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	NCT03938701 (ClinicalTrials.gov)	March 2021	25/2/2019	Fluorescence Imaging of Disease Activity in IBD and Rheumatoid Arthritis Using OTL38	Fluorescence Imaging for the Evaluation of Disease Activity in IBD and Rheumatoid Arthritis Using the Fluorescent Tracer OTL38 Targeting the Folate ß Receptor: a Single-center Pilot Study	IBD;Rheumatoid Arthritis	Drug: OTL38;Device: Fluorescence Imaging	University Medical Center Groningen	GlaxoSmithKline;On Target Laboratories, LLC;VU University Medical Center	Not yet recruiting	18 Years	N/A	All	30	Phase 1	Netherlands
4	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
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	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
7	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
8	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
9	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
10	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
No.	TrialID	Date_ enrollment	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	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
12	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
13	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
14	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
15	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
No.	TrialID	Date_ enrollment	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	NCT04608344 (ClinicalTrials.gov)	November 4, 2020	23/10/2020	Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants	A Phase 1 Study to Evaluate OATP Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants	Rheumatoid Arthritis	Drug: Atorvastatin;Drug: Pravastatin;Drug: Rosuvastatin;Drug: Filgotinib	Gilead Sciences	Galapagos NV	Recruiting	18 Years	55 Years	All	30	Phase 1	United States
17	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
18	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
19	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
20	NCT04311567 (ClinicalTrials.gov)	October 7, 2020	5/3/2020	Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease	Effects of Tofacitinib vs Methotrexate on Clinical and Molecular Disease Activity Markers in Joints and Lungs in Early Rheumatoid Arthritis (PULMORA) - A Randomized, Controlled, Open-label, Assessor-blinded, Phase IV Trial	Rheumatoid Arthritis;Interstitial Lung Disease Due to Systemic Disease (Disorder);RA;ILD	Drug: Tofacitinib;Drug: Methotrexate	Vastra Gotaland Region	Göteborg University	Not yet recruiting	18 Years	80 Years	All	48	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
21	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
22	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
23	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
24	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
25	NCT04586933 (ClinicalTrials.gov)	October 2020	22/9/2020	Nutrition in Rheumatic Diseases	Nutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary Guidance	Spondyloarthritis;Rheumatoid Arthritis;Polyarthritis	Dietary Supplement: Omega-3;Dietary Supplement: Placebo (soya);Behavioral: Dietary guidance	Haukeland University Hospital	GC Rieber Oils AS	Not yet recruiting	18 Years	75 Years	All	120	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
26	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
27	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
28	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
29	NCT04529863 (ClinicalTrials.gov)	August 17, 2020	25/8/2020	Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tocilizumab vs Abatacept	Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines- Tocilizumab vs Abatacept	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Abatacept	Brigham and Women's Hospital	Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging Intramural Research Program (IRP);Rutgers University;Johns Hopkins University	Active, not recruiting	18 Years	N/A	All	30432		United States
30	NCT04529876 (ClinicalTrials.gov)	August 17, 2020	25/8/2020	Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tofacitinib vs Abatacept	Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - Tofacitinib vs Abatacept	Rheumatoid Arthritis	Drug: Tofacitinib;Drug: Abatacept	Brigham and Women's Hospital	Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging Intramural Research Program (IRP);Rutgers University;Johns Hopkins University	Active, not recruiting	18 Years	N/A	All	29464		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
31	NCT04529902 (ClinicalTrials.gov)	August 17, 2020	25/8/2020	Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - (DREAM) TNFi vs Abatacept	Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - Tumor Necrosis Factor Inhibitors vs Abatacept	Rheumatoid Arthritis	Drug: Tumor Necrosis Factor Inhibitors;Drug: Abatacept	Brigham and Women's Hospital	Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging Intramural Research Program (IRP);Rutgers University;Johns Hopkins University	Active, not recruiting	18 Years	N/A	All	66026		United States
32	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
33	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
34	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
35	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
No.	TrialID	Date_ enrollment	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	NCT04246762 (ClinicalTrials.gov)	June 1, 2020	27/1/2020	Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4	A Phase 1, Open-label, Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4	Rheumatoid Arthritis	Drug: Olokizumab;Drug: Omeprazole;Drug: Caffeine;Drug: Warfarin + Vitamin K;Drug: Midazolam	R-Pharm	IQVIA RDS Ireland Ltd;Thermo Fisher Scientific	Not yet recruiting	18 Years	65 Years	All	15	Phase 1	Bulgaria;Moldova, Republic of
37	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
38	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
39	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
40	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
No.	TrialID	Date_ enrollment	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	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
42	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
43	NCT04115423 (ClinicalTrials.gov)	April 1, 2020	2/10/2019	A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab	A Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance Database	Infection;Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)	Sungkyunkwan University	Ministry of Food and Drug Safety, Korea	Active, not recruiting	18 Years	N/A	All	9508		Korea, Republic of
44	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
45	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
No.	TrialID	Date_ enrollment	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	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
47	NCT04222920 (ClinicalTrials.gov)	March 1, 2020	7/1/2020	Adalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease Activity	Adalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease Activity: a Single Blind, Non-inferiority, Randomised Clinical Trial	Rheumatoid Arthritis	Other: Dose reduction to 2mg/L;Other: Dose reduction to 5mg/L;Drug: Adalimumab	Reade Rheumatology Research Institute	ZonMw: The Netherlands Organisation for Health Research and Development;Sint Maartenskliniek	Recruiting	18 Years	N/A	All	89	Phase 4	Netherlands
48	NCT03895879 (ClinicalTrials.gov)	March 1, 2020	26/3/2019	Use of Tocilizumab Drug Levels to Optimize Treatment in RA	Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA)	Rheumatoid Arthritis	Drug: Tocilizumab	Reade Rheumatology Research Institute	ZonMw: The Netherlands Organisation for Health Research and Development	Recruiting	18 Years	N/A	All	98	Phase 4	Netherlands
49	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
50	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
No.	TrialID	Date_ enrollment	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	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
52	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
53	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)
54	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
55	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
No.	TrialID	Date_ enrollment	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	EUCTR2019-000867-26-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
57	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
58	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
59	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
60	NCT04485325 (ClinicalTrials.gov)	November 4, 2019	30/4/2020	Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients	Capability of Tofacitinib or Etanercept to Accelerate Clinical Relevant Tapering of Non-steroidal Anti-inflammatory Drugs (NSAID) and Treat-to-target Guided De-escalation of Corticosteroids in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Previous csDMARD Therapy (AcceleRAte)	Rheumatic Arthritis	Drug: Tofacitinib;Biological: Etanercept	Dr. Frank Behrens	Pfizer	Recruiting	18 Years	65 Years	All	192	Phase 4	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
61	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
62	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
63	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
64	JPRN-jRCTs071190001	29/08/2019	02/04/2019	Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity	Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity - CROWN study	Rheumatoid arthritis	Patients retaining LDA with the combination of CZP and MTX are randomized to two groups consisting of patients who continue MTX at the same doses or discontinue MTX. The effects of both groups are compared 1 year after starting study. Control group combination therapy with subcutaneous CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) and oral MTX (at the same dose before starting the protocol treatment) given for 52 weeks of the protocol treatment, or until the time of discontinuation. Intervention group monotherapy with CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) given for 52 weeks of the protocol treatment, or until the time of discontinuation. The discontinuation criteria for the study are as follows: 1) When subjects requested to discontinue the treatment 2) When the principal investigator or subinvestigator considered that the therapy should be discontinued due to adverse (drug) events 3) When a subject turned out not to fulfil the inclusion criteria or meets the exclusion criteria after starting the study 4) When RA relapses, defined as SDAI over 11, were observed at two consecutive visits 5) When the principal investigator or subinvestigator considered continuation of the study is inappropriate for reasons other than above	Miyazaki Yusuke	Tanaka Yoshiya	Recruiting	>= 16age old	Not applicable	Both	150	Phase 4	Japan
65	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
No.	TrialID	Date_ enrollment	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	EUCTR2018-004605-57-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
67	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
68	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
69	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
70	NCT03656627 (ClinicalTrials.gov)	June 27, 2019	31/8/2018	Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease	Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease	Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis	Drug: Nivolumab	Alliance Foundation Trials, LLC.	Bristol-Myers Squibb	Recruiting	18 Years	N/A	All	72	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
71	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
72	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
73	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
74	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
75	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
No.	TrialID	Date_ enrollment	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	NCT03926195 (ClinicalTrials.gov)	May 28, 2019	19/4/2019	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	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;Non-Radiographical Axial Spondyloarthritis	Drug: Filgotinib;Drug: Placebo;Drug: Standard of Care	Galapagos NV	Gilead Sciences	Active, not recruiting	21 Years	65 Years	Male	109	Phase 2	Belgium;Bosnia and Herzegovina;Bulgaria;Czechia;Estonia;Georgia;Latvia;Poland;Spain;Ukraine
77	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
78	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
79	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
80	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
No.	TrialID	Date_ enrollment	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	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
82	NCT03915964 (ClinicalTrials.gov)	April 25, 2019	12/4/2019	A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis	A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Baricitinib;Drug: TNF Inhibitor	Eli Lilly and Company	Incyte Corporation	Active, not recruiting	18 Years	N/A	All	2600	Phase 4	United States;Australia;Austria;Belgium;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Lithuania;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;United Kingdom
83	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
84	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
85	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
No.	TrialID	Date_ enrollment	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	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
87	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
88	NCT03813771 (ClinicalTrials.gov)	March 2019	12/9/2018	Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification	Targeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.	Rheumatoid Arthritis	Drug: Benepali;Drug: Sulfasalazine;Drug: Methotrexate;Drug: Hydroxychloroquine	University of Leeds	Samsung Bioepis Co., Ltd.	Not yet recruiting	18 Years	N/A	All	106	Phase 4	United Kingdom
89	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
90	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
No.	TrialID	Date_ enrollment	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	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
92	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
93	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
94	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
95	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
96	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
97	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
98	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
99	NCT03729674 (ClinicalTrials.gov)	November 26, 2018	11/10/2018	Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs	Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs	Rheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's Disease	Drug: Biosimilar;Drug: Originator (legacy) drug	McGill University Health Centre/Research Institute of the McGill University Health Centre	Université de Sherbrooke;Institut de rhumatologie de Montréal;Hospital for Special Surgery, New York;University of Manitoba;University of Toronto;University of Alberta;University of British Columbia;Alberta Health Services;McMaster University;The Arthritis Program Research Group	Recruiting	18 Years	N/A	All	800		Canada
100	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
101	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
102	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
103	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
104	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
105	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
106	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
107	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
108	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
109	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
110	NCT03511625 (ClinicalTrials.gov)	October 2, 2018	10/4/2018	The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis	The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study	Rheumatoid Arthritis	Drug: Acthar Injectable Product;Drug: Depo medrol	Attune Health Research, Inc.	Mallinckrodt	Active, not recruiting	18 Years	N/A	All	6	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
111	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
112	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
113	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
114	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
115	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
No.	TrialID	Date_ enrollment	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	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
117	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
118	NCT03535519 (ClinicalTrials.gov)	August 7, 2018	14/5/2018	Rheumatoid Arthritis Response to Methotrexate	Rheumatoid Arthritis Ultrasound Response to Methotrexate	Rheumatoid Arthritis	Drug: Methotrexate	Juan Carlos Nieto	Nordic Pharma SAS	Recruiting	18 Years	N/A	All	50		Spain
119	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
120	NCT03649061 (ClinicalTrials.gov)	June 8, 2018	30/7/2018	COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA	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	Arthritis, Rheumatoid	Drug: Etanercept 50 MG/ML;Drug: Leflunomide 10 milligram (MG)	P. Verschueren	Belgium Health Care Knowledge Centre	Active, not recruiting	18 Years	N/A	All	284	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
121	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
122	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
123	JPRN-UMIN000030584	2018/04/18	27/12/2017	MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study	MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study	Rheumatoid Arthritis	Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR). If the dosage of MTX is maintained >= 10 mg/week and remission (SDAI <= 3.3) is achieved at Week 24, the MTX therapy will be continued up to Week 48 (ARM-1). Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR). If SDAI remission is not achieved despite the dosage of MTX is maintained >= 10 mg/week at Week 24, a bDMARDs will be added to the treatment in line with EULAR Recommendations 2016. Subjects will subcutaneously receive ADA 40 mg as a bDMARDs every other week up to Week 48, and be randomized to a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2) and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3). Then, the efficacy and safety will be evaluated. Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage	Keio University School of MedicineDivision of Rheumatology, Department of Internal Medicine	Eisai Co., Ltd.	Complete: follow-up continuing	18years-old	Not applicable	Male and Female	300	Not selected	Japan,Asia(except Japan)
124	JPRN-jRCT1031180088	18/04/2018	18/01/2019	MIRACLE Study	MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study	Rheumatoid Arthritis Rheumatoid Arthritis	Subjects meeting all of the inclusion criteria and not applicable to any of the exclusion criteria will start receiving MTX 6 to 8 mg/week after the assessment at Week 0. Also, 10 mg of folic acid will be orally administered once a week 48 hours after the first MTX dosing day of the week to prevent ADRs related to MTX (A daily dosage of 1 mg folic acid is acceptable in South Korea on a condition that the dosage cannot be changed during the study period). To achieve remission, the dosage of MTX will be promptly escalated to the maximum tolerable dose (MTD) <=25 mg/week (the maximum dose should be set according to the package insert of each country) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an ADR. Weekly dose of MTX will be administered orally at once or twice a day in principle. If the dosage of MTX is maintained >=10 mg/week and SDAI remission is achieved at Week 24, the MTX therapy will be continued until Week 48 (ARM-1). If SDAI remission is not achieved despite the maintenance of >=10 mg/week MTX dose at Week 24, ADA 40 mg will be administered subcutaneously every other week until Week 48. Subjects then will be stratified by countries (Japan, South Korea, and Taiwan) as a stratification factor, and for each stratum, subjects will be randomized at a 1:1 ratio to either a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2), and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3). The MTX dosage shall be either 6 mg/week or 7.5 mg/week in subjects in ARM-3 whose maintenance dose of MTX at Week 24 is 10 mg/week. Subjects in whom MTX at a dosage >=	Kaneko Yuko	Eisai Co., Ltd.	Not Recruiting	>= 18age old	Not applicable	Both	300	Phase 4	South Korea;Taiwan;Japan
125	NCT03505008 (ClinicalTrials.gov)	April 18, 2018	16/4/2018	Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan	MIRACLE (Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate) Study	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Adalimumab	Keio University	Eisai Co., Ltd.	Active, not recruiting	18 Years	N/A	All	300	Phase 4	Japan;Korea, Republic of;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
126	JPRN-jRCTs071180018	13/04/2018	15/02/2019	Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.	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.	Kawakami Atsushi	Nakagaki Hisashi;Daiichi Sankyo co.,LTD.	Not Recruiting	>= 20age old	Not applicable	Both	44	Phase 4	Japan
127	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
128	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
129	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
130	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
No.	TrialID	Date_ enrollment	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	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
132	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
133	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
134	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
135	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
No.	TrialID	Date_ enrollment	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	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
137	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
138	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
139	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
140	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
No.	TrialID	Date_ enrollment	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	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
142	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
143	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
144	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
145	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
No.	TrialID	Date_ enrollment	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	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
147	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
148	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
149	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
150	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
No.	TrialID	Date_ enrollment	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	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
152	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
153	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
154	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
155	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
No.	TrialID	Date_ enrollment	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	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
157	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
158	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
159	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
160	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
161	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
162	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
163	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
164	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
165	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
No.	TrialID	Date_ enrollment	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	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
167	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
168	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
169	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
170	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
No.	TrialID	Date_ enrollment	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	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
172	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
173	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
174	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
175	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
No.	TrialID	Date_ enrollment	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	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
177	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
178	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
179	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
180	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
No.	TrialID	Date_ enrollment	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	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
182	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
183	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
184	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
185	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
No.	TrialID	Date_ enrollment	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	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
187	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
188	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
189	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
190	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
No.	TrialID	Date_ enrollment	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	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
192	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
193	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
194	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	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	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
195	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	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]	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	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
No.	TrialID	Date_ enrollment	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	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.	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
197	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	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;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Bulgaria;Germany;Korea, Republic of
198	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
199	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	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 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
200	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	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	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
No.	TrialID	Date_ enrollment	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	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	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;Colombia;Germany;Italy;United Kingdom
202	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
203	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	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	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
204	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	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]	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., 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
205	EUCTR2016-002337-30-SK (EUCTR)	10/04/2017	08/02/2017	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: 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]		Pfizer Inc.	,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
No.	TrialID	Date_ enrollment	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	EUCTR2016-001064-11-ES (EUCTR)	07/04/2017	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
207	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	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]	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
208	EUCTR2016-000897-39-BE (EUCTR)	03/04/2017	02/02/2017	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: 19.1;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	75	Phase 2	United States;Hungary;Taiwan;Mexico;Belgium;Australia;Germany
209	NCT02908490 (ClinicalTrials.gov)	April 1, 2017	8/7/2016	Does Sildenafil Improve Endothelial Dysfunction in Rheumatoid Arthritis?	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	26	Phase 2	United States
210	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
No.	TrialID	Date_ enrollment	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	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	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]	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	Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;South Africa;Bulgaria;Germany;Korea, Republic of
212	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
213	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	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: 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: 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., 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
214	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.	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. - NORD-STAR	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
215	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	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 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
216	EUCTR2016-001825-15-CZ (EUCTR)	21/03/2017	21/03/2017	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.	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
217	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	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]		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
218	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	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	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 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	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
219	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	50		United States
220	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	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]	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., 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
No.	TrialID	Date_ enrollment	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	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	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 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
222	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
223	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
224	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	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: 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, 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
225	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	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	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
No.	TrialID	Date_ enrollment	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	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	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;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany
227	NCT03025308 (ClinicalTrials.gov)	February 28, 2017	17/1/2017	Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults 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	Drug: Filgotinib;Drug: Placebo to match filgotinib	Gilead Sciences	Galapagos NV	Active, not recruiting	18 Years	N/A	All	2731	Phase 3	United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;France;Germany;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Netherlands
228	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
229	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	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	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
230	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	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: 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
No.	TrialID	Date_ enrollment	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	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	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 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
232	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	60	Phase 2	Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Romania;Georgia;Bulgaria;Germany
233	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.	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
234	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	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]		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
