoinjector

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

N/A

All

Phase 2

United States

2328

NCT01059448
(ClinicalTrials.gov)

May 2010

28/1/2010

Safety and Efficacy of AMG 827 in Subjects With RA

A Long-Term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AMG 827

Amgen

NULL

Terminated

N/A

Both

211

Phase 2

United States;Bulgaria;Canada;Czech Republic;Latvia;Mexico;Poland;United Kingdom

2329

NCT01253291
(ClinicalTrials.gov)

May 2010

1/12/2010

A Study of Japanese Rheumatoid Arthritis Participants

An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate

Rheumatoid Arthritis

Drug: LY2127399

Eli Lilly and Company

NULL

Completed

20 Years

75 Years

All

Phase 1

Japan

2330

NCT01253265
(ClinicalTrials.gov)

May 2010

1/12/2010

A Study in Rheumatoid Arthritis

Multiple-Dose, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate Treatment

Rheumatoid Arthritis

Drug: LY2439821;Drug: Placebo

Eli Lilly and Company

NULL

Completed

20 Years

75 Years

All

Phase 1

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2331

NCT01250548
(ClinicalTrials.gov)

May 2010

26/8/2010

The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment (CARAT)

The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment

Rheumatoid Arthritis

Biological: apremilast;Other: Placebo

Baylor Research Institute

NULL

Completed

18 Years

N/A

Both

Phase 2

United States

2332

EUCTR2008-002623-85-SE
(EUCTR)

28/04/2010

04/03/2010

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
Product Code: L01BA01
INN or Proposed INN: Methotrexate
Trade Name: Methotrexate Sodium Tablets 2.5mg
Product Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE

Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company, Philadelphia,PA-19101,USA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United Kingdom;Netherlands;France;Spain;Ireland;Italy;Sweden

2333

NCT01077531
(ClinicalTrials.gov)

April 28, 2010

25/2/2010

Safety, Pharmacodynamics and Pharmacokinetics of GSK2136525 Repeat Dose in Rheumatoid Arthritis

A Randomized, Placebo-controlled, Single-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Otelixizumab in Rheumatoid Arthritis Subjects

Arthritis, Rheumatoid

Drug: Otelixizumab;Drug: Matching placebo

GlaxoSmithKline

NULL

Terminated

18 Years

75 Years

All

Phase 1

Russian Federation;Spain;United Kingdom

2334

EUCTR2009-017438-32-BE
(EUCTR)

27/04/2010

24/02/2010

A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis

active rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: N/A
Product Code: VX-509
Product Name: N/A
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Hungary;Poland;Belgium;Germany

2335

EUCTR2009-017379-90-IT
(EUCTR)

27/04/2010

31/03/2010

Characterization of the secondary failure to TNF-blockers monoclonal antibodies. Receptor as a rescue therapy - ND

RA patients fulfilling the 1987 ACR criteria who discontinued a first antibody TNF-i (Infliximab or Adalimumab) because of secondary inefficacy
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

INN or Proposed INN: ETANERCEPT

AZIENDA OSPEDALIERA SENESE

NULL

Not Recruiting

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2336

EUCTR2009-014735-20-CZ
(EUCTR)

23/04/2010

12/11/2009

A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Estonia;Czech Republic;Poland;Ukraine;Lithuania;Romania;Bulgaria;Russian Federation;Latvia;Japan

2337

EUCTR2009-016987-34-CZ
(EUCTR)

23/04/2010

04/03/2010

Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis

PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS

Product Name: Not applicable
Product Code: CP -690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM

Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

2338

EUCTR2009-016987-34-ES
(EUCTR)

19/04/2010

12/02/2010

Estudio de fase 3 aleatorizado y doble ciego de la eficacia y la seguridad de 2 dosis de CP-690,550 en comparación con metotrexato en pacientes con artritis reumatoide no tratados previamente con metotrexato PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS

Artritis Reumatoide activa moderada a grave Moderate to severe active Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Product Code: CP -690,550
Trade Name: Methotrexate Sodium
Product Name: Metotrexato Sodico
INN or Proposed INN: METOTREXATO SODICO

PFIZER

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

Hungary;Czech Republic;Bulgaria;Spain;Poland;Sweden

2339

EUCTR2009-017438-32-HU
(EUCTR)

16/04/2010

24/02/2010

A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis

active rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Germany;Poland

2340

EUCTR2009-011791-30-GB
(EUCTR)

14/04/2010

14/10/2009

A randomised, double-blind, placebo-controlled, multiple dose trial of NNC 0151-0000-0000 in subjects with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Romania;Denmark;Russian Federation;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2341

EUCTR2010-018696-21-FR
(EUCTR)

14/04/2010

15/02/2010

Etude de l’évolution de la réponse immunitaire Th17 chez des patients atteints de polyarthrite rhumatoïde et traités par tocilizumab après échec des autres thérapies - TOCI 17

Polyarthrite rhumatoïde
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoACTEMRA
Product Name: TOCILIZUMAB

CHU DIJON

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

2342

EUCTR2009-012118-27-BE
(EUCTR)

13/04/2010

23/02/2010

JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Name: JNJ-38518168 -AEK - Over Encapsulated Tablet - 50 mg
Product Code: JNJ-38518168
INN or Proposed INN: N/A

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Czech Republic;Spain;Belgium;Netherlands;United Kingdom

2343

EUCTR2009-015835-34-IT
(EUCTR)

09/04/2010

29/03/2010

VITAMIN D EFFECT ON T LYMPHOCYTES AND OSTEOCLASTOGENESIS IN RHEUMAOID ARTHRITIS - ND

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid

Trade Name: DIBASE*IM OS 2F 1ML 300000UI/M
INN or Proposed INN: Colecalciferol

AZIENDA OSPEDALIERA ORDINE MAURIZIANO

NULL

Not Recruiting

Female: yes
Male: no

Phase 3

Italy

2344

EUCTR2009-014296-40-AT
(EUCTR)

07/04/2010

29/12/2009

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: tasocitinib (proposed INN)
Product Code: CP -690,550

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

United Kingdom;Germany;Belgium;France;Ireland;Spain;Italy;Austria

2345

EUCTR2009-016266-90-CZ
(EUCTR)

06/04/2010

22/12/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: SAR153191
Product Code: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

1740

Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Czech Republic;Hungary;Belgium;Romania;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2346

EUCTR2009-012055-19-BE
(EUCTR)

06/04/2010

02/03/2010

A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: GSK315234 Injection 100mg/mL
Product Code: GSK315234

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Belgium;France;Ireland

2347

EUCTR2009-016987-34-BE
(EUCTR)

01/04/2010

11/02/2010

Phase 3 Randomized, Double-Blind Study of the Efficacy and Safety of 2 Doses of CP-690,550 Compared to Methotrexate in Methotrexate-Naïve Patients with Rheumatoid Arthritis

PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS

Product Name: Not applicable
Product Code: CP -690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM

Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

2348

EUCTR2009-011137-26-PL
(EUCTR)

01/04/2010

25/01/2010

An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO-MORE

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland

2349

NCT01117129
(ClinicalTrials.gov)

April 2010

4/5/2010

A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)

Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: placebo;Drug: methotrexate;Drug: rituximab [Mabthera/Rituxan]

Hoffmann-La Roche

NULL

Terminated

18 Years

75 Years

Both

Phase 4

Spain

2350

NCT01287533
(ClinicalTrials.gov)

April 2010

30/1/2011

Efficacy of Monthly Ibandronate in Women With RA and Reduced Bone Mineral Density Receiving Long-term Steroids

Efficacy of Monthly Ibandronate in Women With Rheumatoid Arthritis and Reduced Bone Mineral Density Receiving Long-term Glucocorticoids

Rheumatoid Arthritis;Osteoporosis;Osteopenia

Drug: Ibandronate;Drug: Placebo

Yeong-Wook Song

NULL

Completed

18 Years

75 Years

Female

167

Phase 4

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2351

NCT01067430
(ClinicalTrials.gov)

April 2010

10/2/2010

Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis (RA)

Comparison of the Effect of Etoricoxib and Diclofenac on Early Morning Activity in Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: Etoricoxib;Drug: Diclofenac

Northumbria Healthcare NHS Foundation Trust

NULL

Not yet recruiting

18 Years

N/A

Both

Phase 4

United Kingdom

2352

NCT01060098
(ClinicalTrials.gov)

April 2010

29/1/2010

T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade

T Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha Agents

Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis

Drug: anti-TNF therapy (etanercept or adalimumab)

Imperial College London

NULL

Completed

18 Years

80 Years

All

United Kingdom

2353

NCT01313858
(ClinicalTrials.gov)

April 2010

10/3/2011

A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)

Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

Arthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, Ankylosing

Drug: Simponi ®;Drug: Methotrexate

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

1613

N/A

Germany

2354

EUCTR2009-012566-32-HU
(EUCTR)

31/03/2010

20/11/2009

Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland

2355

EUCTR2007-006657-63-HU
(EUCTR)

26/03/2010

15/02/2010

Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) - DOSERA

Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Enbrel 25 mg powder and solvent for solution for injection
Product Name: Enbrel
Trade Name: Enbrel 50 mg powder and solvent for solution for injection
Product Name: Enbrel

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

186

Finland;Hungary;Iceland;Denmark;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2356

EUCTR2009-015636-15-HU
(EUCTR)

25/03/2010

08/02/2010

Rheumatoid arthritis

An Open-label Extension Study to Assess the Long-term Safety and Tolerability of ATN-103 in Subjects With Rheumatoid Arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company

NULL

Not Recruiting

Female: yes
Male: yes

260

Hungary;Russian Federation;Germany;Canada;Switzerland;Belgium;Japan;United States;South Africa

2357

EUCTR2009-014735-20-PL
(EUCTR)

23/03/2010

21/12/2009

A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan

2358

EUCTR2009-016266-90-FI
(EUCTR)

23/03/2010

29/12/2009

Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sar

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1594

Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand

2359

EUCTR2009-011137-26-GR
(EUCTR)

22/03/2010

20/10/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

2360

EUCTR2009-012759-12-HU
(EUCTR)

17/03/2010

25/01/2010

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2361

EUCTR2007-006657-63-IS
(EUCTR)

10/03/2010

18/02/2010

Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)

Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA

Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Enbrel 25 mg powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel 50 mg powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT

Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Finland;Iceland;Denmark;Norway;Sweden

2362

EUCTR2009-010582-23-IT
(EUCTR)

10/03/2010

08/01/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: golimumab
Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: golimumab

CENTOCOR

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3b

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

2363

EUCTR2009-015653-20-NL
(EUCTR)

08/03/2010

10/03/2010

Prospective study on the effects of etanercept treatment in patients with rheumatoid arthritis who are naïve for TNF-alpha blocking therapy and patients who do not respond (anymore) to prior treatment with other anti-TNF-alpha medication - Not applicable

rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: etanercept
Product Name: Etanercept
INN or Proposed INN: METHOTREXATE
Other descriptive name: methotrexate

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

2364

EUCTR2009-016266-90-HU
(EUCTR)

03/03/2010

30/12/2009

Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1594

2365

EUCTR2009-010516-15-PL
(EUCTR)

03/03/2010

21/08/2009

Rheumatoid arthritis (seropositive)
MedDRA version: 13.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: SBI-087
Product Code: SBI-087
INN or Proposed INN: n/a
Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087

Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Greece;Spain;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2366

EUCTR2009-016266-90-EE
(EUCTR)

02/03/2010

05/01/2010

Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1594

2367

EUCTR2009-011137-26-PT
(EUCTR)

01/03/2010

09/12/2009

Active Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

2368

NCT01034397
(ClinicalTrials.gov)

March 2010

16/12/2009

A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs

A Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDs

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: placebo;Drug: non-biological DMARDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Portugal

2369

NCT01256736
(ClinicalTrials.gov)

March 2010

28/10/2010

To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: DMARDs

JW Pharmaceutical

NULL

Completed

18 Years

N/A

Both

Phase 3

Korea, Republic of

2370

NCT02010216
(ClinicalTrials.gov)

March 2010

4/12/2013

A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)

Non-Randomized Phase IV Trial on Efficacy and Safety of Actemra in the Treatment of Adult Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Kazakhstan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2371

NCT01197066
(ClinicalTrials.gov)

March 2010

17/3/2010

Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

A Phase ? Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801i

Rheumatoid Arthritis

Drug: Certolizumab Pegol

Korea Otsuka Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

N/A

All

110

Phase 3

Korea, Republic of

2372

NCT01610791
(ClinicalTrials.gov)

March 2010

31/5/2012

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)

A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

121

Phase 3

Morocco

2373

NCT01063062
(ClinicalTrials.gov)

February 28, 2010

3/2/2010

A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)

A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

107

Phase 3

Egypt

2374

EUCTR2009-011137-26-CZ
(EUCTR)

26/02/2010

13/10/2009

Active Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

2375

EUCTR2009-011137-26-AT
(EUCTR)

25/02/2010

04/09/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2376

EUCTR2009-016789-10-NL
(EUCTR)

19/02/2010

17/11/2009

Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximab

To assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapy

Trade Name: Focetria
Trade Name: Pandemrix,

Div KIR AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

2377

EUCTR2006-005330-20-CZ
(EUCTR)

19/02/2010

19/04/2007

anti TNF-IR phase III

A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy.

Rheumatoid arthritis
MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

France;Hungary;Czech Republic;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden

2378

EUCTR2009-014735-20-LT
(EUCTR)

18/02/2010

25/11/2009

A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan

2379

EUCTR2009-011137-26-IT
(EUCTR)

15/02/2010

02/10/2009

An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-na?ve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2). - GO -MORE

Active Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073

Product Name: Golimumab
Product Code: SCH900259
Product Name: Golimumab
Product Code: SCH 900259

Shering Plough Research Institute, A division of Schering Plough Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

2380

EUCTR2009-017325-19-FI
(EUCTR)

11/02/2010

28/12/2009

The effect of Six months Adalimumab Treatment on Sick Leaves and retirement in Patients with rheumatoid Arthritis who are at risk of losing their ability to work”

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Term: Rheumatoid arthritis

Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB

Helsingin reumakeskus

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Finland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2381

EUCTR2007-006129-29-NL
(EUCTR)

10/02/2010

18/08/2009

Product Name: MOR103
Product Code: MOR103
Other descriptive name: Human Recombinant IgG1, lambda

MorphoSys AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Ukraine;Belarus;Netherlands;Bulgaria;Poland

2382

EUCTR2009-014296-40-BE
(EUCTR)

10/02/2010

08/10/2009

Rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Code: CP -690,550

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

United States;Tanzania, United Republic of;Taiwan;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Brazil;Australia;Germany;Korea, Republic of;Sweden

2383

EUCTR2009-010582-23-BE
(EUCTR)

10/02/2010

23/09/2009

Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen or prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

2384

EUCTR2009-016987-34-SE
(EUCTR)

09/02/2010

23/12/2009

PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 COMPARED TO METHOTREXATE IN METHOTREXATE-NAÏVE PATIENTS WITH RHEUMATOID ARTHRITIS

Product Code: CP -690,550
Trade Name: Methotrexate Sodium
Product Name: Methotrexate Sodium
INN or Proposed INN: METHOTREXATE SODIUM

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Philippines;Taiwan;Slovakia;Thailand;Costa Rica;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;Peru;Korea, Republic of;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Dominican Republic;Bulgaria;Germany;New Zealand;Sweden

2385

EUCTR2007-000830-38-PL
(EUCTR)

08/02/2010

05/01/2010

A Phase IIIB, multi-centre open label, follow-up study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with DMARDs in subjects with active rheumatoid arthritis who participated in the study C87076.

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Cimzia ®
Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3B

France;Poland;Austria;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2386

EUCTR2009-012566-32-CZ
(EUCTR)

05/02/2010

01/10/2009

Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland

2387

EUCTR2008-007185-33-BE
(EUCTR)

01/02/2010

10/09/2009

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 1;Phase 2

Hungary;United Kingdom;Germany;Netherlands;Belgium

2388

NCT00979771
(ClinicalTrials.gov)

February 2010

17/9/2009

A Study to Investigate the Ability of GSK706769 to Maintain Clinical Remission After Withdrawal of Enbrel in Rheumatoid Arthritis Patients

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Ability of GSK706769 to Maintain Clinical Remission After Withdrawal of Enbrel in Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: GSK706769;Drug: Placebo

GlaxoSmithKline

NULL

Withdrawn

18 Years

N/A

All

Phase 2

Netherlands

2389

NCT01123070
(ClinicalTrials.gov)

February 2010

11/5/2010

TL011 in Severe, Active Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis;Biological: MabThera infusions

Teva Pharmaceutical Industries

NULL

Completed

18 Years

80 Years

Both

Phase 1;Phase 2

Czech Republic;Hungary;Italy;Spain;United Kingdom;Germany

2390

NCT01059864
(ClinicalTrials.gov)

February 2010

28/1/2010

Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550

Phase 2 Study Of The Effects Of Open-Label CP-690,550 And Double-Blind Atorvastatin On Lipids In Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CP -690,550;Drug: Atorvastatin;Drug: Atorvastatin Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

111

Phase 2

United States;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2391

NCT01052194
(ClinicalTrials.gov)

February 2010

18/1/2010

A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis

A 12-week, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Placebo;Drug: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Completed

18 Years

75 Years

Both

206

Phase 2

United States;Belgium;Croatia;Germany;Hungary;Poland;Puerto Rico;Romania;Russian Federation;Serbia

2392

NCT00941707
(ClinicalTrials.gov)

February 2010

16/7/2009

An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis

A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy

Rheumatoid Arthritis

Drug: JNJ 38518168;Drug: Placebo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

NULL

Terminated

18 Years

75 Years

Both

Phase 2

Belgium;Czech Republic;Ireland;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Taiwan;United Kingdom;Ukraine

2393

NCT01038674
(ClinicalTrials.gov)

February 2010

22/12/2009

Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis

A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: anti-IL-20;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

75 Years

All

Phase 1

Belgium;Poland

2394

NCT01063803
(ClinicalTrials.gov)

February 2010

2/2/2010

Study Evaluating Long-Term Safety Of ATN-103 In Subjects With Rheumatoid Arthritis

An Open-Label Extension Study To Assess The Long-term Safety And Tolerability Of ATN-103 In Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ATN-103

Ablynx

NULL

Completed

18 Years

80 Years

Both

266

Phase 2

United States;Canada;Hungary;Japan;Russian Federation;Serbia;South Africa;Switzerland

2395

NCT01111357
(ClinicalTrials.gov)

February 2010

29/1/2010

Study of Human Leukocyte Antigen (HLA) Polymorphisms in Patients With Rheumatoid Arthritis

Study of HLA Polymorphisms in French West-Indian Patients With Rheumatoid Arthritis : A Case Control Study

Rheumatoid Arthritis

Biological: Collect of 10 ml of peripheric blood for DNA extraction

Centre Hospitalier Universitaire de Fort-de-France

NULL

Completed

18 Years

N/A

Both

200

N/A

Martinique

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2396

EUCTR2009-012759-12-IE
(EUCTR)

26/01/2010

05/11/2009

Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden

2397

EUCTR2009-014735-20-HU
(EUCTR)

25/01/2010

02/11/2009

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CAM-3001
Product Code: CAM-3001
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

216

Phase 2

Czech Republic;Estonia;Hungary;Poland;Lithuania;Bulgaria

2398

NCT01754805
(ClinicalTrials.gov)

January 22, 2010

19/12/2012

A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis

A Phase 1b, Open-Label, Single Sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: peficitinib;Drug: methotrexate

Astellas Pharma Inc

NULL

Completed

18 Years

65 Years

All

Phase 1

United States

2399

EUCTR2007-006129-29-BG
(EUCTR)

21/01/2010

26/10/2009

Product Name: MOR103
Product Code: MOR103
Other descriptive name: Human Recombinant IgG1, lambda

MorphoSys AG

NULL

Not Recruiting

Female: yes
Male: yes

Belarus;Poland;Ukraine;Bulgaria;Netherlands;Germany

2400

EUCTR2008-006064-11-HU
(EUCTR)

20/01/2010

27/10/2009

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

564

Hungary;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2401

EUCTR2009-011137-26-BE
(EUCTR)

18/01/2010

19/10/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Phase 3

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

2402

EUCTR2009-012759-12-PT
(EUCTR)

12/01/2010

21/10/2009

A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Australia;Denmark;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden

2403

EUCTR2008-007185-33-DE
(EUCTR)

12/01/2010

02/09/2009

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 1;Phase 2

Hungary;United Kingdom;Germany;Netherlands;Belgium

2404

EUCTR2009-012759-12-SE
(EUCTR)

12/01/2010

17/11/2009

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

2405

EUCTR2009-014296-40-FR
(EUCTR)

11/01/2010

19/11/2009

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

396

Phase 3

United Kingdom;Germany;Belgium;France;Ireland;Spain;Italy;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2406

EUCTR2009-014296-40-IE
(EUCTR)

06/01/2010

06/10/2009

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

United Kingdom;Germany;Belgium;France;Spain;Ireland;Italy;Austria

2407

EUCTR2006-005035-19-IE
(EUCTR)

06/01/2010

07/10/2009

A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib
Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed)
Product Code: CP -690,550-10
INN or Proposed INN: Tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

4500

Phase 2;Phase 3

United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden

2408

EUCTR2009-014296-40-GB
(EUCTR)

05/01/2010

20/10/2010

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

Germany;United Kingdom;Belgium;France;Ireland;Spain;Italy;Austria

2409

EUCTR2009-010582-23-DE
(EUCTR)

04/01/2010

22/09/2009

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3b

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

2410

NCT01071798
(ClinicalTrials.gov)

January 2010

18/2/2010

An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis

A Prospective, Multi-center, Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months (in Case of Re-therapy the First 12 Months) of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine Care

Rheumatoid Arthritis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

1653

N/A

Germany;United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2411

NCT00752154
(ClinicalTrials.gov)

January 2010

11/9/2008

Curcumin in Rheumatoid Arthritis

Curcumin in Rheumatoid Arthritis - ACross-Over Pilot Study

Rheumatoid Arthritis

Drug: Curcumin (Longvida™)

University of California, Los Angeles

NULL

Recruiting

18 Years

N/A

Both

Phase 0

United States

2412

NCT01039688
(ClinicalTrials.gov)

January 2010

23/12/2009

Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX

Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: CP -690,550;Drug: Disease-modifying antirheumatic drug

Pfizer

NULL

Completed

18 Years

99 Years

All

956

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Chile;Colombia;Costa Rica;Czechia;Dominican Republic;Germany;Hungary;India;Korea, Republic of;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Taiwan;Thailand;Ukraine;Czech Republic

2413

NCT00995449
(ClinicalTrials.gov)

January 2010

5/10/2009

Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

A Phase 2, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM-CSF Monoclonal Antibody KB003 in Subjects With Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome From Biologic Therapy

Rheumatoid Arthritis

Biological: KB003;Other: Placebo Comparator

KaloBios Pharmaceuticals

NULL

Terminated

18 Years

N/A

All

Phase 2

United States

2414

NCT02731560
(ClinicalTrials.gov)

January 2010

6/3/2016

Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)

Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Rituximab

Prof. Abid Z. Farooqi

Aga Khan University;Fatima Memorial Hospital;Fauji Foundation Hospital, Rawalpindi

Completed

18 Years

80 Years

Both

Phase 4

NULL

2415

NCT01089023
(ClinicalTrials.gov)

January 2010

8/3/2010

A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2416

NCT01034137
(ClinicalTrials.gov)

January 2010

16/12/2009

A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis

U-ACT-EARLY: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Evaluate Remission in DMARD and Biological naïve Early Rheumatoid Arthritis (RA) Subjects Treated With Tocilizumab (TCZ) Plus Tight Control Methotrexate (MTX) , TCZ Monotherapy or Tight Control MTX Monotherapy

Rheumatoid Arthritis

Drug: methotrexate;Drug: placebo MTX;Drug: placebo TCZ;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

317

Phase 3

Netherlands

2417

NCT02368093
(ClinicalTrials.gov)

January 2010

4/2/2015

Efficacy Study of Dextromethorphan to Treat Rheumatoid Arthritis

A Double-blind, Placebo-controlled, Therapeutic Trial With Antitussive Drug-Dextromethorphan: Aimed to Determine Its Therapeutic Effect in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Dextromethorphan hydrobromide

Taichung Veterans General Hospital

TSH Biopharm Corporation Limited

Completed

18 Years

N/A

All

N/A

NULL

2418

EUCTR2009-010582-23-GB
(EUCTR)

31/12/2009

28/06/2010

Golimumab in rheumatoid arthritis patients with an inadequate response to etanercept (ENBREL) or adalimumab (HUMIRA)

Rheumatoid arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Greece;Belgium;Austria;Germany;Italy;United Kingdom;Sweden

2419

EUCTR2008-006064-11-LT
(EUCTR)

30/12/2009

19/10/2009

An Efficacy and Safety Study of intravenous Golimumab in patients with Active Rheumatoid Arthritis (RA) despite treatment with methotrexate, non steroidal pain medications and/or corticosteroids

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

564

United States;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Mexico;Argentina;Malaysia;Poland;Australia;New Zealand;Korea, Republic of

2420

EUCTR2009-014735-20-EE
(EUCTR)

29/12/2009

27/10/2009

A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Czech Republic;Estonia;Poland;Ukraine;Lithuania;Romania;Bulgaria;Russian Federation;Latvia;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2421

EUCTR2009-012566-32-LV
(EUCTR)

29/12/2009

30/10/2009

Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland

2422

EUCTR2009-014735-20-LV
(EUCTR)

29/12/2009

21/10/2009

A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Estonia;Czech Republic;Poland;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Japan

2423

EUCTR2009-012759-12-FI
(EUCTR)

21/12/2009

28/09/2009

A 2 year, global, randomized, phase III clinical trial stuying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with methotrexate and methotrexate only, in patients with early, moderate to severe rheumatoid arthritis.

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

United States;Portugal;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Peru;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Germany;New Zealand;Sweden

2424

EUCTR2009-011137-26-IE
(EUCTR)

21/12/2009

15/09/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

2425

EUCTR2009-012566-32-PL
(EUCTR)

17/12/2009

09/11/2009

Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2426

EUCTR2009-010582-23-SE
(EUCTR)

16/12/2009

23/10/2009

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3b

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

2427

EUCTR2009-012204-42-BE
(EUCTR)

16/12/2009

28/09/2009

A randomized, double-blind, placebo-controlled, parallel group study to investigate the ability of GSK706769 to maintain clinical efficacy after withdrawal of Enbrel in patients with rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: GSK706769
Product Code: GSK706769

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

Belgium;Ireland

2428

EUCTR2008-002623-85-DE
(EUCTR)

16/12/2009

12/06/2009

Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel ®
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Enbrel ®
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
Product Code: L01BA01
INN or Proposed INN: Methotrexate
Trade Name: Methotrexate Sodium Tablets 2.5mg
Product Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE

Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA

NULL

Not Recruiting

Female: yes
Male: yes

300

Poland;Romania;Germany;Netherlands;Sweden;Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France

2429

EUCTR2009-011137-26-FR
(EUCTR)

15/12/2009

10/09/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Phase 3

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

2430

EUCTR2009-011137-26-DK
(EUCTR)

07/12/2009

02/11/2009

Active Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2431

EUCTR2009-012759-12-DK
(EUCTR)

07/12/2009

03/11/2009

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Denmark;Australia;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden

2432

EUCTR2008-004894-16-HU
(EUCTR)

03/12/2009

17/11/2008

Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Hungary;Czech Republic;Germany;Poland

2433

EUCTR2009-011137-26-NL
(EUCTR)

02/12/2009

31/08/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

2434

EUCTR2009-012566-32-GB
(EUCTR)

02/12/2009

02/08/2010

Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;Czech Republic;United Kingdom;Bulgaria;Latvia;Poland

2435

EUCTR2009-012759-12-ES
(EUCTR)

01/12/2009

23/09/2009

Estudio multicéntrico, doble ciego, randomizado, con grupos de tratamiento paralelos, para evaluar la seguridad, la remisión de la enfermedad y la prevención del daño estructural articular durante el tratamiento con tocilizumab (TCZ) en monoterapia y en combinación con metotrexato (MTX), frente a metotrexato en monoterapia, en pacientes con artritis reumatoide precoz, moderada a severa. A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.

Artritis ReumatoideRheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1128

Hungary;Portugal;Finland;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2436

NCT01044498
(ClinicalTrials.gov)

December 2009

7/1/2010

A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis

An Open-label, Multi-center, One Sequence Cross-over Drug Interaction Study to Investigate the Effect of Tocilizumab (TCZ, RO4877533) on the Pharmacokinetics and Pharmacodynamics of an Oral Contraceptive (OC) in Female Patients With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Ortho-Novum ® 1/35

Hoffmann-La Roche

NULL

Completed

18 Years

44 Years

Female

Phase 3

United States

2437

NCT01040715
(ClinicalTrials.gov)

December 2009

28/12/2009

Immunogenicity and Safety of TNFa Kinoid in Rheumatoid Arthritis With Secondary Resistance to TNFa Antagonists

A Phase II, Randomized, Double-blind, Controlled Study to Evaluate the Immune Responses, Safety and Clinical Efficacy of Three Doses of Neovacs' TNF-Kinoid in Adult Patients With Rheumatoid Arthritis Who Have Relapsed Despite Anti-TNFa Biological Therapy

Rheumatoid Arthritis

Biological: TNFa Kinoid;Biological: TNF kinoid

Neovacs

NULL

Completed

18 Years

70 Years

Both

Phase 2

Argentina;Belgium;Bulgaria;Chile;Croatia;France;Romania;Switzerland

2438

NCT01027728
(ClinicalTrials.gov)

December 2009

7/12/2009

Study to Evaluate Safety and Efficacy of CCX 354-C in Subjects With Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CCX 354 -C

ChemoCentryx

NULL

Completed

18 Years

75 Years

Both

Phase 1;Phase 2

Belgium;Romania

2439

NCT01029613
(ClinicalTrials.gov)

December 2009

9/12/2009

Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers

Adalimumab in Rheumatoid Arthritis. An Investigation of Changes in Disease Activity and Course of Joint Destruction by Use of 3 Tesla Whole-Body MRI, Dedicated 3 Tesla MRI and CT of the Hand, and Soluble Biomarkers

Rheumatoid Arthritis

Drug: Adalimumab

Glostrup University Hospital, Copenhagen

NULL

Completed

18 Years

85 Years

Both

N/A

Denmark

2440

NCT01000441
(ClinicalTrials.gov)

December 2009

22/10/2009

Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: infliximab , etanercept, adalimumab;Drug: abatacept , rituximab or tocilizumab

University Hospital, Strasbourg, France

NULL

Recruiting

18 Years

N/A

Both

300

Phase 4

France;Monaco

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2441

NCT01001832
(ClinicalTrials.gov)

December 2009

26/10/2009

Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients

A Phase II/III, Multicenter, Randomized, Double-Blind, Double-Dummy Study to Assess Similarity of the Efficacy, Pharmacokinetics, Safety and Immunogenicity of Abatacept Administered Subcutaneously or Intravenously in Japanese Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Intravenous (IV) abatacept;Drug: Subcutaneous (SC) abatacept

Bristol-Myers Squibb

NULL

Completed

20 Years

N/A

All

118

Phase 2;Phase 3

Japan

2442

NCT00950989
(ClinicalTrials.gov)

December 2009

30/7/2009

AMG 827 in Rheumatoid Arthritis Subjects With Inadequate Response to Methotrexate

A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: AMG 827 70 mg;Drug: AMG 827 140 mg;Drug: AMG 827 210 mg;Drug: Placebo;Drug: Stable weekly dose of methotrexate

Amgen

NULL

Completed

18 Years

70 Years

Both

240

Phase 2

Bulgaria;Canada;Czech Republic;Hungary;Latvia;Mexico;Poland;United Kingdom;United States

2443

NCT01023256
(ClinicalTrials.gov)

December 2009

19/11/2009

Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of MOR103 Administered Intravenously to Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MOR103

MorphoSys AG

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

Bulgaria;Germany;Netherlands;Poland;Ukraine

2444

EUCTR2009-012041-35-FR
(EUCTR)

27/11/2009

16/10/2009

A phase II, randomized, partially double blind, controlled study to evaluate the immunogenicity, safety, and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis (RA) who have relapsed despite use of an anti-TNFa biological drug, due to anti-drug antibodies

Rheumatoid arthritis
MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: TNF-Kinoid
Product Code: TNF-K

Neovacs SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Bulgaria;France

2445

EUCTR2009-016055-22-FI
(EUCTR)

27/11/2009

09/10/2009

Immuunipuutteisten matkailijoiden A-hepatiittisuojaus

Terveet vapaaehtoiset ja vapaaehtoiset potilaat, joilla on diagnosoitu nivelreuma.
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Epaxal
Product Name: Epaxal

HY, HUS

NULL

Not Recruiting

Female: yes
Male: yes

Finland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2446

EUCTR2009-010582-23-AT
(EUCTR)

26/11/2009

12/10/2009

Golimumab in Rheumatoid Arthritis Patients With An Inadequate Response to Etanercept (ENBREL®) or Adalimumab (HUMIRA®)

Product Name: Golimumab Final Vialed Product (FVP)
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody
Product Name: Golimumab liquid in prefilled pen or Prefilled Syringe
Product Code: CNTO 148
INN or Proposed INN: golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3b

Greece;Belgium;Austria;Germany;United Kingdom;Italy;Sweden

2447

EUCTR2009-012424-87-GB
(EUCTR)

26/11/2009

14/10/2009

T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF

Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.0;Classification code 10037160;Term: Psoriatic arthritis
MedDRA version: 12.0;Classification code 10002556;Term: Ankylosing spondylitis

Imperial College London South Kensington London

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

2448

EUCTR2008-007185-33-GB
(EUCTR)

26/11/2009

28/07/2010

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Pharmaceuticals Inc., Acting through its division Wyeth Research, a Pfizer Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 1;Phase 2

Hungary;Germany;United Kingdom;Netherlands;Belgium

2449

EUCTR2009-013223-37-ES
(EUCTR)

25/11/2009

17/09/2009

Estudio en fase 2a, aleatorizado, doble ciego, controlado con un fármaco activo y con placebo, de PF-04171327 en el tratamiento de los signos y síntomas de la artritis reumatoideA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS

ARTRITIS REUMATOIDE
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: PF-04171327
Product Code: PF-04171327
Product Name: PF-04171327
Product Code: PF-04171327
Trade Name: DECORTIN (PREDNISONA) 5 MG COMPRIMIDOS
INN or Proposed INN: Prednisone
Other descriptive name: Decortin®

Pfizer S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

119

Phase 2A

Hungary;Spain

2450

EUCTR2009-009696-34-DE
(EUCTR)

23/11/2009

14/05/2009

A Study in Patients with Rheumatoid Arthritis

A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients with Active Rheumatoid Arthritis on Concomitant DMARD Therapy

Product Name: LY2439821
Product Code: LY2439821
INN or Proposed INN: N.A.

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

648

Phase 2

India;Russian Federation;Germany;Peru;Taiwan;Argentina;Romania;Korea, Republic of;Chile;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2451

EUCTR2009-012185-32-IT
(EUCTR)

23/11/2009

25/06/2009

Open label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - ND

Moderate to severe active rheumatoid arthritis (RA), who are inadequate responders to DMARDs.
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab
Product Code: Ro487-7533
INN or Proposed INN: RoActemra

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3b

Italy

2452

EUCTR2009-014296-40-ES
(EUCTR)

20/11/2009

24/09/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS. Estudio de fase 3 aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato y con una respuesta insuficiente a inhibidores del TNF.

Rheumatoid arthritisArtritis reumatoide
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

396

Phase 3

United Kingdom;Germany;Belgium;France;Ireland;Spain;Italy;Austria

2453

EUCTR2009-012759-12-DE
(EUCTR)

13/11/2009

25/08/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden

2454

EUCTR2009-012759-12-FR
(EUCTR)

13/11/2009

09/10/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1128

Hungary;Portugal;Finland;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Sweden

2455

EUCTR2009-012204-42-IE
(EUCTR)

13/11/2009

09/09/2009

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: GSK706769
Product Code: GSK706769

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

Belgium;Ireland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2456

EUCTR2009-014296-40-DE
(EUCTR)

12/11/2009

27/08/2009

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: not applicable
Product Code: CP -690,550

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

396

Phase 3

France;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy

2457

EUCTR2009-012759-12-IT
(EUCTR)

12/11/2009

17/11/2009

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: Methotrexate ``Lederle`` 2.5mg tablets
INN or Proposed INN: Methotrexate

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1128

Hungary;Portugal;Finland;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Sweden

2458

EUCTR2008-006924-68-HU
(EUCTR)

11/11/2009

02/09/2009

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
INN or Proposed INN: Tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Portugal;Hungary;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy

2459

EUCTR2009-011137-26-SK
(EUCTR)

11/11/2009

19/11/2009

Active Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Phase 3

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

2460

EUCTR2009-013223-37-CZ
(EUCTR)

10/11/2009

17/08/2009

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: PF-04171327
Product Code: PF-04171327
Product Name: PF-04171327
Product Code: PF-04171327
INN or Proposed INN: Prednisone
Other descriptive name: Decortin®

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

119

Phase 2

Hungary;Czech Republic;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2461

EUCTR2009-013316-12-NL
(EUCTR)

10/11/2009

21/10/2009

A multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-Early

Rheumatoid Arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: RoActemra
Trade Name: Methotrexate 'Lederle' 2,5mg tablets

Roche Nederland B.V.

NULL

Not Recruiting

Female: yes
Male: yes

Netherlands

2462

EUCTR2008-002623-85-IE
(EUCTR)

06/11/2009

15/09/2009

Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA

NULL

Not Recruiting

Female: yes
Male: yes

300

Qatar;Spain;Ireland;Russian Federation;Switzerland;United Kingdom;Italy;France;Poland;Romania;Germany;Netherlands;Sweden

2463

EUCTR2007-003288-36-GB
(EUCTR)

04/11/2009

03/10/2008

A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA) - RESTART

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

France;Finland;Spain;Austria;Germany;Netherlands;United Kingdom

2464

EUCTR2009-014824-40-CZ
(EUCTR)

03/11/2009

03/09/2009

An open label follow on study to evaluate the long-term safety, tolerability and efficacy of ART621 following fortnightly administration for 48 weeks in patients with rheumatoid arthritis concomitantly taking methotrexate.

Rheumatoid arthritis

Product Code: ART621

Arana Therapeutics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

200

Czech Republic

2465

EUCTR2007-006129-29-DE
(EUCTR)

03/11/2009

16/06/2009

Rheumatoid arthritis
MedDRA version: 13.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: MOR103
Product Code: MOR103
Other descriptive name: Human Recombinant IgG1, lambda

MorphoSys AG

NULL

Not Recruiting

Female: yes
Male: yes

Poland;Ukraine;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2466

JPRN-UMIN000002744

2009/11/01

10/11/2009

Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation

rheumatoid arthritis

tocilizumab plus methotrexate
tocilizumab

Keio University

NULL

Complete: follow-up complete

20years-old

75years-old

Male and Female

300

Not selected

Japan

2467

JPRN-UMIN000002687

2009/11/01

16/11/2009

ENBREL Clinical Outcome in RA patients for Growing Evidence

rheumatoid arthritis

MTX/MTX+DMARDs group
MTX+ETN group
ETN continuation group
ETN discontinuation group

TAP Corporation

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

330

Not applicable

Japan,Asia(except Japan)

2468

NCT01173120
(ClinicalTrials.gov)

November 2009

28/7/2010

Methotrexate - Inadequate Response Device Sub-Study

Sub-study-A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

Rheumatoid Arthritis (RA)

Device: Abatacept combination product (ACP)

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

Phase 3

NULL

2469

NCT01006681
(ClinicalTrials.gov)

November 2009

31/10/2009

Vaccination Against Influenza H1N1 in Rheumatic Diseases

Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory Drugs

Influenza;Rheumatic Diseases

Biological: Focetria (Monovalent MF59-Adjuvanted vaccine)

Tel-Aviv Sourasky Medical Center

NULL

Not yet recruiting

18 Years

65 Years

Both

400

Phase 2

NULL

2470

NCT01007175
(ClinicalTrials.gov)

November 2009

2/11/2009

Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Clinical Efficacy Of ATN-103 Administered To Japanese Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate

Rheumatoid Arthritis

Biological: ATN-103 10 mg q4wks;Biological: ATN-103 30 mg q4wks;Biological: ATN-103 80 mg q4wks;Biological: ATN-103 10 mg q8wks;Biological: ATN-103 80 mg q8wks

Ablynx

NULL

Completed

20 Years

75 Years

Both

Phase 1;Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2471

NCT00976599
(ClinicalTrials.gov)

November 2009

11/9/2009

A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis

An Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CP -690,550 + methotrexate;Drug: Placebo + Methotrexate

Pfizer

NULL

Completed

18 Years

N/A

All

Phase 2

United States

2472

NCT01010581
(ClinicalTrials.gov)

November 2009

9/11/2009

SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis

A Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: SC12267 (4SC-101);Drug: Placebo;Drug: Methotrexate;Drug: Folic Acid

4SC AG

NULL

Completed

18 Years

N/A

Both

266

Phase 2

Bulgaria;Czech Republic;Poland;Romania

2473

NCT01007435
(ClinicalTrials.gov)

October 31, 2009

3/11/2009

A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Placebo to tocilizumab;Drug: Methotrexate;Drug: Placebo to methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

1162

Phase 3

United States;Argentina;Australia;Austria;Brazil;Canada;China;Colombia;Denmark;Finland;France;Germany;Greece;Guatemala;Hong Kong;Hungary;Ireland;Israel;Italy;Macedonia, The Former Yugoslav Republic of;Mexico;New Zealand;Panama;Peru;Philippines;Poland;Portugal;Puerto Rico;Russian Federation;Singapore;South Africa;Spain;Sweden;Thailand;Turkey;United Kingdom;Czech Republic

2474

NCT00951275
(ClinicalTrials.gov)

October 31, 2009

30/7/2009

A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Single Arm, Open-label Study of Early Improvement of Anemia and Fatigue During Treatment With Tocilizumab (TCZ) in Combination With DMARDs, in Adult Patients With Moderate to Severe Active Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

105

Phase 3

Italy

2475

NCT00996203
(ClinicalTrials.gov)

October 31, 2009

15/10/2009

A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: DMARDs (disease-modifying antirheumatic drugs)

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

201

Phase 4

Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2476

EUCTR2008-005450-20-BE
(EUCTR)

29/10/2009

01/10/2009

The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)

Rheumatoid arthritis
MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade (infliximab)
INN or Proposed INN: INFLIXIMAB
Other descriptive name: remicade
Trade Name: Humira (adalimumab)
INN or Proposed INN: ADALIMUMAB
Trade Name: Enbrel (etanercept)
INN or Proposed INN: ETANERCEPT
Other descriptive name: Enbrel
Trade Name: Mabthera (rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: Mabthera
Trade Name: Orencia (abatacept)
INN or Proposed INN: ABATACEPT
Other descriptive name: Orencia

Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

261

Belgium

2477

EUCTR2009-012118-27-NL
(EUCTR)

27/10/2009

27/05/2009

JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet
Product Code: GFI 38518168-AEK-B-007

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Czech Republic;United Kingdom;Netherlands;Spain

2478

EUCTR2009-011137-26-ES
(EUCTR)

23/10/2009

06/08/2009

Estudio abierto para evaluar la adición de Golimumab subcutáneo (GLM) al tratamiento convencional con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) en sujetos no tratados previamente con fármacos biológicos que padecen artritis reumatoide (parte 1), seguido de un estudio aleatorizado que evalúa el valor de la administración combinada de GLM intravenoso y subcutáneo dirigida a inducir y mantener la remisión (parte 2). (Fase 3b, protocolo n.º P06129). An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2). (Phase 3b Protocol No. P06129. - GO-MORE

Artritis reumatoide
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Phase 3

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

2479

EUCTR2009-011137-26-FI
(EUCTR)

22/10/2009

25/08/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

2480

EUCTR2009-012953-39-PL
(EUCTR)

19/10/2009

31/07/2009

A Randomized, Double Blind, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination with Methotrexate compared to Methotrexate Alone in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SC12267
Product Code: SC12267
Trade Name: Metex 2,5mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Metex 7,5mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Metex 10mg Tabletten
INN or Proposed INN: METHOTREXATE

4SC AG

NULL

Not Recruiting

Female: yes
Male: yes

244

Phase 2

Czech Republic;Bulgaria;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2481

EUCTR2009-011137-26-HU
(EUCTR)

19/10/2009

02/09/2009

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece;Poland

2482

EUCTR2009-011137-26-GB
(EUCTR)

19/10/2009

18/10/2010

Active Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Phase 3

Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

2483

EUCTR2009-012705-19-CZ
(EUCTR)

16/10/2009

17/07/2009

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201

Rheumatoid Arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:

Product Name: LX3305 Dihydrate
Product Code: LX3305
INN or Proposed INN: None as of yet
Other descriptive name: LX3305
Product Name: LX3305 Dihydrate
Product Code: LX3305
INN or Proposed INN: None as of yet
Other descriptive name: LX3305

Lexicon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Hungary;Czech Republic;Bulgaria

2484

EUCTR2009-013223-37-HU
(EUCTR)

16/10/2009

02/09/2009

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: PF-04171327
Product Code: PF-04171327
Product Name: PF-04171327
Product Code: PF-04171327
INN or Proposed INN: Prednisone
Other descriptive name: Decortin®

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

119

Phase 2A

Hungary;Spain

2485

EUCTR2008-007185-33-HU
(EUCTR)

16/10/2009

09/09/2009

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 1;Phase 2

Hungary;United Kingdom;Germany;Netherlands;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2486

EUCTR2009-012759-12-GB
(EUCTR)

14/10/2009

17/08/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden

2487

EUCTR2009-014394-41-DK
(EUCTR)

12/10/2009

23/09/2009

Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers.Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP)

Reumatoid artritis
MedDRA version: 12.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid

Trade Name: Humira
Product Name: Humira
Product Code: Adalimummab
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Adalimumab

Hvidovre Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Denmark

2488

EUCTR2009-012218-30-PT
(EUCTR)

06/10/2009

12/08/2009

A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT

Men and women > 18 years of age with RA who are currently experiencing an inadequate clinical response to a stable dose of non-biologic DMARDs (at least 12 weeks) and with MRI documented synovitis of dominant hand.

Trade Name: RoActemra

Roche Farmacêutica Química, Lda.

NULL

Not Recruiting

Female: yes
Male: yes

Portugal

2489

EUCTR2009-011137-26-DE
(EUCTR)

05/10/2009

03/08/2009

Active Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

2490

EUCTR2008-002623-85-GB
(EUCTR)

01/10/2009

17/08/2009

Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Moderate to severe early Rheumatoid Arthritis (RA). (Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Wyeth Pharmaceuticals Inc. Philadelphia (A Pfizer Company)

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 4

Qatar;Spain;Ireland;Russian Federation;United Kingdom;Switzerland;Italy;France;Poland;Romania;Germany;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2491

NCT01123655
(ClinicalTrials.gov)

October 2009

12/5/2010

Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients

Phase 1 Trial of CII APL A12 in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: APLA12;Drug: Placebo

VA Office of Research and Development

NULL

Completed

18 Years

85 Years

All

Phase 1

United States

2492

NCT00960440
(ClinicalTrials.gov)

October 2009

14/8/2009

Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors

Arthritis, Rheumatoid

Drug: CP -690,550;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

399

Phase 3

United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Ireland;Italy;Korea, Republic of;Puerto Rico;Spain;Taiwan;United Kingdom

2493

NCT01002716
(ClinicalTrials.gov)

October 2009

15/10/2009

Cell Immunity Response to Vaccination Against Influenza in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Agrippal S1 (Influenza vaccination)

Tel-Aviv Sourasky Medical Center

NULL

Recruiting

18 Years

90 Years

Both

Phase 4

Israel

2494

NCT00929864
(ClinicalTrials.gov)

October 2009

29/6/2009

Abatacept Versus Adalimumab Head-to-Head

A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Abatacept;Drug: Adalimumab

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

869

Phase 3

United States;Argentina;Canada;Chile;Peru

2495

NCT01009242
(ClinicalTrials.gov)

October 2009

4/11/2009

To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Dose Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis on a Stable Dose of Methotrexate

Arthritis;Rheumatoid Arthritis

Biological: CDP6038;Other: Placebo IV;Other: Placebo SC;Drug: CDP 6038 SC;Drug: Methotrexate

UCB Pharma

NULL

Completed

18 Years

75 Years

All

Phase 1;Phase 2

United States;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2496

NCT00993317
(ClinicalTrials.gov)

October 2009

9/10/2009

A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis

A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 24-week Study to Assess the Efficacy and Safety of Certolizumab Pegol as Additional Medication to MTX in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

Rheumatoid Arthritis

Drug: Placebo of CDP870;Drug: CDP870 200mg;Drug: Methotrexate

Korea Otsuka Pharmaceutical Co., Ltd.

NULL

Completed

18 Years

75 Years

All

127

Phase 3

Korea, Republic of

2497

NCT01211834
(ClinicalTrials.gov)

October 2009

29/9/2010

Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy

Rheumatoid Arthritis

Drug: tocilizumab;Drug: DMARDs;Drug: Placebo

JW Pharmaceutical

NULL

Completed

18 Years

N/A

Both

Phase 3

Korea, Republic of

2498

NCT01873625
(ClinicalTrials.gov)

October 2009

5/6/2013

Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis

Resurfacing Articular Cartilage With Mesenchymal Stem Cells Transplantation in Patients With Knee Joint Osteoarthritis Affected by Rheumatoid Arthritis: Randomized Triple Blind Clinical Trial Phase II/III (ACRCT)

Rheumatoid Arthritis

Biological: mesenchymal cell transplantation;Biological: placebo

Royan Institute

NULL

Completed

10 Years

65 Years

Both

Phase 2;Phase 3

Iran, Islamic Republic of

2499

NCT00938587
(ClinicalTrials.gov)

October 2009

13/7/2009

A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis

A Phase 2a, Randomized, Double-Blind, Active And Placebo-Controlled Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: PF-04171327 10 mg;Other: Prednisone Placebo;Drug: PF-04171327 25 mg;Drug: Prednisone 5 mg;Other: Placebo for PF-04171327;Other: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

Phase 2

United States;Czechia;Hong Kong;Hungary;Korea, Republic of;Russian Federation;Serbia;Singapore;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic

2500

NCT01120366
(ClinicalTrials.gov)

October 2009

6/5/2010

Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation

Rheumatoid Arthritis

Drug: Tocilizumab plus methotrexate;Drug: Tocilizumab

SURPRISE Study Group

NULL

Completed

20 Years

75 Years

Both

233

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2501

NCT00996606
(ClinicalTrials.gov)

October 2009

15/10/2009

A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs

Open Label, Multicentric Phase IIIb Study to Evaluate the Effect of Tocilizumab in Combination With DMARDs in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Dedicated Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: DMARDs;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Italy

2502

EUCTR2009-011000-34-DE
(EUCTR)

30/09/2009

09/06/2009

A 16-week multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of subcutaneous AIN457 followed by an extension phase up to a total of 60 weeks in patients with active rheumatoid arthritis despite stable treatment with methotrexate

Moderate to severe Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: AIN457
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Slovakia;Czech Republic;Germany

2503

EUCTR2009-012705-19-BG
(EUCTR)

29/09/2009

06/10/2009

Rheumatoid Arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:

Lexicon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

104

Phase 2

Hungary;Czech Republic;Bulgaria

2504

EUCTR2009-012118-27-ES
(EUCTR)

28/09/2009

03/07/2009

A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy SubstudyEstudio de fase IIa, multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos de JNJ 38518168 en pacientes con artritis reumatoide activa a pesar del tratamiento con metotrexato con un sub-estudio de biopsia sinovial

JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.JNJ-38518168 se está desarrollando para el tratamiento de la Artritis Reumatoide
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet
Product Code: GFI 38518168-AEK-B-007

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Czech Republic;United Kingdom;Netherlands;Spain

2505

EUCTR2006-006373-25-FI
(EUCTR)

21/09/2009

16/06/2009

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A

CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2506

EUCTR2006-005035-19-FI
(EUCTR)

21/09/2009

15/06/2009

A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

4500

Phase 2;Phase 3

2507

EUCTR2009-012759-12-AT
(EUCTR)

14/09/2009

21/08/2009

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

2508

EUCTR2009-012953-39-BG
(EUCTR)

11/09/2009

18/09/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SC12267
Product Code: SC12267
INN or Proposed INN: Vidofludimus
Trade Name: Metex 2,5mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Metex 7,5mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Metex 10mg Tabletten
INN or Proposed INN: METHOTREXATE

4SC AG

NULL

Not Recruiting

Female: yes
Male: yes

244

Phase 2

Czech Republic;Bulgaria;Poland

2509

EUCTR2008-001847-20-DE
(EUCTR)

08/09/2009

03/06/2009

Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate

Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY

Trade Name: RoActemra ®
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Germany;Latvia;Netherlands;Norway;Sweden

2510

EUCTR2009-012118-27-CZ
(EUCTR)

04/09/2009

25/06/2009

JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet
Product Code: GFI 38518168-AEK-B-007

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

United Kingdom;Czech Republic;Netherlands;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2511

EUCTR2009-012118-27-GB
(EUCTR)

04/09/2009

18/06/2009

JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Name: JNJ-38518168 50-mg Over Encapsulated Tablet
Product Code: GFI 38518168-AEK-B-007

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Czech Republic;United Kingdom;Netherlands;Spain

2512

EUCTR2006-006373-25-GB
(EUCTR)

03/09/2009

16/11/2010

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2;Phase 3

Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden

2513

EUCTR2006-005035-19-GB
(EUCTR)

03/09/2009

27/04/2009

A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

4500

Phase 2;Phase 3

United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden

2514

EUCTR2009-011000-34-SK
(EUCTR)

02/09/2009

09/09/2009

Moderate to severe Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Germany;Slovakia

2515

EUCTR2009-012953-39-CZ
(EUCTR)

02/09/2009

03/07/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

4SC AG

NULL

Not Recruiting

Female: yes
Male: yes

244

Phase 2

Czech Republic;Bulgaria;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2516

NCT00984815
(ClinicalTrials.gov)

September 2009

23/9/2009

Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment

Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment

Osteoarthritis;Rheumatoid Arthritis;Chronic Low Back Pain;Chronic Regional Pain Syndrome;Chronic Soft Tissue Pain

Drug: HZT-501

Horizon Pharma Ireland, Ltd., Dublin Ireland

NULL

Completed

40 Years

80 Years

All

Phase 3

United States

2517

NCT00959036
(ClinicalTrials.gov)

September 2009

13/8/2009

Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate

Active Rheumatoid Arthritis

Drug: ATN-103;Drug: Placebo;Drug: Methotrexate

Ablynx

NULL

Completed

18 Years

80 Years

Both

252

Phase 1;Phase 2

United States;Belgium;Canada;Germany;Hungary;Russian Federation;Serbia;South Africa;Switzerland

2518

NCT00969527
(ClinicalTrials.gov)

September 2009

27/8/2009

Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis

Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Dietary Supplement: Oncoxin + Viusid;Dietary Supplement: Placebo

Catalysis SL

NULL

Completed

18 Years

N/A

Both

Phase 3

Cuba

2519

NCT01253226
(ClinicalTrials.gov)

September 2009

1/12/2010

A Study for Japanese Participants With Rheumatoid Arthritis (RA)

Multiple-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate

Rheumatoid Arthritis

Drug: LY2127399 (Tabalumab);Drug: Placebo

Eli Lilly and Company

NULL

Completed

20 Years

75 Years

All

Phase 1

Japan

2520

NCT01360970
(ClinicalTrials.gov)

September 2009

24/5/2011

Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate

Response to Hepatitis A Vaccine

Biological: hepatitis A vaccine ( HAVRIX or EPAXAL)

Lars Rombo

NULL

Completed

18 Years

N/A

Both

Phase 2

Finland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2521

NCT00993668
(ClinicalTrials.gov)

September 2009

9/10/2009

Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines

A Phase 4, Randomized, Single-blind, Placebo-controlled, Multicenter Study to Evaluate the Immunogenicity of Pneumococcal and Influenza Vaccines in Adult Subjects With Rheumatoid Arthritis Receiving Certolizumab Pegol or Placebo

Rheumatoid Arthritis

Other: Placebo;Biological: Certolizumab pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

224

Phase 4

United States

2522

NCT01075477
(ClinicalTrials.gov)

September 2009

24/2/2010

An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)

Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines

Rheumatoid Arthritis

Drug: rituximab [Mabthera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

151

N/A

Finland;United States

2523

NCT00913458
(ClinicalTrials.gov)

September 2009

26/5/2009

Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate

Active Rheumatoid Arthritis;Arthritis, Rheumatoid;Rheumatoid Arthritis

Drug: etanercept

Pfizer

NULL

Completed

18 Years

N/A

All

306

Phase 4

France;Germany;Ireland;Italy;Monaco;Netherlands;Poland;Qatar;Romania;Russian Federation;Spain;Switzerland;United Kingdom

2524

NCT00975130
(ClinicalTrials.gov)

September 2009

20/8/2009

Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)

An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)

Arthritis, Rheumatoid

Biological: SC golimumab;Biological: IV golimumab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

3366

Phase 3

Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;Denmark;Ecuador;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Korea, Republic of;Mexico;Monaco;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;United Kingdom

2525

EUCTR2009-010813-57-DE
(EUCTR)

28/08/2009

24/06/2009

A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate.