235	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	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	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 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	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
No.	TrialID	Date_ enrollment	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	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
237	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	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	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	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
238	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
239	EUCTR2016-000568-41-ES (EUCTR)	13/01/2017	13/01/2017	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: 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
240	EUCTR2016-000570-37-ES (EUCTR)	13/01/2017	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	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	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	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
No.	TrialID	Date_ enrollment	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	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
242	NCT02760433 (ClinicalTrials.gov)	January 9, 2017	29/4/2016	Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Have Active Disease	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	Rheumatoid Arthritis	Drug: Olokizumab q4w;Drug: Olokizumab q2w;Drug: Placebo q2w	R-Pharm	Quintiles, Inc.;OCT Clinical Trials;Mene Research	Active, not recruiting	18 Years	N/A	All	350	Phase 3	United States;Argentina;Brazil;Colombia;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Russian Federation;Czech Republic;Turkey
243	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
244	EUCTR2016-000897-39-HU (EUCTR)	09/01/2017	19/10/2016	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;Taiwan;Hungary;Mexico;Belgium;Australia;Germany
245	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	64	Phase 2	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
246	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	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) 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
247	EUCTR2016-002852-26-GB (EUCTR)	05/01/2017	23/09/2016	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: 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
248	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	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	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
249	EUCTR2016-002852-26-BG (EUCTR)	05/01/2017	03/01/2017	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]		Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
250	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	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]		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
No.	TrialID	Date_ enrollment	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	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	87	Phase 4	Israel
252	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.	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;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
253	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	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	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
254	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	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: 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	80	Phase 2	Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria
255	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	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;Poland;Spain;Romania;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
256	EUCTR2014-004704-29-CZ (EUCTR)	15/12/2016	02/08/2016	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	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
257	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.	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 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: 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	80	Phase 2	Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria
258	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	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: 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
259	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.	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
260	EUCTR2016-002852-26-LT (EUCTR)	07/12/2016	24/10/2016	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: 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
No.	TrialID	Date_ enrollment	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	EUCTR2016-002852-26-CZ (EUCTR)	07/12/2016	21/09/2016	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]		Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	Hungary;Czech Republic;Poland;Lithuania;Bulgaria;Germany;United Kingdom
262	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)	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
263	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	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]		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
264	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	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	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 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	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
265	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	40	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
266	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
267	EUCTR2014-004704-29-BG (EUCTR)	29/11/2016	15/09/2016	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	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;Poland;Spain;Romania;Australia;Bulgaria;Germany
268	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
269	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	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	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	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
270	NCT02960490 (ClinicalTrials.gov)	November 26, 2016	3/11/2016	A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics	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	64	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
271	EUCTR2014-004704-29-PL (EUCTR)	25/11/2016	04/10/2016	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	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;Spain;Poland;Romania;Australia;Bulgaria;Germany
272	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 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	80	Not selected	Japan
273	EUCTR2016-002852-26-HU (EUCTR)	15/11/2016	29/09/2016	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: 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
274	NCT02874092 (ClinicalTrials.gov)	November 15, 2016	17/8/2016	Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis	Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Ticagrelor;Drug: MTX therapy	NYU Langone Health	NULL	Completed	18 Years	N/A	All	9	Phase 4	United States
275	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	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	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 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
276	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	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	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
277	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	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	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	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
278	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
279	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	40	Phase 2	Poland;Romania;Russian Federation
280	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
No.	TrialID	Date_ enrollment	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	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
282	NCT02960438 (ClinicalTrials.gov)	November 2, 2016	3/11/2016	A Dose Response Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Methotrexate	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
283	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	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]	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
284	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
285	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
286	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	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: 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
287	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	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	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: 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
288	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
289	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	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: 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
290	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
291	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	51	N/A	Japan
292	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	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: 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	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
293	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
294	EUCTR2014-004704-29-HU (EUCTR)	05/10/2016	08/08/2016	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	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;Czech Republic;Hungary;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany
295	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.	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	36	Phase 2	Spain;Poland;Romania;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
296	EUCTR2014-004704-29-ES (EUCTR)	03/10/2016	05/08/2016	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	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 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
297	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	80	Not applicable	Japan
298	NCT02881307 (ClinicalTrials.gov)	October 2016	19/8/2016	Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet	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	40	N/A	United States
299	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	22	Phase 1	NULL
300	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)	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).	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
No.	TrialID	Date_ enrollment	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	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
302	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
303	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)	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).	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	India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy
304	EUCTR2014-005368-13-CZ (EUCTR)	13/09/2016	13/09/2016	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).	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 (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	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
305	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
No.	TrialID	Date_ enrollment	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	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	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]	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
307	EUCTR2016-000912-13-GB (EUCTR)	05/09/2016	12/06/2017	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.	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]		GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Poland;Spain;Romania;Germany;Italy;United Kingdom
308	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
309	EUCTR2016-000912-13-DE (EUCTR)	30/08/2016	29/06/2016	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.	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]		GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Poland;Spain;Romania;Germany;Italy;United Kingdom
310	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)	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	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]	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;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
No.	TrialID	Date_ enrollment	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	EUCTR2015-003335-35-BG (EUCTR)	29/08/2016	01/08/2016	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)	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]	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
312	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
313	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
314	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	40	Phase 2	United States;Poland;Germany
315	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
No.	TrialID	Date_ enrollment	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	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
317	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)	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	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 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
318	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	64	Phase 2	United States;Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;Bulgaria
319	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)	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]	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
320	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	60	Phase 2	Serbia;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Russian Federation;Georgia;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
321	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	64	Phase 2	Hungary;Bulgaria
322	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	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	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	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
323	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	18	120	BOTH	408	Phase 2	Japan, Asia except Japan, North America, South America, Europe, Oceania
324	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)	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	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 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	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
325	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	51	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
326	EUCTR2015-003335-35-IT (EUCTR)	18/07/2016	28/02/2018	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) - SELECT-BEYOND	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: 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
327	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	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]	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	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
328	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
329	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	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	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
330	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
No.	TrialID	Date_ enrollment	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	NCT02585258 (ClinicalTrials.gov)	June 30, 2016	20/10/2015	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study	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	RheumatoId Arthritis	Drug: Prednisolone;Other: Placebo	VU University Medical Center	European Commission	Active, not recruiting	65 Years	N/A	All	500	Phase 4	Germany;Hungary;Italy;Netherlands;Portugal;Romania;Slovakia;Finland
332	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	9	Phase 1	Korea, Republic of
333	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)	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	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 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	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
334	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	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]	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	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
335	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	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: 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
No.	TrialID	Date_ enrollment	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	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	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]	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
337	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)	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	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 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	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
338	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)	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	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 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	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
339	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)	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	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]	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	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
340	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
No.	TrialID	Date_ enrollment	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	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	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: 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
342	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)	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	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 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;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
343	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
344	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	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: 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
345	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)	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	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 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	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
No.	TrialID	Date_ enrollment	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	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	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;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
347	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
348	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
349	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
350	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	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;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
351	EUCTR2015-003335-35-FR (EUCTR)	24/05/2016	17/06/2016	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)	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]	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;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
352	NCT02760407 (ClinicalTrials.gov)	May 24, 2016	29/4/2016	Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease	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	Rheumatoid Arthritis	Drug: Olokizumab 64mg q4w;Drug: Olokizumab 64mg q2w;Drug: Adalimumab 40mg q2w;Drug: Placebo q2w	R-Pharm	Quintiles, Inc.;OCT Clinical Trials	Active, not recruiting	18 Years	N/A	All	1575	Phase 3	United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Estonia;Germany;Hungary;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Romania;Russian Federation;Taiwan;United Kingdom;China;Czech Republic
353	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	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: 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
354	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
355	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	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;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
356	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	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	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	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
357	EUCTR2015-003335-35-DK (EUCTR)	03/05/2016	14/03/2016	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)	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]	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
358	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
359	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	48	Phase 1	China
360	NCT02538341 (ClinicalTrials.gov)	May 2016	18/8/2015	Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)	Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)	Rheumatoid Arthritis;Inflammatory Arthritis;Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease	Biological: Herpes Zoster Vaccine;Drug: Placebo	University of Alabama at Birmingham	Oregon Health and Science University	Active, not recruiting	50 Years	N/A	All	617	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
361	NCT01815411 (ClinicalTrials.gov)	May 2016	14/3/2013	Effect of Andosan in Patients With Rheumatoid Arthritis	Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Dietary Supplement: Mushroom extract	Egil Johnson	ImmunoPharma AS	Completed	19 Years	75 Years	All	10	N/A	Norway
362	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	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	Not Recruiting			Female: yes Male: yes	450	Phase 4	Portugal;Hungary;Slovakia;Finland;Germany
363	EUCTR2015-003332-13-FI (EUCTR)	22/04/2016	19/04/2016	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	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	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
364	EUCTR2015-003332-13-NO (EUCTR)	22/04/2016	21/04/2016	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	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]	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
365	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	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]		VU University Medical Center	NULL	Not Recruiting			Female: yes Male: yes	450	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
366	EUCTR2015-003333-95-AT (EUCTR)	20/04/2016	12/04/2016	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)	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]	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
367	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	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: 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	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
368	EUCTR2015-003332-13-AT (EUCTR)	20/04/2016	01/06/2016	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	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: 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	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
369	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	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: 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
370	EUCTR2015-003333-95-DK (EUCTR)	15/04/2016	07/04/2016	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)	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
No.	TrialID	Date_ enrollment	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	EUCTR2015-003332-13-IT (EUCTR)	15/04/2016	28/02/2018	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 - SELECT-NEXT	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: 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
372	EUCTR2015-003332-13-DK (EUCTR)	15/04/2016	07/04/2016	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	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	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
373	NCT02746380 (ClinicalTrials.gov)	April 2016	5/4/2016	A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy	Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX	Arthritis, Rheumatoid	Drug: LBAL;Drug: Humira ®	LG Life Sciences	Mochida Pharmaceutical Company, Ltd.	Active, not recruiting	20 Years	75 Years	All	380	Phase 3	Japan;Korea, Republic of
374	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	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]	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
375	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	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: 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	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
376	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
377	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
378	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
379	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
380	NCT02547493 (ClinicalTrials.gov)	March 3, 2016	7/9/2015	Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients	Comparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With Abatacept	Rheumatoid Arthritis	Biological: pneumococcal polysaccharide vaccine;Biological: pneumococcal conjugate vaccine;Drug: Abatacept	University Hospital, Montpellier	Bristol-Myers Squibb	Active, not recruiting	18 Years	85 Years	All	80	N/A	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
381	JPRN-UMIN000021157	2016/03/01	29/02/2016	Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexate		Rheumatoid arthritis	administration of weekly MTX dose at once. administration by dividing three times of weekly MTX dose.	Yokohama Minami Kyousai Hospital	AYUMI Pharmaceutical corporation	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	120	Not applicable	Japan
382	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	40	Not selected	Japan
383	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
384	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	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]		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
385	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
No.	TrialID	Date_ enrollment	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	EUCTR2015-002634-41-BG (EUCTR)	24/02/2016	21/12/2015	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	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
387	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
388	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
389	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
390	EUCTR2015-001275-50-HU (EUCTR)	09/02/2016	04/12/2015	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: 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
No.	TrialID	Date_ enrollment	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	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
392	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
393	NCT03332719 (ClinicalTrials.gov)	February 2016	21/4/2016	Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis	Multicentric Evaluator-blinded Randomized Non-inferiority Study, to Asses the Compared Efficacy, Safety and Immunogenicity of Enerceptan® With Enbrel® in Combination With Methotrexate for the Treatment of Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Etanercept;Drug: Methotrexate	Gema Biotech S.A.	QUID-Quality in Drugs and Devices Latin American Consulting SRL	Completed	19 Years	99 Years	All	168	Phase 3	Argentina
394	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	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: 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
395	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
396	EUCTR2015-002634-41-PL (EUCTR)	20/01/2016	16/12/2015	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	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
397	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
398	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	50	Not selected	Japan
399	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]	Product Name: Tofacitinib citrate Product Code: CP -690, 550 - 10 INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Trade Name: Humira ® (Adalimumab) 40mg/0.8mL Pre-filled Syringe Product Name: Adalimumab Product Code: L04AB04 INN or Proposed INN: ADALIMUMAB Other descriptive name: Humira Trade Name: Humira ® 40 mg/ 0.8 ml solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB Trade Name: Methotrexate sodium 2.5mg tablets Product Name: Methotrexate sodium 2.5mg tablets INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE SODIUM Trade Name: Zostavax ® Product Name: Zostavax	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
400	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
No.	TrialID	Date_ enrollment	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	NCT02742597 (ClinicalTrials.gov)	January 12, 2016	21/3/2016	Patient-Centred Innovations for Persons With Multimorbidity - Ontario	Patient-Centred Innovations for Persons With Multimorbidity - Ontario	Hypertension;Depression;Anxiety;Musculoskeletal Pain;Arthritis;Rheumatoid Arthritis;Osteoporosis;Chronic Obstructive Pulmonary Disease (COPD);Asthma;Chronic Bronchitis;Cardiovascular Disease;Heart Failure;Stroke;Transient Ischemic Attacks;Ulcer;Gastroesophageal Reflux;Irritable Bowel;Crohn's Disease;Ulcerative Colitis;Diverticulosis;Chronic Hepatitis;Diabetes;Thyroid Disorder;Cancer;Kidney Disease;Urinary Tract Problem;Dementia;Alzheimer's Disease;Hyperlipidemia;HIV;Multimorbidity	Behavioral: TIP / IMPACT Plus Care Coordination	Lawson Health Research Institute	Western University, Canada;Université de Sherbrooke;Canadian Institutes of Health Research (CIHR);Sunnybrook Health Sciences Centre;St. Michael's Hospital, Toronto;University Health Network, Toronto;Toronto East General Hospital;Providence HealthCare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College Hospital	Active, not recruiting	18 Years	80 Years	All	1980	N/A	Canada
402	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	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: 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
403	EUCTR2015-002634-41-HU (EUCTR)	07/01/2016	16/10/2015	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	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 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
404	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	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: 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: 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;France;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Latvia
405	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
No.	TrialID	Date_ enrollment	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	NCT02652273 (ClinicalTrials.gov)	January 2016	8/1/2016	Inhibition of Co-Stimulation in Rheumatoid Arthritis	Inhibition of Co-Stimulation in Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: Abatacept	NHS Greater Glasgow and Clyde	University of Glasgow	Not yet recruiting	18 Years	N/A	Both	25	Phase 4	United Kingdom
407	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
408	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
409	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	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: 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
410	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.	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]		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
No.	TrialID	Date_ enrollment	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	EUCTR2015-001275-50-AT (EUCTR)	20/12/2015	23/11/2015	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: 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: 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;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
412	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
413	EUCTR2015-002634-41-ES (EUCTR)	17/12/2015	30/10/2015	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	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 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
414	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
415	EUCTR2015-001275-50-IT (EUCTR)	17/12/2015	05/11/2020	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 - ND	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
No.	TrialID	Date_ enrollment	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	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
417	EUCTR2015-001275-50-ES (EUCTR)	15/12/2015	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	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;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;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

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

NCT03938701
(ClinicalTrials.gov)

March 2021

25/2/2019

Fluorescence Imaging of Disease Activity in IBD and Rheumatoid Arthritis Using OTL38

Fluorescence Imaging for the Evaluation of Disease Activity in IBD and Rheumatoid Arthritis Using the Fluorescent Tracer OTL38 Targeting the Folate ß Receptor: a Single-center Pilot Study

IBD;Rheumatoid Arthritis

Drug: OTL38;Device: Fluorescence Imaging

University Medical Center Groningen

GlaxoSmithKline;On Target Laboratories, LLC;VU University Medical Center

Not yet recruiting

18 Years

N/A

All

Phase 1

Netherlands

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

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

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

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04608344
(ClinicalTrials.gov)

November 4, 2020

23/10/2020

Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

A Phase 1 Study to Evaluate OATP Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

Rheumatoid Arthritis

Drug: Atorvastatin;Drug: Pravastatin;Drug: Rosuvastatin;Drug: Filgotinib

Gilead Sciences

Galapagos NV

Recruiting

18 Years

55 Years

All

Phase 1

United States

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

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

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

NCT04311567
(ClinicalTrials.gov)

October 7, 2020

5/3/2020

Effects of Tofacitinib vs Methotrexate on Rheumatoid Arthritis Interstitial Lung Disease