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CDP6038
Product Code: CDP6038
Other descriptive name: recombinant human Mab of IgG4 subtype
Product Name: CDP6038
Product Code: CDP6038
Other descriptive name: recombinant human Mab of IgG4 subtype

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2526

EUCTR2009-011000-34-HU
(EUCTR)

27/08/2009

20/07/2009

Moderate to severe Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Slovakia;Czech Republic;Germany

2527

EUCTR2008-006936-37-BE
(EUCTR)

24/08/2009

08/04/2009

A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ILV-094 Administered Subcutaneously to Subjects with Active Rheumatoid Arthritis on a Stable Background of Methotrexate

Rheumatoid Arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ILV-094
Product Code: ILV-094
Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1

Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

Hungary;Belgium;Netherlands;Germany

2528

EUCTR2009-011206-42-CZ
(EUCTR)

18/08/2009

05/06/2009

A Randomized, Double Blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients with Active Rheumatoid Arthritis with Inadequate Response to Any Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy including Biologics

Active Rheumatoid Arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: INCB028050 phosphate
Product Code: INCB028050
Other descriptive name: INCB028050 phosphate salt
Product Name: INCB028050 phosphate
Product Code: INCB028050
Other descriptive name: INCB028050 phosphate salt
Product Name: INCB028050 phosphate
Product Code: INCB028050
Other descriptive name: INCB028050 phosphate salt

Incyte Corporation

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Czech Republic

2529

EUCTR2008-002623-85-FR
(EUCTR)

18/08/2009

04/06/2009

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
Product Code: L01BA01
INN or Proposed INN: Methotrexate
Trade Name: Methotrexate Sodium tablets 2.5mg
Product Name: Methotrexate
INN or Proposed INN: methotrexate

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United Kingdom;Netherlands;France;Spain;Ireland;Italy;Sweden

2530

EUCTR2009-011000-34-CZ
(EUCTR)

18/08/2009

15/06/2009

Moderate to severe Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Slovakia;Germany;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2531

EUCTR2009-012705-19-HU
(EUCTR)

17/08/2009

16/07/2009

Rheumatoid Arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:

Lexicon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

104

Phase 2

Hungary;Czech Republic;Bulgaria

2532

EUCTR2009-011000-34-BE
(EUCTR)

14/08/2009

22/07/2009

Moderate to severe Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: not available
Other descriptive name: rhumAb to Il-17A (IgG1-k-class)

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;Belgium;Germany

2533

EUCTR2009-010516-15-HU
(EUCTR)

14/08/2009

14/07/2009

Rheumatoid arthritis (seropositive)
MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis

Product Name: SBI-087
Product Code: SBI-087
INN or Proposed INN: n/a
Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Greece;Poland;Spain

2534

EUCTR2008-008338-35-FI
(EUCTR)

13/08/2009

14/05/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain

2535

EUCTR2006-005035-19-DK
(EUCTR)

11/08/2009

23/06/2009

A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Product Name: Tofacitinib citrate( Phase III formulation)
Product Code: CP -690,550-10
Product Name: Tofacitinib citrate (Proposed commercial formulation debossed)
Product Code: CP -690,550-10

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

4500

Phase 2;Phase 3

Portugal;United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2536

EUCTR2008-006936-37-DE
(EUCTR)

03/08/2009

16/04/2009

Rheumatoid Arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ILV-094
Product Code: ILV-094
Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1

Wyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer company

NULL

Not Recruiting

Female: yes
Male: yes

180

Hungary;Germany;Netherlands;Belgium

2537

JPRN-UMIN000002340

2009/08/01

20/08/2009

Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET)

Rheumatoid Arthritis

Treatment with higher dosages of infliximab (3-10 mg/Kg)
Every 2 months
Follow-up to 54 weeks
Treatment with one of other biologics (etanercept, adalimumab, tocilizumab) in standard protocol
Follow-up to 54 weeks

Department of Rheumatosurgery, Osaka City University Medical School

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Phase 4

Japan

2538

NCT03681639
(ClinicalTrials.gov)

August 1, 2009

13/9/2018

Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component

A Multi-Centre, Prospective Study to Obtain Survival and Clinical Outcome Data on the Zimmer Hip Resurfacing System Utilising the Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component

Avascular Necrosis of Hip;Osteoarthritis, Hip;Rheumatoid Arthritis;Inflammatory Arthritis;Post-traumatic; Arthrosis

Diagnostic Test: Serum Metal ion levels determined to monitor changes in chromium and cobalt levels

Zimmer Biomet

NULL

Active, not recruiting

18 Years

65 Years

All

225

N/A

Germany

2539

NCT01870128
(ClinicalTrials.gov)

August 2009

30/5/2013

Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial

Rheumatoid Arthritis

Drug: Combination Steroid;Drug: Methotrexate;Drug: Combination

All India Institute of Medical Sciences, New Delhi

NULL

Completed

18 Years

60 Years

Both

Phase 3

India

2540

NCT00965653
(ClinicalTrials.gov)

August 2009

18/8/2009

A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

Open-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: folic acid;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

Both

Phase 1

Canada;New Zealand;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2541

NCT00929357
(ClinicalTrials.gov)

August 2009

25/6/2009

Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.

Rheumatoid Arthritis

Drug: DMARDs or Biologics

Pfizer

NULL

Completed

18 Years

N/A

All

156

N/A

Denmark

2542

NCT00966875
(ClinicalTrials.gov)

August 2009

25/8/2009

A Study in Patients With Rheumatoid Arthritis

A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD Therapy

Rheumatoid Arthritis

Biological: LY2439821;Drug: Placebo

Eli Lilly and Company

NULL

Completed

18 Years

75 Years

All

448

Phase 2

United States;Argentina;Chile;Germany;India;Korea, Republic of;Peru;Poland;Romania;Russian Federation;Taiwan;Hungary

2543

EUCTR2008-006075-75-CZ
(EUCTR)

29/07/2009

28/07/2009

A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2a

Hungary;United Kingdom;Germany;Czech Republic

2544

EUCTR2007-006603-20-HU
(EUCTR)

29/07/2009

14/05/2009

A Phase 2, 2-Part, Multicenter, Randomized, Double-blind,Parallel-group, Placebo-controlled, Proof-of-concept, dose-findingStudy Evaluating the Efficacy and Safety of CNTO 136Administered Subcutaneously in Subjects with Active RheumatoidArthritis Despite Methotrexate Therapy - Not available

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CNTO136
Product Code: CNTO136
INN or Proposed INN: not available
Other descriptive name: CNTO 136 IgG

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

Hungary

2545

EUCTR2008-006936-37-NL
(EUCTR)

27/07/2009

29/04/2009

Rheumatoid Arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ILV-094
Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1

Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development

NULL

Not Recruiting

Female: yes
Male: yes

120

Hungary;Germany;Netherlands;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2546

EUCTR2008-002623-85-ES
(EUCTR)

27/07/2009

19/02/2010

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE Estudio en 3 fases para evaluar el mantenimiento de la remisión y los parámetros de productividad en sujetos con artritis reumatoide en fase inicial que comiencen tratamiento con etanercept más metotrexato.

Moderate to severe early Rheumatoid Arthritis (RA).(Subjects with moderate to severe early Rheumatoid Arthritis (RA), who are currently employed (to constitute a majority of recruited subjects), or if not employed, are able to work and perform a functional role in society, such as caring for home and family, who have had RA symptoms for 1 year or less, and are Methotrexate-naive).Artritis reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United Kingdom;Netherlands;France;Ireland;Spain;Italy;Sweden

2547

EUCTR2008-002623-85-NL
(EUCTR)

27/07/2009

01/05/2009

A 3-PHASE STUDY TO EVALUATE SUSTAINED REMISSION AND PRODUCTIVITY OUTCOMES IN SUBJECTS WITH EARLY RHEUMATOID ARTHRITIS INITIATED ON TREATMENT WITH ETANERCEPT PLUS METHOTREXATE

Trade Name: Enbrel 25mg PFS
Product Name: Enbrel (Etanercept)
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Enbrel 50mg PFS
Product Name: Enbrel (Etanercept)
Product Code: 0881
INN or Proposed INN: Etanercept
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

NULL

Not Recruiting

Female: yes
Male: yes

300

France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden

2548

ChiCTR-TRC-09000472

2009-07-20

2009-07-15

Weekly dose of leflunomide for the treatment of early rheumatoid arthritis

Weekly dose of leflunomide for the treatment of early rheumatoid arthritis: a multicentre, open, randomized clincal trial

Rheumatoid arthritis

Group A:leflunomide 10mg,orally taken once daily for 24 weeks;Group B:leflunomide 50mg, orally taken weekly for 24 weeks;

People's Hospital, Peking University

NULL

Completed

Both

Group A:160;Group B:160;

China

2549

EUCTR2008-005525-11-GR
(EUCTR)

20/07/2009

17/11/2009

A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Greece;Spain;Netherlands;Germany;United Kingdom

2550

ChiCTR-TRC-09000473

2009-07-20

2009-07-15

Efficacy and safety of Alendronate on Structural Benefit and Inflammation in Rheumatoid Arthritis(RA): A randomized, open, placebo-controlled, multicentre clinical trial.

Rheumatoid Arthritis

Group B:MTX 7.5-20mg, orally taken once weekly for 48 week;Group A:MTX7.5-20mg, orally taken once weekly combined Alendronate Sodium 70mg,orally taken once weekly for 48 weeks ;

People's Hospital, Peking University

NULL

Completed

Both

Group B:160;Group A:160;

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2551

EUCTR2008-008338-35-DE
(EUCTR)

14/07/2009

04/05/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Finland;United Kingdom;Czech Republic;Germany;Denmark;Bulgaria;Spain

2552

EUCTR2008-002623-85-IT
(EUCTR)

14/07/2009

30/06/2009

A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate - PRIZE

Moderate to severe early Rheumatoid Arthritis (RA).
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ENBREL *SC 4SIR 25MG 0,5ML+8TAM
INN or Proposed INN: Etanercept
Trade Name: ENBREL *SC 4SIR 50MG 1ML+8TAMP
INN or Proposed INN: Etanercept
Trade Name: METHOTREXATE *25CPR 2,5MG
INN or Proposed INN: Methotrexate

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development

NULL

Not Recruiting

Female: yes
Male: yes

300

France;Spain;Ireland;Germany;Netherlands;United Kingdom;Italy;Sweden

2553

EUCTR2009-010955-29-NL
(EUCTR)

13/07/2009

27/02/2009

Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.

Pre-clinical RA patients with a high risk on developing the disease.

Trade Name: MabThera 500 mg (10mg/ml)
INN or Proposed INN: Rituximab

Division of Clinically Immunology and Rheumatology, AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

2554

EUCTR2008-004875-23-HU
(EUCTR)

08/07/2009

11/05/2009

An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

198

Hungary;Germany;Belgium;France;Austria;Poland

2555

JPRN-UMIN000002169

2009/07/01

07/07/2009

Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritis

Rheumatoid Arthritis

Salazosulfapyridine
Bucillamine

Higashi-Hiroshima Memorial Hospital

NULL

Complete: follow-up complete

20years-old

80years-old

Male and Female

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2556

NCT00903383
(ClinicalTrials.gov)

July 2009

14/5/2009

Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate

A Phase 2, Multi-center, Randomized, Double Blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy

Rheumatoid Arthritis

Drug: LX3305 low dose;Drug: LX3305 mid dose;Drug: LX3305 high dose;Drug: Placebo

Lexicon Pharmaceuticals

NULL

Completed

18 Years

75 Years

All

208

Phase 2

United States;Bulgaria;Czech Republic;Hungary;Poland;Serbia

2557

NCT00928512
(ClinicalTrials.gov)

July 2009

25/6/2009

Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

A 16-week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab (AIN457) Followed by an Extension Phase up to a Total of 60 Weeks in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate

Rheumatoid Arthritis

Drug: Secukinmab;Drug: Placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

N/A

All

237

Phase 2

United States;Belgium;Czech Republic;Germany;Hungary;Japan;Korea, Republic of;Poland;Russian Federation;Slovakia;Taiwan;Puerto Rico

2558

EUCTR2009-012141-34-GB
(EUCTR)

29/06/2009

15/05/2009

Randomised Controlled Trial of the Use of Topical Application of Tranexamic Acid in Primary Total Hip Replacement. - (TRANX-H)

Blood loss in total hip replacement in patient with ostoearthritis and rheumatoid arthritis.

Trade Name: Cyklokapron®
Product Name: Cyklokapron®
Product Code: NA

University Hospital of North Tees and Hartlepool

NULL

Not Recruiting

Female: yes
Male: yes

150

United Kingdom

2559

EUCTR2008-004875-23-AT
(EUCTR)

26/06/2009

30/04/2009

An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: NA
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

236

Hungary;Germany;Belgium;France;Poland;Austria

2560

EUCTR2008-008337-11-GR
(EUCTR)

25/06/2009

20/10/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2561

EUCTR2008-006917-25-PL
(EUCTR)

24/06/2009

10/03/2009

A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).

Patients with active rheumatoid arthritis who are on a stable dose of methotrexate

Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast

Nuon Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United Kingdom;Czech Republic;Germany;Bulgaria;Poland

2562

EUCTR2008-007788-17-DE
(EUCTR)

24/06/2009

08/04/2009

PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Product Code: CP -690,550

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

611

Phase 3

Czech Republic;Bulgaria;Germany

2563

EUCTR2007-000828-40-PL
(EUCTR)

24/06/2009

12/05/2009

A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab'fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis.

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3B

Germany;France;Italy;Austria;Poland

2564

EUCTR2008-008337-11-SK
(EUCTR)

22/06/2009

09/09/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

795

Phase 3

Slovakia;Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden

2565

EUCTR2008-008337-11-ES
(EUCTR)

19/06/2009

27/03/2009

Estudio de fase III, aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP 690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con FARMEsPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Artritis reumatoide RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2566

EUCTR2008-008338-35-ES
(EUCTR)

19/06/2009

27/03/2009

PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEEstudio de fase 3 aleatorizado, doble ciego, con comparador activo y controlado con placebo de la eficacia y la seguridad de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato

CP 690,550 está estudiándose como fármaco antirreumático modificador de la enfermedad (FARME) en el tratamiento de la artritis reumatoide activa moderada o grave en adultosCP-690,550 ins being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB

Pfizer, S.A

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Phase 3

Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain

2567

EUCTR2008-008337-11-DK
(EUCTR)

18/06/2009

15/05/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden

2568

EUCTR2008-008337-11-FI
(EUCTR)

17/06/2009

24/04/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

795

Phase 3

Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden

2569

EUCTR2008-008337-11-DE
(EUCTR)

16/06/2009

07/04/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

795

Phase 3

Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden

2570

EUCTR2008-008338-35-BG
(EUCTR)

16/06/2009

22/05/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2571

EUCTR2008-007023-26-BG
(EUCTR)

16/06/2009

22/05/2009

PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE

CP 690,550 is being studied as a disease modifying antirheumatic drug for the treatment of moderate to severe active rheumatoid arthritis in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Poland;Bulgaria

2572

EUCTR2008-002381-55-ES
(EUCTR)

16/06/2009

01/08/2008

Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR.Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study.

Pacientes con artritis reumatoide (AR) activa refractarios a uno o más fármacos antiTNF (definido por un DAS28>3,2).
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MABTHERA 500 mg concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB

ROCHE FARMA, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Spain

2573

EUCTR2008-008338-35-GB
(EUCTR)

11/06/2009

09/04/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Finland;Germany;Czech Republic;United Kingdom;Denmark;Bulgaria;Spain

2574

EUCTR2008-008337-11-GB
(EUCTR)

10/06/2009

09/04/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;Germany;United Kingdom;Denmark;Spain;Greece;Poland;Sweden

2575

EUCTR2008-008337-11-PL
(EUCTR)

09/06/2009

30/04/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc. 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

795

Phase 3

Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2576

EUCTR2008-006917-25-BG
(EUCTR)

09/06/2009

10/06/2009

A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).

Patients with active rheumatoid arthritis who are on a stable dose of methotrexate

Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE

Nuon Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United Kingdom;Czech Republic;Germany;Bulgaria;Poland

2577

EUCTR2008-007023-26-PL
(EUCTR)

03/06/2009

05/06/2009

PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE

Product Code: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Bulgaria;Poland

2578

EUCTR2008-001105-42-PL
(EUCTR)

03/06/2009

17/04/2009

A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Germany;Belgium;France;Austria;Poland

2579

EUCTR2008-008338-35-DK
(EUCTR)

03/06/2009

29/04/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom

2580

EUCTR2008-006924-68-GR
(EUCTR)

03/06/2009

19/11/2009

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
INN or Proposed INN: Tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2581

JPRN-UMIN000002175

2009/06/01

10/07/2009

Comparison of the clinical responses by the dosage of once or triple a week of MTX in patients with rheumatoid Arthritis

Rheumatoid Arthritis

MTX, once a week
MTX, triple a week

POEM study group

NULL

Complete: follow-up continuing

16years-old

80years-old

Male and Female

Not applicable

Japan

2582

EUCTR2008-007788-17-BG
(EUCTR)

01/06/2009

22/05/2009

PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS -

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Product Code: CP -690,550

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

611

Phase 3

Germany;Czech Republic;Bulgaria

2583

JPRN-JapicCTI-090764

01/6/2009

26/05/2009

Long-Term Treatment Study of Ocrelizumab for Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : Ocrelizumab
Dosage And administration of the intervention : 500 mg will be administered by intravenous infusion on Day 1 and Day 15. Repeat courses of therapy with ocrelizumab may be administered basically every 24 weeks, a minimum interval of 12 weeks, between courses.

Chugai Pharmaceutical Co., Ltd.

NULL

BOTH

200

Phase 3

NULL

2584

NCT00883896
(ClinicalTrials.gov)

June 2009

17/4/2009

Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis

A Randomized, Parallel, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of ILV-094 Administered Subcutaneously To Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate

Rheumatoid Arthritis

Other: Placebo;Drug: ILV-094

Pfizer

NULL

Completed

18 Years

N/A

Both

195

Phase 2

United States;Belgium;Colombia;Croatia;Germany;Hungary;Japan;Mexico;Netherlands;Romania;Russian Federation;Denmark

2585

NCT01038349
(ClinicalTrials.gov)

June 2009

9/12/2009

Applications for Methotrexate Optimization in Rheumatoid Arthritis

Rheumatoid Arthritis

Other: Avise PG - Diagnostic test

Cypress Bioscience, Inc.

NULL

Completed

18 Years

N/A

Both

256

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2586

NCT00927927
(ClinicalTrials.gov)

June 2009

24/6/2009

First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Single and Multiple Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0142-0002 Administered Subcutaneously to Subjects With Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis

Drug: NNC0142-0002;Drug: placebo

Janssen Research & Development, LLC

NULL

Completed

18 Years

75 Years

All

Phase 1

Germany

2587

NCT00947492
(ClinicalTrials.gov)

June 2009

27/7/2009

Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs

Monitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab).

Rheumatoid Arthritis

Biological: Venous blood sample

Assistance Publique Hopitaux De Marseille

NULL

Active, not recruiting

18 Years

N/A

Both

N/A

France

2588

NCT01010503
(ClinicalTrials.gov)

June 2009

9/11/2009

A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

Evaluation of Adherence and Persistence to Tocilizumab in Combination With Methotrexate or Tocilizumab Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis in Local Environment.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Slovakia

2589

NCT00977106
(ClinicalTrials.gov)

June 2009

18/8/2009

TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF

Comparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDO

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: placebo

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

103

Phase 3

France

2590

EUCTR2008-008337-11-SE
(EUCTR)

27/05/2009

23/03/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2591

EUCTR2008-004875-23-DE
(EUCTR)

26/05/2009

09/03/2009

An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: NA
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

236

Hungary;Germany;Belgium;France;Austria;Poland

2592

EUCTR2008-008338-35-SK
(EUCTR)

25/05/2009

09/09/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom

2593

EUCTR2008-006917-25-CZ
(EUCTR)

22/05/2009

11/03/2009

A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).

Patients with active rheumatoid arthritis who are on a stable dose of methotrexate

Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast

Nuon Therapeutics, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

United Kingdom;Germany;Czech Republic;Bulgaria;Poland

2594

EUCTR2008-007788-17-CZ
(EUCTR)

20/05/2009

18/03/2009

PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS -

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

611

Phase 3

Germany;Czech Republic;Bulgaria

2595

NCT00838565
(ClinicalTrials.gov)

May 20, 2009

4/2/2009

Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis

Phase 1, Randomized, Patient And Investigator-blind, Placebo-controlled Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of Pf-04236921 In Patients With Rheumatoid Arthritis Receiving Methotrexate

Rheumatoid Arthritis

Drug: Placebo;Drug: dose level 1;Drug: dose level 2;Drug: dose level 3;Drug: dose level 4

Pfizer

NULL

Completed

18 Years

70 Years

All

Phase 1

United States;Korea, Republic of;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2596

EUCTR2008-008338-35-CZ
(EUCTR)

20/05/2009

18/03/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom

2597

EUCTR2008-006924-68-PT
(EUCTR)

18/05/2009

17/03/2009

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
INN or Proposed INN: Tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

France;Portugal;Hungary;Czech Republic;Spain;Netherlands;United Kingdom;Italy

2598

EUCTR2008-007023-26-CZ
(EUCTR)

18/05/2009

10/03/2009

PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Bulgaria;Poland

2599

EUCTR2008-004875-23-BE
(EUCTR)

18/05/2009

07/01/2009

An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

236

France;Hungary;Poland;Belgium;Austria;Germany

2600

EUCTR2009-011105-17-IT
(EUCTR)

17/05/2009

27/03/2009

A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab
Product Code: Ro 487-7533
INN or Proposed INN: RoActemra

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2601

EUCTR2007-006657-63-FI
(EUCTR)

08/05/2009

27/01/2009

Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)

Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA

Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Finland;Iceland;Denmark;Norway;Sweden

2602

EUCTR2009-011520-53-SK
(EUCTR)

04/05/2009

17/03/2009

Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment

moderate to severe active rheumatoid arthritis

Trade Name: RoActemra ®
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

Roche Slovensko s.r.o.

NULL

Not Recruiting

Female: yes
Male: yes

Slovakia

2603

ChiCTR-TRC-12003871

2009-05-01

2012-01-01

Phase II of Tong Luo Hua Shi Capsules in Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Phase II Study Evaluating the Safety and Efficacy of Tong Luo Hua Shi Capsules in Participants with Rheumatoid Arthritis

Rheumatoid arthritis

A:2 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;B:3 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;C:4 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;D:4 pieces placebo;

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

NULL

Completed

Both

A:60;B:60;C:60;D:60;

I+2 (Phase 1;Phase 2)

China

2604

NCT00902369
(ClinicalTrials.gov)

May 2009

14/5/2009

A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: AK106-001616;Drug: Placebo;Drug: Active comparator

Asahi Kasei Pharma Corporation

NULL

Completed

18 Years

65 Years

Both

130

Phase 2

Czech Republic;Germany;Hungary;Lithuania;Romania;United Kingdom

2605

NCT00279461
(ClinicalTrials.gov)

May 2009

17/1/2006

Vitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid Arthritis

Vitamin D Deficiency Causes Immune Dysfunction and Enables or Perpetuates the Development of Rheumatoid Arthritis: Clinical Trial and Investigations on Dendritic Cells

Arthritis, Rheumatoid;Vitamin D Deficiency

Drug: Placebo in arm A and Vitamin D in arm B;Drug: vitamin D 3 for arm A ,and matching placebo for arm B

Indiana University

NULL

Withdrawn

18 Years

N/A

Both

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2606

NCT00888745
(ClinicalTrials.gov)

May 2009

27/4/2009

A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: placebo;Drug: PRO283698

Genentech, Inc.

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States;Hungary;United Kingdom

2607

NCT00891020
(ClinicalTrials.gov)

May 2009

29/4/2009

A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)

Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Nonbiologic DMARDs of investigator's choice

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

886

Phase 3

United States;Puerto Rico;United Kingdom

2608

NCT00920608
(ClinicalTrials.gov)

May 2009

12/6/2009

A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients

A Phase I, Multi-centre, Open-label, Fixed-sequence Study to Assess the Pharmacokinetics of Methotrexate Alone and When Co-administered With AZD9056 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AZD9056;Drug: Methotrexate

AstraZeneca

NULL

Withdrawn

18 Years

70 Years

Both

Phase 1

NULL

2609

NCT00887341
(ClinicalTrials.gov)

May 2009

22/4/2009

A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Phase II Multi-centre, Randomized, Parallel Group, Pilot Trial to Compare the Incidence of Tocilizumab Related Infusion Reactions in Moderate to Severe RA Patients When Infusion is Made Over 1 Hour Against 31 Minutes

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 2

Spain

2610

NCT00902486
(ClinicalTrials.gov)

May 2009

13/5/2009

INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs

A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics

Rheumatoid Arthritis

Drug: INCB028050;Drug: Placebo

Incyte Corporation

NULL

Completed

18 Years

N/A

All

127

Phase 2

United States;Czechia;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2611

NCT00856544
(ClinicalTrials.gov)

May 2009

3/3/2009

A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS

Arthritis, Rheumatoid

Drug: CP -690,550;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

795

Phase 3

United States;Australia;Chile;China;Colombia;Croatia;Denmark;Finland;Germany;Greece;Malaysia;Mexico;Poland;Russian Federation;Slovakia;Spain;Sweden;Thailand;United Kingdom;Venezuela

2612

NCT00853385
(ClinicalTrials.gov)

May 2009

27/2/2009

A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Rheumatoid Arthritis

Drug: CP 690,550;Drug: CP -690,550;Other: Placebo;Biological: Biologic TNFi

Pfizer

NULL

Completed

18 Years

N/A

All

717

Phase 3

United States;Australia;Bosnia and Herzegovina;Bulgaria;Canada;Chile;Costa Rica;Croatia;Czech Republic;Denmark;Dominican Republic;Finland;Germany;Korea, Republic of;Mexico;Philippines;Poland;Slovakia;Spain;Thailand;United Kingdom

2613

EUCTR2008-007023-26-GR
(EUCTR)

29/04/2009

03/04/2009

PHASE 3 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE

Product Code: CP -690,550

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Greece;Poland;Bulgaria

2614

EUCTR2007-001625-10-GR
(EUCTR)

29/04/2009

06/03/2009

An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra

RHEUMATOID ARTHRITIS

Trade Name: Etanercept
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

700

Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria

2615

EUCTR2008-006924-68-CZ
(EUCTR)

28/04/2009

12/02/2009

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
INN or Proposed INN: Tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2616

EUCTR2008-006917-25-DE
(EUCTR)

24/04/2009

22/01/2009

A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).

Patients with active rheumatoid arthritis who are on a stable dose of methotrexate

Trade Name: Ribazen
Product Name: Tranilast
INN or Proposed INN: Tranilast
Trade Name: Ribazen
Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE

Nuon Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United Kingdom;Czech Republic;Germany;Bulgaria;Poland

2617

EUCTR2008-008309-23-FR
(EUCTR)

24/04/2009

31/03/2009

Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDO

Polyarthrite rhumatoïde active modérée à sévère de moins de 10 ans d'ancienneté, avec réponse inadéquate au méthotrexate (MTX) et/ou à un autre DMARD et/ou à au moins un anti-TNF
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
Product Code: RO487-7533/F01-F05
INN or Proposed INN: tolicizumab

ROCHE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

2618

EUCTR2008-005525-11-DE
(EUCTR)

24/04/2009

09/12/2008

A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;France;Spain

2619

EUCTR2008-006917-25-GB
(EUCTR)

22/04/2009

09/04/2009

A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA). - Tranilast plus Methotrexate vs MTX Alone in Patients with Active RA

Patients with active rheumatoid arthritis who are on a stable dose of methotrexate

Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: methotrexate

Nuon Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

Czech Republic;Germany;United Kingdom;Bulgaria;Poland

2620

EUCTR2008-005427-28-NL
(EUCTR)

22/04/2009

09/12/2008

A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis. - Realistic

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

1048

Phase 3b

Germany;Netherlands;France;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2621

EUCTR2008-006075-75-DE
(EUCTR)

22/04/2009

17/02/2009

A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2a

Hungary;Czech Republic;United Kingdom;Germany

2622

EUCTR2008-004875-23-PL
(EUCTR)

22/04/2009

25/02/2009

An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: NA
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

236

Hungary;Germany;Belgium;France;Austria;Poland

2623

EUCTR2007-006657-63-DK
(EUCTR)

16/04/2009

20/02/2009

Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)

Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA

Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Finland;Denmark;Iceland;Norway;Sweden

2624

NCT01081717
(ClinicalTrials.gov)

April 14, 2009

4/3/2010

Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological Treatments

Rheumatoid Arthritis;Arthritis, Psoriatic;Ankylosing Spondylitis

Drug: systemic non-biological treatments;Biological: anti-TNF biologics;Biological: golimumab;Biological: non-anti-TNF biologics;Other: general population

Janssen Biotech, Inc.

NULL

Completed

N/A

99 Years

All

1064

United States

2625

EUCTR2008-006075-75-GB
(EUCTR)

14/04/2009

28/04/2009

A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2a

Hungary;Czech Republic;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2626

EUCTR2008-004894-16-CZ
(EUCTR)

14/04/2009

26/11/2008

Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company limited

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2

Hungary;Germany;Czech Republic;Poland

2627

EUCTR2009-011044-20-GB
(EUCTR)

08/04/2009

14/04/2009

A Single-Centre, Double-blind, Double-dummy, Randomised, Placebo Controlled, Four Period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600mg and 150mg) on QT/QTc Interval, Compared to Placebo, using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers

rheumatoid arthritis
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Product Code: AZD5672
Trade Name: Avelox®
Product Name: Avelox- Moxifloxacin

AstraZeneca AB

NULL

Not Recruiting

Female: no
Male: yes

United Kingdom

2628

EUCTR2008-006924-68-FR
(EUCTR)

06/04/2009

19/03/2009

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
Product Code: RO4877533/F04-F05
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy

2629

EUCTR2008-006924-68-IT
(EUCTR)

03/04/2009

23/03/2009

Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF therapies.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: TOCILIZUMAB

F. Hoffmann-La Roche

NULL

Not Recruiting

Female: yes
Male: yes

1200

Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy

2630

EUCTR2008-005427-28-ES
(EUCTR)

03/04/2009

26/01/2009

Estudio fase IIIb, multicéntrico, con un período doble ciego controlado con placebo y aleatorizado de 12 semanas, seguido de una fase de extensión abierta para evaluar la seguridad y la eficacia de certolizumab pegol administrado a pacientes con artritis reumatoide activa. (A Phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis). - Realistic

Artritis reumatoide (Rheumatoid arthritis)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

1048

Phase 3b

Germany;Netherlands;France;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2631

EUCTR2008-005427-28-FR
(EUCTR)

02/04/2009

19/03/2009

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1048

Phase 3b

Germany;Netherlands;France;Spain;Italy

2632

EUCTR2008-006924-68-NL
(EUCTR)

02/04/2009

09/02/2009

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: Tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy

2633

JPRN-UMIN000004271

2009/04/01

27/09/2010

Upper gastrointestinal endoscopic findings in Japanese with rheumatoid arthritis (RA) receiving long-term NSAIDs therapy, and the usefulness of switching to selective COX-2 inhibitor celecoxib

Rheumatoid arthritis (RA)NSAIDs-induced gastrointestinal mucosal injury

Japanese rheumatic patients who have been treated with NSAIDs for twelve or more weeks are switched to CEL (400mg/day). Upper GI endoscopy is conducted before and after administration of CEL. Patients with ulcers at the enrollment are switched to CEL (400mg/day) with famotidine (20mg/day) after healing of their pre-existing ulcers following treatment.

Hoshigaoka Koseinenkin Hospital

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

100

Not applicable

Japan

2634

JPRN-JapicCTI-090751

01/4/2009

A study of Adalimumab in Japanese subjects with Rheumatoid Arthritis

A Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : 40 mg every other week, subcutaneous
Control intervention name : Placebo
Dosage And administration of the control intervention : every other week, subcutaneous

Abbott Japan Co., Ltd.

Eisai Co., Ltd.

BOTH

300

Phase 3

NULL

2635

NCT00928317
(ClinicalTrials.gov)

April 2009

24/6/2009

Dose Ranging Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking Methotrexate

Multi-Centre Randomised Double-Blind Pbo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability, Efficacy, PK and Immunogenicity of Multiple Doses of ART621 for 3 Months in Patients With Rheumatoid Arthritis Taking Methotrexate

Rheumatoid Arthritis

Drug: ART621;Drug: Placebo

Arana Therapeutics Ltd

NULL

Terminated

18 Years

80 Years

Both

Phase 2

United States;Argentina;Australia;Czech Republic;India;Malaysia;New Zealand;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2636

EUCTR2008-005525-11-NL
(EUCTR)

31/03/2009

12/12/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

France;Spain;Germany;Netherlands;United Kingdom

2637

EUCTR2008-004875-23-FR
(EUCTR)

31/03/2009

16/04/2009

An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

236

Hungary;Germany;Belgium;France;Austria;Poland

2638

EUCTR2008-006930-92-CZ
(EUCTR)

31/03/2009

06/01/2009

A multi-centre randomised, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of ART621 following multiple dose administration for 3 months in patients with rheumatoid arthritis concomitantly taking methotrexate

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ART621

Arana Therapeutics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

200

Czech Republic

2639

EUCTR2008-003011-12-GB
(EUCTR)

30/03/2009

27/04/2009

Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRA

Rheumatoid Arthritis

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

2640

EUCTR2008-000587-17-DE
(EUCTR)

26/03/2009

17/12/2008

Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2641

EUCTR2007-006657-63-SE
(EUCTR)

25/03/2009

06/02/2009

Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)

Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA). - DOSERA

Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Finland;Denmark;Norway;Iceland;Sweden

2642

EUCTR2008-006936-37-HU
(EUCTR)

25/03/2009

02/03/2009

Rheumatoid Arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ILV-094
Product Code: ILV-094
Other descriptive name: Recombinant human anti IL-22 monoclonal antibody IgG1

Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development

NULL

Not Recruiting

Female: yes
Male: yes

180

Hungary;Germany;Netherlands;Belgium

2643

EUCTR2008-006075-75-HU
(EUCTR)

24/03/2009

18/02/2009

A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2a

Hungary;Czech Republic;United Kingdom;Germany

2644

EUCTR2008-000744-13-BG
(EUCTR)

19/03/2009

26/01/2009

Long Term Follow On Safety Study of Fostamatinib in Patients Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

800

France;United States;Mexico;Belgium;Poland;Romania;Peru;Bulgaria;Germany;Colombia;Italy

2645

EUCTR2007-005288-86-FR
(EUCTR)

18/03/2009

30/07/2008

A Phase IIIb, open-label, run-in and double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with stable-dose methotrexate in patients with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: Anti-TNF humanized antibody Fab' fragment - PEG conjugate

UCB Pharma S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

335

Phase 3b

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2646

EUCTR2008-004754-33-CZ
(EUCTR)

17/03/2009

18/03/2009

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug Therapy

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: BG00012
Other descriptive name: Dimeythl Fumarate

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2a

Czech Republic;Poland

2647

EUCTR2008-000587-17-IT
(EUCTR)

12/03/2009

20/03/2009

Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - ND

Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to DMARDs or anti-TNF therapies
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533
INN or Proposed INN: tocilizumab

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

1500

Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

2648

EUCTR2008-006924-68-GB
(EUCTR)

06/03/2009

29/04/2009

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Italy;United Kingdom

2649

NCT00808210
(ClinicalTrials.gov)

March 5, 2009

11/12/2008

A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab

A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMAB

Rheumatoid Arthritis

Drug: Infliximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: Placebo

Genentech, Inc.

NULL

Terminated

18 Years

N/A

All

Phase 2

United States

2650

NCT00883753
(ClinicalTrials.gov)

March 2009

17/4/2009

An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy

An Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

934

Phase 3

Australia;Canada;Czech Republic;France;Greece;Hungary;Italy;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;United Kingdom;Austria;Turkey

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2651

NCT00847613
(ClinicalTrials.gov)

March 2009

17/2/2009

A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Arthritis, Rheumatoid

Drug: CP -690,550;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

800

Phase 3

United States;Australia;Brazil;Bulgaria;Canada;Colombia;Czech Republic;Greece;India;Japan;Korea, Republic of;Mexico;Poland;Taiwan;Ukraine;Venezuela

2652

NCT02721004
(ClinicalTrials.gov)

March 2009

2/3/2016

Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis

Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

N/A

Both

592

N/A

Austria

2653

NCT00871767
(ClinicalTrials.gov)

March 2009

26/3/2009

AZD5672 Bioavailability Study in Healthy Male and Female Subjects

An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects

Rheumatoid Arthritis

Drug: AZD5672

AstraZeneca

NULL

Completed

18 Years

55 Years

Both

Phase 1

United Kingdom

2654

NCT00882024
(ClinicalTrials.gov)

March 2009

14/4/2009

Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)

A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast With Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients With Active Rheumatoid Arthritis (RA)

Active Rheumatoid Arthritis

Drug: Tranilast;Drug: Placebo

Nuon Therapeutics, Inc.

NULL

Completed

18 Years

75 Years

Both

250

Phase 2

United States;Argentina;Bulgaria;Czech Republic;Germany;Mexico;Serbia;United Kingdom

2655

NCT00687193
(ClinicalTrials.gov)

March 2009

22/5/2008

Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD

Arthritis, Rheumatoid

Drug: Placebo;Drug: CP -690,550

Pfizer

NULL

Completed

20 Years

70 Years

All

318

Phase 2

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2656

NCT00810199
(ClinicalTrials.gov)

March 2009

16/12/2008

A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate;Drug: placebo

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

556

Phase 3

United States;Brazil;Croatia;Denmark;Estonia;France;Germany;Greece;Israel;Italy;Latvia;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Sweden;Thailand;United Kingdom;Monaco

2657

NCT00845832
(ClinicalTrials.gov)

March 2009

17/2/2009

A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate

A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate

Rheumatoid Arthritis

Drug: Placebo;Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Terminated

18 Years

65 Years

All

Phase 2

France;Germany;Greece;Netherlands;Poland;Spain;Switzerland;United Kingdom;Belgium;Sweden

2658

EUCTR2008-000587-17-HU
(EUCTR)

27/02/2009

28/11/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

2659

EUCTR2008-005427-28-DE
(EUCTR)

27/02/2009

10/12/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

1048

Phase 3b

Germany;Netherlands;France;Spain;Italy

2660

EUCTR2008-004754-33-PL
(EUCTR)

25/02/2009

24/11/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: BG00012
Other descriptive name: Dimeythl Fumarate

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2a

Czech Republic;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2661

EUCTR2008-006443-39-ES
(EUCTR)

23/02/2009

09/12/2008

Estudio piloto de fase II multicéntrico, aleatorizado, en grupos paralelos para comparar la incidencia de las reacciones a la infusión de Tocilizumab en pacientes con AR moderada a grave cuando la infusión se realiza en 1 hora frente a 31 minutos.

Pacientes adultos con artritis reumatoide (AR) activa moderada o grave que son respondedores inadecuados a los tratamientos con FAMEs no biológicos o con anti-TNFs.
MedDRA version: 9;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab
Product Code: RO04877533
INN or Proposed INN: Tocilizumab
Other descriptive name: RoActemra

Roche Farma, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Spain

2662

EUCTR2008-005320-81-ES
(EUCTR)

18/02/2009

20/01/2009

Segundo estudio de extensión abierto de 2 años de duración para evaluar la seguridad tolerabilidad y eficacia de canakinumab (ACZ885), un anticuerpo monoclonal anti-interleuquina-1?, en pacientes con artritis reumatoide activa - A2201E2

Artritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class

Novartis Farmacéutica S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Germany;Spain;Austria

2663

EUCTR2008-001847-20-GR
(EUCTR)

17/02/2009

06/03/2009

Rheumatoid Arthritis

Trade Name: RoActemra ®
Product Code: L04AC07
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden

2664

EUCTR2007-001625-10-GB
(EUCTR)

17/02/2009

02/05/2008

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 4

France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom

2665

EUCTR2008-006924-68-ES
(EUCTR)

13/02/2009

19/01/2009

Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - extension MA21573

Artritis reumatoide/Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2666

EUCTR2008-004894-16-DE
(EUCTR)

12/02/2009

11/11/2008

Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company limited

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2

Hungary;Czech Republic;Germany;Poland

2667

EUCTR2008-000744-13-FR
(EUCTR)

10/02/2009

21/10/2008

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Rigel Pharmaceuticals, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Germany;Bulgaria;France;Italy

2668

EUCTR2008-001523-57-ES
(EUCTR)

09/02/2009

22/10/2008

Estudio abierto y multicéntrico de evaluación de la respuesta temprana a abatacept con metotrexato de fondo mediante ecografía Power-Doppler en pacientes con artritis reumatoide activa y respuesta insuficiente a metotrexato Multicenter, Open-Label Study to Assess Early Reponse to Abatacept with Background Methotrexate Using Power Doppler Ultrasound in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Sujetos adultos con artritis reumatoide activa, de acuerdo con los criterios de la asociación de reumatismo Americana para la clasificación de la AR y con respuesta al metotrexate inadecuada.Adult subjects with Active Rheumatoid Arthritis, in accordance with the American Rheumatology Association criteria for the classification of AR with inadequate response to Metotrexate
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy

2669

EUCTR2008-005525-11-FR
(EUCTR)

06/02/2009

13/03/2009

A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera
Product Code: RO452294/V02
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533/F01
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;France;Spain

2670

EUCTR2008-005320-81-DE
(EUCTR)

06/02/2009

17/11/2008

A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to interleukin-1beta of the IgG1-Kappa-class

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

213

Germany;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2671

EUCTR2008-001847-20-SE
(EUCTR)

02/02/2009

23/10/2008

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden

2672

NCT00777816
(ClinicalTrials.gov)

February 2009

17/10/2008

Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis

A Blinded, Placebo-controlled, Study of the Safety and Pharmacokinetics of XOMA 052 Administered to Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: XOMA 052;Drug: Placebo

XOMA (US) LLC

NULL

Suspended

18 Years

75 Years

Both

Phase 2

United States

2673

NCT00847886
(ClinicalTrials.gov)

February 2009

17/2/2009

Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: LX3305;Drug: LX3305 Placebo;Drug: Methotrexate

Lexicon Pharmaceuticals

NULL

Completed

18 Years

N/A

All

Phase 1

United States

2674

NCT00754572
(ClinicalTrials.gov)

February 2009

17/9/2008

A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Single-arm, Open-label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

418

Phase 3

Argentina;Brazil;Chile;Colombia;Costa Rica;Ecuador;Mexico;Peru;Uruguay;Venezuela

2675

NCT00851240
(ClinicalTrials.gov)

February 2009

2/2/2009

BTT-1023 in Rheumatoid Arthritis

A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Repeated Intravenous Doses of BTT-1023 in Patients With Rheumatoid Arthritis - a Double-blind Randomized Placebo-controlled Sequential Group Trial

Rheumatoid Arthritis

Drug: BTT-1023;Drug: Placebo

Biotie Therapies Corp.

NULL

Completed

18 Years

75 Years

Both

Phase 1

Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2676

NCT00837811
(ClinicalTrials.gov)

February 2009

3/2/2009

An Open Label Extension Study in Participants With Rheumatoid Arthritis

An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis

Biological: LY2127399

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

182

Phase 2

United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Germany;Hungary;India;Mexico;Poland;Puerto Rico;Romania;Argentina;Czech Republic;France;Slovakia;Ukraine

2677

NCT00814307
(ClinicalTrials.gov)

February 2009

22/12/2008

A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: CP -690,550;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

611

Phase 3

United States;Brazil;Bulgaria;Chile;Colombia;Czech Republic;Dominican Republic;Germany;India;Malaysia;Mexico;Philippines;Poland;Puerto Rico;Russian Federation;Ukraine

2678

EUCTR2008-005525-11-ES
(EUCTR)

29/01/2009

09/12/2008

Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

Artritis reumatoideRheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MABTHERA 500 mg concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;France;Spain

2679

EUCTR2008-004754-33-SK
(EUCTR)

29/01/2009

14/11/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: BG00012
Other descriptive name: Dimeythl Fumarate

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2

Czech Republic;Slovakia;Poland

2680

EUCTR2008-000744-13-IT
(EUCTR)

28/01/2009

09/01/2009

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study - ND

Reumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: R935788
INN or Proposed INN: Fosfamatinib Disodium
Product Name: R935788
INN or Proposed INN: Fosfamatinib Disodium

RIGEL PHARMACEUTICALS INC

NULL

Not Recruiting

Female: yes
Male: yes

800

France;Bulgaria;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2681

EUCTR2008-005427-28-IT
(EUCTR)

28/01/2009

11/03/2009

A phase IIIb, multicenter study with a 12-week double-blind, placebo-controlled,randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis - Realistic

rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma SA

NULL

Not Recruiting

Female: yes
Male: yes

1048

Phase 3b

Germany;Netherlands;France;Spain;Italy

2682

EUCTR2008-001847-20-IT
(EUCTR)

18/01/2009

18/12/2008

Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ND

Adult patients with active moderate to severe (DAS28 > 4.4) rheumatoid arthritis (RA) who have inadequately responded to prior conventional MTX treatment and have not been treated with any biologic agent before.
MedDRA version: 9.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid

Product Name: Tocilizumab
Product Code: RO04877533
Trade Name: Methotrexate Lederle 2.5 mg Tablets
INN or Proposed INN: Methotrexate
Product Name: Tocilizumab
Product Code: RO04877533

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

470

France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;United Kingdom;Italy;Sweden

2683

EUCTR2008-004894-16-PL
(EUCTR)

15/01/2009

18/12/2008

Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company limited

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2

Hungary;Czech Republic;Germany;Poland

2684

EUCTR2008-000587-17-GR
(EUCTR)

13/01/2009

30/01/2009

Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to DMARDs or anti- TNF therapies
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: Tocilizumab

F. Hoffmann- La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

2685

EUCTR2007-000896-41-GB
(EUCTR)

12/01/2009

19/01/2009

A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate

Rheumatoid arthritis

Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 4

France;Czech Republic;Hungary;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2686

EUCTR2007-006150-25-DE
(EUCTR)

09/01/2009

26/05/2008

A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects with Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate

A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: Prednisone
Trade Name: Solu-Medrone 125mg
INN or Proposed INN: Methylprednisolone Sodium Succinate
Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: Prednisone
Trade Name: Solu-Medrone 125mg
INN or Proposed INN: Methylprednisolone Sodium Succinate

Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

216

Hungary;Germany;Serbia;Netherlands;Belgium;Mexico;France;Romania;Austria

2687

EUCTR2007-001377-28-PT
(EUCTR)

09/01/2009

25/08/2008

Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL

Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

2688

EUCTR2007-003288-36-ES
(EUCTR)

08/01/2009

09/03/2010

Ensayo clínico fase 4, multicéntrico, abierto, asesor ciego, de cambio en el cual se evalúa la eficacia y la seguridad de Infliximab (REMICADE®) en pacientes con artritis reumatoide activa que están respondiendo inadecuadamente a Etanercept (ENBREL®) o Adalimumab (HUMIRA®). - RESTART

Artritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

2689

EUCTR2008-001523-57-DK
(EUCTR)

07/01/2009

14/10/2008

Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

100

France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom

2690

EUCTR2008-007225-39-BE
(EUCTR)

06/01/2009

12/02/2009

A 2 year follow up to assess the effectiveness in daily practice of different treatment strategies for early Rheumatoid Arthritis patients.

A 2 year prospective multicentre randomised controlled trial comparing effectiveness in daily practice of different treatment strategies for early RA - CareRA

early active Rheumatoid Arthritis, previously untreated with DMARDS
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Ledertrexate
INN or Proposed INN: methotrexate
Other descriptive name: METHOTREXATE DISODIUM
Trade Name: Salazopyrine
INN or Proposed INN: SULFASALAZINE
Trade Name: Arava
INN or Proposed INN: LEFLUNOMIDE

University Hospitals Leuven

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 4

Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2691

EUCTR2008-001523-57-GB
(EUCTR)

06/01/2009

22/10/2008

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom

2692

NCT00858780
(ClinicalTrials.gov)

January 2009

6/3/2009

Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA

Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)

Rheumatoid Arthritis

Drug: Etanercept;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

Phase 4

Denmark;Finland;Hungary;Iceland;Norway;Sweden

2693

NCT00825409
(ClinicalTrials.gov)

January 2009

16/1/2009

Safety and Effectiveness Study of Ascension's PyroCarbon Radial Head Compared to Ascension's Metal Radial Head

Safety and Effectiveness Study of Ascension's PyroCarbon Radial Head Compared to Ascension's Metal Radial Head to Treat Arthritis, Fractures of the Radial Head, Relief of Symptoms After Radial Head Resection, or Revision of a Failed Radial Head Implant.

Degenerative Arthritis;Post-Traumatic Arthritis;Rheumatoid Arthritis

Device: Carbon Modular Radial Head;Device: Metal Radial Head

Ascension Orthopedics, Inc.

NULL

Recruiting

18 Years

85 Years

Both

203

N/A

United States

2694

NCT00843778
(ClinicalTrials.gov)

January 2009

5/1/2009

Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

A Phase IIIB, Multi-center, Open Label Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With DMARDs in Patients With Active Rheumatoid Arthritis Who Participated in C87076.

Rheumatoid Arthritis

Biological: Certolizumab Pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

131

Phase 3

Austria;France;Germany;Italy;Poland

2695

NCT02779114
(ClinicalTrials.gov)

January 2009

16/5/2016

RETRO (REduction of Therapy in RA Patients in Ongoing Remission)

A Phase 3, Multicenter, Randomized, Open, Prospective, Controlled, Parallel Group Study of Reduction of Therapy in Patients With Rheumatoid Arthritis in Ongoing Remission.

Rheumatoid Arthritis

Drug: Control group;Other: Reduction group 1;Other: Reduction group 2

University of Erlangen-Nürnberg Medical School

NULL

Recruiting

18 Years

N/A

Both

318

Phase 3

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2696

NCT02405234
(ClinicalTrials.gov)

January 2009

4/11/2014

Ascension PyroCarbon Radial Head Study

Safety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial Head

Degenerative Arthritis;Radial Head Fracture;Rheumatoid Arthritis

Device: Carbon Modular Radial Head replacement;Device: Metal Radial Head replacement

Integra LifeSciences Corporation

NULL

Terminated

18 Years

85 Years

All

N/A

United States

2697

NCT01426347
(ClinicalTrials.gov)

January 2009

29/8/2011

Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

Vitamin Therapy in Rheumatoid Arthritis

Rheumatoid Arthritis;Vitamin D Deficiency

Drug: Placebo sugar pill;Drug: Ergocalciferol

Johns Hopkins University

NULL

Completed

18 Years

75 Years

All

139

N/A

United States

2698

NCT02809833
(ClinicalTrials.gov)

January 2009

20/6/2016

Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine

Tocilizumab for the Treatment of Rheumatoid Arthritis: Findings on The Use of Tocilizumab in Daily Clinical Routine

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

850

N/A

Germany

2699

NCT00838058
(ClinicalTrials.gov)

January 2009

2/2/2009

A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.

An Open-Label Two-Part Randomized, Crossover Study Of The Pharmacokinetics Of CE-224,535 Administered As Controlled And Immediate Release Formulations In Healthy Volunteers

Rheumatoid Arthritis;Healthy Volunteers

Drug: CE-224,535;Drug: CE 224,535

Pfizer

NULL

Completed

18 Years

55 Years

Both

Phase 1

United States

2700

NCT00848120
(ClinicalTrials.gov)

December 31, 2008

19/2/2009

A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis

An Open Label Study to Evaluate the Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Philippines

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2701

EUCTR2008-005525-11-GB
(EUCTR)

29/12/2008

16/12/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Greece;Spain;Netherlands;Germany;United Kingdom

2702

EUCTR2008-001523-57-IT
(EUCTR)

23/12/2008

17/03/2009

active rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid

Trade Name: ORENCIA
INN or Proposed INN: ABATACEPT

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy

2703

EUCTR2008-001847-20-GB
(EUCTR)

19/12/2008

09/09/2008

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

Phase 3

Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden

2704

EUCTR2008-001847-20-LV
(EUCTR)

19/12/2008

29/12/2008

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Latvia;Germany;Netherlands;Norway;Sweden

2705

EUCTR2007-001625-10-IE
(EUCTR)

12/12/2008

07/10/2008

AN OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE RADIOGRAPHIC EFFICACY AND SAFETY OF ENBREL™ (ETANERCEPT) ADDED TO METHOTREXATE IN COMPARISON WITH USUAL TREATMENT IN SUBJECTS WITH MODERATE RHEUMATOID ARTHRITIS DISEASE ACTIVITY

RHEUMATOID ARTHRITIS

Trade Name: Etanercept
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

700

Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Spain;Ireland;Italy;Greece;Poland;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2706

EUCTR2008-001847-20-NL
(EUCTR)

10/12/2008

23/10/2008

Rheumatoid Arthritis

Product Name: Tocilizumab
Product Code: RO04877533
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

470

France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden

2707

EUCTR2008-001847-20-DK
(EUCTR)

10/12/2008

21/10/2008

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden

2708

EUCTR2008-000744-13-BE
(EUCTR)

09/12/2008

08/10/2008

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 2

France;Belgium;Bulgaria;Germany;Italy

2709

EUCTR2008-004931-39-PL
(EUCTR)

08/12/2008

04/11/2008

A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80 mg, 160 mg, and 320 mg ALD518 versus Placebo Administered as Multiple Intravenous Infusions to Patients with Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate.

Active Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ALD518
Product Code: ALD518
Other descriptive name: ALD518 monoclonal antibody (anti IL-6 mAb)

Alder Biopharmaceuticals, Inc

NULL

Not Recruiting

Female: yes
Male: yes

120

Poland

2710

EUCTR2007-003288-36-FR
(EUCTR)

08/12/2008

21/10/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2711

EUCTR2008-002046-27-DE
(EUCTR)

08/12/2008

08/07/2008

Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: GSK1841157
Other descriptive name: HuMax-CD20

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2A

Germany;Belgium;France;Spain

2712

EUCTR2007-000830-38-DE
(EUCTR)

05/12/2008

29/09/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3B

France;Poland;Austria;Germany;Italy

2713

EUCTR2007-006150-25-AT
(EUCTR)

03/12/2008

07/10/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: PREDNISONE
Trade Name: Solu-Medrone 125mg
INN or Proposed INN: METHYLPREDNISOLONE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: PREDNISONE
Trade Name: Solu-Medrone 125mg
INN or Proposed INN: METHYLPREDNISOLONE
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

216

Hungary;Germany;Netherlands;Belgium;France;Austria

2714

EUCTR2007-006150-25-NL
(EUCTR)

01/12/2008

02/06/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: PREDNISONE
Trade Name: Solu-Medrone 125mg
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE
Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: PREDNISONE
Trade Name: Solu-Medrone 125mg
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

216

Hungary;Germany;Netherlands;Belgium;France;Austria

2715

ChiCTR-TRC-10001060

2008-12-01

2010-10-23

Efficacy and safety of infliximab in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial

rheumatoid arthritis;M05.901

infliximab:intravenous injections of infliximab (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy;placebo:intravenous injections of placebo (3 mg/kg) at weeks 0, 2, 6, 14, with concurrent MTX therapy;

People's Hospital, Beijing University; Shanghai Changzheng Hospital

NULL

Completed

Both

infliximab:0;placebo:0;

3 (Phase 3 study)

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2716

NCT01179971
(ClinicalTrials.gov)

December 2008

4/8/2010

n-3 and n-6 Fatty Acids in Rheumatoid Arthritis

Incorporation of n-3 Long Chain Polyunsaturated Fatty Acids and Gamma Linolenic Acid in Plasma Lipids, Cholesteryl Esters, and Erythrocyte Membranes and Their Influence on Disease Activity in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Dietary Supplement: Fish oil , gamma-linolenic acid

Charite University, Berlin, Germany

University of Jena

Completed

18 Years

80 Years

Both

Phase 2

NULL

2717

NCT00805116
(ClinicalTrials.gov)

December 2008

8/12/2008

Marine Oils and Arthritis

Whale Oil Versus Cod Liver Oil in Rheumatoid Arthritis

Rheumatoid Arthritis

Dietary Supplement: Whale blubber oil;Dietary Supplement: Cod liver oil

National Institute of Nutrition and Seafood Research, Norway

NULL

Terminated

18 Years

N/A

Both

N/A

Norway

2718

NCT00810836
(ClinicalTrials.gov)

December 2008

17/12/2008

Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Efficacy, Safety and Tolerability of BG00012 When Given With Methotrexate to Subjects With Active RA Who Have Had an Inadequate Response to Conventional Disease-Modifying Anti-rheumatic Drug Therapy

Rheumatoid Arthritis

Drug: BG00012;Drug: placebo

Biogen Idec

NULL

Completed

18 Years

75 Years

Both

153

Phase 2

Australia;Canada;Czech Republic;India;Poland;Slovakia

2719

NCT00818064
(ClinicalTrials.gov)

December 2008

30/12/2008

Safety and Tolerability of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis

A Randomised, Double-blind, Placebo-controlled, Single- Dose, Dose-escalation Trial of Anti-IL-20 in Healthy Volunteers and Patients With Rheumatoid Arthritis

Inflammation;Rheumatoid Arthritis;Healthy

Drug: anti-IL-20;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

75 Years

All

Phase 1

Netherlands

2720

NCT00767325
(ClinicalTrials.gov)

December 2008

6/10/2008

A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography

Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Abatacept;Drug: Methotrexate

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

104

Phase 3

Denmark;France;Germany;Hungary;Italy;Norway;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2721

NCT00810277
(ClinicalTrials.gov)

November 30, 2008

16/12/2008

A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs

An Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Finland

2722

EUCTR2008-001847-20-EE
(EUCTR)

28/11/2008

13/10/2008

Rheumatoid Arthritis

Trade Name: RoActemra ®
Product Code: L04AC07
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden

2723

EUCTR2007-003288-36-FI
(EUCTR)

28/11/2008

30/09/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

2724

EUCTR2007-001625-10-IT
(EUCTR)

26/11/2008

01/04/2009

An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) added to Methotrexate in Comparison with Usual Treatment in Subjects with Moderate Rheumatoid Arthritis Disease Activity. - EXTRA

Trade Name: ENBREL
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

700

France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;United Kingdom;Italy

2725

EUCTR2008-006256-22-FR
(EUCTR)

21/11/2008

31/10/2008

Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.

rheumatoid arthritis requiring anti-TNF alpha treatment
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: remicade
INN or Proposed INN: infliximab
Trade Name: humira
INN or Proposed INN: adalimumab
Trade Name: enbrel
INN or Proposed INN: etanercept

CHU Saint-Etienne

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2726

EUCTR2008-001847-20-FR
(EUCTR)

17/11/2008

21/10/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab
Product Code: RO04877533/F05/F04
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate

F Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

470

Germany;United Kingdom;Netherlands;Denmark;Estonia;France;Spain;Italy;Greece;Latvia;Sweden

2727

EUCTR2008-001105-42-AT
(EUCTR)

11/11/2008

06/08/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: NA
Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Germany;Belgium;France;Poland;Austria

2728

EUCTR2007-003288-36-DE
(EUCTR)

10/11/2008

03/09/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

2729

EUCTR2007-005434-37-GB
(EUCTR)

07/11/2008

28/05/2008

A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study) Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008), Amendment 08-Site Specific (v1.0, date 11-May-2009) & Amendment 15-Site Specific - UK sites only (v1.0, date 07-OCt-2010). And Pharmacogenetics Blood Sample Protocol Amendment 01 - Site-specific (v1.0, Date 07-Sep-2007). - MTX-IR Study

RHEUMATOID ARTHRITIS, NOS
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

2400

Phase 3

France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom

2730

EUCTR2008-002046-27-BE
(EUCTR)

05/11/2008

17/09/2008

Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: GSK1841157
Other descriptive name: HuMax-CD20

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2A

Germany;Belgium;France;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2731

EUCTR2006-005353-30-GB
(EUCTR)

04/11/2008

01/04/2008

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis.