Effects of Tofacitinib vs Methotrexate on Clinical and Molecular Disease Activity Markers in Joints and Lungs in Early Rheumatoid Arthritis (PULMORA) - A Randomized, Controlled, Open-label, Assessor-blinded, Phase IV Trial

Rheumatoid Arthritis;Interstitial Lung Disease Due to Systemic Disease (Disorder);RA;ILD

Drug: Tofacitinib;Drug: Methotrexate

Vastra Gotaland Region

Göteborg University

Not yet recruiting

18 Years

80 Years

All

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

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

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

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

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

NCT04586933
(ClinicalTrials.gov)

October 2020

22/9/2020

Nutrition in Rheumatic Diseases

Nutritional Intervention in Rheumatic Diseases: Effect of Marine Omega-3 Fatty Acids and Individual Dietary Guidance

Spondyloarthritis;Rheumatoid Arthritis;Polyarthritis

Dietary Supplement: Omega-3;Dietary Supplement: Placebo (soya);Behavioral: Dietary guidance

Haukeland University Hospital

GC Rieber Oils AS

Not yet recruiting

18 Years

75 Years

All

120

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

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

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

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

NCT04529863
(ClinicalTrials.gov)

August 17, 2020

25/8/2020

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tocilizumab vs Abatacept

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines- Tocilizumab vs Abatacept

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Abatacept

Brigham and Women's Hospital

Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging Intramural Research Program (IRP);Rutgers University;Johns Hopkins University

Active, not recruiting

18 Years

N/A

All

30432

United States

NCT04529876
(ClinicalTrials.gov)

August 17, 2020

25/8/2020

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tofacitinib vs Abatacept

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - Tofacitinib vs Abatacept

Rheumatoid Arthritis

Drug: Tofacitinib;Drug: Abatacept

Brigham and Women's Hospital

Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging Intramural Research Program (IRP);Rutgers University;Johns Hopkins University

Active, not recruiting

18 Years

N/A

All

29464

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

NCT04529902
(ClinicalTrials.gov)

August 17, 2020

25/8/2020

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - (DREAM) TNFi vs Abatacept

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - Tumor Necrosis Factor Inhibitors vs Abatacept

Rheumatoid Arthritis

Drug: Tumor Necrosis Factor Inhibitors;Drug: Abatacept

Brigham and Women's Hospital

Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging Intramural Research Program (IRP);Rutgers University;Johns Hopkins University

Active, not recruiting

18 Years

N/A

All

66026

United States

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04246762
(ClinicalTrials.gov)

June 1, 2020

27/1/2020

Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4

A Phase 1, Open-label, Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19, and CYP3A4

Rheumatoid Arthritis

Drug: Olokizumab;Drug: Omeprazole;Drug: Caffeine;Drug: Warfarin + Vitamin K;Drug: Midazolam

R-Pharm

IQVIA RDS Ireland Ltd;Thermo Fisher Scientific

Not yet recruiting

18 Years

65 Years

All

Phase 1

Bulgaria;Moldova, Republic of

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

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

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

No.

TrialID

Date_
enrollment

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

NCT04115423
(ClinicalTrials.gov)

April 1, 2020

2/10/2019

A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab

A Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance Database

Infection;Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)

Sungkyunkwan University

Ministry of Food and Drug Safety, Korea

Active, not recruiting

18 Years

N/A

All

9508

Korea, Republic of

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

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

No.

TrialID

Date_
enrollment

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-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

NCT04222920
(ClinicalTrials.gov)

March 1, 2020

7/1/2020

Adalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease Activity

Adalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease Activity: a Single Blind, Non-inferiority, Randomised Clinical Trial

Rheumatoid Arthritis

Other: Dose reduction to 2mg/L;Other: Dose reduction to 5mg/L;Drug: Adalimumab

Reade Rheumatology Research Institute

ZonMw: The Netherlands Organisation for Health Research and Development;Sint Maartenskliniek

Recruiting

18 Years

N/A

All

Phase 4

Netherlands

NCT03895879
(ClinicalTrials.gov)

March 1, 2020

26/3/2019

Use of Tocilizumab Drug Levels to Optimize Treatment in RA

Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA)

Rheumatoid Arthritis

Drug: Tocilizumab

Reade Rheumatology Research Institute

ZonMw: The Netherlands Organisation for Health Research and Development

Recruiting

18 Years

N/A

All

Phase 4

Netherlands

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

EUCTR2019-001185-15-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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003351-37-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

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

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)

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

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

No.

TrialID

Date_
enrollment

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-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

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]

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

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

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

NCT04485325
(ClinicalTrials.gov)

November 4, 2019

30/4/2020

Capability of Tofacitinib or Etanercept to Accelerate Tapering of NSAID and Treat-to-target Guided De-escalation of Corticosteroids in RA Patients

Capability of Tofacitinib or Etanercept to Accelerate Clinical Relevant Tapering of Non-steroidal Anti-inflammatory Drugs (NSAID) and Treat-to-target Guided De-escalation of Corticosteroids in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Previous csDMARD Therapy (AcceleRAte)

Rheumatic Arthritis

Drug: Tofacitinib;Biological: Etanercept

Dr. Frank Behrens

Pfizer

Recruiting

18 Years

65 Years

All

192

Phase 4

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

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

EUCTR2019-000867-26-HU
(EUCTR)

24/10/2019

28/10/2019

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

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

JPRN-jRCTs071190001

29/08/2019

02/04/2019

Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity

Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity - CROWN study

Rheumatoid arthritis

Patients retaining LDA with the combination of CZP and MTX are randomized to two groups consisting of patients who continue MTX at the same doses or discontinue MTX. The effects of both groups are compared 1 year after starting study.

Control group
combination therapy with subcutaneous CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) and oral MTX (at the same dose before starting the protocol treatment) given for 52 weeks of the protocol treatment, or until the time of discontinuation.

Intervention group
monotherapy with CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) given for 52 weeks of the protocol treatment, or until the time of discontinuation.

The discontinuation criteria for the study are as follows:
1) When subjects requested to discontinue the treatment
2) When the principal investigator or subinvestigator considered that the therapy should be discontinued due to adverse (drug) events
3) When a subject turned out not to fulfil the inclusion criteria or meets the exclusion criteria after starting the study
4) When RA relapses, defined as SDAI over 11, were observed at two consecutive visits
5) When the principal investigator or subinvestigator considered continuation of the study is inappropriate for reasons other than above

Miyazaki Yusuke

Tanaka Yoshiya

Recruiting

>= 16age old

Not applicable

Both

150

Phase 4

Japan

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-004605-57-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

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

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

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

NCT03656627
(ClinicalTrials.gov)

June 27, 2019

31/8/2018

Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis

Drug: Nivolumab

Alliance Foundation Trials, LLC.

Bristol-Myers Squibb

Recruiting

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

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

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

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03926195
(ClinicalTrials.gov)

May 28, 2019

19/4/2019

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

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;Non-Radiographical Axial Spondyloarthritis

Drug: Filgotinib;Drug: Placebo;Drug: Standard of Care

Galapagos NV

Gilead Sciences

Active, not recruiting

21 Years

65 Years

Male

109

Phase 2

Belgium;Bosnia and Herzegovina;Bulgaria;Czechia;Estonia;Georgia;Latvia;Poland;Spain;Ukraine

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

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-002306-31-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

NCT03915964
(ClinicalTrials.gov)

April 25, 2019

12/4/2019

A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis

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

Rheumatoid Arthritis

Drug: Baricitinib;Drug: TNF Inhibitor

Eli Lilly and Company

Incyte Corporation

Active, not recruiting

18 Years

N/A

All

2600

Phase 4

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

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

NCT03813771
(ClinicalTrials.gov)

March 2019

12/9/2018

Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification

Targeted Treatment Early With Etanercept Plus Methotrexate Versus T2T Care for DMARD-naïve Early RA Patients. A Prospective, Longitudinal Cohort Study With Embedded Pilot Randomised Controlled Trial to Assess Treatment Rationalisation Based on naïve T-cell Stratification.

Rheumatoid Arthritis

Drug: Benepali;Drug: Sulfasalazine;Drug: Methotrexate;Drug: Hydroxychloroquine

University of Leeds

Samsung Bioepis Co., Ltd.

Not yet recruiting

18 Years

N/A

All

106

Phase 4

United Kingdom

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-000666-10-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

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

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

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

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

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

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

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

NCT03729674
(ClinicalTrials.gov)

November 26, 2018

11/10/2018

Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs

Rheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's Disease

McGill University Health Centre/Research Institute of the McGill University Health Centre

Université de Sherbrooke;Institut de rhumatologie de Montréal;Hospital for Special Surgery, New York;University of Manitoba;University of Toronto;University of Alberta;University of British Columbia;Alberta Health Services;McMaster University;The Arthritis Program Research Group

Recruiting

18 Years

N/A

All

800

Canada

100

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

101

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

102

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

103

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

104

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

105

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

106

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

107

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

108

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

109

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

110

NCT03511625
(ClinicalTrials.gov)

October 2, 2018

10/4/2018

The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis

The Effects of Acthar on Synovial Inflammation in Rheumatoid Arthritis: A Pilot Study

Rheumatoid Arthritis

Drug: Acthar Injectable Product;Drug: Depo medrol

Attune Health Research, Inc.

Mallinckrodt

Active, not recruiting

18 Years

N/A

All

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

111

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

112

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

113

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

114

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

115

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

No.

TrialID

Date_
enrollment

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

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

117

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

118

NCT03535519
(ClinicalTrials.gov)

August 7, 2018

14/5/2018

Rheumatoid Arthritis Response to Methotrexate

Rheumatoid Arthritis Ultrasound Response to Methotrexate

Rheumatoid Arthritis

Drug: Methotrexate

Juan Carlos Nieto

Nordic Pharma SAS

Recruiting

18 Years

N/A

All

Spain

119

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

120

NCT03649061
(ClinicalTrials.gov)

June 8, 2018

30/7/2018

COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA

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

Arthritis, Rheumatoid

Drug: Etanercept 50 MG/ML;Drug: Leflunomide 10 milligram (MG)

P. Verschueren

Belgium Health Care Knowledge Centre

Active, not recruiting

18 Years

N/A

All

284

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

121

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

122

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

123

JPRN-UMIN000030584

2018/04/18

27/12/2017

MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study

MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study

Rheumatoid Arthritis

Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR).
If the dosage of MTX is maintained >= 10 mg/week and remission (SDAI <= 3.3) is achieved at Week 24, the MTX therapy will be continued up to Week 48 (ARM-1).
Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR).
If SDAI remission is not achieved despite the dosage of MTX is maintained >= 10 mg/week at Week 24, a bDMARDs will be added to the treatment in line with EULAR Recommendations 2016. Subjects will subcutaneously receive ADA 40 mg as a bDMARDs every other week up to Week 48, and be randomized to a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2) and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3). Then, the efficacy and safety will be evaluated.
Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage

Keio University School of MedicineDivision of Rheumatology, Department of Internal Medicine

Eisai Co., Ltd.

Complete: follow-up continuing

18years-old

Not applicable

Male and Female

300

Not selected

Japan,Asia(except Japan)

124

JPRN-jRCT1031180088

18/04/2018

18/01/2019

MIRACLE Study

MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study

Rheumatoid Arthritis
Rheumatoid Arthritis

Subjects meeting all of the inclusion criteria and not applicable to any of the exclusion criteria will start receiving MTX 6 to 8 mg/week after the assessment at Week 0. Also, 10 mg of folic acid will be orally administered once a week 48 hours after the first MTX dosing day of the week to prevent ADRs related to MTX (A daily dosage of 1 mg folic acid is acceptable in South Korea on a condition that the dosage cannot be changed during the study period).
To achieve remission, the dosage of MTX will be promptly escalated to the maximum tolerable dose (MTD) <=25 mg/week (the maximum dose should be set according to the package insert of each country) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an ADR. Weekly dose of MTX will be administered orally at once or twice a day in principle.
If the dosage of MTX is maintained >=10 mg/week and SDAI remission is achieved at Week 24, the MTX therapy will be continued until Week 48 (ARM-1).
If SDAI remission is not achieved despite the maintenance of >=10 mg/week MTX dose at Week 24, ADA 40 mg will be administered subcutaneously every other week until Week 48. Subjects then will be stratified by countries (Japan, South Korea, and Taiwan) as a stratification factor, and for each stratum, subjects will be randomized at a 1:1 ratio to either a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2), and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3).
The MTX dosage shall be either 6 mg/week or 7.5 mg/week in subjects in ARM-3 whose maintenance dose of MTX at Week 24 is 10 mg/week.
Subjects in whom MTX at a dosage >=

Kaneko Yuko

Eisai Co., Ltd.

Not Recruiting

>= 18age old

Not applicable

Both

300

Phase 4

South Korea;Taiwan;Japan

125

NCT03505008
(ClinicalTrials.gov)

April 18, 2018

16/4/2018

Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan

MIRACLE (Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate) Study

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Adalimumab

Keio University

Eisai Co., Ltd.

Active, not recruiting

18 Years

N/A

All

300

Phase 4

Japan;Korea, Republic of;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

126

JPRN-jRCTs071180018

13/04/2018

15/02/2019

Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.

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.

Kawakami Atsushi

Nakagaki Hisashi;Daiichi Sankyo co.,LTD.

Not Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

127

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

Daiichi Sankyo Company, Limited

NULL

Complete: follow-up continuing

20years-old

Not applicable

Male and Female

Not applicable

Japan

128

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

129

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

130

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

No.

TrialID

Date_
enrollment

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

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

132

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

133

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

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

134

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

135

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

No.

TrialID

Date_
enrollment

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

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

137

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

138

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

139

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

140

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

No.

TrialID

Date_
enrollment

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

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

142

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

Phase 2

Denmark;Netherlands;Sweden

143

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

144

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

145

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

No.

TrialID

Date_
enrollment

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

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

147

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

148

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

149

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

150

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

No.

TrialID

Date_
enrollment

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

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

152

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

153

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

154

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

155

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

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

No.

TrialID

Date_
enrollment

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

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

157

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

158

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

159

EUCTR2017-000384-32-CZ
(EUCTR)

26/09/2017

26/07/2017

Phase IIb in Rheumatoid Arthritis

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

160

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

161

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

162

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

Phase 2

Denmark;Netherlands;Sweden

163

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

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

164

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

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

165

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

No.

TrialID

Date_
enrollment

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

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

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

167

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

168

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

169

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

170

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

No.

TrialID

Date_
enrollment

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

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

172

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

173

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

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

174

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

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

175

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

No.

TrialID

Date_
enrollment

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

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

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

177

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

178

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

179

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

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

180

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

No.

TrialID

Date_
enrollment

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

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

182

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

183

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

184

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

185

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

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

No.

TrialID

Date_
enrollment

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

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

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

269

Phase 2

187

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

188

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

189

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

190

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

No.

TrialID

Date_
enrollment

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

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

192

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

193

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

194

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

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

195

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

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: 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

No.

TrialID

Date_
enrollment

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

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

197

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

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

198

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

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

199

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

200

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

No.

TrialID

Date_
enrollment

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

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

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;Colombia;Germany;Italy;United Kingdom

202

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

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

203

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

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

204

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

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

205

EUCTR2016-002337-30-SK
(EUCTR)

10/04/2017

08/02/2017

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: 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]

Pfizer Inc.

,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

206

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

207

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

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: 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

208

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

209

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

210

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

No.

TrialID

Date_
enrollment

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

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

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

Czech Republic;Hungary;Mexico;Poland;Belgium;Australia;United States;Philippines;Slovakia;Spain;Russian Federation;Italy;United Kingdom;South Africa;Bulgaria;Germany;Korea, Republic of

212

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

213

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

214

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

215

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

No.

TrialID

Date_
enrollment

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

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

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

217

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

218

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

219

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

220

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

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

No.

TrialID

Date_
enrollment

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

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

222

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

223

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

224

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

225

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

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

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

No.

TrialID

Date_
enrollment

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

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

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;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany

227

NCT03025308
(ClinicalTrials.gov)

February 28, 2017

17/1/2017

Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults 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

Drug: Filgotinib;Drug: Placebo to match filgotinib

Gilead Sciences

Galapagos NV

Active, not recruiting

18 Years

N/A

All

2731

Phase 3

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

228

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

229

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

230

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

No.

TrialID

Date_
enrollment

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

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

232

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

233

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

234

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

235

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

No.

TrialID

Date_
enrollment

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

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

237

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

238

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

239

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

240

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

Gilead Sciences, Inc.

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

241

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

242

NCT02760433
(ClinicalTrials.gov)

January 9, 2017

29/4/2016

Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Have Active Disease

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

Rheumatoid Arthritis

Drug: Olokizumab q4w;Drug: Olokizumab q2w;Drug: Placebo q2w

R-Pharm

Quintiles, Inc.;OCT Clinical Trials;Mene Research

Active, not recruiting

18 Years

N/A

All

350

Phase 3

United States;Argentina;Brazil;Colombia;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Poland;Russian Federation;Czech Republic;Turkey

243

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

244

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

245

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

No.

TrialID

Date_
enrollment

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

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

247

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

248

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

249

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

250

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

No.

TrialID

Date_
enrollment

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

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

252

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

253

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

254

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

255

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

No.

TrialID

Date_
enrollment

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

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

257

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.

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: 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

258

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

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: 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

259

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

260

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

No.

TrialID

Date_
enrollment

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

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

262

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

263

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

264

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

265

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

No.

TrialID

Date_
enrollment

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

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

267

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

268

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

269

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

270

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

271

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

272

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

273

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

274

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

275

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

No.

TrialID

Date_
enrollment

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

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

277

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

278

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

279

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

280

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

No.

TrialID

Date_
enrollment

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

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

282

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

283

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

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]

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

284

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

285

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

286

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

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: 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

287

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

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: 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

288

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

289

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

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: 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

290

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

291

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

292

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

293

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

294

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

295

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

No.

TrialID

Date_
enrollment

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

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

297

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

298

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

299

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

300

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

No.

TrialID

Date_
enrollment

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

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

302

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

303

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

304

EUCTR2014-005368-13-CZ
(EUCTR)

13/09/2016

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

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

305

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

No.

TrialID

Date_
enrollment

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

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

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]

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

307

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

308

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

309

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

310

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

No.

TrialID

Date_
enrollment

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

EUCTR2015-003335-35-BG
(EUCTR)

29/08/2016

01/08/2016

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

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

312

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)

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

313

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

314

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

315

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

No.

TrialID

Date_
enrollment

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

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

317

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)

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

975

Phase 3

318

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

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;Bulgaria

319

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

320

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

No.

TrialID

Date_
enrollment

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

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

322

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

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

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

323

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

324

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

325

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

No.

TrialID

Date_
enrollment

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

EUCTR2015-003335-35-IT
(EUCTR)

18/07/2016

28/02/2018

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: 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

327

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

328

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

329

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

330

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

No.

TrialID

Date_
enrollment

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

NCT02585258
(ClinicalTrials.gov)

June 30, 2016

20/10/2015

The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study

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

RheumatoId Arthritis

Drug: Prednisolone;Other: Placebo

VU University Medical Center

European Commission

Active, not recruiting

65 Years

N/A

All

500

Phase 4

Germany;Hungary;Italy;Netherlands;Portugal;Romania;Slovakia;Finland

332

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

333

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

334

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

335

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

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: 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

No.

TrialID

Date_
enrollment

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

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

337

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

338

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

339

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

340

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

No.

TrialID

Date_
enrollment

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

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

342

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

343

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

344

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

345

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

No.

TrialID

Date_
enrollment

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

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

347

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

348

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

349

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

350

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

No.

TrialID

Date_
enrollment

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

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

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

352

NCT02760407
(ClinicalTrials.gov)

May 24, 2016

29/4/2016

Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease

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

Rheumatoid Arthritis

Drug: Olokizumab 64mg q4w;Drug: Olokizumab 64mg q2w;Drug: Adalimumab 40mg q2w;Drug: Placebo q2w

R-Pharm

Quintiles, Inc.;OCT Clinical Trials

Active, not recruiting

18 Years

N/A

All

1575

Phase 3

United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Estonia;Germany;Hungary;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Romania;Russian Federation;Taiwan;United Kingdom;China;Czech Republic

353

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

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: 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

354

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

355

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

No.

TrialID

Date_
enrollment

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

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

357

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

358

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

359

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

360

NCT02538341
(ClinicalTrials.gov)

May 2016

18/8/2015

Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)

Safety and Effectiveness of Live Zoster Vaccine in Anti-TNF Users (VERVE Trial)

Rheumatoid Arthritis;Inflammatory Arthritis;Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease

Biological: Herpes Zoster Vaccine;Drug: Placebo

University of Alabama at Birmingham

Oregon Health and Science University

Active, not recruiting

50 Years

N/A

All

617

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

361

NCT01815411
(ClinicalTrials.gov)

May 2016

14/3/2013

Effect of Andosan in Patients With Rheumatoid Arthritis

Effect of the Mushroom Extract Andosan on Symptoms and Inflammatory Parameters in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Dietary Supplement: Mushroom extract

Egil Johnson

ImmunoPharma AS

Completed

19 Years

75 Years

All

N/A

Norway

362

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

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

Not Recruiting

Female: yes
Male: yes

450

Phase 4

Portugal;Hungary;Slovakia;Finland;Germany

363

EUCTR2015-003332-13-FI
(EUCTR)

22/04/2016

19/04/2016

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

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

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

364

EUCTR2015-003332-13-NO
(EUCTR)

22/04/2016

21/04/2016

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

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

365

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

No.

TrialID

Date_
enrollment

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

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

367

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

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

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

368

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

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

369

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

370

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

No.

TrialID

Date_
enrollment

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

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

372

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

373

NCT02746380
(ClinicalTrials.gov)

April 2016

5/4/2016

A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

Arthritis, Rheumatoid

Drug: LBAL;Drug: Humira ®

LG Life Sciences

Mochida Pharmaceutical Company, Ltd.

Active, not recruiting

20 Years

75 Years

All

380

Phase 3

Japan;Korea, Republic of

374

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

375

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

No.

TrialID

Date_
enrollment

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

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

377

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

378

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

379

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

380

NCT02547493
(ClinicalTrials.gov)

March 3, 2016

7/9/2015

Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients

Comparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With Abatacept

Rheumatoid Arthritis

Biological: pneumococcal polysaccharide vaccine;Biological: pneumococcal conjugate vaccine;Drug: Abatacept

University Hospital, Montpellier

Bristol-Myers Squibb

Active, not recruiting

18 Years

85 Years

All

N/A

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

381

JPRN-UMIN000021157

2016/03/01

29/02/2016

Clinical trial for efficacy and safety related to weekly dosage regimens of methotrexate

Rheumatoid arthritis

administration of weekly MTX dose at once.
administration by dividing three times of weekly MTX dose.

Yokohama Minami Kyousai Hospital

AYUMI Pharmaceutical corporation

Complete: follow-up complete

Not applicable

Male and Female

120

Not applicable

Japan

382

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

383

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

384

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

385

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

No.