Rheumatoid arthritis
MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Spain;Lithuania;Austria;Italy;United Kingdom

2732

EUCTR2008-001523-57-FR
(EUCTR)

04/11/2008

21/10/2008

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;Norway;France;Spain;Italy

2733

EUCTR2007-005434-37-GR
(EUCTR)

04/11/2008

06/02/2009

RHEUMATOID ARTHRITIS, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Product Name: Abatacept (SC)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

2400

Phase 3B

France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom

2734

NCT00783536
(ClinicalTrials.gov)

November 2008

29/10/2008

A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis

An Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept + Methotrexate;Drug: DMARDS

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Withdrawn

18 Years

80 Years

Both

402

Phase 4

Mexico

2735

NCT00901550
(ClinicalTrials.gov)

November 2008

13/5/2009

The Chinese University of Hong Kong Early Arthritis Study

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Infliximab

Chinese University of Hong Kong

NULL

Completed

18 Years

80 Years

Both

N/A

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2736

NCT00771030
(ClinicalTrials.gov)

November 2008

9/10/2008

Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AMG 827;Other: Placebo

Amgen

NULL

Completed

18 Years

70 Years

Both

Phase 1;Phase 2

Canada;Mexico;United States

2737

NCT00796705
(ClinicalTrials.gov)

November 2008

20/11/2008

Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)

Switching Anti-TNF-alpha Agents in Patients With RA With An Inadequate Response to TNF-alpha Inhibition

Rheumatoid Arthritis

Drug: Adalimumab;Drug: Adalimumab placebo;Drug: Etanercept

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Terminated

18 Years

N/A

All

Phase 4

United States

2738

NCT00773461
(ClinicalTrials.gov)

October 31, 2008

15/10/2008

A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.

A Randomized, Double Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD Therapy

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo

Hoffmann-La Roche

NULL

Completed

18 Years

70 Years

All

209

Phase 3

China

2739

EUCTR2007-002950-42-GB
(EUCTR)

27/10/2008

20/03/2008

A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

GlaxoSmithKline Research & Development

NULL

Not Recruiting

Female: yes
Male: yes

248

Phase 3

Czech Republic;Hungary;Belgium;Spain;Poland;Lithuania;United Kingdom

2740

EUCTR2008-005320-81-AT
(EUCTR)

21/10/2008

22/09/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab
Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

200

Germany;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2741

EUCTR2008-000742-30-HU
(EUCTR)

18/10/2008

24/04/2008

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Rigel Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 2

Hungary;Bulgaria;Poland

2742

EUCTR2008-001847-20-ES
(EUCTR)

17/10/2008

11/08/2008

Estudio aleatorizado, controlado con placebo, para evaluar la seguridad y eficacia de añadir tocilizumab (TCZ) a metotrexato (MTX) frente al cambio a TCZ (controlado con placebo), con la posibilidad de añadir otros fármacos antirreumáticos modificadores de la enfermedad (FAMEs), en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada al tratamiento previo con MTX.

Artritis reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab
Product Code: RO04877533
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: METOTREXATO SODIO
Other descriptive name: METHOTREXATE SODIUM

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

470

France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden

2743

EUCTR2008-001105-42-DE
(EUCTR)

16/10/2008

04/08/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Germany;Belgium;France;Poland;Austria

2744

EUCTR2007-002536-29-BG
(EUCTR)

16/10/2008

01/10/2008

A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti- TNF alfa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate - August II

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;France;Bulgaria;Spain;Italy;Greece;Poland;Austria;Sweden

2745

EUCTR2007-003288-36-NL
(EUCTR)

15/10/2008

11/07/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2746

EUCTR2008-000742-30-BG
(EUCTR)

15/10/2008

14/08/2008

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Rigel Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 2

Hungary;Bulgaria;Poland

2747

EUCTR2008-002046-27-ES
(EUCTR)

14/10/2008

06/05/2010

Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate. Ensayo clínico fase I/IIA de administración subcutánea de ofatumumab en pacientes con artritis reumatoide tratados con dosis estables de metotrexato.

Rheumatoid ArthritisArtritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: GSK1841157
Other descriptive name: HuMax-CD20

GlaxoSmithKline S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2A

Germany;Belgium;France;Spain

2748

EUCTR2006-004139-31-GR
(EUCTR)

14/10/2008

06/11/2009

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metotab®
INN or Proposed INN: methotrexate

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden

2749

EUCTR2008-005212-40-SE
(EUCTR)

14/10/2008

14/08/2008

Pain mechanisms and fatigue in rheumatoid arthritis (RA) and healthy volunteers. Can antirheumatic and biological therapy affect pain processing and fatigue in RA? - RA PAIN PROCESSING

Rheumatoid arthritis (RA)The overall aim with this project is to investigate central pain mechanisms in RA and healthy controls, and in RA how these are influenced by autonomic neural regulation and TNF-blockade with Remicade.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10060016;Term: Alpha tumor necrosis factor
MedDRA version: 9.1;Classification code 10029817;Term: Nuclear magnetic resonance imaging brain
MedDRA version: 9.1;Classification code 10053689;Term: Cardiovascular autonomic function test

Trade Name: Remicade
INN or Proposed INN: Infliximab

Karolinska Institute

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: no

Sweden

2750

EUCTR2008-000587-17-BE
(EUCTR)

13/10/2008

19/08/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2751

EUCTR2008-001105-42-FR
(EUCTR)

10/10/2008

28/08/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

Germany;Belgium;France;Poland;Austria

2752

EUCTR2007-000830-38-AT
(EUCTR)

09/10/2008

09/09/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3B

France;Poland;Austria;Germany;Italy

2753

EUCTR2007-001625-10-AT
(EUCTR)

09/10/2008

04/06/2008

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Enbrel 50 mg
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

700

Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria

2754

EUCTR2008-004398-16-SE
(EUCTR)

08/10/2008

12/08/2008

A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable RA Patients in Clinical remission - ADMIRE

Adalimumab has the indication for life-long treatment of RA but can adalimumab be discontinued in patients who are in stable clinical remission (DAS28<2.6) with retained low disease activity or will the RA symptoms relapse? If relapse occurs, how is the response if adalimumab is reinstituted?
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab

Abbott Scandinavia AB

NULL

Not Recruiting

Female: yes
Male: yes

Sweden

2755

EUCTR2007-000830-38-FR
(EUCTR)

07/10/2008

10/07/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate

UCB Pharma S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

132

Phase 3B

Germany;France;Italy;Poland;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2756

ChiCTR-TRC-10000850

2008-10-01

2010-04-26

Phase III clinical trial of Iguratimodin rheumatoid arthritis

rheumatoid arthritis

3:Experimental group: Iguratimod tablet, nimesulide dummy tablet; positive control group: taking nimesulide and Iguratimod dummy tablet; placebo group: taking Iguratimod dummy tablet and nimesulide dummy tablet. ;

Anhui Medical University

NULL

Completed

Both

3:600;

3 (Phase 3 study)

China

2757

EUCTR2007-003288-36-AT
(EUCTR)

01/10/2008

18/08/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

2758

EUCTR2007-001625-10-DE
(EUCTR)

01/10/2008

05/05/2008

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Enbrel 50 mg
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

700

Hungary;Czech Republic;United Kingdom;Germany;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria

2759

NCT00785928
(ClinicalTrials.gov)

October 2008

3/11/2008

A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Rheumatoid Arthritis

Biological: LY2127399;Drug: Placebo

Eli Lilly and Company

NULL

Completed

18 Years

75 Years

All

158

Phase 2

United States;Argentina;Australia;Chile;Germany;Hungary;India;Mexico;Poland;Romania;Slovakia;Ukraine;Brazil;Canada;Czech Republic

2760

NCT00771329
(ClinicalTrials.gov)

October 2008

10/10/2008

BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: BIIB023;Other: Placebo (sterile normal saline)

Biogen Idec

NULL

Completed

18 Years

65 Years

Both

Phase 1

United States;Russian Federation;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2761

NCT00867516
(ClinicalTrials.gov)

October 2008

20/3/2009

Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis

A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80,160 and 320mg ALD518 Versus Placebo Administered as Multiple IV Infusions to Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Arthritis, Rheumatoid

Biological: ALD518;Biological: Infusion without ALD518'

CSL Behring

NULL

Completed

18 Years

80 Years

All

127

Phase 2

Canada;Georgia;India;Poland;Russian Federation;Serbia

2762

NCT00779220
(ClinicalTrials.gov)

October 2008

23/10/2008

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Parallel-group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

Rheumatoid Arthritis

Drug: placebo;Drug: methotrexate;Drug: ocrelizumabu 50mg;Drug: ocrelizumabu 200mg;Drug: ocrelizumab 500mg

Chugai Pharmaceutical

NULL

Terminated

20 Years

N/A

Both

152

Phase 2

Japan

2763

NCT00771420
(ClinicalTrials.gov)

October 2008

10/10/2008

A Single Dose Study of the CAM-3001 in Patients With Rheumatoid Arthritis

A Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CAM-3001 in Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: CAM-3001;Other: Placebo

MedImmune Ltd

NULL

Completed

18 Years

70 Years

Both

Phase 1

Germany

2764

EUCTR2008-001282-28-NL
(EUCTR)

23/09/2008

29/08/2008

Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy - Vaccinations in rheumatic autoimmune diseases

Rheumatic autoimmune diseases including rheumatoid arthritis and poly or dermatomyositis.

Trade Name: Influvac
INN or Proposed INN: Influvac
Trade Name: Pneumovax 23
INN or Proposed INN: Pneumovax 23
Trade Name: HBvaxpro
INN or Proposed INN: HBVAXPRO

Radboud University Nijmegen Medical Centre

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

2765

EUCTR2008-000587-17-DK
(EUCTR)

22/09/2008

04/07/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2766

EUCTR2008-001241-26-HU
(EUCTR)

18/09/2008

02/06/2008

A randomized, placebo-controlled, double-blind, dose escalation study to evaluate the efficacy, safety and tolerability of the study drug BT971 in patients with rheumatoid arthritis receiving concomitant Methotrexate - n.a.

Active rheumatoid arthritis, functional class II-III
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: BT061 (CD4 monoclonal antibody)
Product Code: BT971
INN or Proposed INN: BT061 (CD4 monoclonal antibody)

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

110

Hungary;Bulgaria

2767

EUCTR2008-000742-30-PL
(EUCTR)

17/09/2008

30/09/2008

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Rigel Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 2

Hungary;Bulgaria;Poland

2768

EUCTR2008-001105-42-BE
(EUCTR)

16/09/2008

14/07/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

France;Poland;Belgium;Austria;Germany

2769

EUCTR2006-004139-31-NO
(EUCTR)

16/09/2008

19/12/2007

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Netherlands;Germany;Norway;United Kingdom;Sweden

2770

EUCTR2008-000587-17-CZ
(EUCTR)

15/09/2008

20/06/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2771

EUCTR2007-005434-37-IT
(EUCTR)

12/09/2008

11/06/2008

Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate.(Short title: MTX-IR Study) Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008) - MTX-IR Study

RHEUMATOID ARTHRITIS, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Product Name: abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

2400

Phase 3B

France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;United Kingdom;Italy

2772

EUCTR2008-000587-17-IE
(EUCTR)

11/09/2008

05/06/2008

Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab (Actemra)
Product Code: RO4877533 (TCZ)
INN or Proposed INN: Tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

2773

EUCTR2008-000743-34-IT
(EUCTR)

11/09/2008

01/10/2008

Studio di Fase II multicentrico, randomizzato, in doppio cieco, controllato verso placebo, parallel-dose di R935788 in pazienti affetti da artrite reumatoide che hanno sperimentato fallimento di almeno un biologico - ND

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: R935788

RIGEL PHARMACEUTICALS INC

NULL

Not Recruiting

Female: yes
Male: yes

195

Germany;France;Italy

2774

EUCTR2008-000743-34-DE
(EUCTR)

10/09/2008

10/06/2008

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788

Rigel Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

195

Phase 2

Germany;France;Italy

2775

EUCTR2007-001625-10-PL
(EUCTR)

10/09/2008

09/06/2008

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

700

Greece;Austria;Poland;Italy;Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2776

EUCTR2007-006150-25-BE
(EUCTR)

05/09/2008

24/06/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: PREDNISONE
Trade Name: Solu-Medrone 125mg
Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

216

Phase 2

France;Hungary;Belgium;Austria;Netherlands;Germany

2777

EUCTR2008-004126-16-FI
(EUCTR)

05/09/2008

15/07/2008

Local Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDs

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: tocilizumab
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

Roche Oy

NULL

Not Recruiting

Female: yes
Male: yes

Finland

2778

EUCTR2008-002046-27-FR
(EUCTR)

05/09/2008

15/07/2008

OFA110867 : Clinical phase I/IIA study of subcutaneous administration of Ofatumumab in Rheumatoid Arthritis patients on stable dose Methotrexate

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: GSK1841157
Other descriptive name: HuMax-CD20

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

France;Spain;Belgium;Germany

2779

EUCTR2007-001377-28-DE
(EUCTR)

01/09/2008

15/05/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

2780

NCT00724672
(ClinicalTrials.gov)

September 2008

25/7/2008

A Study of Immune Cells in Patients With Rheumatoid Arthritis During Different Types of Anti-TNF Alpha Treatments (Study P05521)

Whole Human Genome Oligo Microarray Analysis of the Peripheral Blood Mononuclear Cells of Patients With Rheumatoid Arthritis During Different Forms of Anti-Tumor Necrosis-Alpha Treatments.

Rheumatoid Arthritis

Drug: etanercept;Drug: infliximab;Drug: adalimumab

Merck Sharp & Dohme Corp.

NULL

Withdrawn

18 Years

N/A

Both

N/A

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2781

NCT00706797
(ClinicalTrials.gov)

September 2008

25/6/2008

Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects

An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity

Rheumatoid Arthritis

Drug: etanercept (EnbrelTM);Drug: methotrexate

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Terminated

18 Years

N/A

All

141

Phase 4

Czech Republic;France;Germany;Hungary;Italy;Poland;Spain;Turkey;United Kingdom;Austria;Croatia;United States

2782

NCT00746512
(ClinicalTrials.gov)

September 2008

3/9/2008

A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)

A Randomized, Double-Blind, Parallel Group, Placebo Controlled Study to Access the Effects of Oral Prednisone on Clinical Efficacy and the Power Doppler Ultrasound Signal of Synovium in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Prednisone 15 mg;Drug: Placebo Tablets;Drug: Prednisone 7.5 mg;Drug: Placebo Over-Encapsulated Tablets

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

Phase 1

United Kingdom

2783

NCT00753454
(ClinicalTrials.gov)

September 2008

5/6/2008

Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)

A Phase IIIb, Multi-center Open-label, Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With Methotrexate in Patients With Active Rheumatoid Arthritis Who Participated in C87077.

Rheumatoid Arthritis

Drug: Certolizumab pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

168

Phase 3

United States;Canada

2784

NCT00750880
(ClinicalTrials.gov)

September 2008

10/9/2008

An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.

International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

1681

Phase 3

Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Luxembourg;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States

2785

EUCTR2008-000170-20-ES
(EUCTR)

26/08/2008

03/06/2008

A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, para evaluar la eficacia clínica y la seguridad de BMS-582949 administrado por vía oral a sujetos con artritis reumatoide que han mostrado respuesta inadecuada al metotrexato.Protocolo Revisado 01, que incorpora la carta administrativa 01 y la enmienda 03 (version 1.0, de fecha 12-Mar-2008).

subjects with rheumatoid arthritis (RA) who are on background therapy with methotrexate (MTX)sujetos con artritis reumatoide (AR) que estan recibiendo tratamiento de fondo con metotrexato (MTX).
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: BMS-582949

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Czech Republic;France;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2786

EUCTR2008-000587-17-FI
(EUCTR)

20/08/2008

05/06/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

2787

EUCTR2008-000105-11-DE
(EUCTR)

19/08/2008

16/05/2008

Effectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

Roche Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany

2788

EUCTR2007-001585-33-DE
(EUCTR)

19/08/2008

14/04/2008

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Netherlands;Latvia;Germany

2789

EUCTR2007-002951-18-DE
(EUCTR)

16/08/2008

30/06/2008

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

GlaxoSmithKline Research & Development

NULL

Not Recruiting

Female: yes
Male: yes

236

Phase 3

France;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden

2790

EUCTR2007-007539-14-HU
(EUCTR)

15/08/2008

26/08/2008

A Randomised, Double-Blind, Placebo-Controlled, Phase IIb Dose-Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate - ESCAPE

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AZD5672
Product Code: AZD5672
Other descriptive name: AZD5672
Product Name: AZD5672
Product Code: AZD5672
Other descriptive name: AZD5672
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: Etanercept

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2791

EUCTR2008-000170-20-CZ
(EUCTR)

14/08/2008

30/04/2008

A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007);Revised Protocol 02, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008) and Amendment 07 (version 1.0 dated on 01-Jul-2008).

subjects with rheumatoid arthritis (RA) who are on background therapy with methotrexate (MTX)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: BMS-582949

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

240

Czech Republic;France;Spain

2792

EUCTR2008-001241-26-BG
(EUCTR)

14/08/2008

27/09/2008

Active rheumatoid arthritis, functional class II-III.
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: BT061 (CD4 monoclonal antibody)
Product Code: BT971

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

110

Hungary;Bulgaria

2793

EUCTR2007-007539-14-BG
(EUCTR)

14/08/2008

06/08/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

2794

EUCTR2006-000923-32-GB
(EUCTR)

13/08/2008

15/10/2007

A randomised, double-blind, placebo-controlled, Bayesian adaptive dose finding study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat intravenous infusions GSK315234A in patients with active rheumatoid arthritis (RA)

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: GSK315234
Product Code: GSK315234

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

112

United Kingdom

2795

EUCTR2008-000587-17-FR
(EUCTR)

12/08/2008

16/07/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tolicizumab Roche
Product Code: RO4877533/F04-F05
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2796

EUCTR2008-000587-17-NL
(EUCTR)

12/08/2008

10/09/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

2797

NCT00718718
(ClinicalTrials.gov)

August 11, 2008

17/7/2008

A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Phase 2, 2-Part, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept, Dose-finding Study Evaluating the Efficacy and Safety of CNTO 136 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Arthritis, Rheumatoid

Drug: CNTO 136 100 mg;Drug: CNTO 136 50 mg;Drug: CNTO 136 25 mg;Drug: Placebo;Drug: Methotrexate

Centocor, Inc.

NULL

Completed

18 Years

N/A

All

187

Phase 2

United States;Hungary;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Argentina;Taiwan;Ukraine

2798

EUCTR2007-005434-37-BE
(EUCTR)

08/08/2008

28/05/2008

A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010), and Administrative Letter 01. And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008) & Amendment 08-Site Specific (v1.0, date 11-May-2009). - MTX-IR Study

RHEUMATOID ARTHRITIS, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

2400

Phase 3B

France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom

2799

EUCTR2007-005434-37-IE
(EUCTR)

08/08/2008

22/05/2008

A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study

RHEUMATOID ARTHRITIS, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

2400

Phase 3B

France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom

2800

EUCTR2008-000587-17-PT
(EUCTR)

08/08/2008

06/06/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2801

EUCTR2007-002951-18-GB
(EUCTR)

07/08/2008

14/03/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

GlaxoSmithKline Research & Development

NULL

Not Recruiting

Female: yes
Male: yes

236

Phase 3

France;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden

2802

EUCTR2007-005434-37-DE
(EUCTR)

05/08/2008

29/05/2008

A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study).Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study

RHEUMATOID ARTHRITIS, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

2400

Phase 3B

France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom

2803

EUCTR2007-007539-14-PL
(EUCTR)

05/08/2008

30/06/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

2804

EUCTR2006-005035-19-BG
(EUCTR)

04/08/2008

10/06/2009

A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Product Name: Tofacitinib citrate (Phase III formulation)
Product Code: CP -690,550-10
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: Tofacitinib citrate (Proposed commercial formulation- debossed)
Product Code: CP -690,550-10
INN or Proposed INN: NA
Other descriptive name: NA

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 2;Phase 3

United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden

2805

EUCTR2006-006373-25-BG
(EUCTR)

04/08/2008

14/09/2009

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A

Product Name: CP -690,550

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

300

Czech Republic;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2806

NCT00754559
(ClinicalTrials.gov)

August 2008

17/9/2008

A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.

Effectiveness After Four and Twentyfour Weeks and Safety of Tocilizumab in Patients With Active RA

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

286

Phase 3

Germany

2807

NCT00805467
(ClinicalTrials.gov)

August 2008

5/12/2008

Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Rheumatoid Arthritis

Drug: Fostamatinib Disodium (R935788)

AstraZeneca

NULL

Terminated

18 Years

N/A

All

624

Phase 2

United States;Belgium;Bulgaria;Colombia;France;Germany;Italy;Mexico;Peru;Poland;Romania

2808

EUCTR2007-007888-24-FR
(EUCTR)

31/07/2008

17/07/2008

Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOW

RHEUMATOID ARTHRITIS

Trade Name: ENBREL
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

107

France

2809

EUCTR2007-005434-37-AT
(EUCTR)

30/07/2008

20/06/2008

A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 02 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007), Protocol amendment 03 (v1.0, date 25-Apr-2008), and Protocol Amendment 06 (v1.0, date 25-Sep-2008). And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008). - MTX-IR Study

RHEUMATOID ARTHRITIS, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

2400

Phase 3B

France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom

2810

EUCTR2007-002950-42-BE
(EUCTR)

25/07/2008

24/06/2008

A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

248

Phase 3

Czech Republic;Hungary;Spain;Poland;Belgium;Lithuania;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2811

EUCTR2007-005434-37-FR
(EUCTR)

24/07/2008

19/05/2008

RHEUMATOID ARTHRITIS, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2400

Phase 3B

Hungary;Germany;United Kingdom;Netherlands;Belgium;France;Ireland;Italy;Greece;Austria

2812

EUCTR2008-000587-17-ES
(EUCTR)

22/07/2008

26/05/2008

Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy

Artritis reumatoideRheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab Roche
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

2813

EUCTR2008-000743-34-FR
(EUCTR)

21/07/2008

17/04/2008

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788

Rigel Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

Germany;France;Italy

2814

EUCTR2007-005434-37-NL
(EUCTR)

16/07/2008

30/05/2008

A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study

RHEUMATOID ARTHRITIS, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

2400

Phase 3B

France;Hungary;Greece;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom

2815

EUCTR2007-000896-41-IT
(EUCTR)

15/07/2008

30/07/2008

A RANDOMIZED, DOUBLE-BLIND STUDY COMPARING THE SAFETY AND EFFICACY OF ONCE-WEEKLY ADMINISTRATION OF ETANERCEPT 50 MG, ETANERCEPT 25 MG, AND PLACEBO IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE ACHIEVED AN ADEQUATE RESPONSE WITH ETANERCEPT 50 MG ONCE WEEKLY AND METHOTREXATE - ND

Moderately Active Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ENBREL *SC 4FL 25MG+4SIR 1ML
INN or Proposed INN: ETANERCEPT
Trade Name: ENBREL *SC 4FL 50MG+4SIR+4AGHI+
INN or Proposed INN: ETANERCEPT
Product Name: metotrexato
INN or Proposed INN: Methotrexate

Wyeth Pharmaceuticals France, Wyeth Research Division

NULL

Not Recruiting

Female: yes
Male: yes

900

Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2816

EUCTR2007-001377-28-NL
(EUCTR)

15/07/2008

29/05/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

2817

ChiCTR-TCC-12002824

2008-07-10

2012-12-08

Traditional Chinese and anti-rheumatic drugs for the treatment of rheumatoid arthritis

Integration of Traditional Chinese and Western Medicine treat rheumatoid witharthritis: A prospective, randomized, controlled trial

rheumatoid arthritis with peptic ulcer

Acupuncture treatment:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint. ;ARD treatment:esomeprazole magnesium enteric-coated tablets ,celecoxib capsules and methotrexate tablets ;Combined therapy:ARD treatment and concomitant ginger-partitioned moxibustion of the Zusanli acupoint + oral Shanhuang Wuji decoction ;

Hospital of Chengdu Military Area Command PLA

NULL

Completed

Both

Acupuncture treatment:20;ARD treatment:20;Combined therapy:20;

China

2818

EUCTR2007-005434-37-HU
(EUCTR)

09/07/2008

26/05/2008

RHEUMATOID ARTHRITIS, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

2400

Phase 3B

France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom

2819

EUCTR2007-001625-10-DK
(EUCTR)

08/07/2008

18/06/2008

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Etanercept
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

700

Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria

2820

EUCTR2007-006150-25-HU
(EUCTR)

04/07/2008

01/04/2009

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: TRU-015
Trade Name: Decortin 5mg tablets
INN or Proposed INN: Prednisone
Trade Name: Solu-Medrone 125mg
INN or Proposed INN: Methylprednisolone Sodium Succinate

Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

216

France;Serbia;Hungary;Mexico;Belgium;Romania;Austria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2821

EUCTR2008-000587-17-SE
(EUCTR)

03/07/2008

21/05/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

2822

EUCTR2007-003508-36-GB
(EUCTR)

02/07/2008

29/02/2008

A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Nitec Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

Hungary;Germany;United Kingdom

2823

JPRN-UMIN000001240

2008/07/01

10/07/2008

The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial

rheumatoid arthritis

Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks for 3 years

Division of Rheumatology & Clinical Immunology, Jichi Medical University

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

2824

JPRN-UMIN000001281

2008/07/01

31/07/2008

Strategic reduction of joint destruction in rheumatoid arthritis

Rheumatoid arthritis

TNF-inhibitors plus MTX
TNF-inhibitors are used for 54 weeks and exchange among them is approved

MTX
MTX is used for 54 weeks and addition of the other DMARD is approved

School of Medicine, University of Occupational and Environmental Health, Japan

NULL

Not applicable

Male and Female

120

Not selected

Japan

2825

JPRN-UMIN000001798

2008/07/01

25/03/2009

Prevention of cartilage destruction in rheumatoid arthritis by etanercept (PRECEPT study)

Rheumatoid arthritis

Injection of etanercept by 50 mg/week for one year
Injection of etanercept by 25 mg/week for one year

Team RA, Rheumatosurgery, Osaka City University Medical School

NULL

Complete: follow-up complete

20years-old

80years-old

Male and Female

100

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2826

JPRN-UMIN000002421

2008/07/01

04/09/2009

Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis

rheumatoid arthritis

tocilizumab
Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab

AA amyloidosis clinical research conference

NULL

Recruiting

20years-old

Not applicable

Male and Female

Not selected

Japan

2827

NCT00718588
(ClinicalTrials.gov)

July 2008

16/7/2008

A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis

A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage, of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous MTRX1011A in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MTRX1011A

Genentech, Inc.

NULL

Terminated

18 Years

80 Years

Both

Phase 1

United States

2828

NCT00717236
(ClinicalTrials.gov)

July 2008

15/7/2008

Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis

A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: Certolizumab pegol (CZP);Other: Placebo

UCB Pharma

NULL

Completed

18 Years

N/A

All

1648

Phase 3

United States;Canada;France;Germany;Italy;Netherlands;Spain

2829

NCT00712114
(ClinicalTrials.gov)

July 2008

6/7/2008

Safety, Tolerance, Pharmacokinetics and Activity of HE3286 in Patients With Rheumatoid Arthritis

A Phase I/II, Open Label, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Anti-Inflammatory Activity of HE3286 When Administered Orally for 29 Days to Patients With Rheumatoid Arthritis on a Stable Dose of Methotrexate

Rheumatoid Arthritis

Drug: HE3286

Harbor Therapeutics

NULL

Completed

18 Years

75 Years

Both

Phase 1;Phase 2

United States

2830

NCT00729209
(ClinicalTrials.gov)

July 2008

4/8/2008

A Study of ARRY-371797 in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ARRY-371797, p38 inhibitor; oral;Drug: Placebo

Array Biopharma, now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

N/A

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2831

NCT00782600
(ClinicalTrials.gov)

July 2008

27/10/2008

Study of Controlled Release Formulations of CE-224,535 Against the Immediate Release Formulation in Normal Volunteers

A Phase 1, Randomized, 4-Period, 4-Sequence Cross-Over Study Of The Pharmacokinetics Of 3 Durations Of Release Of A Controlled Release Formulation And A Single Dose Of An Immediate Release Oral Suspension Of CE-224,535 In Normal Healthy Volunteers

Rheumatoid Arthritis

Drug: suspension IR;Drug: CR 1;Drug: CR 2;Drug: CR 3

Pfizer

NULL

Completed

18 Years

55 Years

Both

Phase 1

United States

2832

NCT00713544
(ClinicalTrials.gov)

July 2008

9/7/2008

A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis

A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (With Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate.

Rheumatoid Arthritis

Drug: AZD5672;Drug: Etanercept;Drug: Placebo

AstraZeneca

NULL

Completed

18 Years

N/A

All

373

Phase 2

Bulgaria;Colombia;Czech Republic;Hungary;Italy;Latvia;Malta;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Ukraine;Argentina;Netherlands;Peru

2833

EUCTR2007-000830-38-IT
(EUCTR)

30/06/2008

21/07/2008

rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Term: Rheumatoid arthritis

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB S.A. (Casa Madre)

NULL

Not Recruiting

Female: yes
Male: yes

132

Phase 3B

Germany;France;Italy;Poland;Austria

2834

EUCTR2007-001377-28-AT
(EUCTR)

26/06/2008

27/05/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

2835

EUCTR2007-004399-38-LT
(EUCTR)

26/06/2008

23/04/2008

A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

United Kingdom;Estonia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2836

EUCTR2007-006150-25-FR
(EUCTR)

24/06/2008

05/05/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

216

Hungary;Germany;Netherlands;Belgium;France;Austria

2837

EUCTR2008-000327-25-PL
(EUCTR)

24/06/2008

20/05/2008

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CE-224,535

Pfizer Inc. 235 East 42nd Street NY10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2A

Czech Republic;Spain;Poland

2838

EUCTR2007-000896-41-DE
(EUCTR)

20/06/2008

21/04/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders
MedDRA version: 9.1;Classification code 10021428;Term: Immune system disorders

Trade Name: Enbrel 25 mg
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel 50 mg
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate Sodium Tablets 2.5 mg
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE Sodium

Wyeth Research Division of Wyeth Pharmceuticals Inc. A Pfizer Company, Philadelphia, PA-19101, USA

NULL

Not Recruiting

Female: yes
Male: yes

900

France;Czech Republic;Hungary;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden

2839

EUCTR2007-001625-10-CZ
(EUCTR)

19/06/2008

21/05/2008

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Etanercept
INN or Proposed INN: ETANERCEPT

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Not Recruiting

Female: yes
Male: yes

700

Hungary;Germany;United Kingdom;Czech Republic;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria

2840

EUCTR2008-000587-17-AT
(EUCTR)

19/06/2008

09/05/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2841

EUCTR2008-000587-17-GB
(EUCTR)

18/06/2008

18/04/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Actemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

2842

EUCTR2007-006527-13-BG
(EUCTR)

18/06/2008

14/06/2008

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients with Active Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CF101
INN or Proposed INN: methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide
Other descriptive name: IB-MECA
INN or Proposed INN: methyl 1-[N6-(3-iodobenzyl)-adenin-9-yl]-ß-Dribofuronamide
Other descriptive name: IB-MECA

Can-Fite BioPharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

228

Phase 2

Bulgaria

2843

EUCTR2008-000743-34-BE
(EUCTR)

18/06/2008

09/04/2008

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788

Rigel Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

195

Phase 2

France;Belgium;Germany;Italy

2844

EUCTR2007-007539-14-IT
(EUCTR)

17/06/2008

06/06/2008

Male and female patients over 18 years of age, with active RA despite current treatment with methotrexate. All patients will continue with background methotrexate therapy.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AZD5672
Product Code: AZD5672
Product Name: AZD5672
Product Code: AZD5672
INN or Proposed INN: ETANERCEPT

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

2845

EUCTR2007-003508-36-HU
(EUCTR)

17/06/2008

18/02/2008

A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Lodotra®
INN or Proposed INN: Prednisone

Nitec Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

350

Hungary;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2846

EUCTR2007-001625-10-HU
(EUCTR)

16/06/2008

18/03/2008

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Etanercept
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

700

Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria

2847

NCT00686868
(ClinicalTrials.gov)

June 13, 2008

28/5/2008

Study to Evaluate SC Route of Administration of Ofatumumab in RA Patients

Clinical Phase I/IIA Study of Subcutaneously Administration of Ofatumumab in Rheumatoid Arthritis Patients on Stable Dose Methotrexate

Arthritis, Rheumatoid

Other: placebo;Drug: ofatumumab

GlaxoSmithKline

NULL

Completed

18 Years

N/A

All

Phase 1

United States;Australia;Belgium;France;Italy;New Zealand;Poland;Russian Federation;Spain;Canada;Germany;Hungary;Netherlands

2848

EUCTR2007-007539-14-CZ
(EUCTR)

12/06/2008

18/04/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

2849

EUCTR2007-001377-28-FR
(EUCTR)

11/06/2008

29/02/2008

Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB

Merck Serono International S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Portugal;Germany;Netherlands;France;Austria

2850

EUCTR2007-002951-18-SE
(EUCTR)

11/06/2008

25/03/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

236

Phase 3

Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2851

EUCTR2007-007859-14-PL
(EUCTR)

11/06/2008

09/05/2008

A 12-WEEK, PHASE 2, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS AND EFFICACY OF ARRY-438162, ADMINISTERED ORALLY DAILY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS INCOMPLETELY RESPONSIVE TO METHOTREXATE

Active Rheumatoid Arthritis incompletely responsive to methotrexate
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ARRY-438162
Product Name: ARRY-438162

Array BioPharma Inc.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Hungary;Poland

2852

EUCTR2006-004834-33-PL
(EUCTR)

09/06/2008

06/05/2008

A Phase II, Randomised, Double-blind, International, Multicentre, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 when Added to Stable Methotrexate in Patients with Moderate or Severe Active Rheumatoid Arthritis - Robust

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Rob 803
Product Code: Rob 803 6.25mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Name: Rob 803
Product Code: Rob 803 12.5mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Name: Rob 803
Product Code: Rob 803 15mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Name: Rob 803
Product Code: Rob 803 25mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline

OxyPharma AB

NULL

Not Recruiting

Female: yes
Male: yes

224

Phase 2

United Kingdom;Bulgaria;Latvia;Poland

2853

EUCTR2007-000886-40-IT
(EUCTR)

04/06/2008

21/03/2008

Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER

Patients with a diagnosis of early active rhematoid arthritis in the previous 6 months, naive of previous treatment by DMARD and who need to be treated by DMARD.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide

sanofi-aventis Groupe

NULL

Not Recruiting

Female: yes
Male: yes

200

Portugal;Italy

2854

EUCTR2007-002951-18-DK
(EUCTR)

03/06/2008

23/04/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

236

Phase 3

France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden

2855

EUCTR2007-002536-29-GR
(EUCTR)

03/06/2008

12/02/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2856

EUCTR2008-000170-20-FR
(EUCTR)

03/06/2008

15/04/2008

A Randomized, Parallel Group, Double-Blind, Placebo Controlled Study to Evaluate theClinical Efficacy and Safety of BMS-582949 Given Orally to Subjects with RheumatoidArthritis Having an Inadequate Response to Methotrexate.Pharmacogenetics Blood Sample Amendment 01 (version 1.0, dated 19-Dec-2007);Revised Protocol 01, incorporating administrative letter 01 and amendment 03 (version 1.0, dated 12-Mar-2008)

subjects with rheumatoid arthritis (RA) who are on background therapy with methotrexate (MTX)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: BMS-582949

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Czech Republic;France;Spain

2857

EUCTR2007-001625-10-FR
(EUCTR)

03/06/2008

13/05/2008

RHEUMATOID ARTHRITIS

Trade Name: Etanercept
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria

2858

JPRN-JapicCTI-080587

01/6/2008

Safety, Efficacy and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis

A Multicenter, Open-label Study of Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis (JRA)

Intervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : adalimumab 20 mg for chldren with body weight < 30 kg; adalimumab 40 mg for chldren with body weight >= 30 kg
Control intervention name : null

Abbott Japan Co., Ltd.

Eisai Co., Ltd.

BOTH

Phase 3

NULL

2859

NCT00700986
(ClinicalTrials.gov)

June 2008

18/6/2008

Cross-over Study to Investigate Retinal Function Following Administration of a Single Dose of AZD9056

A Randomised, Double-Blind, Placebo-Controlled, 2-Period Cross-Over Study in Healthy Male Volunteers, to Investigate Retinal Function Following a Single 800mg Oral Dose of AZD9056

Rheumatoid Arthritis

Drug: AZD9056;Drug: Placebo

AstraZeneca

NULL

Completed

18 Years

65 Years

Male

Phase 1

United Kingdom

2860

NCT02151409
(ClinicalTrials.gov)

June 2008

28/5/2014

Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects

A Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects.

Inflammation;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Healthy

Drug: NNC 0151-0000-0000;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

55 Years

Male

Phase 1

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2861

NCT00689728
(ClinicalTrials.gov)

June 2008

2/6/2008

A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFa Inhibitor Therapy

A Phase 2 Study of Multiple Intravenous Doses of LY2127399 in Patients With Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy

Arthritis, Rheumatoid

Biological: LY2127399;Drug: Placebo

Eli Lilly and Company

NULL

Completed

18 Years

75 Years

All

100

Phase 2

United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Mexico;Poland;Puerto Rico;France

2862

NCT00674362
(ClinicalTrials.gov)

June 2008

5/5/2008

Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Certolizumab pegol;Biological: Placebo

UCB Pharma

NULL

Completed

18 Years

N/A

All

194

Phase 3

Austria;France;Germany;Italy;Poland

2863

NCT00711074
(ClinicalTrials.gov)

June 2008

3/7/2008

Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

An Open-Label, Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of [14C]AZD5672 in Healthy Male Volunteers

Rheumatoid Arthritis

Drug: AZD5672

AstraZeneca

NULL

Completed

50 Years

N/A

Male

Phase 1

United Kingdom

2864

EUCTR2007-001625-10-ES
(EUCTR)

28/05/2008

24/03/2008

Estudio abierto y aleatorizado para evaluar la eficacia radiológica y la seguridad de Enbrel® (etanercept) añadido a metotrexato en comparación con el tratamiento habitual en pacientes con artritis reumatoide moderadaAn Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra

Artritis reumatoideRHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria

2865

EUCTR2008-000327-25-CZ
(EUCTR)

27/05/2008

02/04/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CE-224,535

Pfizer Inc. 235 East 42nd Street NY10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

Czech Republic;Spain;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2866

EUCTR2007-000828-40-DE
(EUCTR)

27/05/2008

10/01/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 3B

Germany;France;Italy;Poland;Austria

2867

EUCTR2007-007859-14-HU
(EUCTR)

22/05/2008

22/01/2008

Active Rheumatoid Arthritis incompletely responsive to methotrexate
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ARRY-438162
Product Name: ARRY-438162

Array BioPharma Inc.

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Hungary;Poland

2868

EUCTR2006-003054-26-HU
(EUCTR)

22/05/2008

14/12/2007

A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms of in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: TAK-783

Takeda Global R&D (Europe) Ltd

NULL

Not Recruiting

Female: yes
Male: yes

230

Hungary;Czech Republic;Latvia

2869

EUCTR2007-005759-41-DE
(EUCTR)

21/05/2008

21/02/2008

A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy - FEATURE: Ocrelizumab in MTX-IR RA-patients; mono- vs. dual infusion

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

300

United Kingdom;Germany;France;Spain;Italy

2870

EUCTR2008-000327-25-ES
(EUCTR)

19/05/2008

18/03/2008

ESTUDIO DE FASE 2A ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS DE CE-224,535, UN ANTAGONISTA DEL RECEPTOR P2X7, EN EL TRATAMIENTO DE LOS SIGNOS Y SÍNTOMAS DE LA ARTRITIS REUMATOIDE EN PACIENTES CON UN CONTROL INADECUADO CON METROTEXATOA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE

Artritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CE-224,535

PFIZER S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2A

Czech Republic;Spain;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2871

EUCTR2007-000896-41-BE
(EUCTR)

16/05/2008

27/02/2008

Rheumatoid arthritis

Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 4

France;Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden

2872

EUCTR2007-007539-14-SK
(EUCTR)

16/05/2008

16/04/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

Hungary;Czech Republic;Slovakia;Poland;Bulgaria;Latvia;Malta;Italy

2873

EUCTR2007-000828-40-IT
(EUCTR)

15/05/2008

14/07/2008

A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFa Fab' fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis - ND

Rheumatoid arthritis with moderate to low disease activity
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB S.A. (Casa Madre)

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 3B

Germany;France;Italy;Poland;Austria

2874

EUCTR2007-002951-18-FR
(EUCTR)

14/05/2008

18/03/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

236

Phase 3

Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden

2875

EUCTR2007-006288-56-AT
(EUCTR)

14/05/2008

14/04/2008

Methotrexat-Polyglutamate als Marker fuer das klinische Outcome in der Therapie der rheumatoiden Arthritis

Rheumatoid Arthritis

Trade Name: Ebetrexat
INN or Proposed INN: METHOTREXATE

Ludwig Boltzmann Cluster für Rheumatologie, Balneologie und Rehabilitation

NULL

Not Recruiting

Female: yes
Male: yes

Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2876

EUCTR2007-005905-23-DE
(EUCTR)

13/05/2008

29/01/2008

A Multi-center, Randomized, Double-blind, Placebo - controlled Study Comparing 80 mg of Adalimumab with Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
INN or Proposed INN: Adalimumab
Other descriptive name: ABT-Humira

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

424

United Kingdom;Germany

2877

EUCTR2007-002536-29-DE
(EUCTR)

08/05/2008

05/12/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Portugal;France;Czech Republic;Greece;Finland;Spain;Poland;Austria;Bulgaria;Germany;Italy;Sweden

2878

EUCTR2007-007539-14-LV
(EUCTR)

07/05/2008

12/05/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

2879

EUCTR2007-000896-41-FR
(EUCTR)

07/05/2008

29/02/2008

Rheumatoid arthritis

Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

2880

EUCTR2007-005759-41-IT
(EUCTR)

06/05/2008

10/10/2008

A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy. - ND

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ocrelizumab
Product Code: RO-496-4913

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

300

France;Spain;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2881

NCT00665925
(ClinicalTrials.gov)

May 2008

22/4/2008

Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate

Rheumatoid Arthritis

Drug: Fostamatinib disodium (R935788);Drug: Placebo

Rigel Pharmaceuticals

NULL

Completed

18 Years

N/A

All

457

Phase 2

United States;Bulgaria;Colombia;Mexico;Poland;Romania;Israel

2882

NCT00665626
(ClinicalTrials.gov)

May 2008

22/4/2008

Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-3)

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic

Rheumatoid Arthritis

Drug: Fostamatinib disodium (R935788);Drug: Placebo

Rigel Pharmaceuticals

NULL

Completed

18 Years

N/A

All

219

Phase 2

United States;Belgium;Colombia;France;Germany;Italy;Peru;Brazil

2883

NCT00695188
(ClinicalTrials.gov)

May 2008

9/6/2008

Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis

Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis A Multicenter, Randomized, Double-blind, Controlled Phase IV Trial

Rheumatoid Arthritis

Drug: methotrexate

Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation

NULL

Completed

18 Years

N/A

All

Phase 4

Austria

2884

EUCTR2007-000896-41-SE
(EUCTR)

29/04/2008

06/02/2008

Rheumatoid arthritis

Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company, Philadelphia,PA-19101,USA

NULL

Not Recruiting

Female: yes
Male: yes

900

Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

2885

EUCTR2007-005759-41-GB
(EUCTR)

29/04/2008

29/02/2008

A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy - FEATURE

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

France;Spain;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2886

EUCTR2007-007539-14-MT
(EUCTR)

25/04/2008

12/05/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Hungary;Czech Republic;Malta;Bulgaria;Italy;Latvia;Poland

2887

EUCTR2007-003508-36-DE
(EUCTR)

25/04/2008

28/03/2008

A randomised multi-centre, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisolone (Lodotra®) in patients with rheumatoid arthritis - CAPRA-2

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

INN or Proposed INN: Prednisone

Nitec Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

350

Hungary;Germany;United Kingdom

2888

EUCTR2007-005759-41-ES
(EUCTR)

23/04/2008

19/02/2008

Estudio internacional randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab administrado en un régimen de una o dos infusiones, comparado con placebo, en pacientes con artritis reumatoide activa que manifiestan una respuesta inadecuada a tratamiento con metotrexato.A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy

Artritis reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United Kingdom;Germany;France;Spain;Italy

2889

EUCTR2007-005905-23-GB
(EUCTR)

22/04/2008

15/02/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

424

Germany;United Kingdom

2890

EUCTR2007-004399-38-EE
(EUCTR)

18/04/2008

29/02/2008

A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

United Kingdom;Estonia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2891

EUCTR2007-000896-41-CZ
(EUCTR)

14/04/2008

04/03/2008

Rheumatoid arthritis

Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA

NULL

Not Recruiting

Female: yes
Male: yes

900

Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

2892

EUCTR2007-004878-31-HU
(EUCTR)

09/04/2008

20/12/2007

An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 antibody, in adult patients with active rheumatoid arthritis who previously received ofatumumab or placebo in Trial Hx-CD20-403 - Long-term efficacy and safety of repeated ofatumumab courses in RA patients who were in Hx-CD20-403

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

GlaxoSmithKline Research & Development Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Denmark;United Kingdom

2893

EUCTR2006-004834-33-BG
(EUCTR)

03/04/2008

24/03/2008

Rheumatiod Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Rob 803 (capsules 6.25 mg)
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803 (capsules 12.5 mg)
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803 (capsules 15 mg)
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803 (capsules 25 mg)
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali

OxyPharma AB

NULL

Not Recruiting

Female: yes
Male: yes

224

Phase 2

United Kingdom;Bulgaria;Latvia;Poland

2894

EUCTR2007-003069-42-LT
(EUCTR)

01/04/2008

05/02/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)

RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole
Product Code: CRx-102
INN or Proposed INN: Prednisolone
INN or Proposed INN: Dipyridamole

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

Hungary;United Kingdom;Estonia;Lithuania

2895

EUCTR2007-003647-75-FR
(EUCTR)

01/04/2008

07/02/2008

A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Netherlands;France;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2896

NCT00661661
(ClinicalTrials.gov)

April 2008

7/2/2008

Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan

A Long-term, Open-label Study Of Cp-690,550 to Confirm The Safety Following Long Term Administration Of Cp-690,550 In The Treatment Of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CP -690,550

Pfizer

NULL

Completed

20 Years

N/A

All

487

Phase 3

Japan

2897

NCT02622503
(ClinicalTrials.gov)

April 2008

2/12/2015

A Study on Rheumatoid Arthritis Patients Treated With Rituximab

Retrospective Data Collection on Rheumatoid Arthritis (RA) Patients Treated With Rituximab in Finland.

Rheumatoid Arthritis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

N/A

Both

N/A

Finland

2898

NCT00674635
(ClinicalTrials.gov)

April 2008

22/4/2008

Phase II Study Evaluating the Safety and Efficacy of GSK315234A in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Bayesian Adaptive Dose Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Intravenous Infusions GSK315234A in Patients With Active Rheumatoid Arthritis (RA)

Arthritis, Rheumatoid

Drug: GSK3152314A;Drug: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

75 Years

Both

135

Phase 2

Australia;New Zealand;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro;United Kingdom

2899

NCT00658047
(ClinicalTrials.gov)

April 2008

8/4/2008

A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis

A Phase II, Multi-center, Randomized, Double-blind, Methotrexate Controlled Study to Assess the Clinical Efficacy, Safety, and Tolerability of CH-1504 in Subjects With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: CH-1504;Drug: Methotrexate (MTX)

Chelsea Therapeutics

NULL

Completed

18 Years

80 Years

Both

201

Phase 2

Canada

2900

EUCTR2007-000593-24-GB
(EUCTR)

28/03/2008

01/08/2007

An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.

Rheumatoid Arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2901

EUCTR2007-002066-35-HU
(EUCTR)

28/03/2008

23/07/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece

2902

EUCTR2007-003069-42-HU
(EUCTR)

27/03/2008

18/09/2007

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)

RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

Hungary;United Kingdom;Estonia;Lithuania

2903

EUCTR2007-000896-41-HU
(EUCTR)

27/03/2008

16/10/2007

Rheumatoid arthritis

Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
Trade Name: Methotrexate
Product Name: Methotrexate

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

900

Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

2904

EUCTR2007-005759-41-FR
(EUCTR)

19/03/2008

12/02/2008

A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913/F03
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United Kingdom;Germany;France;Spain;Italy

2905

NCT01000610
(ClinicalTrials.gov)

March 17, 2008

21/10/2009

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Tunisia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2906

EUCTR2007-006539-29-SE
(EUCTR)

14/03/2008

20/12/2007

Effects of different anti-rheumatic treatments of arthritis on antibody response following pneumococcal vaccination using Prevenar

Patients with rheumatic diseases (rheumatoid arthritis and spondyloarthripaties) who are going to be vaccinated with Prevenar vaccine in order to study the serological responses to two pneumococcal serotypes and to study the impact of different treatment modalities on serological responses.

Trade Name: Prevenar vaccine
Product Name: Prevenar vaccine
INN or Proposed INN: 7-valent Pneumococcal Conjugate vaccine

Dept of Rheumatology, Lund University Hospital, Lund, Sweden

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Sweden

2907

EUCTR2007-003623-20-ES
(EUCTR)

12/03/2008

04/02/2008

Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR).Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).

Se estudiaran los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB

Dr. Juan D. Cañete Crespillo, Hospital Clínic de Barcelona

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

2908

EUCTR2007-000760-24-SK
(EUCTR)

05/03/2008

10/04/2008

Activity and safety of oral administration of SSR150106XB for the reduction of inflammation in patients with active rheumatoid arthritis (RA): A 4-week, multi-center, randomized, double-blind, placebo-controlled parallel group study of 90 µg administrered once daily and 90µg once every other day - ACCORD-RA

Patients with active rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SSR150106XB
Product Code: SSR150106XB
INN or Proposed INN: NA
Other descriptive name: NA

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Slovakia

2909

EUCTR2007-004241-15-IT
(EUCTR)

04/03/2008

27/06/2008

A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis. - ND

Psoriatic arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10032451;Term: Other rheumatoid arthritis with visceral or systemic involvement

Trade Name: ORENCIA
INN or Proposed INN: abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2B

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy

2910

EUCTR2007-004399-38-GB
(EUCTR)

03/03/2008

20/03/2008

A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, 1-YEAR EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFECTIVENESS OF CRx-102 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CRx-102
INN or Proposed INN: Dipyridamole
INN or Proposed INN: Prednisolone
Product Code: CRx-102
INN or Proposed INN: Dipyridamole
INN or Proposed INN: Prednisolone

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

United Kingdom;Estonia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2911

EUCTR2007-002536-29-FR
(EUCTR)

03/03/2008

04/10/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Trade Name: Humira
Product Name: Adalimumab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

2912

EUCTR2007-002536-29-CZ
(EUCTR)

03/03/2008

16/11/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

2913

NCT00620685
(ClinicalTrials.gov)

March 2008

10/1/2008

A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate

A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral Methotrexate

Arthritis, Rheumatoid

Drug: Placebo;Drug: PH-797804

Pfizer

NULL

Completed

18 Years

N/A

All

Phase 2

United States

2914

NCT00628095
(ClinicalTrials.gov)

March 2008

25/2/2008

Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CE-224,535, An Antagonist Of The P2x7 Receptor, In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate

Arthritis, Rheumatoid

Drug: CE-224,535;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

Both

100

Phase 2;Phase 3

United States;Chile;Czech Republic;Korea, Republic of;Mexico;Poland;Spain

2915

NCT00650767
(ClinicalTrials.gov)

March 2008

31/3/2008

A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ARRY-438162, MEK inhibitor; oral;Drug: Placebo

Array Biopharma, now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

N/A

All

201

Phase 2

United States;Argentina;Brazil;Hungary;Peru;Poland;Romania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2916

NCT00565409
(ClinicalTrials.gov)

March 2008

28/11/2007

Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Etanercept;Drug: Methotrexate;Drug: Placebo

Pfizer

NULL

Completed

18 Years

70 Years

All

834

Phase 4

Australia;Austria;Belgium;Chile;Colombia;Czech Republic;Former Serbia and Montenegro;France;Germany;Hungary;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;Spain;Sweden;Taiwan;United Kingdom;Brazil;Korea, Democratic People's Republic of;Serbia

2917

NCT00664521
(ClinicalTrials.gov)

March 2008

21/4/2008

Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)

A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.