TrialID

Date_
enrollment

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

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

387

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

388

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

389

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

390

EUCTR2015-001275-50-HU
(EUCTR)

09/02/2016

04/12/2015

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: 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

No.

TrialID

Date_
enrollment

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

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

392

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

393

NCT03332719
(ClinicalTrials.gov)

February 2016

21/4/2016

Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis

Multicentric Evaluator-blinded Randomized Non-inferiority Study, to Asses the Compared Efficacy, Safety and Immunogenicity of Enerceptan® With Enbrel® in Combination With Methotrexate for the Treatment of Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Etanercept;Drug: Methotrexate

Gema Biotech S.A.

QUID-Quality in Drugs and Devices Latin American Consulting SRL

Completed

19 Years

99 Years

All

168

Phase 3

Argentina

394

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

395

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

396

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

397

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

398

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

399

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

400

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

No.

TrialID

Date_
enrollment

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

NCT02742597
(ClinicalTrials.gov)

January 12, 2016

21/3/2016

Patient-Centred Innovations for Persons With Multimorbidity - Ontario

Hypertension;Depression;Anxiety;Musculoskeletal Pain;Arthritis;Rheumatoid Arthritis;Osteoporosis;Chronic Obstructive Pulmonary Disease (COPD);Asthma;Chronic Bronchitis;Cardiovascular Disease;Heart Failure;Stroke;Transient Ischemic Attacks;Ulcer;Gastroesophageal Reflux;Irritable Bowel;Crohn's Disease;Ulcerative Colitis;Diverticulosis;Chronic Hepatitis;Diabetes;Thyroid Disorder;Cancer;Kidney Disease;Urinary Tract Problem;Dementia;Alzheimer's Disease;Hyperlipidemia;HIV;Multimorbidity

Behavioral: TIP / IMPACT Plus Care Coordination

Lawson Health Research Institute

Western University, Canada;Université de Sherbrooke;Canadian Institutes of Health Research (CIHR);Sunnybrook Health Sciences Centre;St. Michael's Hospital, Toronto;University Health Network, Toronto;Toronto East General Hospital;Providence HealthCare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College Hospital

Active, not recruiting

18 Years

80 Years

All

1980

N/A

Canada

402

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

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: 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

403

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

404

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

405

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

No.

TrialID

Date_
enrollment

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

NCT02652273
(ClinicalTrials.gov)

January 2016

8/1/2016

Inhibition of Co-Stimulation in Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Abatacept

NHS Greater Glasgow and Clyde

University of Glasgow

Not yet recruiting

18 Years

N/A

Both

Phase 4

United Kingdom

407

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

408

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

409

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

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: 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

410

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

No.

TrialID

Date_
enrollment

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

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

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

412

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

413

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

414

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

415

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

No.

TrialID

Date_
enrollment

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

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

417

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

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

418

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

419

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

420

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

421

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

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

422

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

423

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

424

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

425

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

No.

TrialID

Date_
enrollment

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

NCT02758769
(ClinicalTrials.gov)

November 30, 2015

14/4/2016

Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings

Rheumatoid Arthritis

Biological: ORENCIA Subcutaneous Injection

Bristol-Myers Squibb

Ono Pharmaceutical Co. Ltd

Recruiting

20 Years

N/A

All

300

N/A

Japan

427

EUCTR2015-001275-50-FR
(EUCTR)

30/11/2015

04/12/2015

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

428

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

429

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

430

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

No.

TrialID

Date_
enrollment

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

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

432

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

433

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

434

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

435

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

No.

TrialID

Date_
enrollment

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

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

437

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

438

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

439

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

440

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

441

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

442

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

443

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

444

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

445

NCT02543931
(ClinicalTrials.gov)

November 2015

6/8/2015

Curcuma Longa L in Rheumatoid Arthritis

Phase Ib Randomized, Double-Blind, Placebo-Controlled Study of Meriva in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Meriva;Drug: placebo

University of Arizona

Vanderbilt University;National Center for Complementary and Integrative Health (NCCIH);National Institutes of Health (NIH)

Terminated

18 Years

N/A

Both

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

446

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

447

NCT02552940
(ClinicalTrials.gov)

October 31, 2015

16/9/2015

An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice

A PROSPECTIVE, NON-INTERVENTIONAL STUDY TO EVALUATE THE CLINICAL EFFECTIVENESS, THE CONSISTENCY OF EVALUATION SCORES, QUALITY OF LIFE, SAFETY AND TOLERABILITY OF TOCILIZUMAB SUBCUTANEOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY CLINICAL PRACTICE

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

nv Roche sa

Completed

18 Years

N/A

All

140

Belgium;Luxembourg

448

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

449

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.

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: 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

450

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

No.

TrialID

Date_
enrollment

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

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

452

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

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

453

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

454

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

455

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

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: 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

456

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

457

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

458

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

459

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

460

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

No.

TrialID

Date_
enrollment

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

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

462

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.

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: 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

463

NCT02605642
(ClinicalTrials.gov)

September 10, 2015

2/9/2015

Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade

PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)

Rheumatoid Diseases;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis

Drug: CT-P13

Pfizer

Hospira, now a wholly owned subsidiary of Pfizer

Completed

18 Years

N/A

All

351

Bulgaria;Canada;Czechia;Germany;Greece;Spain;United Kingdom;Czech Republic;France;Italy

464

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

465

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

No.

TrialID

Date_
enrollment

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

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

467

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

468

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

469

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

470

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

No.

TrialID

Date_
enrollment

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

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

472

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

473

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

474

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

475

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

No.

TrialID

Date_
enrollment

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

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

477

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

478

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

479

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

480

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

No.

TrialID

Date_
enrollment

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

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

482

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

483

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

484

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

485

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

No.

TrialID

Date_
enrollment

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

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

487

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

488

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

489

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

490

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

491

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

492

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

493

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

494

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

495

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

No.

TrialID

Date_
enrollment

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

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

497

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

498

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

499

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

500

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

No.

TrialID

Date_
enrollment

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

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

502

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

503

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

504

EUCTR2014-005418-45-SE
(EUCTR)

04/05/2015

18/03/2015

Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)

Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE

Rheumatoid Arthritis and Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Plaquenil
INN or Proposed INN: HYDROXYCHLOROQUINE

Christine Bengtsson

Solveig Wållberg-Jonsson

Not Recruiting

Female: yes
Male: yes

Phase 2

Sweden

505

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

No.

TrialID

Date_
enrollment

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

EUCTR2014-002945-23-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

507

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

508

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

509

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

510

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

No.

TrialID

Date_
enrollment

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

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

512

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

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: 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

513

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

514

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

515

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

No.

TrialID

Date_
enrollment

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

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

517

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

518

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

519

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

520

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

521

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

522

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

523

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

524

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

525

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

No.

TrialID

Date_
enrollment

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

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

527

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

528

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

529

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

530

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

No.

TrialID

Date_
enrollment

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

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

532

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

533

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

534

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

535

EUCTR2014-002945-23-CZ
(EUCTR)

18/02/2015

21/11/2014

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.

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Estonia;Czech Republic;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

536

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

537

EUCTR2014-002945-23-GB
(EUCTR)

18/02/2015

04/11/2014

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

538

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

539

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

540

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

No.

TrialID

Date_
enrollment

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

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

542

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

543

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

544

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

545

NCT02357069
(ClinicalTrials.gov)

February 2015

29/1/2015

A Study Comparing LBEC0101 to Enbrel® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

Arthritis, Rheumatoid

Drug: Enbrel;Drug: LBEC0101

LG Life Sciences

Mochida Pharmaceutical Company, Ltd.

Active, not recruiting

20 Years

75 Years

Both

372

Phase 3

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

546

NCT02373202
(ClinicalTrials.gov)

February 2015

12/2/2015

A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: Mizoribine

Sanofi

Regeneron Pharmaceuticals

Completed

20 Years

N/A

All

Phase 3

Japan

547

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

548

NCT02332590
(ClinicalTrials.gov)

February 2015

5/1/2015

Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Sarilumab;Drug: Adalimumab;Drug: Placebo (for sarilumab);Drug: Placebo (for adalimumab)

Sanofi

Regeneron Pharmaceuticals

Active, not recruiting

18 Years

N/A

All

369

Phase 3

United States;Chile;Czechia;Germany;Hungary;Israel;Korea, Republic of;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic;France

549

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

550

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

No.

TrialID

Date_
enrollment

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

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

552

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

553

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

554

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

555

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

No.

TrialID

Date_
enrollment

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

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

557

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

558

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

559

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

560

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

No.

TrialID

Date_
enrollment

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

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

562

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

563

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

564

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

565

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

No.

TrialID

Date_
enrollment

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

EUCTR2014-000443-33-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

567

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

568

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

569

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

570

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

No.

TrialID

Date_
enrollment

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

EUCTR2014-001114-26-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

572

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

573

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

574

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

575

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

No.

TrialID

Date_
enrollment

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

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

577

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

578

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

579

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

580

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

No.

TrialID

Date_
enrollment

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

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

582

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

583

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

584

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

585

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

No.

TrialID

Date_
enrollment

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

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

587

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

588

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

589

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

590

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

No.

TrialID

Date_
enrollment

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

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

592

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

593

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

594

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

595

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

No.

TrialID

Date_
enrollment

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

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

597

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

598

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

599

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

600

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

No.

TrialID

Date_
enrollment

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

NCT02342977
(ClinicalTrials.gov)

November 2014

18/12/2014

Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty:

Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty: A Randomized Double -Blinded, Placebo-controlled Pilot Study.

Osteoarthritis;Rheumatoid Arthritis;Avascular Necrosis

Drug: Placebo;Drug: Lacosamide

Indiana University School of Medicine

VA Office of Research and Development

Withdrawn

18 Years

70 Years

Both

Phase 2

United States

602

NCT02030028
(ClinicalTrials.gov)

November 2014

6/1/2014

ACTH Gel Therapy in Rheumatoid Arthritis

Open Label Study to Evaluate Efficacy and Safety of Short-Term, Adjunctive Adrenocorticotropic Hormone (ACTH) Gel in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ACTHAR gel

Dana Ascherman

Mallinckrodt

Recruiting

18 Years

100 Years

All

N/A

United States

603

NCT02319642
(ClinicalTrials.gov)

November 2014

15/12/2014

An Open-label Extension Study of Certolizumab Pegol in Chinese Patients With Rheumatoid Arthritis Who Enrolled in RA0044

A Phase 3, Multicenter, Open-label Extension Study To Assess The Safety And Efficacy Of Certolizumab Pegol As Additional Medication To Methotrexate In Chinese Subjects With Active Rheumatoid Arthritis Who Participated In RA0044.

Rheumatoid Arthritis

Drug: Certolizumab Pegol

UCB Pharma SA

Parexel

Completed

18 Years

N/A

All

347

Phase 3

China

604

NCT02293902
(ClinicalTrials.gov)

November 2014

13/11/2014

A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

Rheumatoid Arthritis

Drug: Sarilumab SAR153191 (REGN88);Other: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic acid

Sanofi

Regeneron Pharmaceuticals

Completed

20 Years

75 Years

All

243

Phase 3

Japan

605

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

No.

TrialID

Date_
enrollment

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

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

607

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

608

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

609

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

610

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

No.

TrialID

Date_
enrollment

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

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

612

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

613

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

614

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

615

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

616

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

617

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

618

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

619

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

620

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

No.

TrialID

Date_
enrollment

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

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

622

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

623

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

624

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

625

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

No.

TrialID

Date_
enrollment

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

NCT02148640
(ClinicalTrials.gov)

October 2014

23/5/2014

The NOR-SWITCH Study

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 DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY

Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic

Drug: Innovator infliximab;Drug: Biosimilar infliximab

Diakonhjemmet Hospital

South-Eastern Norway Regional Health Authority

Completed

18 Years

N/A

All

482

Phase 4

Norway

627

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

628

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

629

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

630

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

No.