Rheumatoid Arthritis

Biological: Rituximab;Drug: Atacicept;Drug: Placebo matched to atacicept

Merck KGaA

NULL

Completed

18 Years

N/A

All

Phase 2

France;Netherlands;Sweden;United Kingdom;Finland

2918

NCT02109666
(ClinicalTrials.gov)

March 2008

8/4/2014

Long Term Experience With Abatacept in Routine Clinical Practice

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

2364

N/A

Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Greece;Ireland;Italy;Netherlands;Spain;Switzerland

2919

NCT00650078
(ClinicalTrials.gov)

March 2008

28/3/2008

Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis

A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MR prednisone;Drug: Placebo

Horizon Pharma Ireland, Ltd., Dublin Ireland

NULL

Completed

18 Years

80 Years

All

350

Phase 3

United States;Canada;Germany;Hungary;Poland;United Kingdom

2920

NCT00605735
(ClinicalTrials.gov)

March 2008

18/1/2008

PoC in Rheumatoid Arthritis With Methotrexate

A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate

Rheumatoid Arthritis, NOS

Drug: BMS-582949;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

Both

121

Phase 2

United States;Argentina;Czech Republic;France;Korea, Republic of;Mexico;Spain;Taiwan;Brazil

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2921

EUCTR2006-006373-25-GR
(EUCTR)

26/02/2008

20/09/2007

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A

Product Name: CP -690,550

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

2922

EUCTR2006-006591-37-GR
(EUCTR)

26/02/2008

20/09/2007

A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-Injector and the Etanercept Prefilled Syringe) in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis

Trade Name: Enbrel
Product Name: Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Enbrel Auto Injector
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

264

Greece;Austria

2923

EUCTR2007-001585-33-GR
(EUCTR)

26/02/2008

09/08/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman- La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

2924

EUCTR2006-005035-19-GR
(EUCTR)

26/02/2008

20/09/2007

A LONG TERM, OPEN LABEL FOLLOW UP STUDY OF CP 690,550, A MODERATELY SELECTIVE JANUS KINASE 3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS. - N/A

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-
Product Name: CP -690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden

2925

EUCTR2007-000828-40-FR
(EUCTR)

26/02/2008

11/12/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Pharma S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

Phase 3B

Germany;France;Italy;Poland;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2926

EUCTR2007-000828-40-AT
(EUCTR)

21/02/2008

31/03/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

170

Phase 3B

Germany;France;Italy;Poland;Austria

2927

EUCTR2006-006562-42-GB
(EUCTR)

21/02/2008

13/01/2009

An Observational and Exploratory Study to determine the effect of anti TNF Biologic Treatment in Rheumatoid Cachexia

Cachexia in patients with Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Derby Hospitals NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

2928

EUCTR2004-002132-26-GB
(EUCTR)

19/02/2008

11/03/2005

A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of ocrelizumab (Ro 496-4913, PRO70769, rhuMAb 2H7) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A

Rheumatoid Arthritis

F. Hoffmann-La Roche Limited

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 1;Phase 2

Spain;United Kingdom

2929

EUCTR2007-003647-75-GB
(EUCTR)

15/02/2008

10/12/2007

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Finland;Netherlands;United Kingdom;Sweden

2930

EUCTR2007-002066-35-IT
(EUCTR)

13/02/2008

07/09/2007

A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - ND

CP-690,550 is being developed as a disease-modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: CP -690,550
Product Name: CP -690,550
Trade Name: Humira
INN or Proposed INN: Adalimumab

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2931

EUCTR2007-002066-35-GR
(EUCTR)

11/02/2008

20/09/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 2B

Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece

2932

EUCTR2006-005036-24-BG
(EUCTR)

08/02/2008

07/02/2008

A PHASE 2B, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, MULTICENTER STUDY TO COMPARE 6 DOSE REGIMENS OF CP 690,550 VS. PLACEBO, EACH COMBINED WITH METHOTREXATE, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE ALONE. - N/A

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

483

Phase 2B

Hungary;Czech Republic;Bulgaria;Sweden

2933

EUCTR2007-003647-75-NL
(EUCTR)

07/02/2008

29/11/2007

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Sweden;France;Finland;United Kingdom;Netherlands

2934

EUCTR2007-003647-75-SE
(EUCTR)

06/02/2008

04/12/2007

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: MabThera 500 mg (10 mg/ml) concentrate for solution for infusion
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Netherlands;France;Sweden

2935

EUCTR2007-000896-41-ES
(EUCTR)

06/02/2008

18/12/2007

Estudio aleatorizado doble ciego que compara la seguridad y la eficacia de la administración semanal de 50 mg de etanercept, 25 mg de etanercept y placebo en combinación con metotrexato en pacientes con artritis reumatoide moderadamente activa que han obtenido una respuesta adecuada con 50 mg de etanercept semanal y metotrexatoA Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and ethotrexate

Artritis reumatoideRheumatoid arthritis

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

900

Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2936

EUCTR2006-004140-23-GB
(EUCTR)

04/02/2008

07/11/2007

A randomised, double-blind, placebo-controlled, multicentre, Phase II dose-finding study of atacicept given subcutaneously in subjects with rheumatoid arthritis and inadequate response to TNFa antagonist therapy - A Phase II dose-finding study of atacicept in RA

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Finland;Portugal;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden

2937

EUCTR2007-002536-29-BE
(EUCTR)

01/02/2008

20/11/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Portugal;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Sweden

2938

EUCTR2007-002536-29-PT
(EUCTR)

01/02/2008

21/11/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Finland;Portugal;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

2939

EUCTR2007-002066-35-DE
(EUCTR)

01/02/2008

17/02/2009

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Other descriptive name: CP -690,550 -10
Product Name: CP -690,550
Other descriptive name: CP -690,550 -10
Trade Name: Humira ® 40 mg Injektionslösung in Fertigspritze
INN or Proposed INN: Adalimumab

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

Hungary;Czech Republic;Germany;Bulgaria;Italy;Greece

2940

EUCTR2006-005035-19-DE
(EUCTR)

01/02/2008

04/10/2007

A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2941

NCT00556894
(ClinicalTrials.gov)

February 2008

8/11/2007

Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CF101;Drug: Placebo

Can-Fite BioPharma

NULL

Completed

18 Years

75 Years

All

253

Phase 2

Bulgaria;Czechia;Israel;Poland;Serbia;Ukraine;Czech Republic;Former Serbia and Montenegro

2942

NCT01072058
(ClinicalTrials.gov)

February 2008

18/2/2010

Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker

Prospective Evaluation of Heart Function by Echocardiographic Study, Pro-brain Natriuretic Peptide Type B and Troponin T in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker

Arthritis, Rheumatoid;Spondylitis, Ankylosing

Drug: TNF blockers (infliximab, adalimumab, etanercept)

University of Sao Paulo

NULL

Active, not recruiting

18 Years

70 Years

Both

100

Phase 4

Brazil

2943

NCT01017367
(ClinicalTrials.gov)

February 2008

16/11/2009

Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA)

Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: MDX-1100;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

Both

Phase 2

Romania;Ukraine

2944

NCT00639834
(ClinicalTrials.gov)

February 2008

10/1/2008

Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis

A Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: MDX-1342

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

Both

Phase 1

United States;Germany;Hungary;Ukraine;United Kingdom;Poland

2945

EUCTR2007-002066-35-BG
(EUCTR)

31/01/2008

15/02/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

Czech Republic;Hungary;Greece;Bulgaria;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2946

EUCTR2007-003647-75-FI
(EUCTR)

31/01/2008

19/12/2007

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Netherlands;France;Sweden

2947

EUCTR2007-002536-29-IT
(EUCTR)

30/01/2008

09/01/2008

A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED MULTICENTRE PHASE II STUDY OF ATACICEPT IN ANTI-TNFA NAIVE PATIENTS WITH MODERATE TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO METHOTREXATE - ATACICEPT IN ANTI TNF-a NAIVE SUBJECTS WITH RA

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Trade Name: HUMIRA
INN or Proposed INN: Adalimumab

MERCK SERONO INTERNATIONAL SA

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

2948

EUCTR2007-006729-28-GB
(EUCTR)

25/01/2008

04/12/2007

Is a single dose intramuscular (IM) triamcinolone acetonide injection more effective in treating symptomatic flare in established rheumatoid arthritis than equivalent dose of oral prednisolone? - Treatment comparison for symptomatic flare in RA

The objective of this study is to compare the efficacy of equivalent doses of IM triamcinolone acetonide and oral prednisolone in controlling a symptomatic flare in patients with established RA.
MedDRA version: 9.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up

Trade Name: Kenalog
Product Name: Triamcinolone acetonide
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
Trade Name: Prednisolone
Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE

Trafford NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

2949

EUCTR2006-006591-37-AT
(EUCTR)

25/01/2008

04/01/2008

Rheumatoid Arthritis

Trade Name: Enbrel
Product Name: Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Enbrel Auto Injector
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

264

Greece;Austria

2950

EUCTR2007-003069-42-GB
(EUCTR)

24/01/2008

15/08/2007

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)

RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

Hungary;United Kingdom;Estonia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2951

EUCTR2007-000012-90-GB
(EUCTR)

23/01/2008

28/03/2007

The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study - SCOT Trial

The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamlined safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy when used to treat pain and inflammation in osteoarthritis or rheumatoid arthritis patients who are free from ischaemic heart disease, cerebrovascular disease, peripheral arterial disease, and moderate or severe heart failure.
MedDRA version: 13.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 13.1;Level: PT;Classification code 10041591;Term: Spinal osteoarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Celebrex
Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses

University of Dundee

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Denmark;Netherlands;United Kingdom

2952

EUCTR2007-002536-29-ES
(EUCTR)

18/01/2008

14/02/2008

Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, fase II de atacicept en pacientes con artritis reumatoide moderada a gravemente activa, sin tratamiento previo con anti-TNFa y con respuesta insuficiente a metrotexato.A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti-TNFa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate. - Atacicept en pacientes con AR sin tratamiento previo con anti-TNFa

Artritis ReumatoideRheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

2953

EUCTR2007-001420-12-CZ
(EUCTR)

16/01/2008

13/11/2007

A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: Etanercept

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Czech Republic;France;Poland;Sweden

2954

EUCTR2007-000593-24-SE
(EUCTR)

16/01/2008

21/11/2007

An Open-Label, Observational Study of the Effects of Anti-TNF Therapy on Peripheral Blood and Synovial Biomarkers in Patients with Active Rheumatoid Arthritis.

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Enbrel
INN or Proposed INN: Etanercept
Other descriptive name: Enbrel
Trade Name: Humira
INN or Proposed INN: adalimumab
Other descriptive name: Humira

F.Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Sweden

2955

EUCTR2007-002950-42-PL
(EUCTR)

09/01/2008

24/08/2007

A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

GlaxoSmithKline Research and Development

NULL

Not Recruiting

Female: yes
Male: yes

248

Phase 3

Czech Republic;Hungary;Spain;Poland;Lithuania;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2956

EUCTR2007-002066-35-CZ
(EUCTR)

09/01/2008

23/10/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2B

Hungary;Germany;Czech Republic;Bulgaria;Italy;Greece

2957

NCT00611455
(ClinicalTrials.gov)

January 1, 2008

16/1/2008

Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy

A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Adult Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

Arthritis, Rheumatoid

Drug: ofatumumab;Drug: Placebo

GlaxoSmithKline

NULL

Terminated

18 Years

N/A

All

265

Phase 3

Argentina;Australia;Belgium;Chile;Czechia;Hungary;Peru;Poland;Romania;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic

2958

ChiCTR-TRC-09000383

2008-01-01

2009-04-23

Efficacy and safety of recombinant human IL-1 receptor antagonist in Chinese patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled trial

rheumatoid arthritis;M05.901

placebo:daily subcutaneous injections of placebo, with concurrent MTX therapy ;anakinra:daily subcutaneous injections of anakinra (80 mg), with concurrent MTX therapy;

Xi-jing Hospital, the 4th Military Medical University, Shanghai Changzheng Hospital

NULL

Completed

Both

placebo:10;anakinra:30;

3 (Phase 3 study)

China

2959

ChiCTR-CCC-10001054

2008-01-01

2010-08-25

Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis

1:none;2:Infliximab ;

National Sciences Foundation of China

NULL

Completed

Both

1:39;2:39;

China

2960

NCT00655824
(ClinicalTrials.gov)

January 1, 2008

4/4/2008

Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403

An Open-label, International, Multi-center, Phase II, Extension Trial Investigating Long-term Efficacy and Safety of Repeated Treatment Courses of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Adult Patients With Active Rheumatoid Arthritis Who Previously Received Ofatumumab or Placebo

Arthritis, Rheumatoid

Drug: ofatumumab

GlaxoSmithKline

NULL

Terminated

18 Years

N/A

All

124

Phase 2

United States;Denmark;Hungary;Poland;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2961

NCT00741104
(ClinicalTrials.gov)

January 2008

30/7/2008

A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)

A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients

Rheumatoid Arthritis

Drug: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

N/A

All

363

NULL

2962

NCT00559585
(ClinicalTrials.gov)

January 2008

15/11/2007

Methotrexate-Inadequate Response Study

Rheumatoid Arthritis (RA)

Drug: Subcutaneous (SC) Abatacept;Drug: Intravenous (IV) Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

2492

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Mexico;Netherlands;Peru;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Austria;Spain

2963

NCT00603512
(ClinicalTrials.gov)

January 2008

17/1/2008

Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone

Arthritis, Rheumatoid

Drug: Placebo;Drug: CP -690,550

Pfizer

NULL

Completed

20 Years

70 Years

All

140

Phase 2

Japan

2964

NCT00603525
(ClinicalTrials.gov)

January 2008

16/1/2008

Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-a Antagonist Therapy

A Double-blind, Randomized, Placebo Controlled, Parallel Group, Multi-center, Phase III Trial of Ofatumumab Investigating Clinical Efficacy in Patients With Active Rheumatoid Arthritis Who Have Previously Had an Inadequate Response to One or More TNF Antagonist Therapies

Arthritis, Rheumatoid

Drug: Ofatumumab;Drug: Placebo

GlaxoSmithKline

NULL

Terminated

18 Years

N/A

All

169

Phase 3

Argentina;Denmark;France;Germany;Italy;Korea, Republic of;Netherlands;Norway;Peru;Spain;Sweden;United Kingdom

2965

NCT01362153
(ClinicalTrials.gov)

December 26, 2007

10/3/2011

A Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of Golimumab in Patients With Rheumatoid Arthritis (RA)

An Open-label Randomized Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of Subcutaneous and Intravenous Administrations of Golimumab to Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Golimumab

Centocor, Inc.

NULL

Completed

18 Years

99 Years

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2966

EUCTR2006-005137-38-GB
(EUCTR)

21/12/2007

14/08/2007

A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis
MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

534

Phase 3

France;Finland;Denmark;Germany;United Kingdom;Sweden

2967

EUCTR2006-003577-27-ES
(EUCTR)

21/12/2007

09/10/2007

ESTUDIO DE FASE IIA, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO, DE DOCE SEMANAS DE DURACIÓN PARA EVALUAR LA SEGURIDAD, FARMACOCINÉTICA Y EFICACIA DE PH-797804 ADMINISTRADO POR VIA ORAL UNA VEZ AL DÍA EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - n/a

Tratamiento de artritis reumatoide (AR)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: PH-797804
Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide
Product Code: PH-797804
Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide
Product Code: PH-797804
Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide

Pfizer S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

290

Phase 2A

Czech Republic;Estonia;Spain

2968

EUCTR2007-001420-12-PL
(EUCTR)

20/12/2007

17/10/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Czech Republic;France;Poland;Sweden

2969

EUCTR2006-005353-30-AT
(EUCTR)

19/12/2007

23/05/2007

Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

Spain;Lithuania;Austria;United Kingdom;Italy

2970

EUCTR2007-001035-58-PT
(EUCTR)

14/12/2007

16/08/2007

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Maraviroc
Product Code: UK-427,857
INN or Proposed INN: Maraviroc

Pfizer Inc, 235 East 42nd Street,New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

114

Phase 2

Portugal;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2971

EUCTR2007-001114-17-GB
(EUCTR)

12/12/2007

13/02/2008

A Mechanism of Action study to evaluate the effects of IL-6receptor blockade with tocilizumab (TCZ) on lipids, arterialstiffness, and markers of atherogenic risk in patients withmoderate to severe active rheumatoid arthritis (RA).

Rheumatoid Arthritis (RA)

Product Name: Actemra
Product Code: RO4877533 (TCZ)

F. Hoffmann-La Roche Limited

NULL

Not Recruiting

Female: yes
Male: yes

120

United Kingdom

2972

EUCTR2007-002536-29-SE
(EUCTR)

12/12/2007

26/10/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

2973

EUCTR2007-002951-18-NL
(EUCTR)

10/12/2007

09/08/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

236

Phase 3

Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden

2974

EUCTR2007-004878-31-DK
(EUCTR)

10/12/2007

09/10/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Denmark;United Kingdom

2975

EUCTR2007-001665-15-IT
(EUCTR)

10/12/2007

05/10/2007

A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 monoclonal antibody) in patients with rheumatoid arthritis - ND

rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: Canakinumab
Product Code: ACZ885

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

179

Phase 2

Germany;Netherlands;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2976

EUCTR2006-005137-38-DK
(EUCTR)

10/12/2007

08/06/2007

Rheumatoid Arthritis
MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:

Trade Name: Enbrel
Product Name: Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Enbrel Auto Injector
Product Code: Auto Injector
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

534

France;Finland;Denmark;Germany;United Kingdom;Sweden

2977

EUCTR2007-004878-31-GB
(EUCTR)

07/12/2007

16/10/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Denmark;United Kingdom

2978

EUCTR2007-000491-16-AT
(EUCTR)

06/12/2007

05/04/2007

A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

260

Germany;Spain;Austria

2979

EUCTR2006-004139-31-NL
(EUCTR)

02/12/2007

26/04/2007

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden

2980

NCT01231321
(ClinicalTrials.gov)

December 2007

28/10/2010

A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid Arthritis

An Open-label, Prospective, Multi-Centre Study to Assess the Safety and Efficacy of Adalimumab (Humira®) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: adalimumab

Abbott

NULL

Completed

18 Years

N/A

All

100

Phase 3

Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2981

NCT00576433
(ClinicalTrials.gov)

December 2007

18/12/2007

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor

Rheumatoid Arthritis

Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

Both

Phase 4

Russian Federation

2982

NCT00580840
(ClinicalTrials.gov)

December 2007

21/12/2007

Dosing Flexibility Study in Patients With Rheumatoid Arthritis

A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: Certolizumab pegol;Other: Placebo

UCB Pharma

NULL

Completed

18 Years

N/A

All

333

Phase 4

United States;Canada;France;Austria

2983

NCT00576706
(ClinicalTrials.gov)

December 2007

17/12/2007

PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications

Rheumatoid Arthritis;Osteoarthritis;Ankylosing Spondylitis

Drug: Rebamipide;Drug: Misoprostol

Korea Otsuka Pharmaceutical Co.,Ltd.

NULL

Completed

19 Years

N/A

Both

396

Phase 3

Korea, Republic of

2984

NCT00547521
(ClinicalTrials.gov)

December 2007

19/10/2007

Phase IIIB Subcutaneous Abatacept Monotherapy Study

A Phase IIIb, Multi-center, Stratified, Open-Label Study to Evaluate the Immunogenicity, Steady State Trough Level, and Safety of Subcutaneous Abatacept (BMS-188667) in Subjects With Rheumatoid Arthritis Administered With or Without Background Methotrexate

Rheumatoid Arthritis (RA)

Drug: abatacept;Drug: Methotrexate (MTX)

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

119

Phase 3

United States;Australia;Mexico;South Africa;Brazil;Canada;Peru

2985

NCT00647270
(ClinicalTrials.gov)

December 2007

27/3/2008

Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

A Multi-center, Randomized, Double-blind,Placebo-controlled Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing

Rheumatoid Arthritis

Drug: adalimumab;Drug: Placebo

Abbott

NULL

Completed

18 Years

N/A

All

420

Phase 3

United States;Australia;Canada;Germany;Puerto Rico;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2986

NCT00596206
(ClinicalTrials.gov)

December 2007

4/1/2008

Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid Arthritis

Assessment of the Early Efficacy Response Rate of Leflunomide According to the Initial Dosing Regimen in the Treatment of Naive-DMARD (Disease Modifying Anti-Rheumatic Drug) Early RA (Rheumatoid Arthritis)-Patients

Arthritis, Rheumatoid

Drug: leflunomide

Sanofi

NULL

Completed

18 Years

N/A

Both

124

Phase 3

Czech Republic;Italy;Korea, Republic of;Portugal;Romania

2987

NCT00580229
(ClinicalTrials.gov)

December 2007

18/12/2007

A Safety Analysis of Oral Prednisone as a Pre-Treatment for Rituximab in Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: prednisone

University of South Florida

NULL

Completed

18 Years

80 Years

All

Phase 2;Phase 3

United States

2988

EUCTR2007-002951-18-ES
(EUCTR)

27/11/2007

11/10/2007

A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con antagonistas TNFa - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist

Rheumatoid ArthritisArtritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

236

Phase 3

Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden

2989

EUCTR2007-002950-42-ES
(EUCTR)

27/11/2007

11/10/2007

A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con metotrexato. - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX

Rheumatoid ArthritisArtritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

248

Phase 3

Czech Republic;Hungary;Belgium;Poland;Spain;Lithuania;United Kingdom

2990

EUCTR2007-001035-58-IT
(EUCTR)

21/11/2007

05/10/2007

Treatment of rheumatoid arthritis (RA).
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Maraviroc
Product Code: UK-427,857

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

114

Phase 2

Portugal;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2991

EUCTR2007-002536-29-FI
(EUCTR)

19/11/2007

15/10/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

2992

EUCTR2007-001585-33-ES
(EUCTR)

15/11/2007

13/09/2007

Estudio clínico multicéntrico, aleatorizado y controlado con placebo para investigar la eficacia de rituximab (MabThera/Rituxan) en la inhibición del daño estructural articular valorado por resonancia magnética nuclear en pacientes con artritis reumatoide y una respuesta inadecuada al metotrexato - estudio SCORE. - SCORE

Artritis reumatoide (AR)Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

2993

EUCTR2006-005035-19-CZ
(EUCTR)

14/11/2007

20/09/2007

A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Tofacitinib citate (Phase III formulation)
Product Code: CP -690,550-10
Product Name: Tofacitinib citrate (Proposed commercial formulation - debossed)
Product Code: CP -690,550-10

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

4500

Phase 2;Phase 3

2994

EUCTR2006-006373-25-CZ
(EUCTR)

14/11/2007

20/09/2007

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A

Product Name: CP -690,550

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

2995

EUCTR2007-001585-33-LT
(EUCTR)

13/11/2007

05/07/2007

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE

Rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2996

EUCTR2007-002536-29-AT
(EUCTR)

09/11/2007

15/10/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

2997

EUCTR2007-000886-40-PT
(EUCTR)

09/11/2007

07/08/2007

Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER

patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE

sanofi-aventis groupe

NULL

Not Recruiting

Female: yes
Male: yes

200

Portugal;Italy

2998

EUCTR2007-001665-15-NL
(EUCTR)

09/11/2007

17/10/2007

A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

179

Phase 2

Germany;Netherlands;Spain;Italy

2999

EUCTR2007-000896-41-NL
(EUCTR)

05/11/2007

17/10/2007

Rheumatoid arthritis

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

900

Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

3000

EUCTR2007-000012-90-DK
(EUCTR)

02/11/2007

25/09/2007

The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety StudyDansk:Klinisk forsøg med standardbehandling versus celecoxib (SCOT-forsøget)Et stort, strømlinet forsøg i lægemiddelsikkerhed - SCOT Trial

Trade Name: Celebra (celecoxib)
INN or Proposed INN: CELECOXIB
Trade Name: Patients' existing non-steroidal anti-inflammatory drug (NSAID) at approved doses

University of Dundee

NULL

Not Recruiting

Female: yes
Male: yes

13682

Phase 4

Denmark;Netherlands;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3001

NCT00578305
(ClinicalTrials.gov)

November 2007

19/12/2007

A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Biological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folate

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

185

Phase 3

Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom

3002

NCT01245361
(ClinicalTrials.gov)

November 2007

19/11/2010

A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit

A Comparative Study Of A 6-Month Infliximab (Remicade®) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis (RA) : Clinical, Radiological (MRI) And Synovial Benefit P1200/001.

Undifferentiated Arthritis

Drug: Infliximab;Drug: sodium chloride

Patrick Durez

NULL

Completed

N/A

Both

N/A

Belgium

3003

NCT00840957
(ClinicalTrials.gov)

November 2007

10/2/2009

Pharmaco Kinetic Variability of Infliximab in Rheumatoid Arthritis

Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of Infliximab

Rheumatoid Arthritis

Biological: infliximab

University Hospital, Tours

NULL

Completed

18 Years

N/A

Both

N/A

France

3004

NCT00664573
(ClinicalTrials.gov)

November 2007

21/4/2008

Assessment of the Safety and Efficacy of BG9924 in Rheumatoid Arthritis (RA) Patients

Assessment of Safety and Efficacy of BG9924 in Subjects With RA Who Have Participated in Study 104RA202.

Rheumatoid Arthritis

Biological: Baminercept alfa (BG9924)

Biogen Idec

NULL

Terminated

18 Years

75 Years

Both

339

Phase 2

Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom

3005

NCT00533897
(ClinicalTrials.gov)

November 2007

20/9/2007

Phase IIIB Subcutaneous Missed Dose Study

A Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Abatacept;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

270

Phase 3

United States;Argentina;Canada;Mexico;South Africa;Brazil

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3006

NCT00535782
(ClinicalTrials.gov)

October 31, 2007

24/9/2007

A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis

A Mechanism of Action Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) on Lipids, Arterial Stiffness, and Markers of Atherogenic Risk in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA).

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Placebo;Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

All

132

Phase 3

United States;Canada;Puerto Rico;United Kingdom

3007

EUCTR2007-003069-42-EE
(EUCTR)

31/10/2007

10/08/2007

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SUPERIORITY OF CRX-102 OVER EACH OF ITS COMPONENTS WHEN GIVEN TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS (RA)

RHEUMATOID ARTHRITIS (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

CombinatoRx, Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

616

Hungary;United Kingdom;Estonia;Lithuania

3008

EUCTR2007-001035-58-ES
(EUCTR)

30/10/2007

26/07/2007

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATEESTUDIO EN FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y EN GRUPOS PARALELOS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE MARAVIROC (UK 427,857) EN EL TRATAMIENTO DE LA ARTRITIS REUMATOIDE EN PACIENTES QUE RECIBEN METOTREXATO - N/A

ARTRITIS REUMATOIDERHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Maraviroc
Product Code: UK-427,857
INN or Proposed INN: Maraviroc

Pfizer, S. A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

114

Phase 2

Portugal;Spain;Italy

3009

EUCTR2007-001585-33-DK
(EUCTR)

26/10/2007

12/07/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

3010

NCT00502853
(ClinicalTrials.gov)

October 25, 2007

17/7/2007

A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.

Pilot Study to Evaluate the Effect of Mabthera in Combination With MTX in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

All

Phase 4

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3011

EUCTR2006-006591-37-BE
(EUCTR)

25/10/2007

12/06/2007

Rheumatoid Arthritis

Trade Name: Enbrel
Product Name: Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Enbrel Auto Injector
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

264

Greece;Belgium;Austria

3012

EUCTR2006-005137-38-DE
(EUCTR)

23/10/2007

23/08/2007

Rheumatoid Arthritis
MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:

Trade Name: Enbrel
Product Name: Etanercept Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Etanercept Auto-Injector
Product Code: L04AA11
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

534

France;Finland;Denmark;Germany;United Kingdom;Sweden

3013

EUCTR2006-005330-20-SE
(EUCTR)

22/10/2007

27/08/2007

Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden

3014

EUCTR2007-002945-18-IT
(EUCTR)

22/10/2007

07/02/2008

A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs - ND

Rheumatoid arthritis
MedDRA version: 9.1;Level: HLT;Classification code 10039078;Term: Rheumatoid arthropathies

Product Name: Ofatumumab
Product Code: HuMax-CD20

GENMAB A/S

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

Czech Republic;Italy

3015

EUCTR2006-003768-67-ES
(EUCTR)

19/10/2007

10/09/2007

A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with Methotrexate.Estudio de fase IIIB, multicéntrico, aleatorizado, en doble ciego y controlado con placebo, para evaluar los cambios a corto plazo en la sinovitis y el daño estructural en sujetos con artritis reumatoide activa y respuesta inadecuada al metotrexato tratados con abatacept frente a placebo más un tratamiento de fondo de metotrexato+ Protocol Amendment 01 (Version 1.0, Dated 16-May-2007) and Administrative Letter (Version 1.0, Dated 13-Jun-2007).

RHEUMATOID ARTHRITIS,NOSARTRITIS REUMATOIDE, NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Germany;United Kingdom;Netherlands;Spain;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3016

EUCTR2007-002950-42-HU
(EUCTR)

18/10/2007

31/07/2007

A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

248

Phase 3

Czech Republic;Hungary;Belgium;Spain;Poland;Lithuania;United Kingdom

3017

EUCTR2007-001420-12-FR
(EUCTR)

17/10/2007

23/07/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2b

Czech Republic;France;Poland;Sweden

3018

EUCTR2007-001665-15-DE
(EUCTR)

16/10/2007

30/07/2007

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

179

Phase 2

Germany;Netherlands;Spain;Italy

3019

EUCTR2007-002945-18-CZ
(EUCTR)

15/10/2007

27/08/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

Czech Republic

3020

EUCTR2007-001420-12-SK
(EUCTR)

15/10/2007

18/04/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

France;Czech Republic;Slovakia;Poland;Belgium;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3021

EUCTR2007-002950-42-CZ
(EUCTR)

15/10/2007

15/08/2007

A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

GlaxoSmithKline Research and Development

NULL

Not Recruiting

Female: yes
Male: yes

248

Phase 3

Hungary;Czech Republic;Spain;Poland;Lithuania;United Kingdom

3022

EUCTR2006-003698-29-EE
(EUCTR)

12/10/2007

24/08/2007

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;France;Estonia;Ireland;Italy;Latvia;Austria;Sweden

3023

EUCTR2007-001420-12-SE
(EUCTR)

12/10/2007

20/07/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

Czech Republic;France;Poland;Sweden

3024

EUCTR2006-005353-30-LT
(EUCTR)

10/10/2007

28/06/2007

A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM) FILM.

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

600

United States;Panama;Philippines;Taiwan;Thailand;Spain;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand;Korea, Republic of

3025

EUCTR2006-005330-20-IT
(EUCTR)

10/10/2007

15/10/2007

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-α therapy. - ND

Rheumatoid Arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: Ocrelizumab
Product Code: RO 496-4913

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

1000

France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3026

EUCTR2007-001585-33-EE
(EUCTR)

10/10/2007

18/07/2007

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

3027

EUCTR2007-001585-33-FR
(EUCTR)

09/10/2007

23/07/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Germany;Netherlands;Denmark;Estonia;France;Spain;Greece;Latvia;Lithuania

3028

EUCTR2006-003698-29-IT
(EUCTR)

05/10/2007

03/04/2007

A long term assessment of safety and physical function with AMG 108 subcutaneous monthly treatment in subjects with Rheumatoid Arthritis - AMG 108 20060119

Rheumatoid Arthritis AR
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: AMG 108
Product Code: AMG 108

AMGEN S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

3029

EUCTR2007-000733-19-HU
(EUCTR)

04/10/2007

09/08/2007

A Phase 2B, Blinded Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA202

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: BG9924

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2B

Hungary;United Kingdom

3030

EUCTR2007-000734-38-GB
(EUCTR)

02/10/2007

26/06/2007

An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects with Rheumatoid Arthritis Who Previously Participated in Study 104RA203

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: BG9924

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3031

EUCTR2007-000733-19-GB
(EUCTR)

02/10/2007

26/06/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: BG9924

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2B

Hungary;United Kingdom

3032

JPRN-UMIN000000837

2007/10/01

01/10/2007

Combination effect of bucillamine and salazosulphapyridine on rheumatoid arthritis; Prospective randomized controlled study

Rheumatoid arthritis

Bucillamine mono-therapy(It's possible to choose the combination therapy with salazosulphapyridine at 6 months after the start of the treatment)
Salazosulphapyridine mono-therapy(It's possible to choose the combination therapy with bucillamineat 6 months after the start of the treatment)
Combination therapy of bucillamine and salazosulphapyridine (over the study period)

BASIC study group

NULL

Recruiting

20years-old

75years-old

Male and Female

180

Not applicable

Japan

3033

ChiCTR-TRC-11001755

2007-10-01

2011-12-01

Phase II of Tu Fu Ling Tablets in Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Double-dummy, Phase II Study Evaluating the Safety and Efficacy of Tu Fu Ling Tablets in Participants with Rheumatoid Arthritis

Rheumatoid Arthritis

A:Tu Fu Ling Tablets, 200mg Bid. Other: Placebo;B:Tu Fu Ling Tablets, 100mg Tid. Other: Placebo. ;C:Leflunomide Tablets, 20mg Qd. Other: Placebo;

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

NULL

Completed

Both

A:80;B:80;C:80;

2 (Phase 2 study)

China

3034

EUCTR2006-005353-30-IT
(EUCTR)

01/10/2007

19/07/2007

A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab in combinationwith methotrexate (MTX) compared to MTX alone inmethotrexate- naïve patients with active rheumatoid arthritis. - ND

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO496-4913

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

600

Spain;Lithuania;Austria;United Kingdom;Italy

3035

NCT02699892
(ClinicalTrials.gov)

October 2007

25/2/2016

Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis

Post Marketing Non Interventional Clinical Research of Administration of Rituximab in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

130

N/A

Serbia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3036

NCT00626275
(ClinicalTrials.gov)

October 2007

22/2/2008

Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid Arthritis

A Phase 2a Randomized, Placebo- and Active-Controlled, Single-Dose, 3-Period, Crossover Study Followed by a Randomized, Placebo-Controlled, 14-Day, Parallel-Group Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ADL5859;Drug: Naproxen;Drug: Placebo

Cubist Pharmaceuticals LLC

NULL

Completed

18 Years

75 Years

All

Phase 2

United States

3037

NCT00934648
(ClinicalTrials.gov)

October 2007

6/7/2009

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Morocco

3038

NCT00545454
(ClinicalTrials.gov)

October 2007

16/10/2007

Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis

Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis (RA): A 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study of 90 µg Administered Once Daily and 90 µg Once Every Other Day

Rheumatoid Arthritis

Drug: SSR150106;Drug: Placebos

Sanofi

NULL

Completed

18 Years

75 Years

All

Phase 2

Bulgaria;Croatia;Czechia;Romania;Russian Federation;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro

3039

NCT00531817
(ClinicalTrials.gov)

October 2007

18/9/2007

A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Placebo;Drug: Permitted DMARDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

619

Phase 3

United States;Puerto Rico

3040

NCT00551707
(ClinicalTrials.gov)

October 2007

29/10/2007

Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: CRx-102 (2.7/180);Drug: prednisolone;Drug: dipyridamole;Drug: placebo;Drug: CRx-102 (2.7/360)

Zalicus

NULL

Completed

18 Years

N/A

All

Phase 2

United States;Argentina;Canada;Estonia;Hungary;Lithuania;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3041

NCT00550043
(ClinicalTrials.gov)

October 2007

24/10/2007

A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

A Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: INCB018424;Drug: Placebo

Incyte Corporation

NULL

Completed

18 Years

70 Years

All

Phase 2

United States;Poland

3042

NCT00525213
(ClinicalTrials.gov)

October 2007

4/9/2007

Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Methotrexate

Rheumatoid Arthritis

Drug: Rob 803;Drug: Placebo

OxyPharma

NULL

Completed

18 Years

N/A

Both

224

Phase 2

Belgium;Bulgaria;Georgia;Latvia;Lithuania;Poland;Romania;Serbia;Sweden;United Kingdom;Former Serbia and Montenegro

3043

NCT00595517
(ClinicalTrials.gov)

October 2007

7/1/2008

Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

Gastric Ulcer;Duodenal Ulcer;Rheumatoid Arthritis;Osteoarthritis;Lumbago

Drug: Esomeprazole 20 mg

AstraZeneca

NULL

Completed

20 Years

N/A

All

395

Phase 3

Japan

3044

NCT00554606
(ClinicalTrials.gov)

October 2007

5/11/2007

Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis

A 54-week, Phase II, Multi-center, Open-label Extension Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1B Monoclonal Antibody) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ACZ885

Novartis

NULL

Completed

18 Years

75 Years

All

115

Phase 2

United States;Belgium;Germany;Italy;Netherlands;Russian Federation;Spain;Switzerland;Turkey

3045

EUCTR2007-001984-31-IT
(EUCTR)

28/09/2007

17/12/2007

A PHASE 2 RANDOMIZED, MULTICENTER, ACTIVE COMPARATOR-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF COADMINISTRATION OF CP-690,550 AND MYCOPHENOLATE MOFETIL / MYCOPHENOLATE SODIUM IN DE NOVO KIDNEY ALLOGRAFT RECIPIENTS - ND

CP-690,550 is an immunosuppressive agent being developed for the prevention of kidney allograft rejection, and for the treatment of rheumatoid arthritis as a disease-modifying anti-rheumatic drug.
MedDRA version: 9.1;Level: LLT;Classification code 10023439;Term: Kidney transplant rejection

Product Name: CP -690,550
Product Name: CP -690,550
Trade Name: SANDIMMUN NEORAL*50CPS 25MG
INN or Proposed INN: Ciclosporin
Trade Name: SANDIMMUN NEORAL*30CPS 100MG
INN or Proposed INN: Ciclosporin

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Portugal;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3046

EUCTR2007-002951-18-IT
(EUCTR)

28/09/2007

05/10/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: HLT;Classification code 10039078;Term: Rheumatoid arthropathies

Product Name: Ofatumumab
Product Code: HuMax-CD20

Genmab A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

236

Phase 3

Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden

3047

EUCTR2006-005147-28-GB
(EUCTR)

25/09/2007

18/12/2008

MTX-IR Phase III

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.

Rheumatoid Arthritis (RA)
MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

France;Greece;Spain;Belgium;Austria;Germany;United Kingdom

3048

EUCTR2007-001585-33-NL
(EUCTR)

20/09/2007

09/08/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Latvia;Netherlands

3049

EUCTR2006-003768-67-AT
(EUCTR)

20/09/2007

26/04/2007

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany;United Kingdom;Netherlands;Spain;Austria;Sweden

3050

EUCTR2007-004694-26-BE
(EUCTR)

17/09/2007

10/09/2007

A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA

Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: REMICADE® (Infliximab)
Product Code: -

Saint-Luc Universitary Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3051

EUCTR2006-006127-40-GB
(EUCTR)

16/09/2007

07/12/2006

Cerebral Blood Flow following TNF-alpha Antagonism in Rheumatoid Arthritis - a Pilot Study - TNF/CBF in RA

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
Product Name: Humira 40mg solution for injection in pre-filled syringe (adalimumab)
INN or Proposed INN: recombinant human monoclonal antibody

Newcastle-upon-Tyne Hospitals NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

3052

EUCTR2007-001665-15-ES
(EUCTR)

14/09/2007

27/06/2007

Estudio de extensión abierto, multicéntrico, de fase II, de 54 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide.

Artritis Reumatoide
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance

Novartis Farmaceutica S.A.

NULL

Not Recruiting

Female: yes
Male: yes

179

Belgium;Spain;Netherlands;Germany;Italy

3053

EUCTR2007-002752-42-FR
(EUCTR)

13/09/2007

23/07/2007

FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIR

Polyarthrite rhumatoïde
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade ®
INN or Proposed INN: INFLIXIMAB

CHRU de Tours

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

3054

EUCTR2006-004834-33-GB
(EUCTR)

13/09/2007

14/06/2007

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: Rob 803 6.5mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Code: Rob 803 12.5mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Code: Rob 803 15mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline
Product Code: Rob 803 25mg capsule
Other descriptive name: 9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxaline

OxyPharma AB

NULL

Not Recruiting

Female: yes
Male: yes

224

Phase 2

Poland;Belgium;Lithuania;Bulgaria;Latvia;United Kingdom

3055

EUCTR2007-002950-42-LT
(EUCTR)

13/09/2007

31/07/2007

A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy - Investigating clinical efficacy of ofatumumab in RA patients who had an inadequate response to MTX

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

248

Phase 3

Hungary;United Kingdom;Czech Republic;Spain;Poland;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3056

EUCTR2006-004140-23-FI
(EUCTR)

13/09/2007

23/05/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono Int, a branch of Laboratoires Serono SA, an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Portugal;Finland;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden

3057

EUCTR2006-005036-24-HU
(EUCTR)

11/09/2007

05/07/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

483

Phase 2B

Hungary;Czech Republic;Bulgaria;Sweden

3058

EUCTR2006-005147-28-GR
(EUCTR)

11/09/2007

04/05/2007

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.

Rheumatoid Arthritis (RA) Lower Lever Term (LLT) code number 10039073

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

United Kingdom;Germany;France;Spain;Greece;Austria

3059

EUCTR2006-005330-20-SK
(EUCTR)

07/09/2007

10/04/2008

Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

France;Czech Republic;Hungary;Slovenia;Slovakia;Spain;Belgium;Netherlands;Germany;Italy;Sweden

3060

EUCTR2007-002976-32-NL
(EUCTR)

06/09/2007

30/08/2007

COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis.

Patients with early rheumatoid arthritis wil be treated with a combination therapy: COBRA according to BEST or a modified COBRA schedule (COBRA-light).

Trade Name: Prednisone
Trade Name: Methotrexate
Trade Name: Sulphasalazine

TIPharma

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3061

NCT00539760
(ClinicalTrials.gov)

September 5, 2007

4/10/2007

A Phase I Rheumatoid Arthritis Study in Healthy Volunteers

A Phase I, Randomized, Observer- and Subject-Blind, Placebo-Controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK1827771 in Healthy Volunteers

Arthritis, Rheumatoid

Drug: GSK1827771;Drug: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

55 Years

All

Phase 1

United States

3062

EUCTR2006-004139-31-HU
(EUCTR)

05/09/2007

17/05/2007

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden

3063

EUCTR2007-001665-15-BE
(EUCTR)

05/09/2007

02/08/2007

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

179

Phase 2

Spain;Belgium;Netherlands;Germany;Italy

3064

EUCTR2006-005640-81-GB
(EUCTR)

04/09/2007

27/07/2007

A PLACEBO CONTROLLED STUDY OF THE EFFECT OF EXTENDED TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: - EXXTRA

Rheumatoid arthritis

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United Kingdom

3065

EUCTR2006-003698-29-LV
(EUCTR)

03/09/2007

04/09/2007

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3066

NCT00550446
(ClinicalTrials.gov)

September 2007

25/10/2007

A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Adalimumab;Drug: CP -690-550;Drug: CP -690,550;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

386

Phase 2

United States;Brazil;Bulgaria;Chile;Croatia;Czech Republic;Germany;Greece;Hungary;Italy;Korea, Republic of;Mexico;Romania;Slovakia;Ukraine

3067

NCT00411424
(ClinicalTrials.gov)

September 2007

12/12/2006

Safety, Tolerability and Efficacy Study of the New Medication ASK8007 to Treat Patients With Rheumatoid Arthritis

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of ASK8007 in Comparison With Placebo in Patients With Active Rheumatoid Arthritis - a Randomized, Double Blind, Placebo-controlled, Combined Single Dose Escalation and Multiple Dose Study

Rheumatoid Arthritis

Drug: ASK8007;Drug: Placebo

Astellas Pharma Inc

NULL

Completed

18 Years

N/A

Both

Phase 1;Phase 2

Belgium;Hungary;Ireland;Netherlands;Spain;United Kingdom;France

3068

NCT00613106
(ClinicalTrials.gov)

September 2007

28/1/2008

Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)

Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)

Osteoarthritis;Rheumatoid Arthritis;Chronic Low Back Pain;Chronic Regional Pain Syndrome;Chronic Soft Tissue Pain

Drug: HZT-501;Drug: Ibuprofen

Horizon Pharma Ireland, Ltd., Dublin Ireland

NULL

Completed

40 Years

81 Years

All

179

Phase 3

United States

3069

EUCTR2006-003054-26-CZ
(EUCTR)

31/08/2007

06/08/2007

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: TAK-783

Takeda Global R&D (Europe) Ltd

NULL

Not Recruiting

Female: yes
Male: yes

230

Hungary;Czech Republic;Latvia

3070

EUCTR2006-004139-31-DE
(EUCTR)

30/08/2007

24/04/2007

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Czech Republic;United Kingdom;Germany;Netherlands;France;Spain;Greece;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3071

EUCTR2006-005330-20-SI
(EUCTR)

30/08/2007

22/06/2007

anti-TNF-IR phase III

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3A

France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden

3072

EUCTR2006-005036-24-CZ
(EUCTR)

27/08/2007

04/07/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

483

Phase 2B

Hungary;Czech Republic;Bulgaria;Sweden

3073

EUCTR2006-004834-33-BE
(EUCTR)

25/08/2007

21/06/2007

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

OxyPharma AB

NULL

Not Recruiting

Female: yes
Male: yes

224

Phase 2

Poland;Belgium;Bulgaria;Latvia;United Kingdom

3074

EUCTR2007-001420-12-BE
(EUCTR)

23/08/2007

09/07/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2b

France;Czech Republic;Poland;Belgium;Sweden

3075

EUCTR2007-001585-33-CZ
(EUCTR)

22/08/2007

04/09/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

France;Estonia;Czech Republic;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3076

EUCTR2007-000734-38-BE
(EUCTR)

17/08/2007

25/06/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: BG9924

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Belgium;United Kingdom

3077

EUCTR2006-005330-20-NL
(EUCTR)

15/08/2007

13/06/2007

Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

France;Hungary;Slovenia;Spain;Belgium;Germany;Netherlands;Italy;Sweden

3078

EUCTR2006-003698-29-IE
(EUCTR)

08/08/2007

12/01/2007

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Estonia;France;Ireland;Italy;Latvia;Austria;Sweden;Hungary;United Kingdom;Czech Republic;Netherlands

3079

EUCTR2006-004139-31-CZ
(EUCTR)

08/08/2007

15/02/2007

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Germany;United Kingdom;Czech Republic;Netherlands;France;Spain;Greece;Austria;Sweden

3080

EUCTR2007-001754-11-IT
(EUCTR)

03/08/2007

02/07/2007

Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Mabthera
INN or Proposed INN: Rituximab

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3081

NCT00517543
(ClinicalTrials.gov)

August 2007

16/8/2007

A Study to Examine the Effect of Particle Size on Bioequivalence and Bioavailability

A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553

Chronic Obstructive Pulmonary Disease (COPD);Rheumatoid Arthritis;Atherosclerosis

Drug: GW856553

GlaxoSmithKline

NULL

Completed

18 Years

60 Years

Both

Phase 1

United States

3082

NCT00597818
(ClinicalTrials.gov)

August 2007

10/1/2008

Cobiprostone Prevention of NSAID-induced Gastroduodenal Injury

A Multi-center, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone for the Prevention of NSAID-induced Gastroduodenal Injury in Patients With Osteoarthritis and/or Rheumatoid Arthritis Patients

NSAID-induced Gastroduodenal Injury;Ulcers;Rheumatoid Arthritis;Osteoarthritis

Drug: Cobiprostone;Drug: Placebo;Drug: Non-steroidal anti-inflammatory drug

Sucampo Pharma Americas, LLC

NULL

Completed

40 Years

70 Years

All

121

Phase 2

United States

3083

NCT00538902
(ClinicalTrials.gov)

August 2007

1/10/2007

Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

A Multi-center Randomized, Phase 2/3, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Safety and Efficacy of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Rheumatoid Arthritis

Biological: Placebo;Biological: Adalimumab 80 mg;Biological: Adalimumab 40 mg

Abbott

NULL

Completed

18 Years

N/A

All

302

Phase 2;Phase 3

China

3084

NCT03414502
(ClinicalTrials.gov)

August 2007

2/1/2014

Treatment of Rheumatoid Arthritis With Methotrexate: Predictors of Response

Rheumatoid Arthritis

Drug: Methotrexate

University of Nebraska

NULL

Recruiting

19 Years

N/A

All

300

Phase 3

United States

3085

NCT00542789
(ClinicalTrials.gov)

August 2007

11/10/2007

Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

Gastric Ulcer;Duodenal Ulcer;Rheumatoid Arthritis;Osteoarthritis;Lumbago

Drug: Esomeprazole;Drug: Placebo

AstraZeneca

NULL

Completed

20 Years

N/A

All

343

Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3086

NCT00505089
(ClinicalTrials.gov)

August 2007

19/7/2007

Efficacy and Safety of Subcutaneous Versus Intravenous ACZ885 in Adult Patients With Established Rheumatoid Arthritis

An Exploratory, Open Label Pharmacokinetic - Pharmacodynamic Study to Compare Subcutaneous Versus Intravenous Administration of ACZ885 in Adult Patients With Established Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ACZ885

Novartis

NULL

Terminated

18 Years

75 Years

Both

Phase 1;Phase 2

Belgium;Germany;Netherlands;Poland

3087

NCT00550355
(ClinicalTrials.gov)

August 2007

25/10/2007

Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis

A Randomized, Subject and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PD-0360324 in Patients With Rheumatoid Arthritis Receiving Methotrexate

Arthritis, Rheumatoid

Drug: PD 0360324;Drug: Placebo

Pfizer

NULL

Completed

21 Years

70 Years

Both

Phase 1

United States;Argentina;Bulgaria;Czech Republic;Mexico;Poland;Slovakia;Spain

3088

NCT00520572
(ClinicalTrials.gov)

August 2007

22/8/2007

A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

A Randomised, Double-Blind (With Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or Sulphasalazine

Rheumatoid Arthritis

Drug: AZD9056;Drug: Etanercept;Drug: Placebo

AstraZeneca

NULL

Completed

18 Years

N/A

All

385

Phase 2

United States;Argentina;Australia;Belgium;Canada;Czech Republic;France;Mexico;Poland;Romania;Russian Federation;Slovakia;Hungary;Sweden

3089

NCT00760968
(ClinicalTrials.gov)

August 2007

24/9/2008

Efficacy and Safety of TAK-783 in Subjects With Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Evaluate the Safety and Efficacy of Oral TAK-783 in the Treatment of the Signs and Symptoms in Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: TAK-783 and methotrexate;Drug: Methotrexate

Takeda

NULL

Completed

18 Years

N/A

Both

224

Phase 2

Czech Republic;Latvia;Romania;Russian Federation;Slovakia;Ukraine

3090

NCT00523328
(ClinicalTrials.gov)

August 2007

17/8/2007

BG9924 in Combination With Methotrexate Extension of Study 104RA203

An Open-Label Extension Study to Evaluate the Safety and Efficacy of BG9924 When Given in Combination With Methotrexate to Subjects With Rheumatoid Arthritis Who Previously Participated in Study 104RA203

Rheumatoid Arthritis

Drug: BG9924

Biogen Idec

NULL

Terminated

18 Years

75 Years

Both

Phase 2

United States;Belgium;Canada;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3091

EUCTR2007-001585-33-LV
(EUCTR)

26/07/2007

30/07/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

3092

EUCTR2006-004834-33-LV
(EUCTR)

26/07/2007

08/06/2007

Rheumatiod Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Rob 803
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali

OxyPharma AB

NULL

Not Recruiting

Female: yes
Male: yes

224

Phase 2

United Kingdom;Bulgaria;Latvia;Poland

3093

EUCTR2006-005147-28-DE
(EUCTR)

25/07/2007

05/02/2007

MTX-IR Phase III

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.

Rheumatoid Arthritis (RA)
MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

France;Greece;Spain;Belgium;Austria;Germany;United Kingdom

3094

NCT00502840
(ClinicalTrials.gov)

July 23, 2007

17/7/2007

A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070).

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

All

193

Phase 3

Germany

3095

EUCTR2006-003698-29-AT
(EUCTR)

18/07/2007

16/08/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3096

EUCTR2006-005330-20-DE
(EUCTR)

18/07/2007

09/03/2007

anti TNF-IR phase III

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3A

France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden

3097

EUCTR2007-000886-40-CZ
(EUCTR)

17/07/2007

30/05/2007

Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER

Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE
Trade Name: ARAVA®
INN or Proposed INN: LEFLUNOMIDE

sanofi-aventis groupe

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

Portugal;Czech Republic;Italy

3098

EUCTR2006-004666-14-DE
(EUCTR)

17/07/2007

02/04/2007

An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany

3099

EUCTR2006-003698-29-HU
(EUCTR)

16/07/2007

29/05/2007

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

700

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

3100

EUCTR2006-005330-20-FR
(EUCTR)

16/07/2007

26/03/2007

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-a therapy.

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

France;Czech Republic;Hungary;Slovakia;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3101

EUCTR2006-005035-19-SK
(EUCTR)

10/07/2007

09/04/2008

A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Product Name: CP -690,550
Product Code: CP -690,550 -10
Product Name: CP -690,550
Product Code: CP -690,550 -10

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 2;Phase 3

United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden

3102

EUCTR2006-004140-23-PT
(EUCTR)

09/07/2007

05/03/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden

3103

EUCTR2005-001889-13-DE
(EUCTR)

09/07/2007

21/12/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3

Adult subjects with a diagnosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab

Schering-Plough Research Institute (SPRI)

NULL

Not Recruiting

Female: yes
Male: yes

315

Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden

3104

EUCTR2006-004834-33-LT
(EUCTR)

05/07/2007

05/06/2007

Rheumatiod Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Rob 803
Product Code: Rob 803 6.25mg capsule
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803
Product Code: Rob 803 12.5mg capsule
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803
Product Code: Rob 803 15mg capsule
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali
Product Name: Rob 803
Product Code: Rob 803 25mg capsule
Other descriptive name: Rob 803 (9-Chloro-2,3-dimethyl-6-(N,N-dimethylaminoethylamino-2-oxoethyl)-6H-indolo[2,3-b] quinoxali

OxyPharma AB

NULL

Not Recruiting

Female: yes
Male: yes

224

Phase 2

Poland;Belgium;Lithuania;Bulgaria;Latvia;United Kingdom

3105

EUCTR2006-004140-23-GR
(EUCTR)

03/07/2007

04/04/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

288

Phase 2

Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3106

ChiCTR-TRC-09000377

2007-07-01

2009-04-16

Multicentered Clinical Evaluation Studies on Treating Active Rheumatoid Arthritis by the Method of Clearing Heat and Promoting Blood Flow

rheumatoid arthritis

Group of MTX:Methotrexate Tablets: 10mg 1/w ;Group of Both MTX and Herbs:The Formula of Clearing Away Damp-heat and Promoting Blood Flow: 200ml bid; Methotrexate Tablets: 10mg 1/w ;Group of Herbs:The Formula of Clearing Away Damp-heat and Promoting Blood Flow: 200ml bid ;

China Academy of Chinese Medical Science Guang'an Men Hospital

NULL

Completed

Both

Group of MTX:76;Group of Both MTX and Herbs:77;Group of Herbs:77;

China

3107

NCT00664716
(ClinicalTrials.gov)

July 2007

21/4/2008

Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Patients

Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.

Rheumatoid Arthritis

Biological: Placebo;Biological: baminercept alfa;Biological: Baminercept alfa

Biogen Idec

NULL

Completed

18 Years

75 Years

Both

391

Phase 2

Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom

3108

NCT00503139
(ClinicalTrials.gov)

July 2007

16/7/2007

Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan

Enbrel Special Use Result Surveillance

Rheumatoid Arthritis

Drug: Enbrel (etanercept)

Pfizer

NULL

Completed

10 Years

N/A

All

684

Japan

3109

NCT00555230
(ClinicalTrials.gov)

July 2007

7/11/2007

Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis

Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rosuvastatin;Drug: Placebo

Chinese University of Hong Kong

NULL

Completed

18 Years

75 Years

Both

150

Phase 2

China

3110

NCT00504777
(ClinicalTrials.gov)

July 2007

19/7/2007

A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Taiwan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3111

EUCTR2006-006746-33-DE
(EUCTR)

28/06/2007

12/03/2007

Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR

Rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

Roche Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

240

Germany

3112

EUCTR2006-005466-39-HU
(EUCTR)

25/06/2007

22/03/2007

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: BG9924

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2b

Hungary;United Kingdom

3113

EUCTR2007-000491-16-BE
(EUCTR)

22/06/2007

04/05/2007

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Spain;Belgium;Austria;Germany

3114

EUCTR2007-000760-24-CZ
(EUCTR)

21/06/2007

09/05/2007

Patients with active rheumatoid arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SSR150106XB
Product Code: SSR150106XB
INN or Proposed INN: NA
Other descriptive name: NA

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic

3115

EUCTR2006-001553-10-DE
(EUCTR)

19/06/2007

21/02/2007

A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204

Early Rheumatoid Arthritis in adults
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ACZ885
Product Code: ACZ885
Trade Name: Methotrexat 2,5 mg Tabletten medac
Product Name: Methotrexate (MTX)
INN or Proposed INN: Methotrexate
Other descriptive name: MTX

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;Netherlands;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3116

EUCTR2006-005137-38-FR
(EUCTR)

19/06/2007

10/04/2007

Rheumatoid Arthritis
MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:

Trade Name: Enbrel
Product Name: Enbrel Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Enbrel Auto Injector
Product Code: Auto Injector
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

724

Finland;Germany;United Kingdom;Denmark;France;Sweden

3117

EUCTR2006-005137-38-FI
(EUCTR)

18/06/2007

15/05/2007

Rheumatoid Arthritis
MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:

Trade Name: Enbrel
Product Name: Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Enbrel Auto Injector
Product Code: Auto Injector
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

534

Finland;Germany;United Kingdom;Denmark;France;Sweden

3118

EUCTR2007-000491-16-DE
(EUCTR)

08/06/2007

22/03/2007

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

200

Germany;Spain;Austria

3119

EUCTR2006-005330-20-BE
(EUCTR)

07/06/2007

28/02/2007

anti TNF-IR phase III

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3A

Hungary;Germany;Netherlands;Slovenia;Belgium;France;Spain;Italy;Sweden

3120

EUCTR2006-004140-23-CZ
(EUCTR)

06/06/2007

18/12/2006

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3121

EUCTR2006-004140-23-SE
(EUCTR)

04/06/2007

03/05/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono Int, a branch ofLaboratories Serono S.A. an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden

3122

EUCTR2006-004666-14-BE
(EUCTR)

04/06/2007

29/03/2007

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Belgium;Germany

3123

EUCTR2006-003054-26-LV
(EUCTR)

01/06/2007

12/09/2007

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: TAK-783

Takeda Global R&D (Europe) Ltd

NULL

Not Recruiting

Female: yes
Male: yes

230

Hungary;Czech Republic;Latvia

3124

EUCTR2006-005330-20-HU
(EUCTR)

01/06/2007

10/04/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden

3125

EUCTR2006-005035-19-IT
(EUCTR)

01/06/2007

04/07/2007

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550, A MODERATELY SELECTIVE JANUS-KINASE-3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS - ND

Relief of signs and symptoms, improvement of physical function, and structure preservation in rheumatoid arthritis RA .
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Product Name: CP -690,550

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2

Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3126

EUCTR2006-003768-67-GB
(EUCTR)

01/06/2007

12/02/2007

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden

3127

NCT00462345
(ClinicalTrials.gov)

June 2007

18/4/2007

A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.

An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies

Rheumatoid Arthritis

Drug: rituximab;Drug: Methotrexate;Drug: Corticosteroid or NSAID;Dietary Supplement: Folate

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

Phase 4

Korea, Republic of

3128

NCT00491933
(ClinicalTrials.gov)

June 2007

25/6/2007

Quantiferon-TB Gold in the Assessment of Latent TB in Patients Candidate to Treatment or Treated With TNFa Antagonists

Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in the Assessment of Latent Mycobacterium Tuberculosis Infection in Patients Candidate to Treatment or Treated With TNFa Antagonists

Rheumatoid Arthritis;Spondylarthritis;Tuberculosis

Procedure: Quantiferon-TB Gold assay;Procedure: Tuberculin skin test

Ospedale L. Sacco – Polo Universitario

NULL

Recruiting

18 Years

80 Years

Both

100

N/A

Italy

3129

NCT00422227
(ClinicalTrials.gov)

June 2007

11/1/2007

Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

70 Years

All

300

Phase 4

Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand

3130

NCT00896168
(ClinicalTrials.gov)

June 2007

7/5/2009

An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis

A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Infliximab;Drug: Methotrexate

Xian-Janssen Pharmaceutical Ltd.

NULL

Completed

18 Years

65 Years

All

234

Phase 4

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3131

NCT00650156
(ClinicalTrials.gov)

June 2007

28/3/2008

Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis

A Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.

Rheumatoid Arthritis

Biological: adalimumab

AbbVie

NULL

Completed

18 Years

N/A

All

Phase 1

China

3132

EUCTR2006-004140-23-DE
(EUCTR)

31/05/2007

14/08/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono Int, a branch of Laboratoires Seron SA an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Portugal;Greece;Finland;Spain;Belgium;Bulgaria;Netherlands;Germany;United Kingdom;Italy;Sweden

3133

EUCTR2006-005137-38-SE
(EUCTR)

29/05/2007

30/04/2007

Rheumatoid Arthritis
MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:

Trade Name: Enbrel
Product Name: Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Enbrel Auto Injector
Product Code: Auto Injector
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

534

Finland;Germany;United Kingdom;Denmark;France;Sweden

3134

EUCTR2006-005147-28-BE
(EUCTR)

24/05/2007

21/02/2007

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.

Rheumatoid Arthritis (RA)

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

France;Greece;Spain;Belgium;Austria;Germany;United Kingdom

3135

EUCTR2007-000082-38-DK
(EUCTR)

24/05/2007

26/03/2007

The OPERA Study. Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. - The OPERA Study

In early RA methotrexate and intra-articular glucocorticoid in combination with adalimumab is better than methotrexate and intra-articular glucocorticoid in achieving control of the disease as assessed by DAS28 < 3.2.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira (adalimumab)
Product Name: Humira® (adalimumab)
Product Code: 2593
INN or Proposed INN: Adalimumab

Aarhus University Hospital, Denmark

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 4

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3136

EUCTR2006-001553-10-NL
(EUCTR)

23/05/2007

02/04/2007

Early Rheumatoid Arthritis in adults
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: ACZ885 Drug Substance
Other descriptive name: ACZ885 Drug Substance

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;Netherlands;Italy

3137

EUCTR2006-005036-24-SK
(EUCTR)

21/05/2007

03/04/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Ltd - Ramsgate Road, Sandwich CT139NJ, UK.

NULL

Not Recruiting

Female: yes
Male: yes

483

Phase 2

Hungary;Czech Republic;Slovakia;Bulgaria;Sweden

3138

EUCTR2006-003768-67-NL
(EUCTR)

16/05/2007

27/03/2007

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany;United Kingdom;Netherlands;Spain;Austria;Sweden

3139

EUCTR2007-001190-28-GB
(EUCTR)

09/05/2007

17/04/2007

Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Methotrexate
Product Code: Methotrexate
INN or Proposed INN: METHOTREXATE
Product Name: Sulfasalazine
Product Code: Sulfasalazine
INN or Proposed INN: SULFASALAZINE
Product Name: Hydroxychloroquine
Product Code: Hydroxychloroquine
INN or Proposed INN: Hydroxychloroquine
Product Name: Ciclosporin
Product Code: Ciclosporin
INN or Proposed INN: Ciclosporin
Product Name: Leflunomide
Product Code: Leflunomide
INN or Proposed INN: Leflunomide
Product Name: Sodium aurothiomalate (intramuscular gold)
Product Code: Sodium aurothiomalate (intramuscular gold)
INN or Proposed INN: Sodium aurothiomalate
Product Name: methylprednisolone
Product Code: methylprednisolone
INN or Proposed INN: Methylprednisolone
Product Name: Prednisolone
Product Code: Predniso

King's College London

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 4

United Kingdom

3140

EUCTR2006-005467-26-BE
(EUCTR)

08/05/2007

14/02/2007

A phase 2b, randomised, double-blind, placebo-controlled, multi-centre, dose-finding study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of BG9924 when given in combination with methotrexate to subjects with active Rheumatoid Arthritis who have had an inadequate response to anti-TNF therapy

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: BG9924

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2b

Belgium;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3141

EUCTR2006-005147-28-FR
(EUCTR)

07/05/2007

06/03/2007

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.

Rheumatoid Arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913/F03
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

United Kingdom;Germany;France;Spain;Greece;Austria

3142

EUCTR2006-005035-19-SE
(EUCTR)

04/05/2007

16/03/2007

A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

4500

Phase 2;Phase 3

United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden

3143

EUCTR2006-005036-24-SE
(EUCTR)

04/05/2007

16/03/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Ltd - Ramsgate Road, Sandwich CT139NJ, UK.

NULL

Not Recruiting

Female: yes
Male: yes

483

Phase 2B

Hungary;Czech Republic;Bulgaria;Sweden

3144

EUCTR2006-006373-25-SE
(EUCTR)

04/05/2007

16/03/2007

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A

Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

3145

EUCTR2006-004139-31-SE
(EUCTR)

02/05/2007

12/02/2007

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3146

NCT00455208
(ClinicalTrials.gov)

May 2007

30/3/2007

A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis

Study Evaluating Cura-100 in Rheumatoid Arthritis and Osteoarthritis

Rheumatoid Arthritis;Osteoarthritis

Drug: Cura-100

Cura Biotech LLC

NULL

Not yet recruiting

20 Years

50 Years

Both

Phase 1;Phase 2

United States

3147

NCT00504595
(ClinicalTrials.gov)

May 2007

19/7/2007

Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis

A 12-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR20) and to Determine a Biomarker Profile in Adult Patients With Established Rheumatoid Arthritis Responding to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) as Compared to Healthy Subjects Exposed to ACZ885

Rheumatoid Arthritis

Drug: ACZ885 (investigational);Drug: Placebo

Novartis

NULL

Completed

18 Years

75 Years

All

Phase 2

Russian Federation;Spain;Switzerland;Turkey

3148

NCT00420199
(ClinicalTrials.gov)

May 2007

8/1/2007

A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

A Phase IIIB Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess Short-term Changes in Synovitis and Structural Damage Outcomes in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate, Treated With Abatacept Versus Placebo on a Background Therapy With Methotrexate

Active Rheumatoid Arthritis

Drug: Abatacept;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

Phase 3

Belgium;Germany;Netherlands;Spain;Sweden;United Kingdom;Austria

3149

NCT00760669
(ClinicalTrials.gov)

May 2007

24/9/2008

An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants

Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients

Spondylitis, Ankylosing;Arthritis, Rheumatoid;Psoriasis;Arthritis, Psoriatic

Drug: Infliximab; observational study;Drug: Methotrexate

Janssen Korea, Ltd., Korea

NULL

Completed

N/A

All

1061

Korea, Republic of

3150

NCT00480272
(ClinicalTrials.gov)

May 2007

29/5/2007

Prospective Study on Intensive Early Rheumatoid Arthritis Treatment

A Phase IV Multicenter, Randomized, Double-blind Study. prospeCtive Study on Intensive Early Rheumatoid Arthritis Treatment With adalimUmab: Induction of REmission and Maintenance

Rheumatoid Arthritis

Drug: adalimumab , plus prednisone;Drug: adalimumab plus placebo

IRCCS Policlinico S. Matteo

NULL

Completed

18 Years

70 Years

All

251

Phase 4

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3151

EUCTR2007-000491-16-ES
(EUCTR)

30/04/2007

05/03/2007

Estudio de extensión abierto de 76 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide activa - not available

Artritis Reumatoide
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance

Novartis Farmacéutica, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Belgium;Spain;Austria;Germany

3152

EUCTR2006-003768-67-BE
(EUCTR)

27/04/2007

23/04/2007

A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007.

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden

3153

EUCTR2006-004140-23-ES
(EUCTR)

24/04/2007

05/03/2007

Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, en fase II para la determinación de la dosis de atacicept, administrado por vía subcutánea, en pacientes con artritis reumatoide y con respuesta insuficiente al tratamiento con antagonistas del TNF - Atacicept en pacientes con AR y fracaso a anti-TNF, Fase II

Pacientes con Artritis Reumatoide.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Serono International S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

288

Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden

3154

EUCTR2006-004139-31-ES
(EUCTR)

23/04/2007

25/01/2007

A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis.Estudio multicéntrico, aleatorizado, doble ciego, en dos periodos, para determinar el protocolo óptimo de inicio del tratamiento combinado de metotrexato y adalimumab en pacientes con Artritis Reumatoide Temprana. - OPTIMA

Rheumatoid Arthritis. Artritis Reumatoide
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden

3155

EUCTR2006-006373-25-SK
(EUCTR)

20/04/2007

03/04/2007

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF cp 690,550 - N/A

Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3156

EUCTR2006-002216-10-NL
(EUCTR)

20/04/2007

02/11/2006

A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: PG -760564
Product Code: PG -760564

Procter & Gamble Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

270

Hungary;United Kingdom;Czech Republic;Netherlands

3157

EUCTR2005-002660-29-HU
(EUCTR)

20/04/2007

08/11/2005

A Phase 1b/2 Multiple-Dose Safety and Pharmacokinetic/Pharmacodynamic Study of LY2189102 in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis

Product Name: Anti IL-1ß antibody
Product Code: LY2189102
Other descriptive name: Anti IL-1ß antibody , subclass IgG4

Eli Lilly and Company Limited

NULL

Not Recruiting

Female: yes
Male: yes

135

Phase 1b;Phase 2

Hungary;Spain

3158

EUCTR2006-005035-19-BE
(EUCTR)

17/04/2007

09/01/2007

A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Rheumatoid arthritis
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

4500

Phase 2;Phase 3

United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden

3159

EUCTR2006-005147-28-AT
(EUCTR)

16/04/2007

23/03/2007

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. - STAGE

Rheumatoid Arthritis (RA)

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

France;Greece;Spain;Belgium;Austria;Germany;United Kingdom

3160

EUCTR2006-005467-26-GB
(EUCTR)

12/04/2007

16/01/2007

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapy

Rheumatoid Arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Belgium;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3161

EUCTR2006-005466-39-GB
(EUCTR)

12/04/2007

07/01/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2

Hungary;United Kingdom

3162

EUCTR2006-004140-23-BE
(EUCTR)

10/04/2007

07/02/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden

3163

EUCTR2006-004669-32-ES
(EUCTR)

09/04/2007

06/02/2007

Estudio multicéntrico, de fase II, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de duración, para evaluar la respuesta al tratamiento (ACR20) y para determinar un perfil de biomarcadores en pacientes adultos con artritis reumatoide establecida respondedores a ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) comparado con sujetos sanos expuestos a ACZ885 - not available

Artritis reumatoide establecida
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: ACZ885
INN or Proposed INN: Canakinumab (proposed)
Other descriptive name: ACZ885 Drug Substance

Novartis Farmacéutica S.A

NULL

Not Recruiting

Female: yes
Male: yes

Spain

3164

EUCTR2006-004139-31-BE
(EUCTR)

03/04/2007

19/12/2006

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden

3165

EUCTR2006-004140-23-SK
(EUCTR)

02/04/2007

19/01/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Portugal;Slovakia;Greece;Finland;Spain;Italy;United Kingdom;Czech Republic;Belgium;Bulgaria;Netherlands;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3166

EUCTR2005-003558-83-EE
(EUCTR)

02/04/2007

07/02/2007

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden

3167

NCT00484237
(ClinicalTrials.gov)

April 2007

7/6/2007

A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis

A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: etanercept

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

20 Years

75 Years

Both

Phase 3

Japan

3168

NCT00414661
(ClinicalTrials.gov)

April 2007

19/12/2006

Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550

A Prospective Observational Study To Evaluate Long-Term Safety And Functional Status Of Subjects With Rheumatoid Arthritis Previously Enrolled In Studies Of CP-690,550

Arthritis, Rheumatoid

Drug: CP -690,550

Pfizer

NULL

Completed

18 Years

N/A

All

162

N/A

United States;Argentina;Brazil;Bulgaria;Canada;Chile;Czech Republic;Dominican Republic;Finland;Greece;Hungary;India;Italy;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Slovakia;Spain;Ukraine;Australia;Austria;Belgium;Costa Rica;Romania;Sweden

3169

NCT00989235
(ClinicalTrials.gov)

April 2007

2/10/2009

Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis

A Phase 3B, Multi-Center, Randomized, Double-blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate-naïve Early Erosive Rheumatoid Arthritis Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate - Low Dose Sub-Study

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

108

Phase 3

NULL

3170

NCT00409838
(ClinicalTrials.gov)

April 2007

8/12/2006

A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept Administered Intravenously in Korean Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

Rheumatoid Arthritis

Drug: Abatacept;Drug: Methotrexate;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

113

Phase 3

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3171

NCT00446784
(ClinicalTrials.gov)

April 2007

9/3/2007

Study Of The Safety Of CE 224,545 And Methotrexate In Patients With Rheumatoid Arthritis

A Phase 1, Double Blind Study Of The Safety And Pharmacokinetics Of Multiple Doses Of CE 224,535 In Subjects With Rheumatoid Arthritis Receiving Methotrexate

Arthritis, Rheumatoid

Drug: CE-224,535;Drug: Methotrexate

Pfizer

NULL

Completed

18 Years

N/A

Both

Phase 1

United States

3172

EUCTR2006-005035-19-ES
(EUCTR)

26/03/2007

23/01/2007

ESTUDIO ABIERTO DE SEGUIMIENTO A LARGO PLAZO DE CP-690,550, UN INHIBIDOR DE LA JANUS QUINASA 3 MODERADAMENTE SELECTIVO, PARA EL TRATAMIENTO DE LA ARTRITIS REUMATOIDEA LONG TERM, OPEN LABEL FOLLOW UP STUDY OF CP 690,550, A MODERATELY SELECTIVE JANUS KINASE 3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS. - N/A

Artritis reumatoide (AR)Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550
Other descriptive name: (3R,4R)-4-metil-3-(metil-1H-pirrolo [2,3-d]pirimidin-4-ilamino)-ß-oxo-1-
Product Name: CP -690,550
Other descriptive name: (3R,4R)-4-metil-3-(metil-1H-pirrolo [2,3-d]pirimidin-4-ilamino)-ß-oxo-1-

Pfizer S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2

Slovakia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Sweden

3173

EUCTR2006-003768-67-SE
(EUCTR)

23/03/2007

07/02/2007

A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007.

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany;United Kingdom;Netherlands;Spain;Austria;Sweden

3174

EUCTR2006-006373-25-ES
(EUCTR)

23/03/2007

24/01/2007

ESTUDIO OBSERVACIONAL PROSPECTIVO PARA EVALUAR LA SEGURIDAD A LARGO PLAZO Y EL ESTADO FUNCIONAL DE SUJETOS CON ARTRITIS REUMATOIDE INCLUIDOS PREVIAMENTE EN ESTUDIOS DE CP-690,550A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A

CP-690,550 se está desarrollando como fármaco antirreumático modificador de la enfermedad (FARME) para el tratamiento de la artritis reumatoide (AR).CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CP -690,550

Pfizer, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

3175

EUCTR2006-001553-10-BE
(EUCTR)

20/03/2007

21/02/2007

Early Rheumatoid Arthritis in adults
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Netherlands;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3176

EUCTR2006-003768-67-DE
(EUCTR)

19/03/2007

19/02/2007

A Phase III Multicenter, Randomized, Double-Blind, placebo-controlled Study to Assess short-term changes in synovitis and structural damage outcomes in subjects with active Rheumatoid Arthritis and inadequate response to Methotrexate, Treated with Abatacept versus Placebo on a Background Therapy with MethotrexateRevised Protocol 03, incorporating Protocol Amendment 01 (Version 1.0, Date 16-May-2007), Protocol Amendment 03 (Version 1.0, Date 19-Mar-2008), Protocol Amendment 04 (Version 1.0, Date 05-Dec-2008), and Administrative Letter dated 13-Jun-2007. And Protocol Amemdment 02 - Site specific (Version 1.0, Dated 16-May-2007)

RHEUMATOID ARTHRITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United Kingdom;Germany;Netherlands;Spain;Austria;Sweden

3177

EUCTR2006-004139-31-FR
(EUCTR)

12/03/2007

12/02/2007

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden

3178

EUCTR2006-004140-23-BG
(EUCTR)

09/03/2007

01/03/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Serono International S.A.

NULL

Not Recruiting

Female: yes
Male: yes

288

Phase 2

Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden

3179

EUCTR2006-003146-41-DE
(EUCTR)

08/03/2007

23/11/2006

A CONTROLLED RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY COMPARING TWO THERAPY STRATEGIES IN DMARD-NAIVE EARLY RHEUMATOID ARTHRITIS PATIENTS OVER 48 WEEKS: INDUCTION THERAPY WITH ADALIMUMAB AND METHOTREXATE OVER 24 WEEKS FOLLOWED BY METHOTREXATE MONOTHERAPY UP TO WEEK 48 VS. METHOTREXATE MONOTHERAPY - HIT HARD

Musculoskeletal disorders
MedDRA version: 8.1;Level: LLT;Classification code 10048592;Term: Musculoskeletal disorder

Trade Name: Humira
Product Name: HUMIRA
INN or Proposed INN: Adalimumab
Trade Name: Metex
Product Name: Metex

Charité-Universitätsmedizin Berlin; Department of Rheumatology and Clinical Immunology

NULL

Not Recruiting

Female: yes
Male: yes

Germany

3180

EUCTR2005-002909-23-PT
(EUCTR)

08/03/2007

03/01/2007

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA

Rheumatoid arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

2420

Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3181

EUCTR2006-004139-31-GB
(EUCTR)

06/03/2007

02/01/2007

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden

3182

EUCTR2005-003558-83-LV
(EUCTR)

02/03/2007

12/02/2007

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden

3183

NCT04144101
(ClinicalTrials.gov)

March 1, 2007

28/10/2019

Etoricoxib vs Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis

Comparison of Lower Dosage of Etoricoxib Versus Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis: A Single-center, Parallel-group, Randomized Controlled Pilot Study

Rheumatoid Arthritis

Drug: Etoricoxib;Drug: Aceclofenac

Chung Shan Medical University

NULL

Completed

20 Years

80 Years

All

Phase 4

NULL

3184

NCT00487825
(ClinicalTrials.gov)

March 2007

18/6/2007

Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis

A 26-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR50) and to Determine a Biomarker Profile in Responders to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) Plus MTX as Compared to MTX Alone in Early Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: Canakinumab (investigational);Drug: Placebo;Drug: Methotrexate (MTX)

Novartis

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Belgium;Germany;Italy;Netherlands;Spain

3185

NCT00913432
(ClinicalTrials.gov)

March 2007

3/6/2009

Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha

Rheumatoid Arthritis

Drug: masitinib

AB Science

NULL

Completed

18 Years

N/A

All

Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3186

NCT00458861
(ClinicalTrials.gov)

March 2007

22/3/2007

BG9924 in Combination With Methotrexate for Subjects With Active Rheumatoid Arthritis

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, PK, and PD of BG9924 When Given in Combo With MTX to Subjects With Active RA Who Have Had an Inadequate Response to Anti-TNF

Rheumatoid Arthritis

Drug: BG9924;Other: Placebo Comparator

Biogen Idec

NULL

Terminated

18 Years

75 Years

Both

115

Phase 2

United States

3187

EUCTR2006-004140-23-IT
(EUCTR)

26/02/2007

11/04/2007

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATACICEPT
Product Code: TACI - FC5

SERONO INTERNATIONAL SA

NULL

Not Recruiting

Female: yes
Male: yes

288

Phase 2

Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden

3188

EUCTR2006-006380-22-DE
(EUCTR)

22/02/2007

28/12/2006

Biological dosimetry in radiation synovectomy of small finger joints with Erbium [169Er] citrate - ER-MM1 biological dosimetry

Patients with rheumatoid arthritis or seronegative spondylarthropathy with at least one inflamed finger joint (MCP, PIP, DIP) referred for RSO with with Erbium [169Er]citrate
MedDRA version: 8.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: ERMM-1
INN or Proposed INN: erbium citrate

CIS bio international

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

3189

EUCTR2006-006373-25-AT
(EUCTR)

15/02/2007

12/02/2007

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A

Product Name: CP -690,550

Pfizer Ltd, Ramsgate Road, Sandwich CT139NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

300

Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden

3190

EUCTR2006-002216-10-HU
(EUCTR)

15/02/2007

25/10/2006

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: PG -760564
Product Code: PG -760564

Procter & Gamble Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

270

Hungary;United Kingdom;Czech Republic;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3191

EUCTR2006-004139-31-SK
(EUCTR)

15/02/2007

19/01/2007

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 4

Slovakia;Greece;Spain;Austria;United Kingdom;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Norway;Sweden

3192

EUCTR2006-005035-19-AT
(EUCTR)

15/02/2007

12/02/2007

A long term, open label follow up study of Tofacitinib (CP-690,550) for treatment of Rheumatiod Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 2;Phase 3

United States;Philippines;Venezuela, Bolivarian Republic of;Taiwan;Slovakia;Greece;Thailand;Spain;Costa Rica;Ukraine;Ireland;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Dominican Republic;Croatia;Bulgaria;Germany;New Zealand;Sweden

3193

EUCTR2006-001550-27-FI
(EUCTR)

13/02/2007

10/10/2006

A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available

Active Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: N/A
Other descriptive name: N/A

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

260

Finland;Germany;Spain;Austria

3194

EUCTR2006-004139-31-AT
(EUCTR)

13/02/2007

06/02/2007

Rheumatoid Arthritis.
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1000

Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden

3195

EUCTR2006-001550-27-DE
(EUCTR)

13/02/2007

19/10/2006

A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate

Active Rheumatoid Arthritis

Product Name: ACZ885
Product Code: ACZ885

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

293

Finland;Spain;Austria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3196

NCT00413699
(ClinicalTrials.gov)

February 5, 2007

18/12/2006

Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis

A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: CP -690,550

Pfizer

NULL

Completed

18 Years

N/A

All

4488

Phase 3

United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Chile;China;Colombia;Costa Rica;Croatia;Czechia;Denmark;Dominican Republic;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic;United States Minor Outlying Islands

3197

EUCTR2004-002993-49-EE
(EUCTR)

02/02/2007

23/02/2005

A Phase III multicentre, double blind, placebo-controlled, parallel group 52-week study to assess the efficacy and safety of 2 dose regimens of lyophilised CDP870 given subcutaneously as additional medication to methotrexate in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis who have an incomplete response to methotrexate. - CDP870 signs and symptoms and structural damage study

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

3198

EUCTR2005-003558-83-IE
(EUCTR)

01/02/2007

13/03/2006

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)

Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Czech Republic;United Kingdom;Netherlands;Estonia;Spain;Ireland;Italy;Latvia;Austria;Sweden

3199

NCT00461448
(ClinicalTrials.gov)

February 2007

17/4/2007

A Pilot Study of Potassium Supplementation for Adult Patients With Rheumatoid Arthritis

Pilot Study of Potassium Supplementation in the Treatment of Rheumatoid Arthritis: a 4-Week, Randomized, Double-Blind, Placebo-Controlled Trial

Rheumatoid Arthritis

Dietary Supplement: Potassium supplement

Shahid Beheshti Medical University

NULL

Completed

18 Years

60 Years

Both

Phase 1

Iran, Islamic Republic of

3200

NCT00427934
(ClinicalTrials.gov)

February 2007

25/1/2007

Maraviroc in Rheumatoid Arthritis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Maraviroc in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate

Arthritis, Rheumatoid

Drug: Maraviroc;Drug: Maraviroc Placebo

Pfizer

NULL

Terminated

18 Years

N/A

All

128

Phase 2

United States;Australia;Germany;India;Italy;Mexico;Portugal;Spain;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3201

NCT00418717
(ClinicalTrials.gov)

February 2007

2/1/2007

Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA

An Open-label, Multicenter, Dose-regimen Study Evaluating the Efficacy and Safety of Etanercept 50 mg Once-weekly Dose in Japanese Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: etanercept

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

20 Years

75 Years

All

Phase 3

Japan

3202

NCT00458146
(ClinicalTrials.gov)

February 2007

5/4/2007

A Phase 2 Study to Evaluate the Efficacy and Safety of 60mg of MM-093 in Patients With Active Rheumatoid Arthritis

A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 60mg of MM-093 Versus Placebo in Patients With Active Rheumatoid Arthritis on Stable Doses of Methotrexate

Rheumatoid Arthritis

Drug: MM-093

Merrimack Pharmaceuticals

NULL

Completed

18 Years

80 Years

Both

100

Phase 2

United States

3203

EUCTR2006-006186-16-NL
(EUCTR)

30/01/2007

16/07/2007

IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED

rheumatoid arthritis and undifferentiated arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Methotrexate
Product Code: MTX
INN or Proposed INN: METHOTREXATE
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Product Name: Sulfasalazine
INN or Proposed INN: SULFASALAZINE
Trade Name: hydroxychloroquine
Product Name: hydroxychloroquine
Product Code: HCQ
INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE
Trade Name: Humira
Product Name: adalimumab

Leiden University Medical Center, department of rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

3204

EUCTR2006-001553-10-IT
(EUCTR)

26/01/2007

15/05/2007

A 26-week, phase II, multi-center, randomized, doubleblind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - ND

Early rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ACZ885
Product Code: ACZ885

NOVARTIS FARMA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;Netherlands;Italy

3205

EUCTR2006-002216-10-GB
(EUCTR)

22/01/2007

16/02/2012

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Procter & Gamble Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2

Hungary;Czech Republic;Netherlands;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3206

EUCTR2006-003983-73-CZ
(EUCTR)

17/01/2007

22/11/2006

A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients with Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: RWJ-445380 Capsules 50 mg
Product Code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC
Product Name: RWJ-445380 capsule 100 mg
Product Code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC
Product Name: RWJ-445380 capsules 150 mg
Product Code: RWJ-445380-002
Other descriptive name: JNJ-16240159-AAC

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Germany;Czech Republic

3207

EUCTR2006-006275-21-GB
(EUCTR)

10/01/2007

18/10/2011

A Randomised, Pragmatic, Open-label study of Adalimumab versus Etanercept for Rheumatoid Arthritis. - Adalimumab versus Etanercept for RA

Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

University Hospital Birmingham NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 4

United Kingdom

3208

NCT02886689
(ClinicalTrials.gov)

January 2007

29/8/2016

C.O.R.P.U.S.: Observational Cohort of Adult and Child Inflammatory Arthritis in France

C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France

Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Arthitis, Juvenile Idiopathic

Drug: TNF-alpha antagonist and other biotherapy

Central Hospital, Nancy, France

NULL

Completed

3 Years

75 Years

Both

5400

N/A

France

3209

NCT00424502
(ClinicalTrials.gov)

January 2007

18/1/2007

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.

An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Hungary

3210

NCT00413660
(ClinicalTrials.gov)

January 2007

18/12/2006

Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

A Phase 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone

Arthritis, Rheumatoid

Drug: CP -690,550;Other: placebo

Pfizer

NULL

Completed

18 Years

N/A

All

509

Phase 2

United States;Argentina;Brazil;Bulgaria;Chile;Czech Republic;Hungary;Mexico;Poland;Slovakia;Spain;Sweden;Turkey

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3211

EUCTR2005-001889-13-FR
(EUCTR)

27/12/2006

30/11/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3

Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.
MedDRA version: 8.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up

Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 3

Portugal;France;Belgium;Denmark;Austria;Germany;Netherlands;Sweden

3212

EUCTR2006-005386-19-BE
(EUCTR)

19/12/2006

03/11/2006

Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini

Rheumatoid arthritis refractory to TNF blockers patients
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera

Cliniques Universitaires Saint-Luc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

3213

EUCTR2006-003698-29-BE
(EUCTR)

18/12/2006

13/11/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

France;Estonia;Hungary;Czech Republic;Belgium;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden

3214

EUCTR2006-003698-29-GB
(EUCTR)

14/12/2006

29/09/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;Czech Republic;United Kingdom;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

3215

EUCTR2006-004140-23-NL
(EUCTR)

13/12/2006

26/04/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: atacicept
Other descriptive name: TACI-Fc5

Merck Serono Int.a branch of Laboratoires Serono SA an affiliate of Merck KgaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Finland;Portugal;United Kingdom;Germany;Netherlands;Belgium;Bulgaria;Spain;Italy;Greece;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3216

EUCTR2005-003232-21-DE
(EUCTR)

11/12/2006

04/09/2006

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis (RA)

Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

625

Hungary;Germany;Malta;Latvia;Lithuania

3217

EUCTR2005-003232-21-MT
(EUCTR)

07/12/2006

18/01/2007

Rheumatoid Arthritis (RA)

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

625

Hungary;Germany;Malta;Latvia;Lithuania

3218

EUCTR2006-003577-27-EE
(EUCTR)

01/12/2006

29/09/2006

A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOIDARTHRITIS. - na

Treatment of rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Luxembourg SARL Branch Office Estonia

NULL

Not Recruiting

Female: yes
Male: yes

290

Phase 2A

Czech Republic;Estonia;Spain

3219

NCT00425321
(ClinicalTrials.gov)

December 2006

19/1/2007

Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Rheumatoid Arthritis

Drug: RWJ-445380 100 mg;Drug: RWJ-445380 200 mg;Drug: RWJ-445380 300 mg;Drug: Placebo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

NULL

Completed

18 Years

N/A

Both

259

Phase 2

United States;Argentina;Brazil;Czech Republic;Germany;Mexico;Poland

3220

NCT00420927
(ClinicalTrials.gov)

December 2006

9/1/2007

Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis

A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)

Rheumatoid Arthritis

Drug: methotrexate;Biological: placebo;Biological: adalimumab

Abbott

NULL

Completed

18 Years

N/A

All

1032

Phase 4

United States;Argentina;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Mexico;Netherlands;New Zealand;Norway;Poland;Puerto Rico;Slovakia;South Africa;Spain;Sweden;United Kingdom;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3221

NCT00383188
(ClinicalTrials.gov)

December 2006

28/9/2006

An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis

A 12-Week, Phase 2A, Randomized, Double-Blind, Placebo-Controlled Study To Investigate The Safety, Pharmacokinetics, And Efficacy Of PH-797804, Administered Orally Once Daily In Subjects With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: placebo;Drug: PH-797804

Pfizer

NULL

Completed

18 Years

N/A

Both

305

Phase 2

Australia;Brazil;Chile;Czech Republic;Estonia;India;Korea, Republic of;Peru;Poland;Russian Federation;South Africa;Spain

3222

NCT00440492
(ClinicalTrials.gov)

December 2006

23/2/2007

Study To Evaluate The Pharmacokinetic Interaction Between PLA-695 And Methotrexate In Adults With Rheumatoid Arthritis

An Open-Label Study To Evaluate The Potential Pharmacokinetic Interaction Between PLA-695 And Methotrexate When Coadministered Orally To Adult Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: PLA-695

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States;Canada

3223

NCT00484289
(ClinicalTrials.gov)

December 2006

7/6/2007

A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

A Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101-071, IM101-034, and Also Special DMARD Failures

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

20 Years

N/A

All

217

Phase 3

Japan

3224

NCT00392951
(ClinicalTrials.gov)

December 2006

24/10/2006

Sirolimus for Autoimmune Disease of Blood Cells

Sirolimus for Patients With Chronic and/or Refractory Autoimmune Cytopenias: A Pilot Series

Autoimmune Pancytopenia;Autoimmune Lymphoproliferative Syndrome (ALPS);Evans Syndrome;Idiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, Autoimmune;Autoimmune Neutropenia;Lupus Erythematosus, Systemic;Inflammatory Bowel Disease;Rheumatoid Arthritis

Drug: sirolimus

Children's Hospital of Philadelphia

NULL

Completed

1 Year

30 Years

All

Phase 1;Phase 2

United States

3225

EUCTR2006-003142-42-DE
(EUCTR)

30/11/2006

02/02/2007

A Randomized, Double Blind, Placebo-controlled, Proof of Concept Study to evaluate Efficacy, Safety and Pharmacokinetics of two Different Doses of SC12267 (20mg, 35 mg) in Patients with Rheumatoid Arthritis

Active Rheumatoid Arthritis
MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: SC12267

4SC AG

NULL

Not Recruiting

Female: yes
Male: yes

120

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3226

EUCTR2005-003232-21-LT
(EUCTR)

30/11/2006

10/10/2006

Rheumatoid Arthritis (RA)
MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Product Name: Golimumab pre-filled syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

625

Hungary;Germany;Malta;Latvia;Lithuania

3227

EUCTR2006-003577-27-CZ
(EUCTR)

29/11/2006

11/10/2006

Treatment of rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Ltd

NULL

Not Recruiting

Female: yes
Male: yes

290

Phase 2A

Czech Republic;Estonia;Spain

3228

EUCTR2006-002216-10-CZ
(EUCTR)

27/11/2006

12/10/2006

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: PG -760564
Product Code: PG -760564

Procter & Gamble Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

270

Hungary;United Kingdom;Czech Republic;Netherlands

3229

EUCTR2005-003632-22-ES
(EUCTR)

22/11/2006

20/03/2012

A study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with rheumatoid arthritis.

An open-label, exploratory study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with active rheumatoid arthritis

Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

3230

EUCTR2005-003232-21-HU
(EUCTR)

22/11/2006

06/09/2006

Rheumatoid Arthritis (RA)

Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

625

Hungary;Germany;Malta;Latvia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3231

NCT02079532
(ClinicalTrials.gov)

November 2006

4/3/2014

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor

An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent

Rheumatoid Arthritis

Drug: rituximab [MabThera]

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

All

302

Phase 3

Germany

3232

NCT00395577
(ClinicalTrials.gov)

November 2006

1/11/2006

A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 When Administered Concomitantly With Methotrexate

Rheumatoid Arthritis

Drug: VX-702

Vertex Pharmaceuticals Incorporated

NULL

Completed

18 Years

75 Years

Both

120

Phase 2

Bulgaria;Croatia;Former Serbia and Montenegro;Poland;Russian Federation;Slovenia

3233

NCT00424346
(ClinicalTrials.gov)

November 2006

17/1/2007

Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis

A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) With Three Different Dose Regimens in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate Including 76-week and 96-week Extensions

Rheumatoid Arthritis

Drug: Canakinumab;Drug: Placebo

Novartis

NULL

Completed

18 Years

N/A

All

274

Phase 2

United States;Austria;Belgium;Canada;Germany;Spain;Finland

3234

NCT00761514
(ClinicalTrials.gov)

November 2006

25/9/2008

Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira

Evaluation of Quality of Life Changes in Puerto Rican Subjects With Active Rheumatoid Arthritis Treated With Humira as Their First Anti-TNF Monoclonal Antibody (VIVIR)

Rheumatoid Arthritis

Drug: Humira (adalimumab)

Abbott

NULL

Terminated

18 Years

N/A

All

Phase 4

Puerto Rico

3235

NCT00072982
(ClinicalTrials.gov)

November 2006

13/11/2003

Treatment of Rheumatoid Arthritis With Marine and Botanical Oils

Rheumatoid Arthritis

Drug: fish oil;Drug: borage seed oil;Drug: combination fish oil and borage seed oil

National Center for Complementary and Integrative Health (NCCIH)

NULL

Active, not recruiting

18 Years

85 Years

Both

156

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3236

EUCTR2006-004715-22-SI
(EUCTR)

26/10/2006

17/10/2006

A Phase 2, 12-Week, Randomized, Placebo-Controlled Study to Evaluate the Antiinflammatory Effects of VX-702 when Administered Concomitantly with Methotrexate

Rheumatoid Arthritis

Product Code: VX-702

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Slovenia

3237

EUCTR2006-003698-29-NL
(EUCTR)

26/10/2006

14/06/2007

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

3238

EUCTR2005-002219-26-HU
(EUCTR)

25/10/2006

19/04/2006

A randomized, parallel group, placebo-controlled, double blind study to asses the safety and tolerability of SB 681323 at 7.5 mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatois arthritis”

Rheumatoid Arthritis patients with CRP higher than 10 mg/L

Product Code: SB 681323

GlaxoSmithKline

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden

3239

EUCTR2006-003843-22-IT
(EUCTR)

24/10/2006

30/08/2006

prospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE'A Phase IV multicenter, randomized, double-blind study

rheumatoid arthritis
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: HUMIRA *SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab
Trade Name: METHOTREXATE *100CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: DELTACORTENE FORTE*10CPR 25MG
INN or Proposed INN: Prednisone

OSPEDALE POLICLINICO S. MATTEO

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Italy

3240

EUCTR2006-001550-27-BE
(EUCTR)

23/10/2006

17/08/2006

Active Rheumatoid Arthritis

Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: N/A
Other descriptive name: N/A

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

260

Finland;Spain;Belgium;Austria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3241

EUCTR2006-003698-29-CZ
(EUCTR)

20/10/2006

29/08/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

3242

EUCTR2006-003698-29-SK
(EUCTR)

19/10/2006

29/09/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Phase 2

Estonia;Slovakia;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Netherlands;Latvia;Sweden

3243

EUCTR2006-004673-98-HU
(EUCTR)

16/10/2006

08/09/2006

Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker

To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.

Trade Name: MabThera 500 mg concentrate for solution for infusion

Roche (Hungary) Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary

3244

EUCTR2006-003698-29-FR
(EUCTR)

05/10/2006

14/09/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

3245

EUCTR2006-003698-29-SE
(EUCTR)

03/10/2006

17/08/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3246

EUCTR2005-003232-21-LV
(EUCTR)

02/10/2006

29/09/2006

Rheumatoid Arthritis (RA)

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

625

Hungary;Germany;Malta;Latvia;Lithuania

3247

JPRN-UMIN000000512

2006/10/01

03/11/2006

Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate

Rheumatoid Arthritis

If the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks.
If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks.

Rheumatosurgery, Osaka City University Medical School

NULL

Complete: follow-up complete

Not applicable

Male and Female

Not applicable

Japan

3248

NCT00393146
(ClinicalTrials.gov)

October 2006

24/10/2006

A Study To Investigate The Effect Of 28 Days Of Dosing With GW856553 On Patients With Rheumatoid Arthritis

A Randomized, Double Blind, Placebo Controlled Study to Investigate the Safety and Tolerability and Clinical Activity of 28 Days of Oral Repeat Dosing With GW856553 at 7.5mg BID in Subjects With Active Rheumatoid Arthritis on Stable Anti-rheumatic Therapy.

Arthritis, Rheumatoid

Drug: GW856553

GlaxoSmithKline

NULL

Completed

18 Years

N/A

Both

Phase 2

Romania;Russian Federation;Spain

3249

NCT00399282
(ClinicalTrials.gov)

October 2006

13/11/2006

Omega-3 and Vitamin E Supplementation in Patients With Rheumatoid Arthritis

Comparison of the Effects of Simultaneous Administration of Vitamin E and Omega-3 Fatty Acids in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Omega-3 and Vitamin E supplementation

Shahid Beheshti Medical University

NULL

Completed

16 Years

75 Years

Both

Phase 1

Iran, Islamic Republic of

3250

EUCTR2005-002396-33-HU
(EUCTR)

26/09/2006

07/07/2006

A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3251

EUCTR2006-005391-40-IT
(EUCTR)

25/09/2006

05/06/2007

Study on the effect of intra-articular infiltrations of aulogous platelet gel as inhibitor of erosion in rheumatoid arthritis patients - ND

Patients with Rheumatoid Arthritis
Level: PTClassification code 10039073

Product Name: Platelet Rich Plasma
INN or Proposed INN: Triamcinolone

AZIENDA OSPEDALIERA SENESE

NULL

Not Recruiting

Female: yes
Male: yes

Italy

3252

EUCTR2006-001000-37-DE
(EUCTR)

19/09/2006

16/06/2006

Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST

Rheumatoid arthritis
MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

Roche Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

300

Germany

3253

EUCTR2006-001550-27-AT
(EUCTR)

18/09/2006

25/07/2006

Active Rheumatoid Arthritis

Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: N/A
Other descriptive name: N/A

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

260

Finland;Germany;Spain;Austria

3254

EUCTR2006-001428-38-GB
(EUCTR)

18/09/2006

29/09/2006

Remission Induction in Very Early Rheumatoid Arthritis (RIVERA):a comparison of etanercept plus methotrexate plus steroid with standard therapy - RIVERA

Patients with early inflamatory arthritis (duration of symptoms of < 12 weeks) who are at very high risk of the development of rheumatoid arthritis (seropositivity for Rheumatoid factor and anti-CCP antibody)

Trade Name: Enbrel
Trade Name: Methorexate
Trade Name: Depo-Medrone
Trade Name: Salazopyrin En -Tabs
Trade Name: Plaquenil

University Hospitals Birmingham NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

3255

EUCTR2005-002396-33-SK
(EUCTR)

14/09/2006

15/06/2006

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Finland;United Kingdom;Germany;Slovakia;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3256

EUCTR2005-001742-16-NL
(EUCTR)

06/09/2006

22/03/2006

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously in Subjects with Active Rheumatoid Arthritis and Previously Treated with Biologic Anti-TNFalfa Agent(s) - NA

Active rheumatoid arthritis (RA)

Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

420

Germany;United Kingdom;Netherlands;Spain;Austria

3257

EUCTR2005-002219-26-NO
(EUCTR)

05/09/2006

18/07/2005

A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)

Rheumatoid arthritis (RA)

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden

3258

EUCTR2004-001490-26-EE
(EUCTR)

01/09/2006

08/03/2006

A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA

RHEUMATOID ARTHRITIS

Trade Name: Persantin 100 mg
Product Name: N/A
Product Code: CRx-150
INN or Proposed INN: Dipyridamole and Amoxapine
Trade Name: Defanyl 50 and 100 mg
Product Name: N/A
Product Code: CRx-150

CombinatoRx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Estonia

3259

NCT00367211
(ClinicalTrials.gov)

September 2006

18/8/2006

Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis

Drug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole)

POZEN

NULL

Completed

18 Years

N/A

Both

400

Phase 3

United States

3260

NCT01126541
(ClinicalTrials.gov)

September 2006

18/5/2010

SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy

A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)

Rheumatoid Arthritis

Drug: rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

224

Phase 3

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3261

NCT00361634
(ClinicalTrials.gov)

September 2006

4/8/2006

Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) to Measure Response to Etanercept in Rheumatoid Arthritis

DCE-MRI of the Wrist to Measure Short-Term Responses in Rheumatoid Arthritis Subjects Treated With Etanercept

Rheumatoid Arthritis

Drug: Etanercept

Amgen

NULL

Completed

18 Years

N/A

All

Phase 1

United States;United Kingdom

3262

NCT00488475
(ClinicalTrials.gov)

September 2006

18/6/2007

Observational Trial With Enbrel

A 1 Year Observational Study of the Use of Etanercept in Routine German Clinical Practice to Treat Rheumatoid Arthritis Patients: a Health Economic, Safety and Effectiveness Evaluation

Rheumatoid Arthritis

Drug: etanercept

Pfizer

NULL

Completed

18 Years

N/A

All

4945

N/A

Germany

3263

NCT00369473
(ClinicalTrials.gov)

September 2006

24/8/2006

Long-Term Assessment of Safety and Physical Function With AMG 108 in RA

A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: AMG 108

Amgen

NULL

Completed

18 Years

N/A

Both

690

Phase 2

Australia;Belgium;Canada;Czech Republic;Estonia;France;Hungary;Ireland;Italy;Latvia;Mexico;Netherlands;Poland;Puerto Rico;Slovakia;Spain;United Kingdom;United States

3264

NCT01308255
(ClinicalTrials.gov)

September 2006

3/3/2011

Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)

A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: Infliximab;Drug: Methylprednisolone;Drug: Methotrexate;Dietary Supplement: Folic acid

University of Leeds

NULL

Completed

18 Years

80 Years

All

112

Phase 4

United Kingdom

3265

NCT01303874
(ClinicalTrials.gov)

September 2006

24/2/2011

Etanercept and Methotrexate in Patients to Induce Remission in Early Arthritis (EMPIRE)

A Multicentre Randomised Trial Of Etanercept And Methotrexate To Induce Remission In Early Inflammatory Arthritis

Rheumatoid Arthritis;Inflammatory Arthritis

Drug: Etanercept (ETN);Drug: Placebo

University of Leeds

NULL

Completed

18 Years

80 Years

All

112

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3266

EUCTR2006-002645-37-HU
(EUCTR)

25/08/2006

13/06/2006

A Phase II randomized double-blind placebo-controlled Study of KC706 in patients with rheumatoid arthritis inadequately controlled with a stable dose of methotrexate

Active rheumatoid arthritis (RA), patients taking stable doses of methotrexate
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: KC706
Product Code: KR002524

Kémia, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Hungary

3267

NCT02006706
(ClinicalTrials.gov)

August 10, 2006

5/12/2013

A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

Phase 3

Serbia

3268

EUCTR2005-002326-63-EE
(EUCTR)

09/08/2006

26/08/2005

A Phase III Multi–center, Double–blind, Placebo–controlled, Parallel Group 24–Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who have an Incomplete Response to Methotrexate.

Rheumatoid Arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

590

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

3269

JPRN-C000000452

2006/08/01

01/08/2006

Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanercept

rheumatoid arthritis

methotrexate 8mg/week
methotrexate 8mg/week and
etanercept(25mg x1-2/week) for 3 months
methotrexate 8mg/week and
etanercept(25mgx1-2/week) for 6 months

Johoku Biological Summit

NULL

Pending

Not applicable

Male and Female

Phase 4

Japan

3270

NCT00326339
(ClinicalTrials.gov)

August 2006

12/5/2006

Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Dose Ranging Study to Evaluate Up to Three Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate

Rheumatoid Arthritis

Drug: R788;Drug: Placebo

Rigel Pharmaceuticals

NULL

Completed

18 Years

75 Years

Both

189

Phase 2

United States;Mexico

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3271

NCT00369928
(ClinicalTrials.gov)

August 2006

29/8/2006

Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate

A Multicenter, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG-760564 in Adult Patients With RA Receiving Methotrexate

Rheumatoid Arthritis

Drug: PG -760564;Drug: Placebo dose

Procter and Gamble

NULL

Completed

18 Years

70 Years

All

254

Phase 2

United States;Czech Republic;Hungary;Netherlands;Poland;United Kingdom

3272

NCT00732875
(ClinicalTrials.gov)

August 2006

8/8/2008

A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED)

A Placebo-controlled, Double-blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment (Open-label Extension Part)

Arthritis, Rheumatoid

Biological: Infliximab + methotrexate (MTX)

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

75 Years

All

Phase 3

NULL

3273

NCT01272908
(ClinicalTrials.gov)

July 18, 2006

7/1/2011

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)

Rheumatoid Arthritis

Drug: rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

120

Phase 3

Canada;Sweden

3274

EUCTR2006-004062-13-IT
(EUCTR)

18/07/2006

30/08/2006

Randomised, open label, no profit, clinical, multicenter study of phase II and IIIB to assess efficacy and tolerability of oxycodone/paracetamol compared to anti-inflammatory non-steroidal drugs FANS and corticosteroid, in patients suffering moderate to severe chronic pain due to rheumatoid arthritis. - Do.R.A.

RHEUMATOID ARTHRITIS
MedDRA version: 6.1;Level: PT;Classification code 10039073

Trade Name: DEPALGOS*20+325MG 28CPR RP
INN or Proposed INN: OXICODONE DC.IT
INN or Proposed INN: PARACETAMOLO DC.IT FU

A.U.S.L. RIMINI

NULL

Not Recruiting

Female: yes
Male: yes

149

Phase 2

Italy

3275

EUCTR2005-001889-13-NL
(EUCTR)

13/07/2006

20/04/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3

Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 3

France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3276

EUCTR2005-003558-83-NL
(EUCTR)

13/07/2006

20/04/2006

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - Not available

Rheumatoid arthritis (RA)

Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden

3277

EUCTR2004-003296-36-HU
(EUCTR)

10/07/2006

14/06/2006

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy - NA

Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy

Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Hungary;Germany

3278

EUCTR2004-003295-10-HU
(EUCTR)

04/07/2006

30/12/2005

Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)

Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

600

Hungary;United Kingdom;Spain;Italy

3279

NCT00872573
(ClinicalTrials.gov)

July 1, 2006

30/3/2009

A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stem™ AMT in a Total Primary Hip Replacement

Prospective, Uncontrolled, Two-centre, RSA, Post-market Surveillance Study to Evaluate the Stability of the C-Stem™ AMT Femoral Component in Primary Total Hip Arthroplasty.

Rheumatoid Arthritis;Osteoarthritis;Post-traumatic Arthritis;Collagen Disorders;Avascular Necrosis;Traumatic Femoral Fractures;Nonunion of Femoral Fractures;Congenital Hip Dysplasia;Slipped Capital Femoral Epiphysis

Device: C-Stem™ AMT Femoral Component (standard and high off-set variants)

DePuy International

NULL

Terminated

60 Years

80 Years

All

Phase 4

United Kingdom

3280

NCT00445770
(ClinicalTrials.gov)

July 2006

8/3/2007

Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis

A Randomized, Double-Blind, Multicenter, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Etanercept;Drug: Methotrexate

Pfizer

NULL

Completed

20 Years

75 Years

All

550

Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3281

NCT00555542
(ClinicalTrials.gov)

July 2006

7/11/2007

An Analysis of Peripheral Blood T Cell Subsets on Rheumatoid Arthritis

B Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell Subsets

Rheumatoid Arthritis

Drug: rituximab

Chinese University of Hong Kong

NULL

Completed

21 Years

70 Years

Both

Phase 2

China

3282

NCT00369187
(ClinicalTrials.gov)

July 2006

25/8/2006

Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase

Rheumatoid Arthritis

Drug: large protein molecule

Halozyme Therapeutics

NULL

Completed

18 Years

N/A

Both

Phase 4

United States

3283

NCT01685424
(ClinicalTrials.gov)

June 30, 2006

23/8/2012

Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)

Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis

Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis;Gout;Arthritis

Drug: Etoricoxib

Merck Sharp & Dohme Corp.

NULL

Completed

N/A

All

79189

N/A

United States

3284

EUCTR2004-001234-17-GB
(EUCTR)

15/06/2006

15/09/2005

Double-blind, triple dummy, parallel-group, randomized, six-month study to compare celecoxib (200 mg BID) with diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) for gastrointestinal events in subjects with osteoarthritis and rheumatoid arthritis at high-risk of gastrointestinal adverse events - Not Applicable

Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073

Pfizer Limited

NULL

Not Recruiting

Female: yes
Male: yes

4402

Phase 4

Portugal;Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden

3285

EUCTR2005-003558-83-BE
(EUCTR)

09/06/2006

17/05/2006

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)

Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Estonia;Czech Republic;Spain;Belgium;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3286

EUCTR2005-001742-16-DE
(EUCTR)

07/06/2006

23/03/2006

Active rheumatoid arthritis (RA)

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

420

United Kingdom;Germany;Netherlands;Spain;Austria

3287

EUCTR2006-001359-36-NL
(EUCTR)

02/06/2006

29/03/2006

Effects of low-dose aspirin taken at bedtime on pathophysiologic mechanisms underlying hypertension in subjects with grade 1 essential hypertension: the Aspirin In Reduction of Tension (ASPIRETENSION) study - ASPIRETENSION

Patients should have grade 1 essential hypertension (140/90-159/99 mmHg), but free of history of any cardiovascular events, diabetes mellitus type 1 or 2 or rheumatoid arthritis.

Trade Name: Ascal(r) / carbasalate calcium

Leiden University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

3288

EUCTR2005-001742-16-ES
(EUCTR)

02/06/2006

19/04/2006

Estudio múlticéntrico, aleatorio, doble ciego, controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFalfa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa tratados previamente con agentes biológicos anti-TNFalfa.

Active rheumatoid arthritis (RA)Artritis Reumatoide activa

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

420

Germany;United Kingdom;Netherlands;Spain;Austria

3289

NCT00443950
(ClinicalTrials.gov)

June 2006

5/3/2007

Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving Methotrexate

Arthritis, Rheumatoid

Drug: Etanercept

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

N/A

Both

150

Phase 3

China

3290

NCT00439062
(ClinicalTrials.gov)

June 2006

20/2/2007

Treatment of Rheumatoid Arthritis With Roxithromycin

Rheumatoid Arthritis

Drug: Roxithromycin

Nazilli State Hospital

NULL

Completed

18 Years

70 Years

Both

100

Phase 4

Turkey

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3291

NCT00424294
(ClinicalTrials.gov)

June 2006

18/1/2007

A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CP-195543 And Celecoxib Dual Therapy In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate

Arthritis, Rheumatoid

Drug: CP -195,543;Drug: celecoxib;Drug: Methotrexate

Pfizer

NULL

Terminated

18 Years

N/A

All

Phase 2

United States

3292

NCT00280917
(ClinicalTrials.gov)

June 2006

23/1/2006

Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CF101

Can-Fite BioPharma

NULL

Completed

18 Years

75 Years

All

254

Phase 2

United States;Bulgaria;Israel;Poland;Romania;Serbia;Ukraine;Former Serbia and Montenegro

3293

NCT00345748
(ClinicalTrials.gov)

June 2006

23/6/2006

A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

A Phase II, Multi-center, Randomized, Double-Blind, Placebo Controlled, Dose Response Study to Evaluate the Safety and Efficacy of Two Different Doses of Abatacept (BMS-188667) Administered Intravenously to Japanese Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

Rheumatoid Arthritis

Drug: Abatacept;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

20 Years

N/A

Both

194

Phase 2

Japan

3294

EUCTR2006-000854-32-AT
(EUCTR)

29/05/2006

19/05/2006

Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers

Rheumatoid Arthritis

Trade Name: Rituximab - MabThera
Product Name: Rituximab MabThera
Product Code: no

Vienna Medical University

NULL

Not Recruiting

Female: yes
Male: yes

Austria

3295

EUCTR2005-001742-16-GB
(EUCTR)

26/05/2006

03/03/2006

Active rheumatoid arthritis (RA)

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

Finland;Spain;Austria;Germany;Netherlands;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3296

EUCTR2004-001234-17-SE
(EUCTR)

22/05/2006

27/10/2005

Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073

Trade Name: celebra
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole ,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole

Pfizer AB

NULL

Not Recruiting

Female: yes
Male: yes

4402

Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden

3297

EUCTR2004-003295-10-GB
(EUCTR)

17/05/2006

08/12/2005

Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 3

Hungary;Spain;Austria;Italy;United Kingdom

3298

EUCTR2005-001742-16-FI
(EUCTR)

17/05/2006

04/04/2006

Active rheumatoid arthritis (RA)

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

420

Finland;Spain;Austria;Germany;Netherlands;United Kingdom

3299

EUCTR2005-002909-23-IS
(EUCTR)

08/05/2006

25/04/2006

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.

Rheumatoid arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

2420

Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Germany;Iceland;Italy;United Kingdom;Sweden

3300

EUCTR2005-001889-13-DK
(EUCTR)

04/05/2006

16/03/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3

Trade Name: Remicade

Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.

NULL

Not Recruiting

Female: yes
Male: yes

315

Portugal;Germany;Netherlands;Belgium;Denmark;France;Greece;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3301

EUCTR2005-000158-61-LT
(EUCTR)

03/05/2006

06/01/2006

A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis -

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: CELEBREX
Product Name: Celebrex
INN or Proposed INN: Celecoxib

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

2210

Phase 3

Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania

3302

EUCTR2005-001889-13-GR
(EUCTR)

02/05/2006

23/05/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3

Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.

Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 3

France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden

3303

EUCTR2005-001742-16-AT
(EUCTR)

01/05/2006

30/03/2006

Active rheumatoid arthritis (RA)

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

420

Germany;United Kingdom;Netherlands;Spain;Austria

3304

NCT00497614
(ClinicalTrials.gov)

May 2006

4/7/2007

Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)

18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis. A Monocentric Pilot Study

Rheumatoid Arthritis

Drug: adalimumab

University Hospital, Tours

NULL

Completed

18 Years

75 Years

Both

N/A

France

3305

NCT01078571
(ClinicalTrials.gov)

May 2006

1/3/2010

Safety and Effectiveness of Adalimumab in Patients Diagnosed With Rheumatoid Arthritis

Safety and Effectiveness of Adalimumab (HUMIRA®) in Patients Diagnosed With Rheumatoid Arthritis (DALI Study)

Rheumatoid Arthritis

Biological: adalimumab (HUMIRA®)

Abbott

NULL

Completed

18 Years

N/A

All

705

N/A

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3306

NCT00380601
(ClinicalTrials.gov)

May 2006

25/9/2006

Phase?Open-label Study of MRA for Rheumatoid Arthritis(RA)

An Open-label, Phase? Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Rheumatoid Arthritis

Drug: MRA(Tocilizumab)

Chugai Pharmaceutical

NULL

Completed

20 Years

N/A

Both

Phase 3

Japan

3307

EUCTR2005-003558-83-IT
(EUCTR)

28/04/2006

23/06/2006

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis. - AMG 108

Rheumatoid Arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Code: AMG 108
Product Code: AMG 108
Product Code: AMG 108

AMGEN S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

784

Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden

3308

EUCTR2005-002396-33-DE
(EUCTR)

27/04/2006

10/11/2005

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

3309

EUCTR2005-002395-15-DE
(EUCTR)

27/04/2006

22/11/2005

A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.

Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

3310

EUCTR2004-003295-10-ES
(EUCTR)

25/04/2006

17/02/2006

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Methotrexate-naïve Subjects with Active Rheumatoid ArthritisEnsayo múlticéntrico, aleatorizado, en doble ciego y controlado con placebo, de golimumab, un anticuerpo monoclonal anti-TNFa totalmente humano, administrado subcutáneamente, en sujetos con artritis reumatoide activa no tratados previamente con metotrexato

Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)Artritis Reumatoide activa (no tratada previamente con metotrexato)

Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium tablets 2.5 mg
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

600

Hungary;United Kingdom;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3311

EUCTR2005-002392-32-DE
(EUCTR)

20/04/2006

29/09/2005

A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.