TrialID

Date_
enrollment

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

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

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

Not Recruiting

Female: yes
Male: yes

250

Phase 2

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

632

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

633

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

634

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

635

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

No.

TrialID

Date_
enrollment

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

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

637

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

638

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

639

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

640

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

No.

TrialID

Date_
enrollment

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

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

642

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

643

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

644

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

645

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

646

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

647

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

648

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

649

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

650

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

No.

TrialID

Date_
enrollment

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

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

652

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

653

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

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

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

654

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

655

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

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

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

No.

TrialID

Date_
enrollment

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

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

657

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

658

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

659

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

660

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

No.

TrialID

Date_
enrollment

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

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

662

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

663

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

664

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

665

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

No.

TrialID

Date_
enrollment

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

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

667

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

668

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

669

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

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
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

670

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

No.

TrialID

Date_
enrollment

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

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

672

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

673

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

674

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

675

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

No.

TrialID

Date_
enrollment

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

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

677

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

678

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

679

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

680

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

No.

TrialID

Date_
enrollment

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

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

682

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

683

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

684

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

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
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

685

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

No.

TrialID

Date_
enrollment

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

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

687

EUCTR2013-003413-18-GB
(EUCTR)

13/05/2014

04/04/2014

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]

King’s College London

Guy's and St. Thomas' NHS Foundation Trust;Leiden University Medical Center

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

206

Phase 2

Netherlands;United Kingdom

688

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

689

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

690

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

No.

TrialID

Date_
enrollment

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

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

692

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

693

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

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

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

694

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

695

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

696

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

697

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

698

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

699

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

700

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

No.

TrialID

Date_
enrollment

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

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

702

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

703

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

704

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

705

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

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

Not Recruiting

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

706

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

707

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

708

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

709

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

710

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

No.

TrialID

Date_
enrollment

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

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

712

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

713

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

714

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

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

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

715

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

No.

TrialID

Date_
enrollment

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

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

717

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

718

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

719

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

720

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

No.

TrialID

Date_
enrollment

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

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

722

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

723

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

724

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

725

NCT02065700
(ClinicalTrials.gov)

February 25, 2014

14/2/2014

Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients

A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Filgotinib

Gilead Sciences

Galapagos NV

Active, not recruiting

18 Years

N/A

All

739

Phase 2

United States;Argentina;Australia;Belgium;Bulgaria;Chile;Colombia;Czechia;France;Germany;Guatemala;Hungary;Israel;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine;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

726

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

727

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

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;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

728

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

729

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

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

730

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

731

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

732

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

733

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

734

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

735

NCT02173587
(ClinicalTrials.gov)

February 2014

22/6/2014

Study Evaluating the Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis

Efficacy of Thick Shell Mussel Lipid Extract in Chinese Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Dietary Supplement: Mussel oil capsules;Dietary Supplement: Corn oil capsules

Zhejiang University

Sir Run Run Shaw Hospital

Active, not recruiting

18 Years

75 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

736

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

737

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

738

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

739

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

740

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

No.

TrialID

Date_
enrollment

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

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

742

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

743

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

744

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

745

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

746

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

747

NCT01988506
(ClinicalTrials.gov)

January 6, 2014

7/11/2013

Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases

Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach

Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis

Drug: Interleukin 2

Assistance Publique - Hôpitaux de Paris

Iltoo Pharma

Active, not recruiting

18 Years

N/A

All

Phase 2

France

748

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

749

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

750

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

No.

TrialID

Date_
enrollment

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

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

752

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

753

EUCTR2013-002777-22-DE
(EUCTR)

17/12/2013

22/11/2013

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]

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

754

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

755

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

756

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

757

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

758

JPRN-UMIN000018816

2013/12/05

26/08/2015

Study on the relationship between arthritis and sleep disturbance

Study on the relationship between arthritis and sleep disturbance - Sleep study in arthritis

Rheumatoid Arthritis

Treatment with melatonin-mimetics, ramelteon.
Treatment with biological disease-modifying anti-rheumatic drugs.

Shunichi Shiozawa

Rheumatic Diseases Center, Kohnan Kakogawa Hospital

Complete: follow-up complete

20years-old

Not applicable

Male and Female

200

Not applicable

Japan

759

JPRN-UMIN000012473

2013/12/03

04/12/2013

Study for variations of safety and efficacy profile caused by division of weekly dose of methotrexate(preliminary study)

Rheumatoid arthritis

administration of weekly MTX dose at once
administration by dividing three times of weekly MTX dose

Yokohama Minami Kyousai HospitalSanten Pharmaceutical CO.,Ltd.

Santen Pharmaceutical CO.,Ltd.

Complete: follow-up complete

Not applicable

Male and Female

Not applicable

Japan

760

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

No.

TrialID

Date_
enrollment

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

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

762

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

763

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

764

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

765

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

No.

TrialID

Date_
enrollment

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

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

767

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

768

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

769

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

770

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

No.

TrialID

Date_
enrollment

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

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

772

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

773

NCT02293590
(ClinicalTrials.gov)

November 2013

30/10/2014

RICE: Remission by Intra-articular Injection Plus CErtolizumab

An Open Label, Randomised Study to Compare the Efficacy of Certolizumab Pegol (CZP) Plus a Dynamic or Fixed Dose Treatment Strategy in Patients With Rheumatoid Arthritis, a Phase II Study

Rheumatoid Arthritis

Drug: Certolizumab Pegol

Rüdiger B. Müller

UCB Pharma

Completed

18 Years

N/A

All

Phase 2

Switzerland

774

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

775

NCT02027298
(ClinicalTrials.gov)

November 2013

18/11/2013

Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study

Primary Sjogren's Syndrome;Secondary Sjogren's Syndrome;Inflammatory Arthritis;Rheumatoid Arthritis

Drug: Abatacept

The Cleveland Clinic

Bristol-Myers Squibb

Withdrawn

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

776

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

777

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

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]

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

778

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

779

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

780

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

No.

TrialID

Date_
enrollment

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

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

782

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

783

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

784

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

785

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

No.

TrialID

Date_
enrollment

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

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

787

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

788

JPRN-UMIN000012399

2013/10/16

26/11/2013

Performance of Rheumascan in healthy subjects and patients with active rheumatoid arthritis

Rheumatoid arthritis

Patients with active rheumatoid arthritis
(1)Assessment of tender and swollen joints by physical examination
(2)Joint ultrasonography (assessment of active synovitis by grading and quantification of vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands
(3)Gadolinium-enhanced MRI of the hand with more severe arthritis
(4)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG)
Healthy subjects
(1)Assessment of tender and swollen joints by physical examination
(2)Joint ultrasonography (assessment of active synovitis by grading and quantification of vascularity using power Doppler or color Doppler ultrasonography) in 22 joints of bilateral hands
(3)Examination by Rheumascan, a fluorescence optical imaging device using intravenous indocyanine green (ICG)

Tokyo Medical and Dental University

Diagnostic Imaging Center, Ochanomizu Surugadai Clinic

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not applicable

Japan

789

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

790

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

No.

TrialID

Date_
enrollment

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

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

792

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

793

NCT02538757
(ClinicalTrials.gov)

October 2013

18/8/2015

Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE)

Safety and Effectiveness Study of the Live Zoster Vaccine in Anti-TNF Users (VERVE)

Arthritis;Rheumatoid Arthritis;Psoriatic Arthritis;Psoriasis;Ankylosing Spondylitis;Enteropathic Arthritis;Crohn's Disease;Inflammatory Arthritis

Biological: Herpes Zoster Vaccine;Drug: Placebo

University of Alabama at Birmingham

Oregon Health and Science University

Active, not recruiting

50 Years

N/A

All

125

Phase 2

United States

794

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

795

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-003654-86-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

797

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

798

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

799

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

800

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

No.

TrialID

Date_
enrollment

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

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

802

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

803

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

804

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

805

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

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: 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

806

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

807

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

808

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

809

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

810

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

811

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

812

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

813

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

814

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

815

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

No.

TrialID

Date_
enrollment

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

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

817

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

818

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

819

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

820

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

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: 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

821

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

822

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

823

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

824

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

825

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

No.

TrialID

Date_
enrollment

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

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

827

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

828

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

829

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

830

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

No.

TrialID

Date_
enrollment

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

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

832

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.

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]

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

833

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

834

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

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: 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

835

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

No.

TrialID

Date_
enrollment

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

NCT01915537
(ClinicalTrials.gov)

August 2013

30/7/2013

Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients

A Prospective Cohort Study to Observe the Difference of Efficacy Between Infliximab With Methotrexate and Classic DMARDs in the Severe Rheumatoid Arthritis Patients With Poor Prognosis

Rheumatoid Arthritis(RA)

Drug: Infliximab group;Drug: Classic DMARDs treatment group

Zhang, Xiao, M.D.

Central South University;Tianjin Medical University General Hospital;Xijing Hospital

Not yet recruiting

18 Years

70 Years

Both

170

N/A

China

837

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

838

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

839

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

840

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

No.

TrialID

Date_
enrollment

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

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

842

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

843

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

844

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

845

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

No.

TrialID

Date_
enrollment

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

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

847

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

848

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

849

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

850

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

851

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

852

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

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

5910

853

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

854

NCT01893996
(ClinicalTrials.gov)

July 2013

2/7/2013

Study of Adalimumab to Lower Cardiovascular Risk in RA Patients With Well Controlled Joint Disease

Adalimumab to Mitigate Cardiovascular Risk in RA Patients With Well-Controlled Joint Disease

Rheumatoid Arthritis;Cardiovascular Disease

Drug: Adalimumab;Drug: Placebo

University of California, San Francisco

American College of Rheumatology Research and Education Foundation;AbbVie

Active, not recruiting

18 Years

N/A

All

Phase 4

United States

855

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

856

NCT01851070
(ClinicalTrials.gov)

July 2013

19/4/2013

A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFa Inhibitor

A Double-blind, Randomized, Placebo-controlled, Dose-escalation, Multi-center Study a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFa Inhibitor

Rheumatoid Arthritis

Drug: Allogeneic Mesenchymal Precursor Cells;Drug: Normal Saline

Mesoblast, Ltd.

PPD

Completed

18 Years

80 Years

All

Phase 2

United States;Australia

857

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

858

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

859

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

860

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

No.

TrialID

Date_
enrollment

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

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

862

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

863

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

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

5910

864

NCT01881308
(ClinicalTrials.gov)

June 17, 2013

17/6/2013

Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis

REmission in Rheumatoid Arthritis - Assessing WIthrawal of Disease-modifying Antirheumatic Drugs in a Non-inferiority Design

Rheumatoid Arthritis

Drug: TNF inhibitors;Drug: Synthetic DMARD(s);Drug: Co-medication: Synthetic DMARDs

Diakonhjemmet Hospital

The Research Council of Norway;South-Eastern Norway Regional Health Authority

Active, not recruiting

18 Years

80 Years

All

360

Phase 4

Norway

865

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

No.

TrialID

Date_
enrollment

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

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.

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
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

867

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

868

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

869

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

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

5910

870

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

No.

TrialID

Date_
enrollment

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

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

872

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

873

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

874

NCT01961271
(ClinicalTrials.gov)

June 2013

7/10/2013

Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain

Multicentre Study To Evaluate Efficacy And Safety Of Buprenorphine Transdermal Patch (Norspan) In Chronic Non-Malignant Pain Of Moderate To Severe Intensity Due To Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain And Joint / Muscle Pain, When Opioid Is Needed For Analgesia

Osteoarthritis;Rheumatoid Arthritis;Lower Back Pain;Joint Pain;Muscle Pain

Drug: Buprenorphine transdermal patch

Mundipharma Pte Ltd.