Active rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Slovenia;Ireland;Germany;United Kingdom;Sweden

3312

EUCTR2005-002909-23-FI
(EUCTR)

19/04/2006

23/01/2006

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.

Rheumatoid arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

2420

Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden

3313

EUCTR2005-000158-61-DE
(EUCTR)

18/04/2006

16/05/2006

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: Celecoxib
INN or Proposed INN: Celecoxib

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

2210

Phase 3

Hungary;Czech Republic;United Kingdom;Germany;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania

3314

EUCTR2004-001930-18-EE
(EUCTR)

17/04/2006

19/01/2006

A MULTI-CENTER, RANDOMIZED, BLINDED STUDY COMPARING THE EFFECT OF CRx-102 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS - CRx-102-RA

RHEUMATOID ARTHRITIS

Trade Name: Persantin 100 mg and
Product Name: N/A
Product Code: CRx-102
INN or Proposed INN: prednisolone & dipyridamole

CombinatoRx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Estonia

3315

EUCTR2004-005102-68-CZ
(EUCTR)

14/04/2006

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, Version 1.0 dated 7-Feb-2006.

RHEUMATOID ARTHRITIS,NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Germany;United Kingdom;Czech Republic;Belgium;Spain;Ireland;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3316

EUCTR2005-003558-83-AT
(EUCTR)

13/04/2006

20/03/2006

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden

3317

EUCTR2005-002909-23-IT
(EUCTR)

11/04/2006

14/03/2006

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.

Trade Name: RoActemra
INN or Proposed INN: Ro Actemra

F. Hoffmann - La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

2420

Sweden;Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;United Kingdom;Italy

3318

EUCTR2005-001633-14-SE
(EUCTR)

11/04/2006

27/02/2006

Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira[R]) 40 mg s.c. eow versus infliximab (Remicade[R]) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study

Rheumatoid arthritis

Trade Name: Humira
Product Name: Humira
Trade Name: Remicade
Product Name: Remicade

Hvidovre Hospital, Dept. Rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

112

Denmark;Sweden

3319

EUCTR2004-004995-35-DK
(EUCTR)

10/04/2006

20/09/2005

A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA

ACTIVE RHEUMATOID ARTHRITIS

Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone

CombinatoRx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

Czech Republic;Germany;United Kingdom;Denmark;Italy

3320

EUCTR2005-003558-83-CZ
(EUCTR)

07/04/2006

23/01/2006

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108

Rheumatoid arthritis (RA)

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

United Kingdom;Czech Republic;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3321

EUCTR2005-001889-13-PT
(EUCTR)

07/04/2006

17/01/2006

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab

Schering Plough Research Institute, a Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

315

Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden

3322

EUCTR2005-005013-37-GB
(EUCTR)

06/04/2006

20/01/2006

A multi-centre randomised double dummy double blind study comparing two regimens of combination induction therapy in early DMARD naive Rheumatoid Arthritis: The IDEA study (Infliximab as Induction Therapy in Early Rheumatoid Arthritis) - IDEA

Early Rheumatoid Arthritis

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

112

Phase 4

United Kingdom

3323

EUCTR2005-003558-83-ES
(EUCTR)

04/04/2006

16/02/2006

Estudio aleatorizado, doble ciego, controlado con placebo, y de dosis múltiple, para evaluar la eficacia, seguridad y farmacocinética de AMG 108 subcutáneo en sujetos con artritis reumatoide. (A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis).

Artritis Reumatoide (Rheumatoid arthritis - RA)

Product Code: AMG 108

Amgen Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

784

Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden

3324

NCT00319917
(ClinicalTrials.gov)

April 2006

27/4/2006

A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

Rheumatoid Arthritis

Drug: tacrolimus;Drug: placebo

Astellas Pharma Inc

NULL

Completed

20 Years

64 Years

Both

123

Phase 4

Japan

3325

NCT00303563
(ClinicalTrials.gov)

April 2006

16/3/2006

A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

A Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: P38 Inhibitor (4);Drug: Placebo

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

204

Phase 2

United States;Canada;Croatia;Czech Republic;France;Italy;Mexico;Romania;Serbia;South Africa;Spain;Taiwan;Former Serbia and Montenegro

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3326

EUCTR2005-002909-23-NO
(EUCTR)

30/03/2006

11/01/2006

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.

Rheumatoid arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

2420

Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Norway;Germany;Iceland;Sweden

3327

EUCTR2004-001234-17-PT
(EUCTR)

30/03/2006

26/05/2006

Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073

Trade Name: Celebrex
Product Name: Celebrex
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole ,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole

Laboratórios Pfizer, Lda

NULL

Not Recruiting

Female: yes
Male: yes

4402

Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden

3328

EUCTR2004-003296-36-DE
(EUCTR)

29/03/2006

24/11/2005

Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin
Product Name: Golimumab Pre-Filled Syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor B.V.

NULL

Not Recruiting

Female: yes
Male: yes

400

Hungary;Germany

3329

NCT00308282
(ClinicalTrials.gov)

March 28, 2006

28/3/2006

A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Participants With Rheumatoid Arthritis

Phase II Study of Safety and Efficacy of Intravenous LY2127399 in Patients With Rheumatoid Arthritis Treated With Methotrexate

Arthritis, Rheumatoid

Drug: LY2127399;Drug: Placebo

Eli Lilly and Company

NULL

Completed

18 Years

75 Years

All

136

Phase 2

Romania

3330

EUCTR2005-002396-33-GB
(EUCTR)

28/03/2006

11/05/2006

Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 3

Hungary;Slovakia;Finland;Belgium;Spain;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3331

EUCTR2005-002909-23-GB
(EUCTR)

27/03/2006

13/01/2006

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA

Rheumatoid arthritis

F Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

2420

Phase 3

Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden

3332

EUCTR2005-004582-41-GB
(EUCTR)

24/03/2006

27/01/2006

Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA

Active Rheumatoid Arthritis

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

3333

EUCTR2005-000784-26-AT
(EUCTR)

22/03/2006

21/02/2006

A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with MethotrexateProtocol Version 1.0 dated 06-May-2005, andProtocol Amendments 3 & 4 - Site Specific dated 28-Dec-2005.

Rheumatoid Arthritis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3B

Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy;Austria

3334

EUCTR2005-003558-83-SK
(EUCTR)

22/03/2006

23/01/2006

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis - AMG 108

Rheumatoid arthritis (RA)

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Phase 2

Estonia;Czech Republic;Slovakia;Belgium;Spain;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden

3335

EUCTR2005-003558-83-GB
(EUCTR)

21/03/2006

13/01/2006

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Phase 2

Estonia;Czech Republic;Slovakia;Belgium;Spain;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3336

EUCTR2004-001234-17-DE
(EUCTR)

20/03/2006

14/12/2005

Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073

Trade Name: Celebrex 200 mg Hartkapseln
Product Name: Celebrex
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)- 1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltarol SR
Product Name: Voltarol SR
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]- phenyl]-acetate
Trade Name: Losec Capsules 20 mg
Product Name: Losec
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole ,5-methoxy-2-[[(4-methoxy- 3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole

Pfizer Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

4402

Portugal;Estonia;Czech Republic;Greece;Spain;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden

3337

EUCTR2005-002219-26-GB
(EUCTR)

20/03/2006

13/01/2006

Rheumatoid arthritis (RA)

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden

3338

EUCTR2005-002909-23-SI
(EUCTR)

16/03/2006

20/02/2006

A long-term 5-year study investigation whethetr tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96

Trade Name: RoActemra
Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody

F Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

2420

United States;Portugal;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Norway;Germany;Sweden

3339

EUCTR2005-002909-23-CZ
(EUCTR)

13/03/2006

13/01/2006

A long-term 5-year study investigating whether tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96

Trade Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody

F Hoffmann La-Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2420

France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Norway;Germany;Sweden;Portugal;United States;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland

3340

EUCTR2005-002909-23-LT
(EUCTR)

07/03/2006

11/01/2006

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.

Rheumatoid arthritis

Trade Name: RoActemra
INN or Proposed INN: tocilizumab

F Hoffmann La-Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2420

Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3341

EUCTR2005-001889-13-BE
(EUCTR)

06/03/2006

19/12/2005

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3

Schering Plough Research Institute, a Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 3

France;Portugal;Belgium;Denmark;Austria;Germany;Netherlands;Sweden

3342

EUCTR2005-002396-33-FI
(EUCTR)

06/03/2006

22/12/2005

Rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
Product Name: Methotrexate
Product Code: Methotrexate

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

United Kingdom;Germany;Spain;Italy;Hungary;Finland;Slovakia

3343

EUCTR2004-003771-37-HU
(EUCTR)

03/03/2006

03/11/2005

A double-blind, randomized, placebo controlled, dose escalation, multi-center phase I/II trial of HuMax-CD20, a fully human monoclonal anti-CD20 antibody, in patients with active rheumatoid arthritis who have previously failed one or more disease modifying anti-rheumatic drugs. - HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II

Active Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Product Name: HuMax-CD20
Product Code: HuMax-CD20
INN or Proposed INN: N/A
Other descriptive name: Human monoclonal antibody directed against CD20 on B-cells

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 1;Phase 2

Hungary

3344

NCT00293826
(ClinicalTrials.gov)

March 2006

17/2/2006

A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: AMG 108;Drug: Placebo

Amgen

NULL

Completed

18 Years

70 Years

Both

813

Phase 2

United States;Australia;Austria;Belgium;Canada;Czech Republic;Estonia;France;Hungary;Ireland;Italy;Latvia;Mexico;Netherlands;Poland;Slovakia;Spain;Sweden;United Kingdom;Puerto Rico

3345

EUCTR2005-002395-15-CZ
(EUCTR)

27/02/2006

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3346

EUCTR2004-001234-17-LV
(EUCTR)

27/02/2006

13/02/2008

Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073

Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole ,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole

NULL

Not Recruiting

Female: yes
Male: yes

4402

Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden

3347

EUCTR2005-002629-30-LV
(EUCTR)

27/02/2006

01/03/2006

A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients with Active Rheumatoid Arthritis who participated in Study CDP870-050. - Follow on study to CDP870-050

Rheumatoid arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

3348

EUCTR2005-003694-25-CZ
(EUCTR)

27/02/2006

17/03/2006

A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA).

Rheumatoid Arthritis

Product Name: P38 (4) Map Kinase Inhibitor
Product Code: RO4402257
Other descriptive name: P38(4) Map Kinase Inhibitor
Product Name: P38 (4) Map Kinase Inhibitor
Product Code: RO4402257
Other descriptive name: P38(4) Map Kinase Inhibitor
Product Name: P38 (4) Map Kinase Inhibitor
Product Code: RO4402257
Other descriptive name: P38(4) Map Kinase Inhibitor
Trade Name: Methotrexate Sodium 2.5mg Tablets
Product Name: Methotrexate Sodium 2.5mg Tablets
Product Code: PL 00095/5079R
Other descriptive name: Methotrexate Sodium 2.5mg Tablets

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

200

Czech Republic;Spain;Italy

3349

EUCTR2005-003495-38-GR
(EUCTR)

27/02/2006

30/06/2006

Part A: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.Part B: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 1 dose of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

440

United Kingdom;Germany;Estonia;Spain;Ireland;Greece

3350

EUCTR2004-004995-35-GB
(EUCTR)

24/02/2006

16/03/2005

ACTIVE RHEUMATOID ARTHRITIS

Trade Name: Paroxetine hydrochloride 10 & 20 mg and Prednisolone 1 mg BP
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone

CombinatoRx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

Czech Republic;Austria;Denmark;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3351

EUCTR2005-002909-23-DK
(EUCTR)

21/02/2006

23/01/2006

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA

Rheumatoid arthritis

Trade Name: RoActemra
INN or Proposed INN: tocilizumab

F Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

2420

Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden

3352

EUCTR2004-003295-10-IT
(EUCTR)

20/02/2006

29/11/2006

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNF 945; Monoclonal Antibody, Administered Subcutaneously, in Methotrexatena ve Subjects with Active Rheumatoid Arthritis - CNTO148 T05

RA in subjects who are naive to metotrexate
MedDRA version: 8.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders

Product Name: golimumab
Product Code: CNTO148
INN or Proposed INN: Methotrexate
Product Name: golimumab
Product Code: CNTO148

CENTOCOR

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Hungary;United Kingdom;Spain;Italy

3353

EUCTR2005-003558-83-SE
(EUCTR)

16/02/2006

24/01/2006

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)

Product Code: AMG 108

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

784

Czech Republic;United Kingdom;Netherlands;Estonia;Ireland;Spain;Italy;Latvia;Austria;Sweden

3354

EUCTR2005-002629-30-CZ
(EUCTR)

15/02/2006

01/02/2006

Rheumatoid arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Inc

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

3355

EUCTR2005-003436-21-CZ
(EUCTR)

15/02/2006

07/11/2005

A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib

Dainippon Sumitomo Pharma Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Hungary;Germany;United Kingdom;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3356

EUCTR2005-002395-15-SE
(EUCTR)

13/02/2006

12/12/2005

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

3357

EUCTR2005-002629-30-EE
(EUCTR)

13/02/2006

23/02/2006

Rheumatoid arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Inc

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Czech Republic;Estonia;Lithuania;Latvia

3358

EUCTR2005-002909-23-SE
(EUCTR)

09/02/2006

23/12/2005

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96

Trade Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody

F Hoffmann La-Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2420

Portugal;United States;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Germany;Norway;Sweden

3359

NCT00286689
(ClinicalTrials.gov)

February 3, 2006

1/2/2006

Effects of Growth Hormone in Chronically Ill Children

Hurler Syndrome;Cerebral Palsy;Juvenile Rheumatoid Arthritis;Crohn Disease;HIV Infections

Drug: Growth Hormone;Procedure: Whole body Protein turnover;Procedure: DEXA scan

University of Texas Southwestern Medical Center

NULL

Withdrawn

3 Years

17 Years

All

N/A

United States

3360

EUCTR2005-002629-30-SK
(EUCTR)

03/02/2006

04/01/2006

Rheumatoid arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Estonia;Czech Republic;Slovakia;Lithuania;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3361

EUCTR2004-001234-17-BE
(EUCTR)

02/02/2006

24/10/2005

Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073

Trade Name: Celebrex
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltarol SR (generics also available in the EU)
Product Name: Voltarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole ,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole

Pfizer SA/NV

NULL

Not Recruiting

Female: yes
Male: yes

4402

Portugal;Estonia;Czech Republic;Greece;Spain;Belgium;Ireland;Lithuania;Latvia;Germany;United Kingdom;Sweden

3362

EUCTR2005-005295-32-GB
(EUCTR)

01/02/2006

02/12/2005

Trial in rheumatoid arthritis of lisinopril (TRALIS) - TRALIS

Rheumatoid arthritis

Research and Development Department, Addenbrookes NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United Kingdom

3363

NCT00287794
(ClinicalTrials.gov)

February 2006

6/2/2006

Quality of Sleep in Patients With Rheumatoid Arthritis

Study on the Quality of Sleep in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: diazepam , melatonin

Kobe University

NULL

Recruiting

17 Years

N/A

Both

1000

Japan

3364

NCT00422383
(ClinicalTrials.gov)

February 2006

15/1/2007

A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

378

Phase 3

Australia;Belgium;Brazil;Canada;China;Finland;France;Germany;Hungary;Italy;Netherlands;New Zealand;Slovakia;South Africa;Spain;Taiwan;Thailand;United Kingdom;Switzerland;United States

3365

NCT00296257
(ClinicalTrials.gov)

February 2006

22/2/2006

Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114

A Phase 2, Multi-Centre, Randomised, Double Blind, Placebo Controlled Study Evaluating the Efficacy, Safety and Pharmacokinetics of Two Doses of a Candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg Once Daily), Administered in Combination With Ongoing Methotrexate Treatment in Patients With Active Rheumatoid Arthritis.

Rheumatoid Arthritis (RA)

Drug: SMP-114

Dainippon Sumitomo Pharma Europe LTd.

NULL

Terminated

18 Years

N/A

Both

312

Phase 2

Czech Republic;Germany;Hungary;Netherlands;Poland;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3366

NCT00502996
(ClinicalTrials.gov)

February 2006

17/7/2007

A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)

Rheumatoid Arthritis

Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

246

Phase 3

Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela

3367

EUCTR2005-002629-30-LT
(EUCTR)

30/01/2006

06/12/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Inc

NULL

Not Recruiting

Female: yes
Male: yes

634

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

3368

EUCTR2005-003694-25-ES
(EUCTR)

27/01/2006

28/11/2005

Ensayo randomizado, doble ciego, con doble enmascaramiento, de grupos paralelos para evaluar la eficacia y seguridad de RO4402257 como monoterapia en comparación con la monoterapia de metotrexato para pacientes con artritis reumatoide activa (AR)A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA).

Artritis ReumatoideRheumatoid Arthritis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Czech Republic;Spain;Italy

3369

EUCTR2005-000784-26-IT
(EUCTR)

25/01/2006

17/01/2007

A phase IIIB multi-center, randomized, double-blind study to evaluate remission and joint damage progression in methotrexate naive early erosive RA subjects treated with abatacept plus methotrexate compared with methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005.

Arthritis rheumatoid treatment
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: abatacept
Product Code: BMS-188667
INN or Proposed INN: abatacept

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3B

Czech Republic;Belgium;Spain;Ireland;Austria;Germany;United Kingdom;Italy

3370

NCT00282308
(ClinicalTrials.gov)

January 23, 2006

24/1/2006

A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

A Phase II, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

Rheumatoid Arthritis

Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisone;Biological: C. albicans;Biological: Tetanus toxoid adsorbed booster vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: Keyhole limpet hemocyanin

Genentech, Inc.

NULL

Completed

18 Years

65 Years

All

103

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3371

EUCTR2004-003295-10-AT
(EUCTR)

20/01/2006

16/12/2005

Active Rheumatoid Arthritis (methotrexate [MTX]-naïve)

Product Name: Golimumab
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium tablets 2.5 mg
Product Code: NA
INN or Proposed INN: Methotrexate sodium
Other descriptive name: Methylaminopterin

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

600

Hungary;Spain;Austria;Italy;United Kingdom

3372

EUCTR2005-002395-15-GB
(EUCTR)

20/01/2006

25/04/2006

Rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Phase 3

Czech Republic;Finland;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden

3373

EUCTR2005-000158-61-CZ
(EUCTR)

18/01/2006

05/12/2005

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

2210

Phase 3

Czech Republic;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania;Hungary;Germany;United Kingdom

3374

EUCTR2005-003436-21-DE
(EUCTR)

18/01/2006

24/10/2005

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib

Dainippon Sumitomo Pharma Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Hungary;Czech Republic;United Kingdom;Germany

3375

EUCTR2004-001234-17-IE
(EUCTR)

16/01/2006

02/11/2006

Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073

Pfizer Healthcare Ireland

NULL

Not Recruiting

Female: yes
Male: yes

4402

Portugal;Czech Republic;United Kingdom;Estonia;Spain;Ireland;Greece;Latvia;Lithuania;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3376

EUCTR2005-000158-61-EE
(EUCTR)

16/01/2006

11/11/2005

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

2210

Phase 3

Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania

3377

EUCTR2005-003694-25-IT
(EUCTR)

12/01/2006

27/01/2006

rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: P38 Map Kinase Inhibitor
Product Name: P38 Map Kinase Inhibitor
Product Name: P38 Map Kinase Inhibitor
INN or Proposed INN: Methotrexate

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

200

Czech Republic;Spain;Italy

3378

EUCTR2005-002909-23-DE
(EUCTR)

10/01/2006

07/10/2005

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.

Rheumatoid arthritis

Trade Name: RoActemra
Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

2420

Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden

3379

EUCTR2005-002395-15-FI
(EUCTR)

09/01/2006

26/10/2005

Rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
Product Name: Methotrexate
Product Code: Methotrexate
INN or Proposed INN: methotrexate

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

3380

EUCTR2005-002395-15-DK
(EUCTR)

06/01/2006

19/06/2007

Rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Phase 3

Czech Republic;Finland;Belgium;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3381

EUCTR2005-004385-16-GB
(EUCTR)

03/01/2006

08/12/2005

CIRCADIAN VARIATIONS IN CYTOKINES AND THE EFFECT OF TIMED RELEASE TABLET PREDNISONE IN RHEUMATOID ARTHRITIS

Rheumatoid arthritis

United Bristol Healthcare NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

3382

NCT03496831
(ClinicalTrials.gov)

January 1, 2006

5/4/2018

Predicting Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs

Development of a Prediction Model for the Risk of Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs

Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis

Drug: Biologic Agents

Simon Krabbe

University of Aarhus;Zealand University Hospital;University of Southern Denmark

Completed

18 Years

N/A

All

7500

NULL

3383

NCT00422942
(ClinicalTrials.gov)

January 2006

15/1/2007

A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)

An Open-label, Exploratory Study of the Pharmacokinetic and Pharmacodynamic Activity of MabThera in Combination With Methotrexate in Synovial Tissue and in Peripheral Blood of Patients With Active Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Terminated

18 Years

80 Years

All

Phase 2

Netherlands;Spain

3384

NCT00379990
(ClinicalTrials.gov)

January 2006

21/9/2006

A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.

A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects.

Arthritis, Rheumatoid

Drug: GW274150;Drug: Prednisolone;Other: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

N/A

Both

Phase 2

Serbia;United Kingdom

3385

NCT00264147
(ClinicalTrials.gov)

January 2006

9/12/2005

Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: etoricoxib;Drug: Comparator: placebo;Drug: Comparator: diclofenac

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

761

Phase 2

Canada;Colombia;Puerto Rico;Switzerland;United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3386

NCT00266227
(ClinicalTrials.gov)

January 2006

14/12/2005

A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Retreatment With Rituximab in Subjects With Rheumatoid Arthritis Receiving Background Methotrexate

Rheumatoid Arthritis

Drug: placebo;Drug: rituximab;Drug: methotrexate;Drug: folate

Genentech, Inc.

NULL

Completed

18 Years

80 Years

All

559

Phase 3

United States

3387

NCT00724243
(ClinicalTrials.gov)

January 2006

25/7/2008

Safety and Effectiveness of Infliximab in Slovakia When Used for Rheumatoid Arthritis (Study P04741)(COMPLETED)

Remicade Treatment Registry in Rheumatoid Arthritis I

Rheumatoid Arthritis

Drug: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

N/A

All

N/A

Slovakia

3388

NCT02922192
(ClinicalTrials.gov)

January 2006

28/9/2016

Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis

Rheumatoid Arthritis;Inflammatory Bowel Disease;Psoriasis;Psoriatic Arthritis;Ankylosing Spondylitis

Drug: TNF-a antagonists, non-TNFs, DMARD non-biologics

Biologics & Biosimilars Collective Intelligence Consortium

HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMC;HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMC

Active, not recruiting

18 Years

N/A

Both

100000

N/A

NULL

3389

NCT00254293
(ClinicalTrials.gov)

January 2006

15/11/2005

Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)

A Study to Assess the Steady-State Trough Serum Concentration, Safety, and Immunogenicity of Abatacept (BMS-188667) Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Who Are Receiving Disease Modifying Ant-Rheumatic Drugs (DMARDs)

Rheumatoid Arthritis

Drug: Abatacept or Placebo (both as IV & SC Solution);Drug: Abatacept or Placebo (both as IV & SC solution);Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

3390

NCT00234234
(ClinicalTrials.gov)

January 2006

5/10/2005

Predictors of the Response to Adalimumab in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Adalimumab

University Hospital, Rouen

NULL

Completed

18 Years

N/A

Both

200

Phase 4

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3391

EUCTR2005-004530-40-AT
(EUCTR)

30/12/2005

25/11/2005

Induction of remission in RA patients at low disease activity by additional Infliximab-therapy

Patients with a diagnose of rheumatoid arthritis according to ACR-criteria at least 1 year (max. 10 years) prior to start of therapy with active disease: DAS 28 between 2,8 and 3,5 and a change in DAS 28 score <0.6 during the last 6 weeks before inclusion.

Trade Name: Remicade
Product Name: Remicade

AESCA Pharma Ges.m.b.H

NULL

Not Recruiting

Female: yes
Male: yes

160

Austria

3392

EUCTR2005-002395-15-ES
(EUCTR)

29/12/2005

31/10/2005

Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”

Artritis reumatoide / Rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

3393

EUCTR2005-002395-15-BE
(EUCTR)

29/12/2005

24/11/2005

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy;Sweden

3394

EUCTR2004-001234-17-LT
(EUCTR)

29/12/2005

23/11/2005

Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

4402

Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Sweden;Lithuania

3395

EUCTR2005-002396-33-ES
(EUCTR)

27/12/2005

28/10/2005

Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.

Artritis Reumatoide (Rheumatoid arthritis)

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3396

EUCTR2005-002396-33-BE
(EUCTR)

27/12/2005

24/11/2005

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 3

Hungary;Slovakia;Finland;Spain;Belgium;Germany;United Kingdom;Italy

3397

EUCTR2004-001234-17-ES
(EUCTR)

20/12/2005

21/10/2005

Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073

Trade Name: Celebrex
Product Name: Celebrex
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole ,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole

Pfizer, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

4402

Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden

3398

EUCTR2005-002423-13-HU
(EUCTR)

19/12/2005

05/11/2005

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - NA

Rheumatoid arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Slovakia;Germany;Bulgaria;Italy

3399

EUCTR2005-003436-21-HU
(EUCTR)

15/12/2005

11/10/2005

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073

Product Name: SMP-114
Product Code: SMP-114

Sumitomo Pharmaceuticals Europe Limited

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Hungary;Czech Republic;Germany;United Kingdom

3400

EUCTR2004-001234-17-CZ
(EUCTR)

14/12/2005

31/10/2005

Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073

Trade Name: Celebrex
Product Name: Celebrex
Product Code: not applicable
INN or Proposed INN: Celecoxib
Other descriptive name: 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide
Trade Name: Voltrarol SR
Product Name: Voltrarol SR
Product Code: Not Applicable
INN or Proposed INN: Diclofenac sodium
Other descriptive name: sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate
Trade Name: Losec
Product Name: Losec
Product Code: not applicable
INN or Proposed INN: Omeprazole
Other descriptive name: benzimidazole ,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H-benzimidazole

Pfizer Limited

NULL

Not Recruiting

Female: yes
Male: yes

4402

Portugal;United Kingdom;Czech Republic;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3401

EUCTR2005-003495-38-DE
(EUCTR)

13/12/2005

06/10/2005

A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

440

United Kingdom;Germany;Estonia;Spain;Ireland;Greece

3402

EUCTR2005-000902-30-GB
(EUCTR)

09/12/2005

05/08/2005

A Study of the Pharmacodynamic Effects of Prednisolone on Whole Blood Protein and Gene Expression in Rheumatoid Arthritis Patients

Rheumatoid arthritis

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

3403

EUCTR2005-002392-32-GB
(EUCTR)

07/12/2005

15/09/2005

Active rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Slovenia;Ireland;Germany;United Kingdom;Sweden

3404

EUCTR2005-003495-38-EE
(EUCTR)

05/12/2005

29/11/2005

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

440

United Kingdom;Germany;Estonia;Spain;Ireland;Greece

3405

EUCTR2005-002395-15-IT
(EUCTR)

02/12/2005

02/03/2006

Trade Name: METHOTREXATE *100CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *25CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: MabThera
INN or Proposed INN: Rituximab

F. Hoffmann - La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;Spain;Czech Republic;Denmark;Germany;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3406

EUCTR2004-002482-20-GB
(EUCTR)

02/12/2005

15/02/2005

A Pilot Study to Test the Effect of Treating Depression Associated with Rueumatoid Arthritis (RA) using Venlaflaxine - Venlaflaxine & Numact Study

Symptoms of Depression as defined by the Hospital Anxiety and Depression Questionnaire associated with Rheumatoid Arthritis

Trade Name: Efexor XL 75 mg
Product Name: Efexor XL 75 mg (venlafaxine)
Product Code: NA
INN or Proposed INN: Venlafaxine Hydrochloride

Newcastle upon Tyne Hospitals NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

3407

NCT00705289
(ClinicalTrials.gov)

December 2005

23/6/2008

A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250)

Epidemiology, Correlation and Predictive Value of Disease Activity and Biomarkers in RA Patients Initiated on Infliximab in Clinical Practice

Rheumatoid Arthritis

Biological: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

N/A

All

728

N/A

NULL

3408

NCT00669942
(ClinicalTrials.gov)

December 2005

29/4/2008

Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients

A Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients With Pharmacodynamics Assessed in an Expanded Cohort at the Maximum Tolerated Dose

Rheumatoid Arthritis

Biological: AIN457;Drug: Placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

75 Years

All

104

Phase 1;Phase 2

United States;Belgium;Germany;Netherlands;Singapore;Spain

3409

NCT00642629
(ClinicalTrials.gov)

December 2005

20/3/2008

A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, Administered to Patients With Rheumatoid Arthritis to Determine Safety, Tolerability, Pharmacokinetic and Synovial Tissue Outcomes

Active, Moderate to Severe Rheumatoid Arthritis

Drug: STA 5326 mesylate;Drug: Placebo

Synta Pharmaceuticals Corp.

NULL

Completed

18 Years

N/A

Both

Phase 2

Netherlands

3410

NCT00281294
(ClinicalTrials.gov)

December 2005

20/1/2006

A Phase 2 Study to Evaluate the Safety, Tolerability, and Activity of Fontolizumab in Subjects With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Fontolizumab

PDL BioPharma, Inc.

NULL

Terminated

18 Years

N/A

Both

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3411

EUCTR2005-002396-33-IT
(EUCTR)

30/11/2005

01/03/2006

Trade Name: Mabthera
INN or Proposed INN: Rituximab

F. Hoffmann- La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

3412

EUCTR2005-003495-38-ES
(EUCTR)

25/11/2005

06/10/2005

Rheumatoid Arthritis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

United Kingdom;Germany;Estonia;Ireland;Spain;Greece

3413

EUCTR2005-002969-37-ES
(EUCTR)

25/11/2005

19/10/2005

A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship.Estudio aleatorizado, de grupos paralelos y controlado con placebo de la administración de una dosis única de GW856553 en pacientes con Artritis Reumatoide activa para investigar la relación entre la dosis y respuesta sobre la proteína C reactiva - GM2005/00244/00

Rheumatoid Arthritis

Product Code: GW856553
Product Code: GW856553
Product Code: GW856553

GlaxoSmithKline S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany;Spain;Sweden

3414

EUCTR2005-000784-26-GB
(EUCTR)

25/11/2005

15/07/2005

A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept plus Methotrexate Compared with Methotrexate Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005.

Rheumatoid Arthritis, Nos

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Belgium;Spain;Ireland;Austria;Germany;Italy;United Kingdom

3415

EUCTR2005-001889-13-SE
(EUCTR)

24/11/2005

13/10/2005

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - Re3

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: infliximab

Schering-Plough Research Institute, a division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

315

Portugal;Germany;Netherlands;Denmark;Belgium;France;Greece;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3416

EUCTR2005-000784-26-DE
(EUCTR)

23/11/2005

28/09/2005

A Phase IIIB, Multi-Center, Randomized, Double Blind, Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated with Abatacept Plus Methotrexate Compared with Methotrexate. Revised Protocol 04, incorporating Protocol Amendments 05, 06, 08, 09 (V1.0 dated 18-Nov-2008) and Administrative Letter 02. Pharmacogenetics Amendment 1 dated 16-May-2005. Protocol Amendments 3 & 4 - Site Specific - dated 28-Dec-2005. And Protocol Amendment 07 - Site Specific (v2.0, date 27-Jul-2007).

Rheumatoid Arthritis, Nos

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3B

Czech Republic;United Kingdom;Germany;Belgium;Spain;Ireland;Italy;Austria

3417

EUCTR2005-002392-32-IE
(EUCTR)

23/11/2005

13/09/2005

Active rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Slovenia;Ireland;Germany;United Kingdom;Sweden

3418

EUCTR2005-003495-38-IE
(EUCTR)

17/11/2005

13/09/2005

Rheumatoid Arthritis

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 2

Estonia;Greece;Spain;Ireland;Germany;United Kingdom

3419

EUCTR2004-005210-37-FI
(EUCTR)

17/11/2005

14/03/2005

A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

1200

Finland;Czech Republic;Germany;Spain;Sweden

3420

EUCTR2004-005102-68-BE
(EUCTR)

15/11/2005

25/07/2005

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating Amendments 2, 3 and 8. + Protocol Amendments 1 & 5.+ Protocol Amendment 11 - Site specific: All sites in Belgium (v1.0, dated 23-Sep-2008)

RHEUMATOID ARTHRITIS,NOS

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3421

EUCTR2005-002219-26-IT
(EUCTR)

11/11/2005

16/03/2007

Rheumatoid arthritis RA
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: SB-681323
Product Code: SB-681323
Product Name: SB-681323
Product Code: SB-681323

GLAXO SMITHKLINE

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden

3422

EUCTR2005-002219-26-DE
(EUCTR)

09/11/2005

20/07/2005

Rheumatoid arthritis (RA)

Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden

3423

EUCTR2004-000482-35-LT
(EUCTR)

08/11/2005

26/09/2005

A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis. - HM2004/00255/03

Rheumatoid Arthritis

Product Name: Rosiglitazone Extended Release Tablets
Product Code: BRL-049653
INN or Proposed INN: Rosiglitazone
Other descriptive name: Rosiglitazone maleate

GlaxoSmithKline Research & Development Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Lithuania

3424

EUCTR2004-004995-35-IT
(EUCTR)

08/11/2005

02/02/2007

Evaluate the difference in ACR-20 response between rheumatoid arthritis subjects treated with each of two doses of CRx-139 plus DMARD therapy and subjects treated with steroid plus DMARD therapy after 8 weeks of treatment.
MedDRA version: 6.1;Level: PT;Classification code 10039073

INN or Proposed INN: Paroxetine
INN or Proposed INN: Paroxetine
Trade Name: Prednisolene tablets BP 1 mg
INN or Proposed INN: Prednisolone

COMBINATORX, INC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 2

Czech Republic;Germany;United Kingdom;Denmark;Italy

3425

EUCTR2004-001825-69-IT
(EUCTR)

04/11/2005

14/12/2005

A Multi Center, Open label, Extension study of RA 1 using Extracoproreal photoimmune therapy with Uvadex

Rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073

Trade Name: UVADEX
INN or Proposed INN: Methoxsalen

THERAKOS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3426

EUCTR2004-005102-68-IT
(EUCTR)

03/11/2005

04/11/2005

Rheumatiod arthritis
MedDRA version: 6.1;Level: HLT;Classification code 10039075

Product Name: abatacept
Product Code: BMS-188667

BRISTOL-M.SQUIBB

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy

3427

NCT00162292
(ClinicalTrials.gov)

November 2005

9/9/2005

Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background

Rheumatoid Arthritis

Drug: BMS-582949 and Methotrexate

Bristol-Myers Squibb

NULL

Completed

18 Years

70 Years

Both

Phase 1

United States;Mexico

3428

NCT00256919
(ClinicalTrials.gov)

November 2005

21/11/2005

Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)

A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response Relationship

Arthritis, Rheumatoid

Drug: GW856553

GlaxoSmithKline

NULL

Completed

18 Years

N/A

Both

Phase 2

Bulgaria;Germany;Spain;Sweden;Ukraine

3429

NCT00316771
(ClinicalTrials.gov)

November 2005

20/4/2006

A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy

A Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy.

Rheumatoid Arthritis

Drug: P38 Inhibitor (4) 150mg;Drug: P38 Inhibitor (4) 25mg;Drug: P38 Inhibitor (4) 300mg;Drug: P38 Inhibitor (4) 50mg;Drug: P38 Inhibitor (4) 75mg;Drug: Placebo

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

374

Phase 2

South Africa;Spain;United Kingdom;United States;Australia;Brazil;Canada;Estonia;Germany;Greece;Ireland;Mexico;New Zealand;Poland

3430

NCT00292422
(ClinicalTrials.gov)

November 2005

15/2/2006

Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis

A Randomized, Blinded, Placebo-Controlled, Multicenter, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD Therapy

Rheumatoid Arthritis

Drug: BG9924

Biogen Idec

NULL

Completed

18 Years

75 Years

Both

Phase 2

United States;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3431

NCT00320450
(ClinicalTrials.gov)

November 2005

28/4/2006

SB-681323 In Subjects With Rheumatoid Arthritis

A Randomised, Parallel Group, Placebo-controlled, Double Blind Study to Assess the Safety and Tolerability of SB-681323 at 7.5mg Daily Dose for 28 Days and Its Effect on the Levels of Serum C-reactive Protein (CRP) in Subjects With Rheumatoid Arthritis (RA)

Arthritis, Rheumatoid

Drug: SB-681323

GlaxoSmithKline

NULL

Completed

18 Years

N/A

Both

Phase 2

Denmark;Germany;Hong Kong;Italy;Norway;Poland;Spain;Sweden;United Kingdom;Hungary

3432

NCT00380744
(ClinicalTrials.gov)

November 2005

22/9/2006

A Safety and Pharmacokinetics Study in Participants With Rheumatoid Arthritis

A Phase 1b/2 Multiple-Dose Safety Study and Pharmacokinetic/ Pharmacodynamic Study of LY2189102 in Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: LY2189102;Drug: placebo

Eli Lilly and Company

NULL

Completed

18 Years

75 Years

All

121

Phase 1;Phase 2

United States;Poland;Argentina;Hungary;Spain

3433

NCT00160641
(ClinicalTrials.gov)

November 2005

8/9/2005

A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050

Rheumatoid Arthritis

Biological: Certolizumab Pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

567

Phase 3

United States;Bulgaria;Croatia;Czechia;Estonia;Israel;Latvia;Lithuania;Poland;Russian Federation;Serbia;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro

3434

EUCTR2005-000158-61-LV
(EUCTR)

28/10/2005

22/11/2005

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: Celecoxib
INN or Proposed INN: Celecoxib

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

2210

Phase 3

Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania

3435

EUCTR2005-002326-63-LV
(EUCTR)

28/10/2005

22/11/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

590

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3436

EUCTR2005-003436-21-GB
(EUCTR)

26/10/2005

05/09/2005

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib

Dainippon Sumitomo Pharma Europe Ltd

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Hungary;Czech Republic;Germany;United Kingdom

3437

EUCTR2005-000784-26-IE
(EUCTR)

21/10/2005

15/08/2005

Rheumatoid Arthritis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3B

Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy;Austria

3438

EUCTR2005-000784-26-BE
(EUCTR)

21/10/2005

28/10/2005

Rheumatoid Arthritis, Nos

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3B

Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy;Austria

3439

EUCTR2005-000158-61-IE
(EUCTR)

21/10/2005

13/09/2005

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: Celebrex
Product Name: Celecoxib
INN or Proposed INN: Celecoxib

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

2210

Phase 3

Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Spain;Ireland;Italy;Latvia;Lithuania

3440

EUCTR2005-001319-23-IT
(EUCTR)

21/10/2005

30/09/2005

Rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: ERB-041
Product Code: ERB-041
Other descriptive name: NA
Product Name: ERB-041
Product Code: ERB-041
Other descriptive name: NA
Product Name: ERB-041
Product Code: ERB-041
Other descriptive name: NA

WYETH LEDERLE

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3441

EUCTR2005-002421-31-DE
(EUCTR)

20/10/2005

03/11/2005

A phase II randomised, double-blind, multicenter, placebo-controlled, dose-ranging, parallel group study to compare the efficacy, safety and tolerability of 3 strengths of AD 452 in adult subjects with active rheumatoid arthritis who are currently taking methotrexate. - Efficacy, safety and tolerability of AD 452 in patients wih RA

The purpose of this clinical trial is to evaluate the clinical efficacy, safety and tolerability of three doses of AD 452 in comparison with placebo in the treatment of subjects with active rheumatoid arthritis.
MedDRA version: 7.0;Level: PT;Classification code 10039073

Product Name: AD 452
INN or Proposed INN: (+) isomer of racemic mefloquine
Other descriptive name: (+)erythromefloquine
Product Name: AD 452
INN or Proposed INN: (+) isomer of racemic mefloquine
Other descriptive name: (+) erythromefloquine
Product Name: AD 452
INN or Proposed INN: (+) isomer or racemic mefloquine
Other descriptive name: (+) erythromefloquine

Arakis Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

292

Phase 2

United Kingdom;Germany

3442

EUCTR2005-002423-13-SK
(EUCTR)

18/10/2005

20/09/2005

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822

Rheumatoid arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Slovakia;Austria;Bulgaria;Germany;Italy

3443

EUCTR2005-003495-38-GB
(EUCTR)

18/10/2005

Rheumatoid Arthritis

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 2

Estonia;Greece;Spain;Ireland;Germany;United Kingdom

3444

EUCTR2004-004995-35-AT
(EUCTR)

16/10/2005

09/11/2005

ACTIVE RHEUMATOID ARTHRITIS

Trade Name: Paroxetine Hydrochloride tablets 10 & 20 mg and Prednisolone 1 mg BP
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone

CombinatoRx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

Czech Republic;Denmark;Austria;Germany;Italy;United Kingdom

3445

EUCTR2005-002969-37-SE
(EUCTR)

14/10/2005

29/08/2005

A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/02

Rheumatoid Arthritis

Product Code: GW856553
Product Code: GW856553
Product Code: GW856553

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Spain;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3446

EUCTR2005-001319-23-ES
(EUCTR)

14/10/2005

22/06/2005

A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy.Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, dirigido a evaluar la eficacia y la seguridad de 3 dosis orales distintas de ERB-041 en sujetos con artritis reumatoide en tratamiento de fondo con metotrexato

Rheumatoid arthritis

Product Name: ERB-041
Product Code: ERB-041
Product Name: ERB-041
Product Code: ERB-041
Product Name: ERB-041
Product Code: ERB-041

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and Development

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Hungary;Spain;Italy

3447

EUCTR2004-002846-36-AT
(EUCTR)

13/10/2005

08/09/2005

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Product Name: CP690,550
Product Code: CP690,550
INN or Proposed INN: N/A
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Product Name: CP690,550
Product Code: CP690,550
INN or Proposed INN: N/A
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,

Pfizer Corporation Austria Ges.m.b.H.

NULL

Not Recruiting

Female: yes
Male: yes

312

Phase 2A

Spain;Austria;Germany;Italy

3448

EUCTR2005-002392-32-SE
(EUCTR)

12/10/2005

19/09/2005

Active rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Slovenia;Ireland;Germany;United Kingdom;Sweden

3449

EUCTR2005-002392-32-SI
(EUCTR)

11/10/2005

26/10/2005

Active rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Slovenia;Ireland;Germany;United Kingdom;Sweden

3450

EUCTR2005-000784-26-ES
(EUCTR)

11/10/2005

13/09/2005

Rheumatoid Arthritis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3B

Czech Republic;Germany;United Kingdom;Belgium;Ireland;Spain;Italy;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3451

EUCTR2005-000784-26-CZ
(EUCTR)

04/10/2005

Rheumatoid Arthritis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3B

Germany;United Kingdom;Czech Republic;Belgium;Spain;Ireland;Italy;Austria

3452

EUCTR2004-002846-36-SK
(EUCTR)

03/10/2005

19/07/2005

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, DMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - N/A

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Pfizer Global & Developement, Pfizer Limited

NULL

Not Recruiting

Female: yes
Male: yes

312

Phase 2

Slovakia;Spain;Austria;Germany;Italy

3453

NCT00141102
(ClinicalTrials.gov)

October 2005

29/8/2005

Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis

Double-Blind, Triple Dummy, Parallel-Group, Randomized, Six-Month Study To Compare Celecoxib (200 Mg BID) With Diclofenac Sr (75 Mg BID) Plus Omeprazole (20 Mg QD) For Gastrointestinal Events In Subjects With Osteoarthritis And Rheumatoid Arthritis At High-Risk Of Gastrointestinal Adverse Events

Osteoarthritis;Arthritis, Rheumatoid

Drug: Celecoxib;Drug: Diclofenac + Omeprazole

Pfizer

NULL

Completed

18 Years

N/A

All

4484

Phase 4

Belgium;Brazil;Canada;China;Colombia;Costa Rica;Croatia;Czech Republic;Ecuador;Estonia;France;Germany;Greece;Guatemala;Hong Kong;India;Korea, Republic of;Latvia;Lithuania;Netherlands;Panama;Peru;Portugal;Russian Federation;Serbia;Singapore;South Africa;Spain;Sweden;Taiwan;Ukraine;United Kingdom;Former Serbia and Montenegro;Ireland

3454

NCT02720120
(ClinicalTrials.gov)

October 2005

22/3/2016

A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

A Randomized Placebo-Controlled, Multi-Center, Phase I/II Study of the Safety of Escalating Single Intravenous Doses of Ocrelizumab (rhuMAb 2H7, RO4964913, PRO70769) in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate But With Unsatisfactory Clinical Response

Rheumatoid Arthritis

Drug: Ocrelizumab;Drug: Placebo

Hoffmann-La Roche

NULL

Terminated

18 Years

80 Years

Both

175

Phase 1;Phase 2

Australia;Belgium;Canada;Netherlands;New Zealand;Russian Federation;Spain;United Kingdom

3455

EUCTR2005-001138-33-PT
(EUCTR)

29/09/2005

21/09/2005

A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
Trade Name: Methotrexate sodium tablets 2.5 mg
Product Name: Methotrexate sodium
INN or Proposed INN: Methotrexate sodium

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

650

Portugal;Denmark;Slovenia;Norway;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3456

EUCTR2005-002423-13-IT
(EUCTR)

28/09/2005

04/11/2005

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA 17822

Trade Name: RoActemra
INN or Proposed INN: RoActemra

F.Hoffmann La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Slovakia;Bulgaria;Germany;Italy

3457

EUCTR2005-001138-33-IT
(EUCTR)

28/09/2005

01/02/2007

A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate MTX monotherapy, in patients with active rheumatoid arthritis.

rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab
Product Code: Ro 48-77533
Trade Name: METHOTREXATE *25CPR 2,5MG
INN or Proposed INN: Methotrexate

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

650

Portugal;Denmark;Slovenia;Norway;Spain;Italy

3458

EUCTR2005-002219-26-ES
(EUCTR)

21/09/2005

10/10/2005

Rheumatoid arthritis (RA)

Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323

GlaxoSmithKline S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden

3459

EUCTR2005-002909-23-ES
(EUCTR)

21/09/2005

08/09/2005

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Estudio de extensión, a largo plazo, de la seguridad durante el tratamiento con tocilizumab (MRA) en pacientes con artritis reumatoide que hayan terminado el tratamiento en estudios trocales con MRA

Rheumatoid arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

2420

Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden

3460

EUCTR2005-002326-63-LT
(EUCTR)

21/09/2005

04/08/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

590

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3461

EUCTR2005-002326-63-SK
(EUCTR)

20/09/2005

05/08/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

590

Phase 3

Estonia;Czech Republic;Slovakia;Lithuania;Latvia

3462

EUCTR2005-002421-31-GB
(EUCTR)

16/09/2005

26/07/2005

A phase II randomized, double-blind, multicentre, placebo-controlled, dose-ranging, parallel group study to compare the efficacy, safety and tolerability of 3 strengths of AD 452 in adult subjects with active rheumatoid arthritis who are currently taking methotrexate

Rheumatoid arthritis
Level: PTClassification code 10039073

Product Name: AD 452 4.5 mg Tablet
Other descriptive name: (+) erythromefloquine
Product Name: AD 452 9 mg tablet
Other descriptive name: (+)erythromefloquine
Product Name: AD 452 18 mg tablet
Other descriptive name: (+)erythromefloquine

Arakis Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

292

Phase 2

Germany;United Kingdom

3463

EUCTR2004-005102-68-DE
(EUCTR)

15/09/2005

15/07/2005

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5. RNA Exploratory Research Sub-Study Amendment 7 Site-Specific, version 1.0 dated 7-Feb-2006.

RHEUMATOID ARTHRITIS,NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;United Kingdom;Germany;Belgium;Spain;Ireland;Italy

3464

EUCTR2005-001889-13-AT
(EUCTR)

15/09/2005

08/11/2005

Randomised controlled trial evaluating strategies to optimize disease activity control in RA patients treated with infliximab in clinical practice. - RE3

Adult subjects with a diganosis of Rheumatoid Arthritis presenting with a disease flare after an initial response to infliximab.

Trade Name: Remicade
Product Name: Remicade

Integrated Therapeutics Group, Inc. - A subsidiary of Schering-Plough Corp.

NULL

Not Recruiting

Female: yes
Male: yes

315

France;Portugal;Greece;Belgium;Denmark;Austria;Germany;Netherlands;Sweden

3465

EUCTR2004-005115-29-DE
(EUCTR)

14/09/2005

16/05/2006

A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship

Rheumatoid arthritis

Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: Overencapsulated Prednisolone Tablets
INN or Proposed INN: Prednisolone

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3466

EUCTR2005-001977-82-GB
(EUCTR)

09/09/2005

14/07/2005

A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety, tolerability, pharmacokinetics and effect on synovial thickness and vascularity of 28 days repeat dosing of GW274150 or 7.5mg prednisolone in RA subjects

Rheumatoid arthritis

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

3467

EUCTR2005-002219-26-SE
(EUCTR)

08/09/2005

14/07/2005

Rheumatoid arthritis (RA)

Product Name: SB-681323 Tablets
Product Code: SB-681323

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden

3468

EUCTR2005-002423-13-DE
(EUCTR)

06/09/2005

05/07/2005

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822

Rheumatoid arthritis

Trade Name: RoActemra
Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Slovakia;Germany;Bulgaria;Italy

3469

EUCTR2005-000551-15-GB
(EUCTR)

05/09/2005

05/08/2005

Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate

Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory polyarthritis associated with excess cardiovascular (CV) mortality. Hyperhomocysteinaemia is recognized as an independent CV risk factor and homocysteine levels are frequently elevated in RA patients.Endothelial dysfunction is considered a marker of early atherosclerotic disease and seems to correlate well with future increase CV risk. RA patients are known to have endothelial dysfunction.

Product Name: Allopurinol
Product Code: Allopurinol
INN or Proposed INN: Allopurinol
Product Name: Folic acid
Product Code: Folic acid
INN or Proposed INN: Folic acid

University of Dundee

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

3470

EUCTR2005-002326-63-CZ
(EUCTR)

05/09/2005

08/08/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

634

Phase 3

Czech Republic;Estonia;Latvia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3471

EUCTR2004-005102-68-GB
(EUCTR)

01/09/2005

27/05/2005

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options. Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5.

RHEUMATOID ARTHRITIS,NOS

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Belgium;Spain;Ireland;Germany;Italy;United Kingdom

3472

NCT00466037
(ClinicalTrials.gov)

September 2005

24/4/2007

The Effect of Rituximab on the Humoral Response to Influenza Vaccine

Vaccination Against Influenza in Rheumatoid Arthritis Patients: The Effect of Rituximab on the Humoral Response

Rheumatoid Arthritis

Biological: Influenza vaccine

Tel-Aviv Sourasky Medical Center

NULL

Terminated

18 Years

85 Years

Both

N/A

NULL

3473

NCT00691028
(ClinicalTrials.gov)

September 2005

3/6/2008

Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: TA-650 3 mg/kg;Drug: TA-650 6 mg/kg;Drug: TA-650 10 mg/kg

Mitsubishi Tanabe Pharma Corporation

NULL

Completed

20 Years

75 Years

All

327

Phase 3

NULL

3474

NCT00720798
(ClinicalTrials.gov)

September 2005

22/7/2008

An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Disease-modifying anti-rheumatic drugs;Drug: Non-steroidal anti-inflammatory drugs;Drug: Oral corticosteroids

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

2067

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Canada;China;Costa Rica;Czech Republic;Denmark;Finland;France;Germany;Hong Kong;Iceland;Israel;Italy;Lithuania;Mexico;Netherlands;Norway;Panama;Peru;Portugal;Puerto Rico;Russian Federation;Serbia;Slovenia;South Africa;Spain;Sweden;Switzerland;Thailand;United Kingdom

3475

EUCTR2004-004995-35-CZ
(EUCTR)

30/08/2005

ACTIVE RHEUMATOID ARTHRITIS

Trade Name: Prednisolone Tablets BP 1 mg
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone

CombinatoRx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

Germany;United Kingdom;Czech Republic;Denmark;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3476

EUCTR2005-002219-26-DK
(EUCTR)

23/08/2005

09/08/2005

Rheumatoid arthritis (RA)

Product Name: SB-681323 Tablets
Product Code: SB-681323

GlaxoSmithKline R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom;Sweden

3477

EUCTR2005-001138-33-DK
(EUCTR)

23/08/2005

20/06/2005

A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.

Rheumatoid Arthritis

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

650

Portugal;Slovenia;Denmark;Norway;Spain;Italy

3478

EUCTR2005-002423-13-AT
(EUCTR)

22/08/2005

18/07/2005

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822

Rheumatoid arthritis

Trade Name: RoActemra
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Slovakia;Austria;Bulgaria;Germany;Italy

3479

EUCTR2005-001633-14-DK
(EUCTR)

17/08/2005

30/06/2005

Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study

Rheumatoid arthritis

Trade Name: Humira
Product Name: Humira
Trade Name: Remicade
Product Name: Remicade

Hvidovre Hospital, Dept. Rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

112

Denmark;Sweden

3480

EUCTR2004-005102-68-ES
(EUCTR)

16/08/2005

17/06/2005

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including Protocol amendment 2 + Pharmacogenetic Amendment 1.

RHEUMATOID ARTHRITIS,NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Czech Republic;Germany;United Kingdom;Belgium;Ireland;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3481

EUCTR2005-000884-25-SE
(EUCTR)

11/08/2005

07/06/2005

A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann-La Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

450

United Kingdom;Germany;Iceland;Italy;Sweden

3482

EUCTR2005-000158-61-AT
(EUCTR)

10/08/2005

07/06/2005

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

2210

Phase 3

Czech Republic;Estonia;Hungary;Spain;Ireland;Lithuania;Denmark;Austria;Germany;Latvia;Italy;United Kingdom

3483

EUCTR2005-000158-61-ES
(EUCTR)

09/08/2005

09/06/2005

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: Artilog
Product Name: Celecoxib
INN or Proposed INN: Celecoxib

GlaxoSmithKline s.a.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2210

Phase 3

Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania

3484

EUCTR2005-000158-61-HU
(EUCTR)

08/08/2005

08/06/2005

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: Celecoxib
INN or Proposed INN: Celecoxib

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

2210

Phase 3

Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania

3485

EUCTR2004-005102-68-IE
(EUCTR)

05/08/2005

02/06/2005

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Protocol Version 4.0 including protocol amendment 2 + Pharmacogenetic Amendment 1.

RHEUMATOID ARTHRITIS,NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3486

EUCTR2005-001350-24-FI
(EUCTR)

04/08/2005

23/06/2005

A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Hungary;Finland;Czech Republic;Estonia;Latvia;Lithuania

3487

EUCTR2005-001350-24-HU
(EUCTR)

01/08/2005

19/05/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania

3488

NCT00508768
(ClinicalTrials.gov)

August 2005

27/7/2007

A Study of Oral SCIO-469 Pharmacokinetics (Study of a Drug in the Body to Watch How the Drug is Absorbed, Distributed, Metabolized and Eliminated Over a Period of Time) in the Body of Female Patients With Active Rheumatoid Arthritis

A Randomized, Double-Blind, Parallel-Group, Pharmacokinetic Study of Oral SCIO-469 (90 mg qd and 30 mg Tid) in Female Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Oral SCIO-469 capsule

Scios, Inc.

NULL

Completed

18 Years

N/A

Female

Phase 1

NULL

3489

NCT00141830
(ClinicalTrials.gov)

August 2005

30/8/2005

Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate plus ERB-041 for 12 weeks;Drug: Placebo for 12 weeks

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

80 Years

All

159

Phase 2

United States;Canada;Hungary;Italy;Mexico;Spain

3490

NCT00721123
(ClinicalTrials.gov)

August 2005

22/7/2008

A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis

Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in WA17822

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

538

Phase 3

Argentina;Australia;Austria;Brazil;Bulgaria;Canada;France;Germany;Hong Kong;Hungary;Israel;Italy;Mexico;Singapore;Slovakia;Switzerland;Thailand;China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3491

NCT00111410
(ClinicalTrials.gov)

August 2005

20/5/2005

Evaluating the Effect of Anakinra (r-metHuIL-1ra) on Vaccine AntibodyResponse in Subjects With Rheumatoid Arthritis (RA)

A Multicenter, Double-Blind, Randomized, Placebo Controlled Study to Estimate the Effect of Anakinra (r-metHuIL-1ra) on Vaccine Antibody Response in Subjects With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Anakinra (r-metHuIL-1ra)

Amgen

NULL

Completed

18 Years

74 Years

Both

Phase 4

NULL

3492

NCT00370435
(ClinicalTrials.gov)

August 2005

17/8/2006

Study Of 90mg Of GW274150 In Subjects Over 50 Years, Who Have Rheumatoid Arthritis (RA)

An Open-label, Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of 90mg of GW274150 in Adult and Elderly RA Subjects.

Arthritis, Rheumatoid

Drug: GW274150

GlaxoSmithKline

NULL

Completed

50 Years

N/A

All

Phase 2

United Kingdom

3493

NCT00141934
(ClinicalTrials.gov)

August 2005

31/8/2005

A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.

Phase II Randomised, Double-Blind, Multicentre, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of 3 Strengths of AD 452 in Adults With Active RA Who Are Currently Taking Methotrexate.

Rheumatoid Arthritis

Drug: AD 452

Sosei

NULL

Completed

18 Years

75 Years

Both

232

Phase 2

United States

3494

NCT00243412
(ClinicalTrials.gov)

August 2005

21/10/2005

A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate

A Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of Methotrexate

Rheumatoid Arthritis

Drug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: Placebo;Drug: Rituximab

Genentech, Inc.

NULL

Completed

18 Years

65 Years

All

Phase 2

United States

3495

EUCTR2005-001319-23-HU
(EUCTR)

22/07/2005

03/06/2005

Rheumatoid arthritis

Product Name: ERB-041
Product Code: ERB-041
INN or Proposed INN: Not available
Product Name: ERB-041
Product Code: ERB-041
INN or Proposed INN: Not available
Product Name: ERB-041
Product Code: ERB-041
INN or Proposed INN: Not available

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and Development

NULL

Not Recruiting

Female: yes
Male: yes

260

Hungary;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3496

EUCTR2004-002215-80-HU
(EUCTR)

20/07/2005

17/05/2005

A Double-Blind, Parallel, Randomized Extension Trial to Evaluate Safety and Efficacy of TMI-005 (Apratastat) in Subjects with Rheumatoid Arthritis on Methotrexate Who Have Completed Protocol 3140A1-200-WW

Rheumatoid Arthritis

Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005
Product Name: TMI-005 (WAY-177005)
Product Code: TMI-005 (WAY-177005)
INN or Proposed INN: Not yet established
Other descriptive name: WAY-177005

Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Hungary

3497

EUCTR2005-001350-24-EE
(EUCTR)

18/07/2005

14/06/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Hungary;Czech Republic;Estonia;Finland;Lithuania;Latvia

3498

EUCTR2005-000158-61-GB
(EUCTR)

18/07/2005

27/05/2005

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: Celebrex 200 mg capsule, hard
Product Name: Celecoxib
INN or Proposed INN: Celecoxib

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

2210

Phase 3

Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania

3499

EUCTR2005-001350-24-LT
(EUCTR)

14/07/2005

08/06/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania

3500

EUCTR2005-001138-33-LT
(EUCTR)

14/07/2005

30/05/2005

A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
Product Name: Methotrexate sodium
INN or Proposed INN: Methotrexate sodium

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

650

Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3501

EUCTR2004-004995-35-DE
(EUCTR)

14/07/2005

17/03/2005

ACTIVE RHEUMATOID ARTHRITIS

Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine
Product Name: N/A
Product Code: CRX-139
INN or Proposed INN: Prednisolone
Product Name: N/A
Product Code: CRX-139
INN or Proposed INN: paroxetine

CombinatoRx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

Czech Republic;United Kingdom;Germany;Denmark;Italy

3502

EUCTR2005-000884-25-GB
(EUCTR)

11/07/2005

19/04/2005

A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.

Rheumatoid Arthritis

F. Hoffmann-La Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Iceland;Germany;Italy;United Kingdom;Sweden

3503

EUCTR2005-001138-33-NO
(EUCTR)

06/07/2005

06/06/2005

A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.

Rheumatoid Arthritis

F. Hoffmann La-Roche AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

650

Portugal;Denmark;Slovenia;Norway;Spain;Italy

3504

EUCTR2005-001138-33-ES
(EUCTR)

05/07/2005

16/05/2006

A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.

Rheumatoid Arthritis

F. Hoffmann La-Roche AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

650

Portugal;Denmark;Slovenia;Norway;Spain;Italy

3505

EUCTR2004-005210-37-CZ
(EUCTR)

01/07/2005

30/06/2005

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

1200

Finland;Germany;Czech Republic;Spain;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3506

NCT00122382
(ClinicalTrials.gov)

July 2005

19/7/2005

Remission and Joint Damage Progression in Early Rheumatoid Arthritis

A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

Rheumatoid Arthritis

Drug: Abatacept;Drug: placebo;Drug: methotrexate

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

1052

Phase 3

United States;Australia;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Russian Federation;South Africa;Spain;United Kingdom;Austria;Ireland

3507

NCT00109408
(ClinicalTrials.gov)

July 2005

27/4/2005

A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

673

Phase 3

United States;Argentina;Australia;Canada;China;Denmark;France;Israel;Italy;Lithuania;Mexico;Norway;Peru;Portugal;Serbia;Slovenia;South Africa;Spain;Croatia;Former Serbia and Montenegro

3508

NCT00503425
(ClinicalTrials.gov)

June 30, 2005

17/7/2007

A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy.

An Open Label Study to Assess the Safety and Effect on Disease Activity of MabThera in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With DMARDs and/or One Anti-TNF Alpha Agent

Rheumatoid Arthritis

Drug: Rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

215

Phase 3

Israel

3509

EUCTR2004-002620-18-BE
(EUCTR)

30/06/2005

04/08/2005

Rheumatoid Arthritis, NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

250

United Kingdom;Germany;Belgium;Spain;Italy

3510

EUCTR2005-000884-25-IS
(EUCTR)

27/06/2005

27/04/2005

A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann-La Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Germany;Iceland;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3511

EUCTR2005-000158-61-DK
(EUCTR)

24/06/2005

02/06/2005

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: Celecoxib
INN or Proposed INN: Celecoxib

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

2210

Phase 3

Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania

3512

EUCTR2004-005115-29-GB
(EUCTR)

24/06/2005

27/05/2005

A randomised, placebo-controlled, parallel group single dose study of SB681323 in patients with active RA to investigate the CRP dose response relationship

Rheumatoid arthritis

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany;United Kingdom

3513

NCT00134693
(ClinicalTrials.gov)

June 21, 2005

24/8/2005

A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis

A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship

Arthritis, Rheumatoid

Drug: Prednisolone;Drug: SB-681323

GlaxoSmithKline

NULL

Completed

18 Years

N/A

All

Phase 2

Australia;France;Germany;Russian Federation;United Kingdom

3514

EUCTR2005-001350-24-LV
(EUCTR)

21/06/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania

3515

EUCTR2004-003741-40-SK
(EUCTR)

16/06/2005

07/12/2004

A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

Hungary;Slovakia;Austria;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3516

EUCTR2005-000549-13-CZ
(EUCTR)

15/06/2005

02/05/2005

A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA

rheumatoid arthritis

Product Code: VX-702

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Czech Republic

3517

EUCTR2005-000884-25-DE
(EUCTR)

14/06/2005

13/04/2005

A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann-La Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

450

United Kingdom;Germany;Iceland;Italy;Sweden

3518

EUCTR2004-002846-36-DE
(EUCTR)

14/06/2005

01/03/2005

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Pfizer Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

312

Phase 2A

Germany;Spain;Italy

3519

EUCTR2004-002993-49-DE
(EUCTR)

10/06/2005

25/01/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

3520

EUCTR2005-000158-61-IT
(EUCTR)

09/06/2005

05/01/2006

RHEUMATOID ARTHRITIS
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: GW406381
Product Code: GW406381
Product Name: GW406381
Product Code: GW406381
Product Name: GW406381
Product Code: GW406381
Product Name: GW406381
Product Code: GW406381
Trade Name: CELEBREX 200MG 20CPS
INN or Proposed INN: Celecoxib

GLAXO SMITHKLINE

NULL

Not Recruiting

Female: yes
Male: yes

2208

Phase 3

Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3521

NCT00202852
(ClinicalTrials.gov)

June 1, 2005

13/9/2005

A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED)

A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate

Arthritis, Rheumatoid

Other: Placebo;Drug: MTX;Biological: Infliximab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

75 Years

All

143

Phase 3

Korea, Republic of

3522

NCT00113308
(ClinicalTrials.gov)

June 2005

7/6/2005

COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg Administered Orally Once Daily, in Adults With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: GW406381

GlaxoSmithKline

NULL

Completed

18 Years

N/A

All

2208

Phase 3

United States;Argentina;Austria;Belgium;Bulgaria;Canada;Chile;Costa Rica;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Latvia;Mexico;Netherlands;New Zealand;Norway;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic;Estonia;Lithuania;Pakistan;Slovakia;Taiwan

3523

NCT00160602
(ClinicalTrials.gov)

June 2005

8/9/2005

A Study of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

A Phase III Multi-center, Double-blind, Placebo-controlled, Parallel Group 24-Week Study to Assess the Efficacy and Safety of Two Dose Regimens of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate.

Rheumatoid Arthritis

Drug: Certolizumab Pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

590

Phase 3

United States;Bulgaria;Chile;Croatia;Czechia;Estonia;Israel;Latvia;Lithuania;Mexico;Poland;Russian Federation;Serbia;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro

3524

NCT00233558
(ClinicalTrials.gov)

June 2005

13/9/2005

Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis

Multicentre, Randomised, Open Label Study Comparing a Scheduled Steroid Reduction Strategy” Versus a Free Steroid Reduction Strategy (Physician’s Usual Practice for Reducing Steroids) in Patients With Active RA Treated With Humira 40 mg Eow + MTX During 9 Months

Rheumatoid Arthritis

Drug: adalimumab (up to 9 months exposure);Drug: methotrexate

Abbott

NULL

Terminated

18 Years

N/A

Both

160

Phase 4

United States

3525

NCT00175877
(ClinicalTrials.gov)

June 2005

9/9/2005

A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Certolizumab Pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

857

Phase 3

United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Croatia;Czechia;Estonia;Finland;France;Hungary;Israel;Latvia;Lithuania;Mexico;New Zealand;Russian Federation;Serbia;Slovakia;Ukraine;Czech Republic;Former Serbia and Montenegro;Netherlands;Spain;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3526

NCT00205478
(ClinicalTrials.gov)

June 2005

12/9/2005

Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo Controlled Study of Two Doses of VX-702 in Subjects With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: VX-702

Vertex Pharmaceuticals Incorporated

NULL

Completed

18 Years

75 Years

Both

300

Phase 2

Bulgaria;Croatia;Czech Republic;Former Serbia and Montenegro;Poland;Russian Federation;Slovakia;Slovenia;Ukraine

3527

NCT00688103
(ClinicalTrials.gov)

June 2005

25/5/2008

Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan

Efficacy and Safety of Etanercept in Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan

Rheumatoid Arthritis

Drug: ETN Alone;Drug: ETN +MTX

Japan Biological Agent Study Integrated Consortium

NULL

Completed

18 Years

N/A

All

151

Phase 4

Japan

3528

EUCTR2005-001350-24-SK
(EUCTR)

31/05/2005

21/04/2005

A Phase III multi-centre, open-label, follow-on study to CDP870-027, to assess the efficacy and safety of lyophilised CDP870 an engineered human anti-TNF PEG conjugate, dosed subcutaneously at 400 mg every two weeks as additional medication to methotrexate, in the treatment of signs and symptoms and preventing structural damage in patients with active rheumatoid arthritis - Follow-on study for CDP870-027

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Latvia

3529

EUCTR2005-001350-24-CZ
(EUCTR)

27/05/2005

04/05/2005

Rheumatoid arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: CDP870 Fab'-PEG

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Finland;Hungary;Czech Republic;Estonia;Latvia;Lithuania

3530

EUCTR2004-002993-49-GB
(EUCTR)

17/05/2005

23/02/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;United Kingdom;Estonia;Latvia;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3531

EUCTR2004-002620-18-DE
(EUCTR)

13/05/2005

16/02/2005

A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid Arthritis.Revised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03;and Pharmacogenetics Blood Sample Amendment Number 01

Rheumatoid Arthritis, NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

250

United Kingdom;Germany;Belgium;Spain;Italy

3532

EUCTR2004-002620-18-IT
(EUCTR)

11/05/2005

19/09/2005

A multi-national randomized, double-blind exploratory study of Abatacept versus placebo in preventing the development of rheumatoid arthritis in adults subjects with undifferentiated inflammatory arthritis at high risk for the development of rheumatoid arthritis.

rheumatoid arthritis
MedDRA version: 6.1;Level: HLT;Classification code 10039075

Product Name: CTLA4Ig
Product Code: BMS-188667

BRISTOL-M.SQUIBB

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Germany;Belgium;Spain;Italy

3533

EUCTR2004-002620-18-ES
(EUCTR)

06/05/2005

29/03/2006

Rheumatoid Arthritis, NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

United Kingdom;Germany;Belgium;Spain;Italy

3534

EUCTR2004-002993-49-BE
(EUCTR)

05/05/2005

19/07/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Estonia;Czech Republic;Hungary;Finland;Belgium;Lithuania;Latvia;Sweden

3535

EUCTR2004-005210-37-DE
(EUCTR)

04/05/2005

10/03/2005

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

1200

Finland;Czech Republic;Germany;Spain;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3536

EUCTR2005-000549-13-SK
(EUCTR)

03/05/2005

05/04/2005

A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo-Controlled Study of Two Doses of VX-702 in Subjects with Moderate to Severe Rheumatoid Arthritis - VeRA

rheumatoid arthritis

Product Code: VX-702

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Czech Republic;Slovakia

3537

EUCTR2005-000884-25-IT
(EUCTR)

02/05/2005

22/06/2005

A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combionation with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.

rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: Tocilizumab
Product Code: Ro 48-77533
Trade Name: METHOTREXATE *2,5MG 25CPR
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *7,5MG/ML 4SIR.
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *10MG/1,33ML 4S
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *20MG/2,66ML 4S
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *15MG/2ML 4SIR
INN or Proposed INN: Methotrexate

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

570

United Kingdom;Germany;Iceland;Italy;Sweden

3538

NCT00115219
(ClinicalTrials.gov)

May 2005

21/6/2005

Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis (RA) Subjects Who Are Sub-Optimal Responders to Etanercept 50 mg Once Weekly (QW)

A Multi-center, Randomized, Double-Blind, Active-Controlled Study Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis Subjects Who Are Sub-optimal Responders to Etanercept 50 mg Once Weekly (QW)

Rheumatoid Arthritis

Drug: Etanercept

Amgen

NULL

Completed

18 Years

N/A

Both

200

Phase 4

United States

3539

NCT00419809
(ClinicalTrials.gov)

May 2005

5/1/2007

SB-681323-Methotrexate Interaction Study

A Placebo Controlled Study to Evaluate the Safety and Tolerability of Repeat Doses of SB-681323 in Patients Receiving Methotrexate for Rheumatoid Arthritis.

Arthritis, Rheumatoid

Drug: SB-681323 oral tablets

GlaxoSmithKline

NULL

Completed

18 Years

75 Years

Both

Phase 1

Australia

3540

NCT00432484
(ClinicalTrials.gov)

May 2005

6/2/2007

Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis

Lingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I Study

Rheumatoid Arthritis

Drug: Lingzhi and Sen Miao San

Chinese University of Hong Kong

NULL

Completed

18 Years

N/A

Both

Phase 2

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3541

NCT00106522
(ClinicalTrials.gov)

May 2005

25/3/2005

A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy

A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

499

Phase 3

United States;Australia;Belgium;Canada;France;Germany;Iceland;Italy;Mexico;Netherlands;Puerto Rico;Sweden;Switzerland;United Kingdom

3542

EUCTR2004-005210-37-SE
(EUCTR)

26/04/2005

10/03/2005

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

1200

Finland;Czech Republic;Germany;Spain;Sweden

3543

EUCTR2004-002846-36-IT
(EUCTR)

26/04/2005

20/06/2005

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO COMPARE 3 DOSE LEVELS OF CP-690,550 VERSUS PLACEBO, ADMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: CP 690,550
Product Code: CP 690,550
Product Name: CP 690,550
Product Code: CP 690,550
Product Name: CP 690,550
Product Code: CP 690,550

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

312

Phase 2A

Germany;Spain;Italy

3544

EUCTR2004-003741-40-HU
(EUCTR)

15/04/2005

07/02/2005

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Germany;Italy

3545

EUCTR2004-002620-18-GB
(EUCTR)

14/04/2005

15/06/2005

A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versusPlacebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects withUndifferentiated Inflammatory Arthritis at High Risk for the Development ofRheumatoid ArthritisRevised protocol 2, dated 02-Feb-06, incorporating Amendments 02 and 03;and Pharmacogenetics Blood Sample Amendment Number 01

Rheumatoid Arthritis, NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

Spain;Belgium;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3546

EUCTR2004-002846-36-ES
(EUCTR)

12/04/2005

24/01/2006

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTERSTUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, DMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE IGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLD;Classification code 10039073

Product Name: CP690,550
Product Code: CP690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Product Name: CP690,550
Product Code: CP690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,

Pfizer, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

312

Phase 2A

Germany;Spain;Italy

3547

EUCTR2005-000674-43-GB
(EUCTR)

06/04/2005

03/10/2005

AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis

Rheumatoid Arthritis

University of Leeds

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

3548

NCT00106574
(ClinicalTrials.gov)

April 2005

25/3/2005

A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

Rheumatoid Arthritis

Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

1220

Phase 3

United States;Argentina;Australia;Brazil;Canada;China;Costa Rica;Czech Republic;Finland;France;Germany;Hong Kong;Mexico;Panama;Russian Federation;South Africa;Spain;Sweden;Thailand

3549

NCT00124982
(ClinicalTrials.gov)

April 2005

30/6/2005

Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options

Rheumatoid Arthritis

Drug: Abatacept;Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD);Drug: Anti-Tumor Necrosing Factor (TNF) Therapy

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

1286

Phase 3

United States;Belgium;Czech Republic;France;Germany;Ireland;Italy;Mexico;Spain;United Kingdom;Canada

3550

NCT01745055
(ClinicalTrials.gov)

April 2005

4/12/2012

Co-Administration Of Methotrexate And CP-690,550

A Phase 1, Open Label Study Of The Pharmacokinetics Of Multiple Doses Of Oral CP-690,550 And Single Doses Of Oral Methotrexate In Rheumatoid Arthritis Subjects

Rheumatoid Arthritis

Drug: CP -690,550 (tofacitinib);Drug: Methotrexate (MTX)

Pfizer

NULL

Completed

18 Years

70 Years

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3551

EUCTR2004-005210-37-ES
(EUCTR)

29/03/2005

04/11/2005

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Finland;Czech Republic;Germany;Spain;Sweden

3552

EUCTR2004-002993-49-FI
(EUCTR)

29/03/2005

16/12/2004

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870

Celltech R&D Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Hungary;Finland;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

3553

EUCTR2004-004022-27-ES
(EUCTR)

24/03/2005

04/11/2005

Phase IIa, multicenter, randomised, double-blind, placebo controlled study of the efficacy and safety of RO0506997, an a4 integrin antagonist, in combination with methotrexate, versus methotrexate alone, in patients with mild/moderate active rheumatoid arthritis (RA) who have had a partial response to a stable dose of methotrexate.

Rhematoid Arthritis
Classification code 10039073

Product Code: RO0506997
INN or Proposed INN: N/A
Product Code: RO0506997
INN or Proposed INN: N/A
Product Code: RO0506997
INN or Proposed INN: N/A
Product Code: RO0506997
INN or Proposed INN: N/A

F.Hoffmann - La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2a

Spain

3554

EUCTR2004-003733-14-FI
(EUCTR)

23/03/2005

17/11/2004

A study investigating whether tocilizumab (study drug) prevents joint damage, and how safe it is, in patients with moderate to severe rheumatoid arthritis randomly divided to groups receiving treatment with tocilizumab and methotrexate or methotrexate and placebo.

A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. - LITHE

Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: Tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody

F. Hoffmann La-Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1170

France;Norway;Italy;Australia;Brazil;South Africa;Finland;Denmark;Mexico;China;Spain;United States;Greece;Poland

3555

EUCTR2004-004302-24-DE
(EUCTR)

23/03/2005

11/01/2005

A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability, and Satety Study in Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA

Merck & Co. Inc.

NULL

Not Recruiting

Female: yes
Male: yes

136

Finland;Czech Republic;Germany;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3556

EUCTR2005-000129-47-SE
(EUCTR)

21/03/2005

25/02/2005

The effect of Adalimumab (Humira) on vascular abnormalities in rheumatoid arthritis. A pilot study.

Rheumatoid Arthritis.

Trade Name: Humira
Product Name: Humira
INN or Proposed INN: Adalimumab

Dept. of Rhematology UMAS

NULL

Not Recruiting

Female: yes
Male: yes

Sweden

3557

EUCTR2004-000074-31-BE
(EUCTR)

15/03/2005

07/07/2004

A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of L-000124467 in Rheumatoid Arthritis Patients - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis

rheumatoid arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Merck Sharp & Dohme BV

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2

Belgium;Sweden

3558

EUCTR2004-002993-49-SE
(EUCTR)

15/03/2005

05/01/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870

UCB Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania;Sweden

3559

EUCTR2004-000922-59-CZ
(EUCTR)

15/03/2005

Rheumatoid Arthrithis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

675

Phase 3

Czech Republic;Denmark;Spain;Sweden

3560

EUCTR2004-004302-24-CZ
(EUCTR)

09/03/2005

04/02/2005

A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA
Trade Name: PARALEN 500
Product Name: PARALEN 500
Product Code: 8594739041288
INN or Proposed INN: paracetamol
Other descriptive name: NA

Merck & Co., Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Finland;Germany;Czech Republic;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3561

EUCTR2004-004302-24-IT
(EUCTR)

09/03/2005

10/08/2007

A Randomized, Placebo-Controlled, Parallel-Group, Double Blind, 12 week study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: L-883191

MERCK SHARP DOHME

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Finland;Czech Republic;Germany;Spain;Italy

3562

EUCTR2004-000563-96-FI
(EUCTR)

08/03/2005

11/10/2004

A 24-MONTH, RANDOMIZED, DOUBLE-BLIND, TWO PERIOD STUDY TO EVALUATE THE EFFICACY AND SAFETY OF THE COMBINATION OF ETANERCEPT AND METHOTREXATE AND METHOTREXATE ALONE IN SUBJECTS WITH ACTIVE EARLY RHEUMATOID ARTHRITIS: COMBINATION OF METHOTREXATE AND ETANERCEPT IN ACTIVE EARLY RHEUMATOID ARTHRITIS (COMET) - COMET

Rheumatoid Arthritis

Product Name: Enbrel (etanercept)
Product Code: 0881
INN or Proposed INN: etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Product Name: methotrexate sodium tablets 2.5 mg
INN or Proposed INN: methotrexate
Other descriptive name: methotrexate
Product Name: methotrexate sodium tablets 2.5 mg
INN or Proposed INN: methotrexate
Other descriptive name: methotrexate

Wyeth Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

580

Hungary;Finland;Denmark;Norway;Ireland;Spain;Italy;Sweden

3563

NCT00144586
(ClinicalTrials.gov)

March 2005

2/9/2005

Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA220JP or MRA221JP

Rheumatoid Arthritis

Drug: MRA(Tocilizumab)

Chugai Pharmaceutical

NULL

Completed

20 Years

75 Years

Both

Phase 3

NULL

3564

NCT00503503
(ClinicalTrials.gov)

March 2005

16/7/2007

Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan

Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan

Rheumatoid Arthritis

Drug: Enbrel (etanercept)

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

11 Years

90 Years

Both

NULL

3565

EUCTR2004-003741-40-DE
(EUCTR)

28/02/2005

01/12/2004

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3566

EUCTR2004-002993-49-LV
(EUCTR)

28/02/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

3567

EUCTR2004-000012-13-IT
(EUCTR)

18/02/2005

12/04/2007

A Double-Blind, Placebo-controlled, Parallel, Randomized Study to evaluate the Efficacy and Safety of 3 Oral Dose levels of TMI-005 in Subjects with Active Rheumatoid Arthritis on A Background of Methotrexate -

heumatoid Artrhitis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: TMI-005 WAY-177005
Product Code: TMI-005 WAY-177005
INN or Proposed INN: Apratastat
Product Name: TMI-005 WAY-177005
Product Code: TMI-005 WAY-177005
INN or Proposed INN: Apratastat
Product Name: TMI-005 WAY-177005
Product Code: TMI-005 WAY-177005
INN or Proposed INN: Apratastat

WYETH LEDERLE

NULL

Not Recruiting

Female: yes
Male: yes

360

Czech Republic;Estonia;Italy

3568

EUCTR2004-004302-24-ES
(EUCTR)

16/02/2005

04/11/2005

Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA
Trade Name: Paracetamol
Product Name: Paracetamol
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: NA

Merck & Co. Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Finland;Czech Republic;Germany;Spain;Italy

3569

EUCTR2004-002993-49-CZ
(EUCTR)

11/02/2005

04/02/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Germany;Czech Republic;Estonia;Latvia;Sweden;Lithuania

3570

EUCTR2004-002993-49-HU
(EUCTR)

11/02/2005

15/12/2004

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3571

EUCTR2004-002993-49-LT
(EUCTR)

09/02/2005

03/01/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

3572

EUCTR2004-002993-49-SK
(EUCTR)

08/02/2005

31/01/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Celltech

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Estonia;Czech Republic;Hungary;Slovakia;Finland;Belgium;Lithuania;Latvia;Sweden

3573

EUCTR2004-002132-26-ES
(EUCTR)

07/02/2005

07/12/2005

A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of rhuMAb 2H7 (Ro 496-4913, PRO70769) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A

Rheumatoid Arthritis

Product Name: rhuMAb 2H7
Product Code: Ro 496-4913
INN or Proposed INN: N/A
Other descriptive name: rhuMAb 2H7

F Hoffmann-La Roche Limited

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 1;Phase 2

United Kingdom;Spain

3574

EUCTR2004-004893-96-GB
(EUCTR)

04/02/2005

15/02/2005

Randomised double-blind trial of combination antibiotic therapy in rheumatoid arthritis

Patients with medical diagnosis of Rheumatoid Arthritis

Trade Name: Dalacin C phosphate
Product Name: Clindamycin
Trade Name: Tetraccycline
Product Name: Tetraccycline -hydrochloride

Hammersmith Hospitals NHS trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

United Kingdom

3575

EUCTR2004-001909-10-GB
(EUCTR)

02/02/2005

15/08/2005

Effect of Rosuvastatin on surrogate markers for cardiovascular events and joint disease progression in patients with rheumatoid arthritis - RORA trial

Rheumatoid Arthritis

Trade Name: rosuvastatin
Product Name: rosuvastatin
Product Code: ZD 4522

University of Dundee

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3576

EUCTR2004-000922-59-DK
(EUCTR)

02/02/2005

01/12/2004

Rheumatoid Arthrithis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

675

Phase 3

Czech Republic;Denmark;Spain;Sweden

3577

NCT00105976
(ClinicalTrials.gov)

February 2005

18/3/2005

Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX)

A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Dose Levels (2.5, 7.5 and 20 mg) of MM-093 in Patients With Active Rheumatoid Arthritis on Stable Doses of Methotrexate

Rheumatoid Arthritis

Drug: MM-093

Merrimack Pharmaceuticals

NULL

Completed

18 Years

80 Years

Both

260

Phase 2

United States

3578

NCT00124449
(ClinicalTrials.gov)

February 2005

30/6/2005

Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients

A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

Arthritis, Rheumatoid

Drug: Abatacept;Drug: placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Australia;Belgium;France;Germany;Italy;Mexico;Puerto Rico;Spain;United Kingdom

3579

NCT00144560
(ClinicalTrials.gov)

February 2005

2/9/2005

Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)

An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA

Rheumatoid Arthritis

Drug: MRA(Tocilizumab)

Chugai Pharmaceutical

NULL

Completed

20 Years

75 Years

Both

N/A

NULL

3580

NCT00291928
(ClinicalTrials.gov)

February 2005

14/2/2006

HuMax-CD20 in Active Rheumatoid Arthritis, Phase I/II

A Double-blind, Randomized, Placebo Controlled, Dose Escalation, Multi-centerphase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20antibody, in Patients With Active Rheumatoid Arthritis Who Have Previously Failedone or More Disease Modifying Anti-rheumatic Drugs

Arthritis, Rheumatoid

Drug: Part A;Drug: Part B

GlaxoSmithKline

NULL

Completed

18 Years

N/A

Both

201

Phase 2

United States;Denmark;Finland;France;Hungary;Poland;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3581

NCT00152386
(ClinicalTrials.gov)

February 2005

7/9/2005

A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis

A Phase III Multicentre, Double Blind, Placebo-controlled, Parallel Group 52-week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

Rheumatoid Arthritis

Drug: Certolizumab pegol (CDP870)

UCB Pharma

NULL

Completed

18 Years

N/A

All

950

Phase 3

Croatia;Czechia;Israel;Latvia;Russian Federation;Ukraine;United States;Czech Republic;Argentina;Australia;Belgium;Bulgaria;Canada;Chile

3582

NCT00095147
(ClinicalTrials.gov)

February 2005

1/11/2004

Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate

Rheumatoid Arthritis

Drug: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB);Drug: Infliximab (INF) + MTX, DB;Drug: Placebo (PLA) + MTX, DB;Drug: PLA + MTX switched to ABA+ MTX, DB;Drug: ABA, open-label (OL)

Bristol-Myers Squibb

NULL

Completed

18 Years

75 Years

All

431

Phase 3

United States;Argentina;Australia;Brazil;Canada;Czech Republic;Denmark;Korea, Republic of;Mexico;Peru;Poland;Puerto Rico;Russian Federation;South Africa;Spain;Sweden;Switzerland

3583

EUCTR2004-003733-14-ES
(EUCTR)

28/01/2005

07/12/2005

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

1170

Finland;Denmark;Spain;Italy

3584

EUCTR2004-003733-14-DK
(EUCTR)

26/01/2005

07/12/2004

A randomized, double-blind, parallel group study of the safetyand prevention of structural joint damage during treatment withMRA versus placebo, in combination with methotrexate, inpatients with moderate to severe active rheumatoid arthritis.

Rheumatoid arthritis

Trade Name: RoActemra ®
Product Name: Tocilizumab Roche
Product Code: RO4877533
INN or Proposed INN: Tocilizumab Roche
Other descriptive name: MRA, Actemra

F Hoffmann La-Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1170

Finland;Spain;Denmark;Italy

3585

EUCTR2004-000012-13-EE
(EUCTR)

20/01/2005

A Double-Blind, Placebo-Controlled, Parallel, Randomized Study To Evaluate The Efficacy And Safety Of 3 Oral Dose Levels Of TMI-005 In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate -

Rheumatoid Arthritis

Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development

NULL

Not Recruiting

Female: yes
Male: yes

360

Czech Republic;Estonia;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3586

EUCTR2004-000563-96-AT
(EUCTR)

19/01/2005

15/12/2004

Rheumatoid Arthritis

Trade Name: Enbrel (etanercept)
Product Name: Enbrel (etanercept)
Product Code: 0881
INN or Proposed INN: etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: METHOTREXAT Lederle - Tabletten
Product Name: methotrexate sodium tablets 2.5 mg
INN or Proposed INN: methotrexate
Other descriptive name: methotrexate
Trade Name: METHOTREXAT Lederle - Tabletten
Product Name: methotrexate sodium tablets 2.5 mg
INN or Proposed INN: methotrexate
Other descriptive name: methotrexate

Wyeth Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

580

Hungary;Finland;Spain;Ireland;Denmark;Austria;Norway;Italy;Sweden

3587

EUCTR2004-004302-24-FI
(EUCTR)

18/01/2005

17/11/2004

Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Suomen MSD Oy

NULL

Not Recruiting

Female: yes
Male: yes

136

Finland;Czech Republic;Germany;Spain;Italy

3588

NCT00246168
(ClinicalTrials.gov)

January 2005

28/10/2005

ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.

ULTRACET (Tramadol Hydrochloride and Acetaminophen) add-on Therapy for the Treatment of the Pain of Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled Study

Arthritis, Rheumatoid

Drug: tramadol hydrochloride + acetaminophen

Janssen Korea, Ltd., Korea

NULL

Completed

18 Years

79 Years

Both

277

Phase 4

NULL

3589

NCT00365001
(ClinicalTrials.gov)

January 2005

15/8/2006

A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.

A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate;Drug: Simvastatin

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States;New Zealand

3590

NCT00106535
(ClinicalTrials.gov)

January 2005

25/3/2005

A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)

A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

1196

Phase 3

United States;Australia;Brazil;China;Denmark;Finland;France;Greece;Italy;Mexico;Norway;Poland;Puerto Rico;South Africa;Spain;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3591

NCT00144573
(ClinicalTrials.gov)

January 2005

2/9/2005

Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment

An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment

Rheumatoid Arthritis

Drug: MRA(Tocilizumab)

Chugai Pharmaceutical

NULL

Completed

20 Years

75 Years

Both

N/A

NULL

3592

NCT00132769
(ClinicalTrials.gov)

January 2005

2/8/2005

A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)

A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MK-0873;Drug: Comparator: Placebo

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

65 Years

All

106

Phase 2

Belgium;Canada;Czech Republic;Finland;Germany;Italy;Norway;Spain;Switzerland

3593

NCT00147498
(ClinicalTrials.gov)

January 2005

2/9/2005

Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: CP -690,550;Other: Placebo

Pfizer

NULL

Completed

18 Years

70 Years

All

264

Phase 2

United States;Belgium;Brazil;Canada;Germany;Italy;Mexico;Slovakia;Spain;Austria

3594

NCT00106548
(ClinicalTrials.gov)

January 2005

25/3/2005

A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

623

Phase 3

Argentina;Australia;Austria;Brazil;Bulgaria;Canada;China;France;Germany;Hungary;Israel;Italy;Mexico;Singapore;Slovakia;Switzerland;Thailand;Spain

3595

NCT00583557
(ClinicalTrials.gov)

January 2005

20/12/2007

A Continuation Trial for Subjects With Rheumatoid Arthritis That Have Completed Protocol LBRA01

A Multi-Center, Open-Label, Continuation Trial of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA) Who Completed the Phase 2 Protocol LBRA01

Rheumatoid Arthritis

Drug: belimumab

Human Genome Sciences Inc.

NULL

Terminated

18 Years

N/A

All

155

Phase 2

United States;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3596

NCT00123149
(ClinicalTrials.gov)

January 2005

19/7/2005

Open-Label Extension Safety Study of PROCRIT in Patients With Anemia of Chronic Disease Due to Rheumatoid Arthritis

An Open-Label (OL) Extension Study to Assess Safety of PROCRIT (Epoetin Alfa) in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis (RA)

Anemia;Rheumatoid Arthritis

Drug: Epoetin alfa

Ortho Biotech Products, L.P.

NULL

Withdrawn

18 Years

99 Years

Both

Phase 2

NULL

3597

EUCTR2004-002157-30-SK
(EUCTR)

27/12/2004

10/11/2004

A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis

Rheumatoid Arthritis

Product Code: TAK-715
Product Code: TAK-715

Takeda Europe R&D Centre Ltd. (TEuR&D)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

Slovakia;Finland;Denmark

3598

EUCTR2004-000563-96-ES
(EUCTR)

22/12/2004

26/10/2004

Rheumatoid Arthritis

Trade Name: Enbrel (etanercept)
Product Name: Enbrel (etanercept)
Product Code: 0881
INN or Proposed INN: etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: METOTREXATO -LEDERLE 2,5 MG COMPRIMIDOS
Product Name: methotrexate sodium tablets 2.5 mg
INN or Proposed INN: methotrexate
Other descriptive name: methotrexate
Trade Name: METOTREXATO -LEDERLE 2,5 MG COMPRIMIDOS
Product Name: methotrexate sodium tablets 2.5 mg
INN or Proposed INN: methotrexate
Other descriptive name: methotrexate

Wyeth Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

580

Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden

3599

EUCTR2004-000922-59-ES
(EUCTR)

21/12/2004

18/05/2005

Rheumatoid Arthrithis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

675

Phase 3

Czech Republic;Denmark;Spain;Sweden

3600

EUCTR2005-000492-18-IT
(EUCTR)

16/12/2004

09/11/2007

Insulin resistance and endothelial dysfunction TNF-Alpha dependent in patients with rheumatoid arthritis or metabolic syndrome

Metabolic Syndrome and Rheumatoid Arthritis
MedDRA version: 6.1;Level: SOC;Classification code 10021428

Trade Name: REMICADE *EV F 100MG+F 2ML
INN or Proposed INN: Infliximab

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

NULL

Not Recruiting

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3601

EUCTR2004-002157-30-DK
(EUCTR)

07/12/2004

05/11/2004

A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis

Rheumatoid Arthritis

Product Code: TAK-715
Product Code: TAK-715

Takeda Europe R&D Centre Ltd. (TEuR&D)

NULL

Not Recruiting

Female: yes
Male: yes

400

Finland;Denmark

3602

EUCTR2004-000922-59-SE
(EUCTR)

01/12/2004

13/10/2004

A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled ComparativeStudy of Abatacept or Infliximab in Combination with Methotrexate in ControllingDisease Activity in Subjects with Rheumatoid Arthritis Having an Inadequate ClinicalResponse to Methotrexate.Revised Protocol 1 , incorporating Amendment 02 (v5.0). Pharmacogenomic Amendment 01. Protocol Amendment 03 - Long-Term Extension. Protocol Amendment 05 - Long Term Extension Site Specific (V2.0, Date 23-Dec-2006).

Rheumatoid Arthrithis, Nos

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

660

Phase 3

Czech Republic;Denmark;Spain;Sweden

3603

EUCTR2004-002157-30-FI
(EUCTR)

01/12/2004

22/10/2004

A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis

Rheumatoid Arthritis

Product Code: TAK-715
Product Code: TAK-715

Takeda Europe R&D Centre Ltd. (TEuR&D)

NULL

Not Recruiting

Female: yes
Male: yes

400

Finland;Denmark

3604

EUCTR2004-000563-96-IE
(EUCTR)

26/11/2004

29/01/2007

Rheumatoid Arthritis

Trade Name: Enbrel
Product Name: Enbrel (etanercept)
Product Code: 0881
INN or Proposed INN: etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: Methotrexate sodium tablets 2.5mg
Product Name: methotrexate sodium tablets 2.5 mg
INN or Proposed INN: methotrexate
Other descriptive name: methotrexate
Trade Name: Methotrexate sodium tablets 2.5mg
Product Name: methotrexate sodium tablets 2.5 mg
INN or Proposed INN: methotrexate
Other descriptive name: methotrexate

Wyeth Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

580

Finland;Hungary;Denmark;Norway;Spain;Ireland;Italy;Sweden

3605

EUCTR2004-003741-40-AT
(EUCTR)

26/11/2004

22/10/2004

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: Tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Austria;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3606

EUCTR2004-000563-96-DK
(EUCTR)

23/11/2004

28/08/2007

Rheumatoid Arthritis

Wyeth Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

580

Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden

3607

EUCTR2004-000563-96-SE
(EUCTR)

17/11/2004

15/09/2004

Rheumatoid Arthritis

Wyeth Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

580

Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden

3608

EUCTR2004-002006-30-GB
(EUCTR)

17/11/2004

17/02/2005

Triple therapy in early active rheumatoid arthritis - TEAR

Rheumatoid arthritis

Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Trade Name: Salazopyrin En -Tabs
Product Name: sulfasalazine
INN or Proposed INN: Sulfasalazine
Trade Name: Plaquenil
Product Name: Hydroxychloroquine
INN or Proposed INN: Hydroxychloroquine

North Glasgow NHS Trust

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

3609

EUCTR2004-000563-96-HU
(EUCTR)

12/11/2004

13/09/2004

Rheumatoid Arthritis

Trade Name: Enbrel (etanercept)
Product Name: Enbrel (etanercept)
Product Code: 0881
INN or Proposed INN: etanercept
Other descriptive name: TNR-001; TNFR:Fc; rhuTNFR:Fc
Trade Name: Methotrexate -Lachema
Product Name: methotrexate sodium tablets 2.5 mg
INN or Proposed INN: methotrexate
Other descriptive name: methotrexate
Trade Name: Methotrexate -Lachema
Product Name: methotrexate sodium tablets 2.5 mg
INN or Proposed INN: methotrexate
Other descriptive name: methotrexate

Wyeth Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

580

Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden

3610

EUCTR2004-003733-14-IT
(EUCTR)

09/11/2004

18/05/2005

active rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: Tocilizumab
Product Code: RO 487-7533
INN or Proposed INN: Tocilizumab
Other descriptive name: NA
Trade Name: METHOTREXATE *2,5MG 25CPR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *10MG/1,33ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *15MG/2ML 4SIR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *20MG/2,66ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

1170

Finland;Denmark;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3611

NCT00195494
(ClinicalTrials.gov)

November 2004

13/9/2005

Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis

A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept;Drug: Methotrexate;Drug: Placebo

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

N/A

All

542

Phase 4

United States

3612

NCT00854321
(ClinicalTrials.gov)

November 2004

2/3/2009

Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University Hospital

One Centre Follow-up Study on Safety and Efficacy

Rheumatoid Arthritis

Drug: rituximab;Drug: rituximab , observational study amon patients with active RA

Kuopio University Hospital

NULL

Completed

18 Years

N/A

Both

N/A

Finland

3613

NCT00747214
(ClinicalTrials.gov)

November 2004

3/9/2008

A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA

A Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RA

Rheumatoid Arthritis

Drug: CRx-102;Drug: Placebo;Drug: DMARD Therapy

Zalicus

NULL

Completed

18 Years

N/A

All

Phase 2

NULL

3614

NCT00379600
(ClinicalTrials.gov)

November 2004

21/9/2006

The Anti-Inflammatory And Metabolic Effects Of Rosiglitazone In Subjects With Rheumatoid Arthritis

A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Anti-inflammatory and Metabolic Effects of Rosiglitazone XR, 8mg Once Daily, in Subjects With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: rosiglitazone XR

GlaxoSmithKline

NULL

Completed

18 Years

N/A

Both

Phase 2

Lithuania;United Kingdom

3615

NCT00170872
(ClinicalTrials.gov)

November 2004

9/9/2005

6 Week Open-label Trial With Lumiracoxib 200mg o.d. in Primary Knee Osteoarthritis or Rheumatoid Arthritis

A 6 Week, Multicenter, Open-label Trial to Evaluate the Safety, Tolerability and Efficacy of Lumiracoxib 200mg o.d. in Patients With Primary Knee Osteoarthritis or Rheumatoid Arthritis

Osteoarthritis;Rheumatoid Arthritis

Drug: Lumiracoxib

Novartis

NULL

Completed

18 Years

N/A

Both

135

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3616

NCT00236028
(ClinicalTrials.gov)

November 2004

7/10/2005

A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis

A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Infliximab

Centocor, Inc.

NULL

Completed

18 Years

75 Years

Both

607

Phase 3

NULL

3617

NCT01600521
(ClinicalTrials.gov)

November 2004

5/4/2012

A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications

Rheumatoid Arthritis

Drug: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs

University of Minnesota - Clinical and Translational Science Institute

NULL

Completed

18 Years

N/A

Both

1748

N/A

China

3618

NCT00651625
(ClinicalTrials.gov)

November 2004

21/3/2008

Reciprocating Medical Devices - a Study of a New Safety Device

Randomized Controlled Trial of the Reciprocating Procedure Device Versus the Conventional Syringe in Syringe-and-Needle Procedures

Osteoarthritis;Rheumatoid Arthritis;Trauma;Thyroid Nodule;Cancer

Device: Reciprocating Procedure Device (RPD) - AVANCA Re No. 1091001;Device: conventional syringe - BD Ref 309604

University of New Mexico

NULL

Completed

18 Years

N/A

All

437

N/A

United States

3619

EUCTR2004-003741-40-IT
(EUCTR)

28/10/2004

21/09/2005

Active rheumatoid arthritis.
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: Tocilizumab
Product Code: RO 487-7533
INN or Proposed INN: Tocilizumab
Trade Name: METHOTREXATE *2,5MG 25CPR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *10MG/1,33ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *15MG/2ML 4SIR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *20MG/2,66ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;Italy

3620

EUCTR2004-000012-13-CZ
(EUCTR)

26/10/2004

03/11/2004

Rheumatoid Arthritis

Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Czech Republic;Estonia;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3621

EUCTR2004-000482-35-GB
(EUCTR)

11/10/2004

08/02/2005

Rheumatoid Arthritis

GlaxoSmithKline Research & Development Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Lithuania;United Kingdom

3622

NCT00242853
(ClinicalTrials.gov)

October 2004

19/10/2005

A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis

An Enabling Study to Investigate the Correlation of Biomarkers of the Activity of Inducible Nitric Oxide Synthase (iNOS) With Disease Activity and Treatment Response in Patients With Rheumatoid Arthritis(RA)

Rheumatoid Arthritis;Osteoarthritis

Procedure: Power doppler ultrasonography;Procedure: High frequency ultrasonography;Procedure: Exhaled nitric oxide assessment

GlaxoSmithKline

NULL

Completed

18 Years

75 Years

Both

N/A

United Kingdom

3623

NCT00650390
(ClinicalTrials.gov)

October 2004

28/3/2008

Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

Rheumatoid Arthritis

Biological: adalimumab

Abbott

NULL

Approved for marketing

18 Years

N/A

Both

N/A

NULL

3624

NCT00094341
(ClinicalTrials.gov)

October 2004

16/10/2004

Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes

An Open-Label, Randomized, Crossover Study to Assess Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes

Rheumatoid Arthritis

Drug: Etanercept

Amgen

NULL

Completed

18 Years

N/A

Both

215

Phase 4

United States

3625

EUCTR2004-001490-26-GB
(EUCTR)

15/09/2004

01/06/2005

A SINGLE-CENTER, RANDOMIZED, SINGLE-BLIND STUDY COMPARING THE EFFECT OF CRx-150 PLUS DMARD THERAPY TO THAT OF PLACEBO PLUS DMARD THERAPY ON SERUM C-REACTIVE PROTEIN (CRP) AND CYTOKINES IN SUBJECTS WITH RHEUMATOID ARTHRITIS. - CRx-150-RA

RHEUMATOID ARTHRITIS

Trade Name: Asendis 50 mg
Product Name: N/A
Product Code: CRx-150
INN or Proposed INN: Amoxapine & dipyridamole

CombinatoRx, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Estonia;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3626

EUCTR2004-000563-96-IT
(EUCTR)

13/09/2004

14/03/2007

A 24-Month, Randomized, Double-Blind, Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects with Active Early Rheumatoid Arthritis COMET

Active Early Rheumatoid Arthritis
MedDRA version: 6.1;Level: SOC;Classification code 10028395

Trade Name: ENBREL *SC 4FL 25MG+4SIR 1ML
Product Name: ETANERCEPT
INN or Proposed INN: Etanercept

WYETH LEDERLE

NULL

Not Recruiting

Female: yes
Male: yes

540

Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden

3627

EUCTR2004-000612-54-SE
(EUCTR)

11/09/2004

07/07/2004

A Multicenter, Randomized, Parallel-Group, Active-Controlled Double-Blind Study Conducted Under In-House Blinding Conditions to Determine the Incidence of Gastroduodenal Ulcers in Patients With Osteoarthritis or Rheumatoid Arthritis After 12 Weeks of Treatment With L-001069957 21 mg Plus Low-Dose Aspirin, L- 01069957 42 mg Plus Low-Dose Aspirin, Celecoxib 400 mg Plus Low-Dose Aspirin, or Low-Dose Aspirin Alone - 12-Week NO-Rofecoxib Plus Aspirin Endoscopy Study

Osteoarthritis (OA) ICD: M19.9 MedDRA: 10031161 Rheumatoid Arthritis (RA) ICD: M06.9 MedDRA: 10039037

Merck Sharp & Dohme (Sweden) AB

NULL

Not Recruiting

Female: yes
Male: yes

1360

Phase 2

Sweden

3628

EUCTR2004-000106-41-SE
(EUCTR)

07/09/2004

03/08/2004

A study to investigate the effect of GW406381 on methotrexate pharmacokinetics in patients treated with methotrexate for rheumatoid arthritis - GW406381 and methotrexate

The patients entering the trial have rheumatoid arthritis although treatment of the disease itself is not under investigation in this study.

Product Name: GW406381
Product Code: GW406381

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Sweden

3629

ChiCTR-TRC-08000093

2004-09-01

2008-04-28

Phase ?clinical trial of chicken type II collagen in rheumatoid arthritis

Rheumatoid arthritis

MTX group:MTX (10 mg/week) is applied in the treatment of ac;CII group:MTX (10 mg/week) is applied in the treatment of ac;

Shanghai Materia Medica Bioengineering Institute

NULL

Completed

Both

MTX group:160;CII group:300;

3 (Phase 3 study)

China

3630

NCT00638950
(ClinicalTrials.gov)

September 2004

29/2/2008

A Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products in Patients With Rheumatoid Arthritis

Long-term Moderate Intervention With n-3 LC-PUFA-supplemented Dairy Products: Effects on Pathophysiological Biomarkers in Rheumatoid Arthritis

Rheumatoid Arthritis

Dietary Supplement: n-3 LC-PUFA;Dietary Supplement: Placebo

University of Jena

NULL

Completed

35 Years

74 Years

Both

N/A

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3631

NCT00117091
(ClinicalTrials.gov)

September 2004

30/6/2005

Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)

An Open-Label Multicentre Study of Anakinra (Kineret®) in Combination With DMARDS in Subjects With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Anakinra (Kineret®)

Amgen

NULL

Completed

18 Years

N/A

Both

Phase 3

NULL

3632

NCT00831922
(ClinicalTrials.gov)

September 2004

28/1/2009

Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

A Multicenter, Open Label, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis With Inadequate Response to at Least One Disease Modifying Anti Rheumatic Drugs (DMARD)

Rheumatoid Arthritis

Drug: masitinib (AB1010)

AB Science

NULL

Completed

18 Years

N/A

All

Phase 2

NULL

3633

NCT00831649
(ClinicalTrials.gov)

September 2004

27/1/2009

A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201

Rheumatoid Arthritis

Drug: natalizumab

Biogen

Elan Pharmaceuticals

Terminated

18 Years

75 Years

Both

Phase 2

NULL

3634

NCT00412256
(ClinicalTrials.gov)

September 2004

15/12/2006

Omegaven in Patients With Rheumatoid Arthritis (ORA-Trial)

Clinical Trial to Evaluate the Effect of Parenteral Supplementation With Omega-3-Fatty Acids in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi)

Humanis Klinikum Niederosterreich

NULL

Completed

18 Years

N/A

Both

Phase 3

Austria

3635

NCT00146640
(ClinicalTrials.gov)

August 31, 2004

6/9/2005

Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis

A New Timed-Release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-Centre, Double-Blind, Active Controlled Study With Open Extension on the New Drug Only

Rheumatoid Arthritis

Drug: MR Prednisone;Drug: IR Prednisone;Drug: Placebo - MR Prednisone;Drug: Placebo - IR Prednisone

Merck KGaA, Darmstadt, Germany

NULL

Completed

18 Years

80 Years

All

288

Phase 3

Germany;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3636

NCT00234897
(ClinicalTrials.gov)

August 2004

13/9/2005

Efficacy of HUMIRA in Subjects With Active Rheumatoid Arthritis

Humira Efficacy Response Optimization Study in Subjects With Active Rheumatoid Arthritis (HERO)

Rheumatoid Arthritis

Drug: adalimumab

Abbott

NULL

Completed

18 Years

N/A

Both

1938

Phase 4

United States

3637

NCT00279734
(ClinicalTrials.gov)

August 2004

19/1/2006

Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers

An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects

Rheumatoid Arthritis

Drug: Tetanus + pnemococcal vaccines alone;Drug: Abatacept + vaccines;Drug: Abatacept + Vaccines

Bristol-Myers Squibb

NULL

Completed

18 Years

65 Years

Both

Phase 1

United States

3638

NCT00095498
(ClinicalTrials.gov)

August 2004

5/11/2004

Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: placebo;Drug: denosumab

Amgen

NULL

Completed

18 Years

N/A

All

227

Phase 2

United States

3639

NCT00760864
(ClinicalTrials.gov)

August 2004

24/9/2008

Safety and Efficacy of TAK-715 in Subjects With Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Oral TAK-715 in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: TAK-715 and methotrexate;Drug: Methotrexate

Takeda

NULL

Completed

18 Years

N/A

Both

432

Phase 2

NULL

3640

EUCTR2004-000362-12-CZ
(EUCTR)

23/07/2004

20/08/2004

A Double-Blind, Randomised, Dose-Ranging Study to Compare K-832 with Placebo in the treatment of Patients with Active Rheumatoid Arthritis - N/A

Rheumatoid Arthritis
MedDRA version: 6.0;Level: LLT;Classification code 10028395

Product Name: K-832
Product Code: K-832
INN or Proposed INN: To be confirmed
Other descriptive name: N/A
Product Name: K-832
Product Code: K-832
INN or Proposed INN: To be confirmed
Other descriptive name: N/A

Kowa Research Europe Ltd

NULL

Not Recruiting

Female: yes
Male: yes

260

Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3641

EUCTR2004-000074-31-SE
(EUCTR)

06/07/2004

21/05/2004

rheumatoid arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467 -009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467 -009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Product Name: 1,5-anhydro-2,3-dideoxy-3-[[(1R,3S)-3-[[7,8-dihydro-3- (trifluoromethyl)-1,6-naphthyridin-6(5H)-yl]c
Product Code: L-000124467 (freebase); L-000124467 -009J (succinat
INN or Proposed INN: not available
Other descriptive name: L-000124467
Trade Name: paracetamol (acetaminophen)
Product Name: paracetamol (acetaminophen)

Merck Sharp & Dohme (Sweden) AB

NULL

Not Recruiting

Female: yes
Male: yes

150

Sweden

3642

NCT00239382
(ClinicalTrials.gov)

July 1, 2004

13/10/2005

A Study to Compare Meloxicam IM Once Daily Versus Meloxicam Orally Once Daily in Patients With Rheumatoid Arthritis

A Randomized, Open-labelled Study to Compare the Efficacy and Safety of Meloxicam 15 mg IM Ampoules Once Daily and Meloxicam 15 mg Tablets Administered Orally Once Daily Over a Period of 7 Days in Patients With RA.

Arthritis, Rheumatoid

Drug: Meloxicam ampoule;Drug: Meloxicam tablet

Boehringer Ingelheim

NULL

Completed

18 Years

N/A

All

150

Phase 3

China

3643

NCT00089921
(ClinicalTrials.gov)

July 2004

17/8/2004

SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate

A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine

Arthritis, Rheumatoid

Drug: SCIO-469;Drug: Placebo

Scios, Inc.

NULL

Completed

18 Years

N/A

Both

302

Phase 2

United States

3644

NCT00236678
(ClinicalTrials.gov)

July 2004

7/10/2005

Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With ACD Due to RA Receiving PROCRIT

A Randomized, Double-blind, Placebo-controlled Study to Assess Fatigue in Patients With Anemia of Chronic Disease (ACD) Due to Rheumatoid Arthritis Receiving PROCRIT? (Epoetin Alfa)

Anemia;Rheumatoid Arthritis

Drug: Epoetin alfa

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Ortho Biotech Products, L.P.

Terminated

18 Years

N/A

Both

Phase 2

NULL

3645

NCT00506896
(ClinicalTrials.gov)

July 2004

20/7/2007

Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients

Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients: A Randomized Double-Blind Controlled Study

Rheumatoid Arthritis

Drug: intraarticular injection

Federal University of São Paulo

NULL

Completed

18 Years

65 Years

Both

Phase 2

Brazil

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3646

NCT00154336
(ClinicalTrials.gov)

July 2004

8/9/2005

A Study of Imatinib 400 mg Once Daily in Combination With Methotrexate in the Treatment of Rheumatoid Arthritis.

3-Month, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety & Tolerability of Imatinib 400 mg Daily in Combination With Methotrexate (MTX)Compared to MTX Alone in the Treatment of Rheumatoid Arthritis (RA).

Rheumatoid Arthritis

Drug: Imatinib;Drug: Methotrexate;Drug: Imatinib Placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

75 Years

All

Phase 2

Austria;Canada;Finland;United Kingdom

3647

NCT00144534
(ClinicalTrials.gov)

June 2004

2/9/2005

Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JP

Rheumatoid Arthritis

Drug: MRA (Tocilizumab)

Chugai Pharmaceutical

NULL

Completed

20 Years

75 Years

Both

115

Phase 3

NULL

3648

NCT00252668
(ClinicalTrials.gov)

June 2004

9/11/2005

Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects

Rheumatoid Arthritis

Drug: Etanercept;Drug: Methotrexate

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

N/A

Both

300

Phase 4

NULL

3649

NCT00542022
(ClinicalTrials.gov)

June 2004

5/10/2007

Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)

A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK0812 in Rheumatoid Arthritis Patients

Arthritis, Rheumatoid

Drug: MK0812 / Duration of Treatment: 12 Weeks;Drug: Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

65 Years

Both

149

Phase 2

NULL

3650

NCT00244153
(ClinicalTrials.gov)

June 2004

25/10/2005

Intraarticular Opioids Vs Glucocorticosteroids in Gonarthritis

Intraarticular Application of Opioids Versus Glucocorticosteroids Versus Placebo in Rheumatoid Arthritis

Rheumatic Disease

Drug: intraarticular morphine;Drug: intraarticular dexamethasone

Charite University, Berlin, Germany

NULL

Recruiting

19 Years

N/A

Both

120

Phase 1;Phase 2

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3651

NCT00110903
(ClinicalTrials.gov)

May 2004

16/5/2005

Treatment for Subjects With Active Rheumatoid Arthritis (RA)

Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Etanercept Liquid

Amgen

NULL

Completed

18 Years

N/A

Both

Phase 3

NULL

3652

NCT00195403
(ClinicalTrials.gov)

May 2004

12/9/2005

A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA

A Drug Use Investigation of Enbrel for Post-Marketing Surveillance

Rheumatoid Arthritis

Drug: Etanercept

Pfizer

NULL

Completed

4 Years

N/A

All

1014

N/A

Korea, Republic of

3653

NCT00099554
(ClinicalTrials.gov)

May 2004

16/12/2004

Effectiveness and Safety of Enbrel® (Etanercept) in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)

A Phase 4, Open-Label, Single Arm, Observational Study Evaluating the Effectiveness and Safety of Enbrel® (Etanercept) 50 mg Once Weekly in Rheumatoid Arthritis Subjects Who Have Failed Remicade® (Infliximab)

Rheumatoid Arthritis

Drug: Etanercept

Amgen

NULL

Completed

18 Years

N/A

Both

200

Phase 4

United States;Canada

3654

NCT00291915
(ClinicalTrials.gov)

May 2004

14/2/2006

Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis

Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis

Rheumatoid Arthritis;Arthritis

Drug: Adalimumab;Drug: Methotrexate

Goupe d'Etudes et de Recherche Clinique En Rhumatologie

NULL

Recruiting

18 Years

N/A

Both

Phase 4

France

3655

NCT00144547
(ClinicalTrials.gov)

April 2004

2/9/2005

Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JP

Rheumatoid Arthritis

Drug: MRA(Tocilizumab)

Chugai Pharmaceutical

NULL

Completed

20 Years

N/A

Both

241

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3656

NCT00280644
(ClinicalTrials.gov)

April 2004

19/1/2006

Leflunomide in Rheumatoid Arthritis

Efficacy of Leflunomide on Joint Inflammation and Destruction of Joint Integrity in Active Rheumatoid Arthritis (RA) Patients

Arthritis, Rheumatoid

Drug: Leflunomide

Sanofi

NULL

Completed

18 Years

75 Years

Both

Phase 4

Turkey

3657

NCT00484809
(ClinicalTrials.gov)

March 2004

8/6/2007

Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children

A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).

Rheumatoid Arthritis

Drug: Enbrel (Etanercept)

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

4 Years

N/A

Both

100

NULL

3658

NCT00367965
(ClinicalTrials.gov)

February 2004

23/8/2006

Study of Eszopiclone Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis

The Effect of Eszopiclone 3 mg Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis

Insomnia;Arthritis, Rheumatoid

Drug: Eszopiclone;Drug: placebo

Sunovion

NULL

Completed

25 Years

64 Years

Both

153

Phase 3

United States

3659

NCT00077870
(ClinicalTrials.gov)

February 2004

12/2/2004

A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis

A Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate

Rheumatoid Arthritis

Drug: ocrelizumab

Genentech, Inc.

NULL

Completed

18 Years

80 Years

Both

237

Phase 1;Phase 2

United States

3660

NCT00144521
(ClinicalTrials.gov)

February 2004

2/9/2005

Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)

A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Rheumatoid Arthritis

Drug: MRA(Tocilizumab);Drug: MRA placebo;Drug: MTX;Drug: MTX placebo

Chugai Pharmaceutical

NULL

Completed

20 Years

75 Years

Both

127

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3661

NCT00224562
(ClinicalTrials.gov)

February 2004

14/9/2005

The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists

The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists

Rheumatoid Arthritis;Crohn's Disease;Ankylosing Spondylitis;Psoriasis

Drug: TNF-alpha antagonists

Assistance Publique - Hôpitaux de Paris

NULL

Recruiting

N/A

Both

N/A

France

3662

NCT00679510
(ClinicalTrials.gov)

February 2004

15/5/2008

Rosuvastatin in Rheumatoid Arthritis (RORA)

Phase 2: Effects of Rosuvastatin on Surrogate Markers for Cardiovascular Events in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: rosuvastatin;Drug: placebo

University of Dundee

NULL

Completed

40 Years

N/A

All

Phase 2;Phase 3

United Kingdom

3663

NCT00157872
(ClinicalTrials.gov)

January 7, 2004

7/9/2005

A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)

A Multicenter, Randomized, Parallel-Group, 8-Week, Double-Blind, and Active Comparator-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Rofecoxib Tablet 25 mg Once Daily Versus Naproxen Table 500 mg Twice Daily in the Treatment of Chinese Patient With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MK0966; rofecoxib;Drug: Comparator: naproxen tablet 500 mg

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

150

Phase 4

China

3664

NCT00378261
(ClinicalTrials.gov)

January 2004

15/9/2006

APART Advanced Profiling of Anti-Rheumatic Therapies

A Multicenter, Randomized, Open Study to Evaluate the Impact of an Electronic Data Capture System on the Care of Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid

Procedure: Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects.

Centocor Ortho Biotech Services, L.L.C.

NULL

Completed

18 Years

N/A

Both

1079

Phase 4

NULL

3665

NCT00619905
(ClinicalTrials.gov)

December 2003

8/2/2008

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Rheumatoid Arthritis With Ongoing Treatment With Methotrexate

A Randomized, Double-Blind, Placebo-Controlled, Cohort Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 (Anti-Interleukin-1Beta Monoclonal Antibody) in Patients With Active Rheumatoid Arthritis (RA) Despite Ongoing Treatment With Methotrexate (MTX) 15 mg or More Weekly for at Least 3 Months.

Rheumatoid Arthritis

Drug: ACZ885

Novartis

NULL

Completed

18 Years

75 Years

Both

Phase 1;Phase 2

Germany;Netherlands;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3666

NCT00076206
(ClinicalTrials.gov)

December 2003

15/1/2004

Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

A Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

Rheumatoid Arthritis

Drug: CCI-779;Drug: Placebo

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Terminated

18 Years

75 Years

Both

Phase 2

United States

3667

NCT00071812
(ClinicalTrials.gov)

December 2003

31/10/2003

A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

Arthritis, Rheumatoid

Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 4 mg/kg;Drug: Belimumab 10 mg/kg

Human Genome Sciences Inc.

NULL

Completed

18 Years

65 Years

All

283

Phase 2

United States

3668

NCT00234936
(ClinicalTrials.gov)

December 2003

16/9/2005

Quality of Life Study With Adalimumab in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Adalimumab;Drug: Methotrexate

Abbott

NULL

Completed

18 Years

N/A

Both

200

Phase 3

NULL

3669

NCT00095173
(ClinicalTrials.gov)

December 2003

1/11/2004

BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)

Juvenile Rheumatoid Arthritis

Drug: Abatacept;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

6 Years

17 Years

All

214

Phase 3

United States;Austria;Brazil;France;Germany;Italy;Mexico;Peru;Portugal;Spain;Switzerland

3670

NCT00207714
(ClinicalTrials.gov)

November 2003

13/9/2005

An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate

Rheumatoid Arthritis

Drug: Golimumab;Drug: MTX;Drug: Placebo;Drug: Infliximab

Centocor, Inc.

Centocor BV

Completed

18 Years

N/A

All

172

Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3671

NCT00649922
(ClinicalTrials.gov)

October 2003

28/3/2008

Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: adalimumab;Biological: placebo

Abbott

NULL

Completed

20 Years

N/A

Both

226

Phase 4

NULL

3672

NCT00162201
(ClinicalTrials.gov)

October 2003

9/9/2005

An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

Phase 1

United Kingdom

3673

NCT00234884
(ClinicalTrials.gov)

September 2003

16/9/2005

Post-marketing Observational Study in Subjects With Rheumatoid Arthritis

A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira

Rheumatoid Arthritis

Biological: adalimumab

Abbott

NULL

Completed

18 Years

N/A

All

3435

Australia;Austria;Belgium;France;Germany;Greece;Italy;Netherlands;Portugal;Spain;United Kingdom

3674

NCT00069017
(ClinicalTrials.gov)

September 2003

12/9/2003

Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate

A Phase II, Randomized, Double-Blind Study to Evaluate the Effects of MEDI-522, a Humanized MAb to Integrin Alpha V Beta 3, On Disease Activity and Progression of Joint Damage in Pts With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate

Rheumatoid Arthritis

Biological: MEDI-522;Other: Placebo

MedImmune LLC

NULL

Completed

18 Years

N/A

Both

300

Phase 2

United States;Canada

3675

NCT00221000
(ClinicalTrials.gov)

August 2003

13/9/2005

Safety and Efficacy of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis

A Phase II, Multicenter, Randomized, Double-blind, Sham Pheresis-controlled, Study of Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Rheumatoid Arthritis in Patients Who Have an Inadequate Response to Disease Modifying Antirheumatic Drugs and Biological Agents

Rheumatoid Arthritis

Drug: Methoxsalen;Procedure: Extracorporeal Photopheresis

Mallinckrodt

NULL

Completed

18 Years

N/A

Both

Phase 2

United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Mexico;Slovakia;South Africa

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3676

NCT00794898
(ClinicalTrials.gov)

July 1, 2003

19/11/2008

Efficacy of Remicade in the Treatment of Active Rheumatoid Arthritis Despite Methotrexate (Study P03027)

Onset of Efficacy of Anti-TNF Chimeric Monoclonal Antibody (Remicade) in the Treatment of Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment

Arthritis, Rheumatoid

Biological: Infliximab (Remicade)

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

75 Years

All

Phase 4

NULL

3677

NCT00649545
(ClinicalTrials.gov)

July 2003

27/3/2008

Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis

A Multi-Center Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: adalimumab

Abbott

NULL

Approved for marketing

18 Years

N/A

Both

N/A

NULL

3678

NCT00235859
(ClinicalTrials.gov)

July 2003

7/10/2005

Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

Rheumatoid Arthritis

Drug: adalimumab;Drug: methotrexate

Abbott

Eisai Limited

Completed

18 Years

N/A

Both

128

Phase 3

NULL

3679

NCT02184052
(ClinicalTrials.gov)

July 2003

3/7/2014

Safety and Efficacy of Mobic® Ampoules in the Initiation of Treatment of Painful Exacerbations of Osteoarthritis, Rheumatoid Arthritis and Other Similar Painful Inflammatory Conditions

Meloxicam (MOBIC®) Ampoule Post Marketing Surveillance Study

Arthritis, Rheumatoid

Drug: Meloxicam

Boehringer Ingelheim

NULL

Completed

N/A

Both

121

N/A

NULL

3680

NCT00195364
(ClinicalTrials.gov)

July 2003

13/9/2005

Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain

Long-Term Safety Study of Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain

Rheumatoid Arthritis;Inflammation

Drug: Etanercept

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

N/A

Both

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3681

NCT00647920
(ClinicalTrials.gov)

July 2003

28/3/2008

Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Study of the Human Anti-TNF-Antibody Adalimumab

Rheumatoid Arthritis

Biological: adalimumab;Biological: placebo

Abbott

NULL

Completed

18 Years

N/A

Both

Phase 3

Taiwan

3682

NCT00245934
(ClinicalTrials.gov)

June 2003

26/10/2005

Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

Observational Study With Enbrel in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Enbrel

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

N/A

Both

1500

N/A

NULL

3683

NCT00062465
(ClinicalTrials.gov)

June 2003

5/6/2003

Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine

A 24-Week, Double Blind, Randomized Study to Determine the Effects of 24 Weeks of Dosing With Tripterygium Wilfordii Hook F (TwHF) or Sulfasalazine, in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: TwHF

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Completed

N/A

Both

157

Phase 2

United States

3684

NCT00213538
(ClinicalTrials.gov)

June 2003

13/9/2005

Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Response to anakinra associated with methotrexate

University Hospital, Rouen

NULL

Completed

18 Years

N/A

All

341

N/A

France

3685

NCT00317538
(ClinicalTrials.gov)

June 2003

21/4/2006

Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Switch to Infliximab After Incomplete Response to Etanercept

Rheumatoid Arthritis

Drug: infliximab , etanercept

Centocor Ortho Biotech Services, L.L.C.

NULL

Completed

18 Years

N/A

Both

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3686

NCT00396747
(ClinicalTrials.gov)

June 2003

6/11/2006

A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study

Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone

Rheumatoid Arthritis

Drug: Infliximab , methylprednisolone, methotrexate;Drug: Methotrexate;Drug: Methotrexate + Methylprednisolone;Drug: Methotrexate + Infliximab

Université Catholique de Louvain

NULL

Completed

18 Years

N/A

Both

Phase 4

Belgium

3687

NCT00548834
(ClinicalTrials.gov)

June 2003

15/10/2007

Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis

Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD

Rheumatoid Arthritis

Drug: CDP870

UCB Pharma

NULL

Completed

18 Years

75 Years

Both

220

Phase 3

NULL

3688

NCT02214888
(ClinicalTrials.gov)

May 2003

12/8/2014

Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets in Patients With Active Rheumatoid Arthritis

A 12 Week Double-blind, Randomized, Placebo-controlled Trial to Investigate Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets at Doses of 50 and 70 mg Administered Twice a Day in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARD

Arthritis, Rheumatoid

Drug: BIRB 796 BS, low dose;Drug: BIRB 796 BS, high dose;Drug: Placebo

Boehringer Ingelheim

NULL

Terminated

18 Years

75 Years

Both

170

Phase 2

NULL

3689

NCT00563849
(ClinicalTrials.gov)

May 2003

21/11/2007

Leflunomide + Methotrexate in Rheumatoid Arthritis

An Open-Label, Multi-Center Study to Evaluation of Leflunomide Plus Methotexate for the Treatment of Rheumatoid Arthritis in DMARDs:(Disease-Modifying Antirheumatic Drug) na¿ve or Restart (Skip DMARDs More Than 4 Weeks) Subjects.

Rheumatoid Arthritis

Drug: Leflunomide

Sanofi

NULL

Completed

18 Years

75 Years

Both

Phase 4

Korea, Republic of

3690

NCT00095342
(ClinicalTrials.gov)

May 2003

2/11/2004

Study Evaluating TMI-005 in Active Rheumatoid Arthritis

A Double-Blind, Placebo-Controlled, Parallel, Randomized Study to Evaluate the Efficacy and Safety of 3 Oral Dose Levels of TMI-005 in Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate

Rheumatoid Arthritis

Drug: TMI-005

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

75 Years

Both

390

Phase 2

United States;Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3691

NCT00195377
(ClinicalTrials.gov)

April 2003

13/9/2005

Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain

Evaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study

Arthritis, Psoriatic;Arthritis, Rheumatoid

Drug: Etanercept

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

4 Years

N/A

Both

1000

Spain

3692

NCT00213564
(ClinicalTrials.gov)

April 2003

13/9/2005

Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: response to infliximab associated with methotrexate

University Hospital, Rouen

NULL

Completed

18 Years

N/A

Both

France

3693

NCT00244556
(ClinicalTrials.gov)

March 2003

12/10/2005

Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy

A Randomized Comparison of the Safety and Efficacy of Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Patients With Active Rheumatoid Arthritis Despite Current Methotrexate Therapy

Rheumatoid Arthritis

Drug: Methotrexate plus ENBREL or ENBREL alone

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

N/A

Both

300

Phase 4

NULL

3694

NCT00234845
(ClinicalTrials.gov)

March 2003

13/9/2005

Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis

A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: adalimumab;Drug: methotrexate

Abbott

NULL

Completed

18 Years

N/A

Both

148

Phase 3

United States

3695

NCT00356473
(ClinicalTrials.gov)

March 2003

25/7/2006

Effects of Atorvastatin on Disease Activity and HDL Cholesterol Function in Patients With Rheumatoid Arthritis

Effects of Atorvastatin on Disease Activity and HDL Cholesterol Anti-inflammatory Properties in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Atorvastatin

University of California, Los Angeles

NULL

Completed

18 Years

N/A

Both

Phase 4

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3696

NCT00144508
(ClinicalTrials.gov)

March 2003

2/9/2005

Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)

An Open-Label, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Rheumatoid Arthritis

Drug: MRA (Tocilizumab);Other: current treatment

Chugai Pharmaceutical

NULL

Completed

20 Years

N/A

Both

306

Phase 3

NULL

3697

NCT00160693
(ClinicalTrials.gov)

March 2003

6/9/2005

Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis

A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Certolizumab Pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

402

Phase 3

United Kingdom;Austria;Belgium;Czechia;Germany;Ireland;United States;Czech Republic

3698

NCT00092742
(ClinicalTrials.gov)

February 2003

23/9/2004

Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)

A Randomized, Double-Blind, Multicenter Study to Evaluate the Tolerability and Effectiveness of Etoricoxib 90 mg q.d. vs. Diclofenac Sodium 75 mg b.i.d. in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MK0663, etoricoxib;Drug: Comparator: Diclofenac sodium

Merck Sharp & Dohme Corp.

NULL

Completed

50 Years

N/A

Both

4086

Phase 3

United States

3699

NCT00650455
(ClinicalTrials.gov)

February 2003

28/3/2008

Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients

Clinical Protocol for a Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Bextra® (Valdecoxib) 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe RA Population

Arthritis, Rheumatoid

Drug: valdecoxib;Drug: naproxen;Drug: placebo

Pfizer

NULL

Completed

18 Years

N/A

Both

489

Phase 4

United States;Canada

3700

NCT00546533
(ClinicalTrials.gov)

January 2003

18/10/2007

Study Evaluating the Efficacy and Safety of Etanercept

Open-Label Evaluation Of The Efficacy And Safety Of Etanercept In Patients With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Etanercept

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

N/A

Both

Phase 4

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3701

NCT00250445
(ClinicalTrials.gov)

January 2003

7/11/2005

A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066)

A Randomized, Double-Blind, Active-Comparator-Controlled, Parallel-Group Study to Evaluate the Safety of Etoricoxib in Patients With Osteoarthritis or Rheumatoid Arthritis

Rheumatoid Arthritis,Osteoarthritis

Drug: MK0663, etoricoxib;Drug: Comparator: Diclofenac sodium

Merck Sharp & Dohme Corp.

NULL

Completed

50 Years

N/A

Both

23498

Phase 3

NULL

3702

NCT00482417
(ClinicalTrials.gov)

December 2002

1/6/2007

Efficacy and Safety Study of MK0359 in Patients With Arthritis (0359-017)

Rheumatoid Arthritis

Drug: MK0359

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

65 Years

Both

Phase 2

NULL

3703

NCT00433875
(ClinicalTrials.gov)

December 2002

8/2/2007

Phase 2 AMG 714 in Rheumatoid Arthritis

A Double-Blind, Placebo Controlled, Randomized, Parallel-Group Clinical Trial With Multiple Dose Treatment of Anti-IL 15 Human Monoclonal Antibody (AMG 714) in Patients With Active Rheumatoid Arthritis Who Have Previously Failed One or More Disease Modifying Anti-Rheumatic Drugs

Rheumatoid Arthritis

Drug: AMG 714

Amgen

NULL

Completed

18 Years

N/A

Both

180

Phase 2

NULL

3704

NCT00764725
(ClinicalTrials.gov)

December 2002

1/10/2008

Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)

A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX

Rheumatoid Arthritis

Drug: conventional DMARD combination;Biological: MTX plus anti-TNF

Karolinska Institutet

NULL

Completed

18 Years

N/A

Both

487

Phase 4

NULL

3705

NCT00048568
(ClinicalTrials.gov)

December 2002

2/11/2002

A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Abatacept;Drug: Methotrexate;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

1250

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3706

NCT00048932
(ClinicalTrials.gov)

December 2002

11/11/2002

A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Double-blind Abatacept;Drug: Double-blind Placebo;Drug: Open-label Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

1795

Phase 3

United States

3707

NCT00048581
(ClinicalTrials.gov)

December 2002

2/11/2002

Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.

A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy

Rheumatoid Arthritis

Drug: Abatacept;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

738

Phase 3

United States

3708

NCT00121043
(ClinicalTrials.gov)

October 2002

30/6/2005

Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire

An Open Label, Randomized, Crossover Study to Assess Acceptability and Functionality of SimpleJectTM Vs Pre-Filled Syringe(s) Using Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using A Self-Reported Questionnaire

Rheumatoid Arthritis

Device: SimpleJectTM;Drug: Kineret® (Anakinra)

Amgen

NULL

Completed

18 Years

N/A

Both

Phase 4

NULL

3709

NCT00544154
(ClinicalTrials.gov)

October 2002

15/10/2007

Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis

Efficacy and Safety of CDP870 400 mg in Combination With Methotrexate Compared to Methotrexate Alone in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Are Partial Responders to Methotrexate

Arthritis, Rheumatoid

Drug: CDP870

UCB Pharma

NULL

Completed

18 Years

75 Years

Both

247

Phase 3

NULL

3710

NCT00448383
(ClinicalTrials.gov)

September 2002

14/3/2007

A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

An Open-Label, Multi-Center Study to Assess the Safety and Efficacy of the Fully Human Anti-TNF-a Monoclonal Antibody Adalimumab (D2E7) When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: adalimumab

Abbott

NULL

Completed

18 Years

N/A

Both

6610

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3711

NCT00282412
(ClinicalTrials.gov)

September 2002

24/1/2006

Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism

Rheumatoid Arthritis: Tolerance Induction by Mixed Chimerism

Rheumatoid Arthritis

Biological: Hematopoietic Stem Cell Transplantation

Northwestern University

NULL

Terminated

18 Years

60 Years

Both

Phase 1

United States

3712

NCT00042406
(ClinicalTrials.gov)

September 2002

29/7/2002

Trial With HuMax-CD4 in Patients With Rheumatoid Arthritis Failing Treatment With Methotrexate and a TNF-alpha Blocker

A Double-Blind, Placebo-Controlled, Randomized, Parallel Group Clinical Trial of Anti-CD4 Receptor Human Monoclonal Antibody (HuMax-CD4) in Patients With Active RA Failing Treatment With Methotrexate and TNF-alpha Blocking Agents

Rheumatoid Arthritis

Drug: HuMax-CD4

Emergent Product Development Seattle LLC

NULL

Terminated

18 Years

N/A

Both

Phase 2;Phase 3

United States;Canada

3713

NCT00121056
(ClinicalTrials.gov)

September 2002

30/6/2005

REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations

Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations (REKinDLE)

Rheumatoid Arthritis

Drug: Enbrel ®;Drug: Kineret ®

Amgen

NULL

Completed

18 Years

N/A

Both

N/A

NULL

3714

NCT00946686
(ClinicalTrials.gov)

September 2002

24/7/2009

To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions

A Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions

Rheumatoid Arthritis;Psoriatic Arthritis

Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical);Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.)

Sandoz

NULL

Completed

18 Years

N/A

All

Phase 1

NULL

3715

NCT00055133
(ClinicalTrials.gov)

September 2002

19/2/2003

A Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid Arthritis

A Phase 2 Open-Label Clinical Study Using Intravenous Paxceed™ to Treat Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Micellar Paclitaxel for Injection

Angiotech Pharmaceuticals

NULL

Completed

21 Years

70 Years

Both

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3716

NCT00049751
(ClinicalTrials.gov)

September 2002

13/11/2002

Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis

A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Adalimumab

Abbott

NULL

Completed

18 Years

N/A

Both

3000

Phase 3

United States

3717

NCT00111423
(ClinicalTrials.gov)

August 2002

20/5/2005

Evaluating the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI)in Subjects With Rheumatoid Arthritis (RA)

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of Extended Treatment With Pegsunercept (PEG sTNF-RI) in Subjects With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Pegsunercept (PEG sTNF-RI)

Amgen

NULL

Completed

18 Years

N/A

Both

216

Phase 2

NULL

3718

NCT00650026
(ClinicalTrials.gov)

July 2002

27/3/2008

Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis

Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: adalimumab

Abbott

NULL

Approved for marketing

18 Years

N/A

Both

N/A

NULL

3719

NCT00043732
(ClinicalTrials.gov)

July 2002

12/8/2002

Safety Study of SCIO-469 to Treat Patients With Active Rheumatoid Arthritis Receiving Methotrexate

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study of SCIO-469 in Patients in Active Rheumatoid Arthritis Receiving Methotrexate

Rheumatoid Arthritis

Drug: SCIO-469

Scios, Inc.

NULL

Completed

18 Years

N/A

Both

120

Phase 2

United States

3720

NCT00042068
(ClinicalTrials.gov)

June 2002

22/7/2002

A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis

A Multi-center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Meloxicam

Boehringer Ingelheim

NULL

Completed

18 Years

80 Years

Both

1000

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Canada;France;Germany;Hungary;Italy;Korea, Republic of;Russian Federation;Taiwan;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3721

NCT00034060
(ClinicalTrials.gov)

April 2002

19/4/2002

The Role of Cytokines on Growth Hormone Suppression in Premenopausal Women With Rheumatoid Arthritis and the Effect of Treatment With Etanercept

Suppression of the Growth Hormone/ Insulin-Like Growth Factor-1 (GH/IGF-1) Axis in Women With Rheumatoid Arthritis

Rheumatoid Arthritis;Healthy

Drug: Etanercept

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Completed

N/A

Female

Phase 2

United States

3722

NCT00034203
(ClinicalTrials.gov)

April 2002

23/4/2002

Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: efalizumab

XOMA (US) LLC

NULL

Completed

18 Years

80 Years

Both

Phase 2

United States

3723

NCT00038298
(ClinicalTrials.gov)

April 2002

29/5/2002

A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of AMG 719 in Subjects With Rheumatoid Arthritis Receiving Methothrexate

Rheumatoid Arthritis

Drug: Placebo;Drug: AMG 719;Drug: AGM 719;Drug: placebo to AMG 719

Amgen

NULL

Completed

18 Years

N/A

Both

Phase 2

United States

3724

NCT00959439
(ClinicalTrials.gov)

March 2002

13/8/2009

Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)

A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg.

Rheumatoid Arthritis;Osteoarthritis

Drug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.);Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)

Sandoz

NULL

Completed

21 Years

50 Years

All

Phase 1

NULL

3725

NCT00451971
(ClinicalTrials.gov)

March 2002

23/3/2007

Objective Study in Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: LEFLUNOMIDE

Sanofi

NULL

Completed

18 Years

75 Years

Both

249

Phase 4

Australia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3726

NCT00029042
(ClinicalTrials.gov)

January 2002

4/1/2002

Infliximab to Treat Children With Juvenile Rheumatoid Arthritis

A Randomized Double Blind Controlled Intra-Patient Dose Escalation Phase II Trial of Infliximab in Pediatric Patients With Refractory Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis

Drug: Infliximab

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Terminated

N/A

Both

Phase 2

United States

3727

NCT00048321
(ClinicalTrials.gov)

January 2002

29/10/2002

ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis

ISIS 104838-CS7, A Double-Blind, Placebo-Controlled, Randomized Trial of the Safety, Efficacy and Pharmacokinetic Profile of ISIS 104838 (TNF-Alpha Antisense Oligonucleotide) Subcutaneous Injections in Active Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: ISIS 104838

Isis Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

160

Phase 2

United States;Canada

3728

NCT00246064
(ClinicalTrials.gov)

December 2001

28/10/2005

The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol

The Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) Protocol. Tapering Methotrexate in Patients With Rheumatoid Arthritis Beginning Therapy With Infliximab

Arthritis, Rheumatoid

Drug: infliximab

Centocor Ortho Biotech Services, L.L.C.

NULL

Completed

18 Years

80 Years

Both

210

Phase 4

NULL

3729

NCT00036387
(ClinicalTrials.gov)

October 2001

9/5/2002

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Rheumatoid Arthritis.

A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug Background Therapy.

Arthritis, Rheumatoid

Drug: Infliximab

Centocor, Inc.

NULL

Completed

18 Years

N/A

Both

347

Phase 3

United States

3730

NCT00036374
(ClinicalTrials.gov)

October 2001

9/5/2002

A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis

A Randomized, Double-Blind Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate for the Treatment of Patients With Polyarticular Juvenile Rheumatoid Arthritis

Rheumatoid Arthritis, Juvenile

Drug: Infliximab

Centocor, Inc.

NULL

Completed

4 Years

18 Years

Both

123

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3731

NCT02180516
(ClinicalTrials.gov)

October 2001

1/7/2014

Safety and Efficacy of Meloxicam Compared to Other Nonsteroidal Antiinflammatory Drugs (NSAIDs) in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome

Safety and Efficacy of Meloxicam (MOBIC) Compared to Other NSAIDs in Approved Therapeutic Dosages and Routes of Administration in an Observational Cohort Study of Patients With Rheumatoid Arthritis, Osteoarthritis, Lumbago, Scapulohumeral Periarthritis, Neck, Shoulder and Arm Syndrome

Arthritis, Rheumatoid

Drug: Meloxicam;Drug: Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac

Boehringer Ingelheim

NULL

Completed

N/A

Both

9984

N/A

NULL

3732

NCT00144651
(ClinicalTrials.gov)

August 2001

2/9/2005

Study of MRA in Patients With Rheumatoid Arthritis (RA)

An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP

Rheumatoid Arthritis

Drug: MRA(Tocilizumab)

Chugai Pharmaceutical

NULL

Completed

20 Years

N/A

Both

135

Phase 2

NULL

3733

NCT00537667
(ClinicalTrials.gov)

August 2001

27/9/2007

The SPECTRA Study

A Single Centre, Open-Label, Randomised, Study to Evaluate the Effect of Anakinra (r-metHuIL-1ra) Alone and in Combination With PEGylated Recombinant Methionyl Human Soluble Tumour Necrosis Factor Receptor Type I (PEG sTNF-RI) on Synovial Inflammation in Subjects With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: anakinra;Drug: anakinra and PEG sTNF-R1

Amgen

NULL

Terminated

18 Years

N/A

Both

Phase 2

NULL

3734

NCT00524160
(ClinicalTrials.gov)

July 2001

31/8/2007

A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, in Patients With Rheumatoid Arthritis or Osteoarthritis

Open-Label Study To Assess The Effect On Pain Control Of Durogesic (Fentanyl Transdermic Therapeutic System) Treatment In Subjects With Rheumatoid Arthritis Or Osteoarthritis Of The Knee Or Hip.

Arthritis;Osteoarthritis;Rheumatoid Arthritis

Drug: Fentanyl transdermal patch

Janssen Pharmaceutica N.V., Belgium

NULL

Completed

18 Years

N/A

Both

264

Phase 4

NULL

3735

NCT02209779
(ClinicalTrials.gov)

May 2001

5/8/2014

Efficacy and Safety of Different Doses of BIRB 796 BS in Patients With Active Rheumatoid Arthritis

A Randomised, Parallel, Double-blind, Placebo-controlled Study to Investigate Efficacy and Safety of Different Doses (5, 10, 20 and 30 mg) of BIRB 796 BS Administered Twice a Day Orally Over 4 Weeks in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARD

Arthritis, Rheumatoid

Drug: BIBR 796 BS;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

18 Years

75 Years

Both

167

Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3736

NCT02251210
(ClinicalTrials.gov)

May 2001

25/9/2014

Efficacy and Safety of BIIL 284 BS in Adult Patients With Active Rheumatoid Arthritis

Three Month, Randomised, Double-blind, Double-dummy, Placebo-controlled, Multiple Dose-range Study of the Efficacy and Safety of BIIL 284 BS (5, 25 and 75 mg p.o. Once Daily) in Adult Patients With Active Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: BIIL 284 BS low dose;Drug: BIIL 284 BS medium dose;Drug: BIIL 284 BS high dose;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

18 Years

70 Years

Both

404

Phase 2

NULL

3737

NCT00037700
(ClinicalTrials.gov)

May 2001

20/5/2002

Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: anakinra;Drug: pegsunercept

Amgen

NULL

Completed

18 Years

N/A

Both

Phase 2

United States

3738

NCT00014794
(ClinicalTrials.gov)

April 2001

11/4/2001

Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate Synovial Blood Flow in Rheumatoid Arthritis Patients

H215O Positron Emission Tomography (PET) in the Assessment of Synovial Blood Flow in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: 15-O labeled water

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Completed

N/A

Both

Phase 1

United States

3739

NCT02693210
(ClinicalTrials.gov)

February 2001

23/2/2016

A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis

A Randomised, Double Dummy Controlled, Parallel Group Study of the Efficacy and Safety of MabThera (Rituximab) Alone or in Combination With Either Cyclophosphamide or Methotrexate, in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Cyclophosphamide;Drug: Methotrexate;Other: Placebo Cyclophosphamide;Other: Placebo Methotrexate;Other: Placebo Rituximab;Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

21 Years

N/A

Both

161

Phase 2

Australia;Belgium;Canada;Czech Republic;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom

3740

NCT00579644
(ClinicalTrials.gov)

January 2001

18/12/2007

Treatment of Early RA: Minocycline in Combination With Methotrexate vs Methotrexate Alone

Treatment of Early Rheumatoid Arthritis: Minocycline in Combination With Methotrexate Versus Methotrexate Alone

Rheumatoid Arthritis

Drug: Combination of Minocycline and MTX or MTX alone;Drug: methotrexate

University of Nebraska

NULL

Completed

19 Years

75 Years

All

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3741

NCT00034853
(ClinicalTrials.gov)

December 2000

2/5/2002

Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis

Arthritis, Juvenile Rheumatoid

Drug: meloxicam oral suspension;Drug: naproxen oral suspension

Boehringer Ingelheim

NULL

Completed

2 Years

17 Years

Both

180

Phase 3

United States;Brazil;Mexico;Ukraine;Argentina

3742

NCT00195663
(ClinicalTrials.gov)

December 2000

13/9/2005

Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis

A Prospective Multi-Centre Randomised, Double-Blind, Active Comparator-Controlled, Parallel-Groups Study Comparing the Fully Human Monoclonal Anti-TNFa Antibody Adalimumab Given Every Second Week With Methotrexate Given Weekly and the Combination of Adalimumab and Methotrexate Administered Over 2 Years in Patients With Early Rheumatoid Arthritis (PREMIER).

Early Rheumatoid Arthritis

Biological: Adalimumab;Drug: Methotrexate;Biological: Adalimumab placebo;Drug: Methotrexate placebo

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

N/A

All

799

Phase 3

United States;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Slovakia;Spain;Sweden;Switzerland;United Kingdom

3743

NCT00162266
(ClinicalTrials.gov)

October 2000

9/9/2005

Abatacept With Methotrexate- Phase IIB

A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of BMS-188667 Administered Intravenously to Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

Rheumatoid Arthritis

Drug: Abatacept (BMS-188667);Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

524

Phase 2

United States;Argentina;Australia;Belgium;Canada;France;Germany;Ireland;Netherlands;South Africa;United Kingdom

3744

NCT00393471
(ClinicalTrials.gov)

October 2000

26/10/2006

Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.

A Double-Blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.

Active Rheumatoid Arthritis

Drug: Etanercept

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

N/A

Male

615

Phase 3

Australia;Austria;Belgium;Czech Republic;Denmark;Finland;France;Germany;Greece;Israel;Italy;Netherlands;Norway;Poland;Portugal;Romania;Spain;Sweden;United Kingdom

3745

NCT00162279
(ClinicalTrials.gov)

October 2000

9/9/2005

The Study of Abatacept in Combination With Etanercept

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Intravenous Infusions of BMS-188667 (10 mg/kg) Given Monthly in Combination With Subcutaneous Injections of Etanercept (25mg)Given Twice Weekly to Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

Both

141

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3746

NCT00006292
(ClinicalTrials.gov)

September 2000

23/9/2000

Infliximab for the Treatment of Early Rheumatoid Arthritis

Randomized Double Blind Active Treatment Controlled Trial of the Anti-TNF-Alpha Antibody Infliximab in Patients With Erosive Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Infliximab

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Completed

N/A

Both

Phase 2

United States

3747

NCT00279747
(ClinicalTrials.gov)

September 2000

19/1/2006

A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)

A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension 0.25mg/kg and 0.125 mg/kg Administered Once Daily in Comparison to Naproxen Oral Suspension 5mg/kg Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis.

Arthritis, Juvenile Rheumatoid

Drug: meloxicam 0.25 mg/kg;Drug: meloxicam 0.125 mg/kg;Drug: naproxen 10 mg/kg

Boehringer Ingelheim

NULL

Completed

2 Years

16 Years

Both

226

Phase 3

Austria;Belgium;France;Germany;Italy;Russian Federation;United Kingdom

3748

NCT03781375
(ClinicalTrials.gov)

August 24, 2000

18/12/2018

Etanercept Plus Methotrexate Versus Methotrexate Alone in Children With Polyarticular Course Juvenile Rheumatoid Arthritis

A Phase III Double Blind Randomized Study Comparing Etanercept (Enbrel) Combined With Methotrexate vs Methotrexate Alone in Children With Polyarticular Course Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis

Drug: Etanercept;Drug: Placebo to Etanerceot;Drug: Methotrexate

Amgen

NULL

Terminated

N/A

All

Phase 3

NULL

3749

NCT00037648
(ClinicalTrials.gov)

July 2000

17/5/2002

Juvenile Rheumatoid Arthritis

A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Open-label Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuIL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis

Juvenile Chronic Arthritis

Drug: Anakinra;Drug: Placebo

Amgen

NULL

Completed

2 Years

17 Years

Both

Phase 2

United States

3750

NCT00195650
(ClinicalTrials.gov)

July 2000

13/9/2005

Long Term Open Label Continuation Study

A Multi-Center Continuation Study of the Human Anti-TNF Antibody D2E7 Administered as a Subcutaneous Injection in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Adalimumab

Abbott

NULL

Completed

18 Years

N/A

All

846

Phase 3

United States;Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3751

NCT00233571
(ClinicalTrials.gov)

June 2000

13/9/2005

A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis

A Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab)

Rheumatoid Arthritis

Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)

Abbott

NULL

Completed

18 Years

N/A

Both

796

Phase 3

NULL

3752

NCT00006055
(ClinicalTrials.gov)

March 2000

5/7/2000

Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases

Purpura, Schoenlein-Henoch;Graft Versus Host Disease;Anemia, Hemolytic, Autoimmune;Rheumatoid Arthritis;Churg-Strauss Syndrome;Hypersensitivity Vasculitis;Wegener's Granulomatosis;Systemic Lupus Erythematosus;Giant Cell Arteritis;Pure Red Cell Aplasia;Juvenile Rheumatoid Arthritis;Polyarteritis Nodosa;Autoimmune Thrombocytopenic Purpura;Takayasu Arteritis

Drug: anti-thymocyte globulin;Drug: cyclophosphamide;Drug: cyclosporine;Drug: filgrastim;Drug: methylprednisolone;Drug: prednisone;Procedure: Autologous Peripheral Blood Stem Cell Transplantation

Fairview University Medical Center

NULL

Active, not recruiting

1 Year

55 Years

Both

N/A

United States

3753

NCT00195702
(ClinicalTrials.gov)

February 2000

13/9/2005

Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Rheumatoid Arthritis Patients Currently Receiving Treatment With Methotrexate

Rheumatoid Arthritis

Biological: Adalimumab;Drug: Placebo

Abbott

NULL

Completed

18 Years

N/A

All

619

Phase 3

United States;Canada

3754

NCT02247375
(ClinicalTrials.gov)

January 2000

19/9/2014

Pharmacokinetics, Safety and Efficacy of BIIL 284 BS in Patients With Rheumatoid Arthritis (RA)

A Double-blind, Randomized, Three Parallel Group Placebo-controlled Study to Investigate Pharmacokinetics, Effect on Expression of CD11b/CD18 (Mac-1), as Well as Safety and Efficacy of Two Oral Doses of BIIL 284 BS (Dosage: 25 mg Daily, 150 mg Daily) in Patients With Rheumatoid Arthritis Over Two Weeks

Arthritis, Rheumatoid

Drug: Low dose of BIIL 284 BS tablets;Drug: High dose of BIIL 284 BS tablets;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

18 Years

65 Years

Both

Phase 1

NULL

3755

NCT00279760
(ClinicalTrials.gov)

January 2000

18/1/2006

Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis

A Pilot, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of LEA29Y and CTLA4Ig Administered Intravenously to Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Belatacept;Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

65 Years

Both

210

Phase 1;Phase 2

United States;Belgium;Canada;France;Germany;Ireland;Netherlands;Switzerland;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3756

NCT00579878
(ClinicalTrials.gov)

December 1999

17/12/2007

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations (Leflunomide-Hydroxychloroquine-Sulfasalazine or Methotrexate-Hydroxychloroquine-Sulfasalazine) in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Leflunomide;Drug: Methotrexate -Sulfasalazine-Hydroxychloroquine;Drug: Leflunomide -Sulfasalazine-Hydroxychloroquine

University of Nebraska

NULL

Completed

19 Years

80 Years

All

Phase 3

United States

3757

NCT00012506
(ClinicalTrials.gov)

October 1999

10/3/2001

The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis

Uveitis;Arthritis, Juvenile Rheumatoid

Drug: TNFR:Fc

National Eye Institute (NEI)

NULL

Recruiting

2 Years

18 Years

Both

Phase 3

United States

3758

NCT02932644
(ClinicalTrials.gov)

October 1999

12/10/2016

Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

Association Between Baseline Vitamin D Metabolite Levels and Risk of Cardiovascular Events in Rheumatoid Arthritis Patients. A Cohort Study With Patient-record Evaluated Outcomes.

Rheumatoid Arthritis;Cardiovascular Disease

Other: Baseline serum vitamin D level below 50 nmol/l;Other: Baseline serum vitamin D level at or above 50 nmol/l

Odense University Hospital

The Danish Rheumatism Association;University of Southern Denmark;Region of Southern Denmark;Pfizer;Odense Patient Explorative data Network (OPEN);The Danish Rheumatism Association;University of Southern Denmark;Region of Southern Denmark;Pfizer;Odense Patient Explorative data Network (OPEN)

Completed

18 Years

75 Years

Both

160

N/A

NULL

3759

NCT00000435
(ClinicalTrials.gov)

September 1999

21/1/2000

dnaJ Peptide for Relieving Rheumatoid Arthritis

A Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: dnaJ peptide;Drug: None-placebo

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Completed

18 Years

85 Years

Both

160

Phase 2

United States

3760

NCT00001862
(ClinicalTrials.gov)

February 1999

3/11/1999

TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis

The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis;Uveitis

Drug: Enbrel

National Eye Institute (NEI)

NULL

Completed

N/A

Both

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3761

NCT00209859
(ClinicalTrials.gov)

October 1998

16/9/2005

Methotrexate and Cyclosporine in Treatment of Early Rheumatoid Arthritis

Combination Treatment With Methotrexate and Cyclosporine in Early Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Intraarticular betamethasone;Drug: Cyclosporine/placebo-cyclosporine

Hvidovre University Hospital

NULL

Completed

18 Years

75 Years

Both

160

Phase 4

Denmark

3762

NCT00001677
(ClinicalTrials.gov)

June 1998

3/11/1999

Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis: Safety, Tolerance and Efficacy

Arthritis, Rheumatoid;Synovitis

Drug: Methotrexate;Drug: Fludarabine

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Completed

N/A

Both

Phase 2

United States

3763

NCT00001614
(ClinicalTrials.gov)

July 1997

3/11/1999

The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis

Arthritis, Juvenile Rheumatoid;Uveitis

Drug: Chicken type II collagen

National Eye Institute (NEI)

NULL

Completed

N/A

Both

Phase 1

United States

3764

NCT00278551
(ClinicalTrials.gov)

June 1997

15/1/2006

Stem Cell Support in Patients With Rheumatoid Arthritis

Immune Ablation and Hematopoietic Stem Cell Support in Patients With Rheumatoid Arthritis and High Risk Factors

RHEUMATOID ARTHRITIS

Biological: Immune ablation and hematopoietic stem cell transplant

Richard Burt, MD

NULL

Terminated

18 Years

60 Years

Both

Phase 1

United States

3765

NCT03780959
(ClinicalTrials.gov)

May 1, 1997

18/12/2018

Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA)

Safety, Population Pharmacokinetics, and Efficacy of Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) in Children With Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis

Drug: Etanercept;Drug: Placebo

Amgen

NULL

Completed

4 Years

18 Years

All

Phase 2;Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3766

NCT00269867
(ClinicalTrials.gov)

March 1997

22/12/2005

Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment

Rheumatoid Arthritis

Drug: Placebo;Drug: Infliximab 3 mg/kg;Drug: Infliximab 10 mg/kg

Centocor, Inc.

NULL

Completed

18 Years

75 Years

Both

428

Phase 3

NULL

3767

NCT00570934
(ClinicalTrials.gov)

March 1995

7/12/2007

Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA

Effect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis

Dietary Supplement: Cholecalciferol;Dietary Supplement: Calcium;Dietary Supplement: Calcium and cholecalciferol;Drug: Placebo

University of Missouri-Columbia

NULL

Completed

3 Years

15 Years

Both

Phase 3

United States

3768

NCT00004420
(ClinicalTrials.gov)

September 1994

18/10/1999

Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis

Drug: gamma-Linolenic acid

FDA Office of Orphan Products Development

University of Massachusetts, Worcester

Completed

1 Year

15 Years

Both

N/A

NULL

3769

JPRN-JapicCTI-111601

05/09/2011

Rheumatoid Arthritis

Intervention name : Secukinumab
INN of the intervention : Secukinumab
Dosage And administration of the intervention : s.c. i.v.

Novartis Pharma K.K.

NULL

BOTH

Phase 3

NULL

3770

EUCTR2016-003630-25-BG
(EUCTR)

17/07/2017

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3068

Phase 3

United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3771

EUCTR2007-003591-19-DE
(EUCTR)

05/09/2007

AN OPEN, COMPARATIVE, WITHIN PATIENT CONTROLLED MULTICENTRE STUDY OF REPEATED SUBCUTANEOUS INJECTIONS OF METHOTREXATE 50MG/ML AND 10MG/ML TO COMPARE PATIENT SATISFACTION AND LOCAL TOLERABILITY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS - MTX 50 versus 10mg/ml

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Methotrexate 50mg/ml solution for injection, pre-filled syringe
INN or Proposed INN: Methotrexate disodium
Other descriptive name: Methotrexate disodium
Trade Name: Metex 10 mg/ml Injektionslösung, Fertigspritze
INN or Proposed INN: methotrexate disodium
Other descriptive name: Methotrexate disodium

medac Gesellschaft für klinische Spezialpräparate mbH

NULL

Not Recruiting

Female: yes
Male: yes

Germany

3772

JPRN-JapicCTI-121843

28/05/2012

OSKIRA-Asia-1

A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy

Rheumatoid Arthritis

Intervention name : Fostamatinib
Dosage And administration of the intervention : 100mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 75mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 50mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12
Control intervention name : Placebo
Dosage And administration of the control intervention : twice daily for 12 weeks

AstraZeneca

NULL

BOTH

Phase 2

NULL

3773

EUCTR2009-015019-42-Outside-EU/EEA
(EUCTR)

08/03/2012

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)

Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Female: yes
Male: yes

170

Peru;Russian Federation;United States;Argentina;Brazil;Canada;Mexico

3774

EUCTR2011-002896-40-ES
(EUCTR)

26/06/2012

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

RHEUMATOID ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

195

Phase 2

United States;Taiwan;Spain;Korea, Democratic People's Republic of;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany

3775

JPRN-JapicCTI-080565

09/04/2008

A Long Term Study to Investigate the Efficacy and Safety Study of D961H (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use

Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago

Intervention name : esomeprazole
Dosage And administration of the intervention : Oral

AstraZeneca

NULL

BOTH

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3776

EUCTR2012-001145-40-Outside-EU/EEA
(EUCTR)

07/03/2012

Study evaluating long-term safety in adults with rheumatoid arthritis and in children and adolescents with childhood arthritis

Open-label Extension Treatment with TNFR:Fc for Participating Patients in TNFR:Fc Clinical Trials

Rheumatoid arthritis (RA) in adults and juvenile idiopathic arthritis (JIA) for subjects who did not respond to conventional DMARDS;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT

Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320

NULL

Female: yes
Male: yes

783

Canada;United States

3777

EUCTR2007-002536-29-PL
(EUCTR)

15/01/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Austria;Poland;Sweden

3778

JPRN-JapicCTI-050016

02/09/2005

A controlled, randomized trial of MRA monotherapy in patients with rheumatoid arthritis(RA)

Intervention name : MRA (tocilizumab)
Dosage And administration of the intervention : Intravenous infusion

Chugai Pharmaceutical Co., Ltd.

NULL

Phase 3

NULL

3779

EUCTR2011-001626-15-ES
(EUCTR)

20/10/2011

A study of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with rheumatoid arthritis with inadequate response to prior treatment with methotrexate and low disease activity with the combination de RoActemra/Actemra y methotrexate.

A multi-centre, randomized, double-blind study of the safety and efficacy of tocilizumab (TCZ) in combination with methotrexate (MTX), versus TCZ (placebo controlled) in patients with active rheumatoid arthritis (RA) with inadequate response to prior MTX treatment and low disease activity (DAS 28 ? 3.2) with the combination TCZ and MTX.

Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium

Roche Farma, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Spain

3780

EUCTR2015-002466-22-Outside-EU/EEA
(EUCTR)

23/12/2015

A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Openlabel Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: anakinra
INN or Proposed INN: ANAKINRA

Amgen Inc

NULL

Female: yes
Male: yes

United States;Australia;Canada;Costa Rica;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3781

EUCTR2015-002156-27-AT
(EUCTR)

30/09/2015

Reduced-dose Rituximab in rheumatoid arthritis patients in remission – theREDOREM study

Prospective controlled study of reduced-dose Rituximab in rheumatoidarthritis patients in low disease activity and remission – the REDOREMstudy

rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
INN or Proposed INN: RITUXIMAB

Medical University of Vienna

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Austria

3782

JPRN-JapicCTI-070479

26/11/2007

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy.

Rheumatoid arthritis

Intervention name : Ocrelizumab
Dosage And administration of the intervention : Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26.

Chugai Pharmaceutical Co., Ltd.

NULL

BOTH

Phase 3

NULL

3783

EUCTR2012-003655-11-DE
(EUCTR)

09/12/2013

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

moderately to severely active rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: GLPG0634
Product Code: GLPG0634
INN or Proposed INN: FILGOTINIB
Other descriptive name: GLPG0634

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

600

Phase 2

3784

JPRN-JapicCTI-080650

23/10/2008

Dose-Response Study of Ocrelizumab for Rheumatoid Arthritis.

Rheumatoid Arthritis

Intervention name : Ocrelizumab
Dosage And administration of the intervention : 50mg,200mg,500mg twice as an IV infusion on Days1 and 15
Control intervention name : Placebo
Dosage And administration of the control intervention : administered twice as an IV infusion on Days1 and 15

Chugai Pharmaceutical Co., Ltd.

NULL

BOTH

Phase 2

NULL

3785

JPRN-JapicCTI-050018

02/09/2005

Double-blind, parallel-group, controlled Phase 3 study of MRA in rheumatoid arthritis(RA)

Intervention name : MRA (tocilizumab)
Dosage And administration of the intervention : Intravenous infusion

Chugai Pharmaceutical Co., Ltd.

NULL

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3786

JPRN-JapicCTI-132125

14/05/2013

Rheumatoid Arthritis

Intervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 52
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous injection every 2 weeks through Week 50
Control intervention name : Adalimumab
Dosage And administration of the control intervention : Adalimumab administered by SC injection every 2 weeks through Week 50

Eli Lilly Japan K.K.

NULL

BOTH

Phase 3

NULL

3787

EUCTR2012-000609-58-ES
(EUCTR)

09/07/2012

A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-TNF? biologics

Product Code: 0109-0012A 100 mg/ml
Product Code: 0109-0012A 50 mg/ml
Product Code: 0109-0012A 25 mg/ml

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

268

Phase 2b

United States;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Germany

3788

EUCTR2014-004558-33-Outside-EU/EEA
(EUCTR)

09/12/2014

A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

Abbott Japan Co., Ltd.

NULL

Female: yes
Male: yes

Japan

3789

EUCTR2015-005450-36-Outside-EU/EEA
(EUCTR)

01/08/2016

Pilot to Evaluate the Safety and Efficacy of Abatacept in Adults and Children Over the Age of 6 With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms With Switchover, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change)

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT

Bristol-Myers Squibb Company

NULL

Female: yes
Male: yes

100

Phase 2

United States

3790

EUCTR2011-001661-40-Outside-EU/EEA
(EUCTR)

07/02/2012

A multicenter study of the safety, efficacy effects on the body of Humira (adalimumab) in children with polyarticular Juvenile Rheumatoid Arthritis (a form of reheumatoid arthritis in children / young people with unknown cause).

A Multicenter, Randomized, Double-blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Juvenile Rheumatiod Arthritis

Polyarticular Juvenile Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10036039;Term: Polyarticular juvenile rheumatoid arthritis, chronic or unspecified;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Humira 40mg/0.8 ml solution for injection for paediatric use
INN or Proposed INN: ADALIMUMAB

Abbott Laboratories

NULL

Female: yes
Male: yes

171

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3791

EUCTR2005-002969-37-DE
(EUCTR)

17/05/2006

A randomised, placebo-controlled, parallel group single dose study of GW856553 in patients with active RA to investigate the CRP dose response relationship. - GM2005/00244/00

Rheumatoid Arthritis

Product Code: GW856553
Product Code: GW856553
Product Code: GW856553
Product Name: Methotrexat
INN or Proposed INN: Methotrexate Disodium

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Spain;Sweden

3792

JPRN-JapicCTI-142405

06/01/2014

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily
Intervention name : placebo
Dosage And administration of the intervention : Placebo administered orally once daily

Eli Lilly Japan K.K.

NULL

other

BOTH

Phase 3

NULL

3793

EUCTR2019-000868-18-LT
(EUCTR)

19/07/2019

Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Trade Name: Kevzara
Product Name: Sarilumab
INN or Proposed INN: SARILUMAB
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal
Product Name: otilimab
Product Code: GSK3196165
INN or Proposed INN: OTILIMAB
Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of

3794

EUCTR2010-023692-26-DE
(EUCTR)

07/12/2010

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared with Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

370

Phase 2B

United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Germany;Netherlands

3795

JPRN-JapicCTI-080531

21/02/2008

A Phase III, Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use

Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago

Intervention name : esomeprazole
Dosage And administration of the intervention : Oral

AstraZeneca

NULL

BOTH

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3796

EUCTR2008-000744-13-DE
(EUCTR)

07/10/2008

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

800

France;Belgium;Bulgaria;Germany;Italy

3797

EUCTR2012-001171-37-Outside-EU/EEA
(EUCTR)

07/03/2012

Study evaluating safety and effectiveness in children with childhood arthritis

A Phase IV Registry of Etanercept in Children With Juvenile Rheumatoid Arthritis

Juvenile idiopathic arthritis (JIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT

Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320

NULL

Female: yes
Male: yes

594

Phase 4

Canada;United States

3798

EUCTR2019-000878-30-EE
(EUCTR)

12/05/2020

A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan;Lithuania;United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of

3799

JPRN-JapicCTI-121990

22/10/2012

OSKIRA-Asia-1X

A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Rheumatoid Arthritis

Intervention name : Fostamatinib
Dosage And administration of the intervention : 100mg once daily

AstraZeneca

NULL

BOTH

Phase 2

NULL

3800

JPRN-JapicCTI-132156

12/06/2013

Rheumatoid Arthritis

Intervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.

Eli Lilly Japan K.K.

NULL

recruiting

BOTH

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3801

EUCTR2005-001138-33-SI
(EUCTR)

13/06/2005

A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.

Rheumatoid Arthritis

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

650

Portugal;Denmark;Slovenia;Norway;Spain;Italy

3802

EUCTR2009-017438-32-DE
(EUCTR)

22/02/2010

A 12-week study of 4 doses of VX-509 in subjects with active rheumatoid arthritis

A 12-week, double-blind, randomized, parallel-group, placebo-controlled study of 4 doses of VX-509 in subjects with active rheumatoid arthritis

Active rheumatoid arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: VX-509
Product Code: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Russian Federation;Germany;Serbia;Belgium;Romania;United States;Croatia;Poland

3803

JPRN-JapicCTI-050146

12/10/2005

Clinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : TA-650 (Infliximab)
Dosage And administration of the intervention : Intravenous drip infusion

Mitsubishi Tanabe Pharma Corporation

NULL

BOTH

Phase 3

NULL

3804

JPRN-JapicCTI-132138

28/05/2013

Rheumatoid Arthritis

Eli Lilly Japan K.K.

NULL

BOTH

Phase 3

NULL

3805

EUCTR2004-000563-96-NO
(EUCTR)

06/10/2004

Rheumatoid Arthritis

Wyeth Pharmaceuticals

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

580

Finland;Hungary;Denmark;Norway;Ireland;Spain;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

3806

EUCTR2006-003983-73-DE
(EUCTR)

23/03/2007

Rheumatoid arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Janssen-Cliag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2a

Czech Republic;Germany

3807

EUCTR2005-000443-28-Outside-EU/EEA
(EUCTR)

22/09/2011

A Phase III Study of BMS-188667 in Children and Adolescents with Juvenile Rheumatoid Arthritis

A Phase III, Multi-Center, Multi-National, Randomized, Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents with Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)

Juvenile Rheumatoid Arthritis
MedDRA version: 14.0;Level: LLT;Classification code 10023267;Term: Juvenile rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: abatacept

Bristol Myers Squibb International Corporation

NULL

Female: yes
Male: yes

200

Phase 3

Austria;Brazil;France;Germany;Italy;Mexico;Peru;Portugal;Spain;Switzerland;United States

3808

JPRN-JapicCTI-132134

23/05/2013

A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs

Rheumatoid Arthritis

Intervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 52.
Control intervention name : Placebo
Dosage And administration of the control intervention : Baricitinib placebo administered orally once daily through Week 52 and MTX placebo administered orally once weekly through Week 52.
Control intervention name : Methotrexate
Dosage And administration of the control intervention : Methotrexate (MTX) administered orally once weekly with dose ranging from 7.5 to 12.5 mg per week through Week 52.

Eli Lilly Japan K.K.

NULL

complete

BOTH

Phase 3

NULL

3809

EUCTR2005-002423-13-BG
(EUCTR)

03/08/2010

Study of safety and efficacy of long-term treatment with tocilizumab in adult patients with rheumatoid arthritis.

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - GROWTH95

Trade Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody

F. Hoffmann La-Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Germany;Switzerland;Bulgaria;France;Italy;Singapore;Hong Kong;Austria;Australia;Brazil;Israel;Slovakia;Canada;Mexico;Argentina;Thailand