Mundipharma Korea Ltd;Mundipharma (Hong Kong) Ltd;Mundipharma Distribution GmBH (Philippine Branch)

Completed

18 Years

80 Years

All

114

Phase 4

Hong Kong;Korea, Republic of;Philippines

875

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

No.

TrialID

Date_
enrollment

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

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

877

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

878

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)

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

879

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

880

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

No.

TrialID

Date_
enrollment

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

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

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: 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]

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

Not Recruiting

Female: yes
Male: yes

596

Hungary;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Bulgaria;Colombia;United Kingdom;Korea, Republic of;India

882

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

883

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

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

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

884

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

885

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

No.

TrialID

Date_
enrollment

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

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

887

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

888

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

889

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

890

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

891

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

892

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

893

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

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

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

894

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

895

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

No.

TrialID

Date_
enrollment

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

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

897

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

898

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

899

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

900

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

No.

TrialID

Date_
enrollment

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

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

902

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

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

903

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

904

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

905

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)

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: 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

906

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

907

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

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: 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

908

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

909

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

910

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)

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: 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

No.

TrialID

Date_
enrollment

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

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

912

NCT01764997
(ClinicalTrials.gov)

April 2013

8/1/2013

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

Rheumatoid Arthritis

Drug: Sarilumab;Drug: Etanercept;Drug: Methotrexate;Drug: Placebo (for sarilumab);Drug: Placebo (for etanercept);Drug: Adalimumab

Sanofi

Regeneron Pharmaceuticals

Terminated

18 Years

N/A

All

776

Phase 3

United States;Argentina;Australia;Brazil;Chile;Colombia;Czechia;Ecuador;Finland;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;New Zealand;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic

913

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

914

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

915

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

No.

TrialID

Date_
enrollment

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

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

917

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

918

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

919

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

920

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-002322-73-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]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1280

Phase 3

922

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

923

EUCTR2012-002339-27-DE
(EUCTR)

21/03/2013

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;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of

924

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

925

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

No.

TrialID

Date_
enrollment

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

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

927

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

928

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

929

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)

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: 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

930

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

No.

TrialID

Date_
enrollment

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

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

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]

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

932

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

933

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

934

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

935

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

No.

TrialID

Date_
enrollment

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

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

937

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

938

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

939

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

940

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

No.

TrialID

Date_
enrollment

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

NCT01768572
(ClinicalTrials.gov)

March 2013

11/1/2013

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

Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placebo

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

202

Phase 3

United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic

942

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

943

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

944

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

945

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

No.

TrialID

Date_
enrollment

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

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

947

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

948

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

949

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

950

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

951

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

952

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)

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: 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

953

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

954

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

955

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

No.

TrialID

Date_
enrollment

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

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)

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: 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

957

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

958

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

959

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

960

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

No.

TrialID

Date_
enrollment

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

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

962

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

963

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

964

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

965

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

No.

TrialID

Date_
enrollment

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

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

967

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

968

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

969

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

970

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

No.

TrialID

Date_
enrollment

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

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

972

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

973

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

974

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

975

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

No.

TrialID

Date_
enrollment

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

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

977

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

978

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

979

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

980

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

No.

TrialID

Date_
enrollment

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

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

982

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

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Slovakia;Puerto Rico;Belgium;Romania;Germany

983

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

984

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

985

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

No.

TrialID

Date_
enrollment

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

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

987

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

988

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

989

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

990

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

No.

TrialID

Date_
enrollment

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

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

992

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

993

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

994

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

995

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

No.

TrialID

Date_
enrollment

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

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

997

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)

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: 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

998

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

999

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

1000

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

No.

TrialID

Date_
enrollment

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

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

1002

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

1003

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

1004

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

1005

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

No.

TrialID

Date_
enrollment

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

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

1007

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

1008

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

1009

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

1010

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

No.

TrialID

Date_
enrollment

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

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

1012

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

1013

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

1014

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

1015

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

No.

TrialID

Date_
enrollment

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

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

1017

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

1018

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

1019

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

1020

NCT01793519
(ClinicalTrials.gov)

January 2013

14/2/2013

Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis

Stopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis (STARA) Clinical Trial

Rheumatoid Arthritis

Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Placebo

Georgetown University

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);University of Maryland, College Park;Washington D.C. Veterans Affairs Medical Center;Medstar Health Research Institute;Patient-Centered Outcomes Research Institute;Arthritis and Pain Associates of PG County;Arthritis & Rheumatism Associates, P.C.;Rheumatology Associates of Baltimore, L.L.C.;The Arthritis Clinic of Northern Virginia, P.C.;Arthritis and Rheumatic Disease Associates, P.C.

Recruiting

18 Years

N/A

All

290

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

1021

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

1022

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

1023

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

1024

EUCTR2011-006018-15-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] - Musculoskeletal Diseases [C05]

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

1025

EUCTR2011-006020-20-CZ
(EUCTR)

12/12/2012

03/08/2012

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

1026

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

1027

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

1028

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

1029

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

1030

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

No.

TrialID

Date_
enrollment

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

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

1032

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

1033

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

1034

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

1035

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

1036

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

1037

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

1038

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

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]

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

1039

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

1040

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

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]

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

No.

TrialID

Date_
enrollment

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

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

1042

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

1043

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

1044

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

1045

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

No.

TrialID

Date_
enrollment

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

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

1047

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

1048

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

1049

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

1050

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.

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]

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

1051

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

1052

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

1053

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

1054

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

1055

NCT01689532
(ClinicalTrials.gov)

November 2012

18/9/2012

A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine

A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously as Monotherapy, in Japanese Subjects With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine

Arthritis, Rheumatoid

Drug: Sirukumab 100 mg;Drug: Sirukumab 50 mg;Drug: Placebo

Janssen Pharmaceutical K.K.

GlaxoSmithKline

Completed

20 Years

N/A

All

122

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

1056

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

1057

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

1058

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

1059

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

1060

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

No.

TrialID

Date_
enrollment

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

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

1062

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

1063

EUCTR2011-005634-19-BG
(EUCTR)

24/10/2012

19/10/2012

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

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

1064

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

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]

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

1065

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

No.

TrialID

Date_
enrollment

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

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

1067

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

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]

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

1068

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

1069

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.

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

100

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany

1070

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

No.

TrialID

Date_
enrollment

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

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

1072

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

1073

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

1074

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

1075

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

No.

TrialID

Date_
enrollment

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

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

1077

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

1078

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

1079

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

1080

JPRN-UMIN000010315

2012/10/01

26/03/2013

Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment

Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment - PROUD study

rheumatoid arthritis

In patients with clinical remission by adalimumab (DAS28-CRP <2.6) maintained over 24 weeks, to stop the Adalimumab.

Osaka City University Medical School

Metabolism, Endocrinology, and Molecular Medicine. Osaka City University Graduate School of Medicine.The center for rheumatic diseases. Nara Medical University.Rheumatology. Kitano Hospital.

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

1081

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

1082

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

1083

NCT01709578
(ClinicalTrials.gov)

October 2012

15/10/2012

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

Rheumatoid Arthritis

Drug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

546

Phase 3

United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic;Hong Kong

1084

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

1085

NCT01619176
(ClinicalTrials.gov)

October 2012

5/6/2012

Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: methotrexate;Drug: non-steroidal anti-inflammatory drug (NSAID);Drug: leflunomide;Procedure: Acupuncture

Chinese Academy of Sciences

Shanghai GuangHua Hospital of integrated traditional and western medicine

Completed

18 Years

65 Years

Female

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

1086

NCT01789151
(ClinicalTrials.gov)

October 2012

7/2/2013

99m-Technetium- Glucosamine in Arthritis

99mTc-labelled D-Glucosamine in the Evaluation of Disease Activity in Patients With Degenerative and Inflammatory Rheumatic Conditions

Rheumatoid Arthritis;Ankylosing Spondylitis

Device: Technetium labelled glucosamine

University of Sydney

AbbVie

No longer available

18 Years

90 Years

Both

N/A

Australia

1087

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

1088

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

1089

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

1090

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

No.

TrialID

Date_
enrollment

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

NCT01711814
(ClinicalTrials.gov)

September 26, 2012

19/10/2012

A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

A Phase 2 Open-Label, Noncomparative, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study

Arthritis, Rheumatoid

Drug: peficitinib

Astellas Pharma Global Development, Inc.

Janssen Biotech, Inc.

Completed

18 Years

N/A

All

611

Phase 2

United States;Belgium;Bulgaria;Colombia;Czechia;Hungary;Mexico;Poland;Czech Republic

1092

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

1093

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

1094

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

1095

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

No.

TrialID

Date_
enrollment

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

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

1097

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

1098

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

1099

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

1100

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

No.

TrialID

Date_
enrollment

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

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.

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

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany

1102

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

1103

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

1104

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

1105

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

No.

TrialID

Date_
enrollment

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

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

1107

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

1108

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.

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

100

Phase 2

United States;Czech Republic;Slovakia;Puerto Rico;Poland;Belgium;Romania;Germany

1109

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

1110

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.

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

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

1111

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

1112

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

1113

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

1114

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

1115

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

No.

TrialID

Date_
enrollment

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

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.

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

100

United States;Czech Republic;Slovakia;Puerto Rico;Belgium;Poland;Romania;Germany

1117

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

1118

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

1119

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

1120

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

No.

TrialID

Date_
enrollment

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

JPRN-UMIN000008572

2012/07/31

31/07/2012

The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients

Rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX)

Tacrolimus group patients receive daily the optimal dosage of tacrolimus within the range between 1.5-3.0 mg/day for 52 weeks.
Etanercept group patient receive weekly subcutaneous injection of etanercept 50mg for 52 weeks.

Department of Rheumatology and infectious disease, Kitasato university school of medicine

1)Kitasato institute medical center hospital2)Kitasato institute hospital3)Ishikawa internal medicine clinic

Recruiting

20years-old

70years-old

Male and Female

Not applicable

Japan

1122

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

1123

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

1124

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

1125

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

No.

TrialID

Date_
enrollment

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

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

1127

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

1128

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

1129

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

1130

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

No.

TrialID

Date_
enrollment

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

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

1132

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

1133

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

1134

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

1135

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

No.

TrialID

Date_
enrollment

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

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

1137

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

1138

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

1139

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

1140

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

No.

TrialID

Date_
enrollment

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

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

1142

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

1143

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

1144

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

1145

EUCTR2012-000439-17-DK
(EUCTR)

15/06/2012

A Study to Evaluate Safety, Tolerability and Effecacy of MK-8457 plus Methotrexate 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
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
Product Name: MK-8457
Product Code: MK-8457

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.

,NULL

Not Recruiting

Female: yes
Male: yes

342

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

1146

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

1147

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

1148

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

1149

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

1150

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

No.

TrialID

Date_
enrollment

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

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

1152

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

1153

EUCTR2011-004419-22-HU
(EUCTR)

06/06/2012

21/03/2012

Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate

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: 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

1154

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

1155

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

1156

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

1157

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)

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

Complete: follow-up complete

Not applicable

Male and Female

Phase 2

Japan

1158

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

1159

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

1160

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

No.

TrialID

Date_
enrollment

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

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

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]

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

1162

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

1163

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

1164

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

1165

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

No.

TrialID

Date_
enrollment

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

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

1167

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

1168

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

1169

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

1170

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

1171

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

1172

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

1173

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

1174

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

1175

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

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]

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

1176

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)

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]

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

1177

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

1178

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

1179

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

1180

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

1181

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

1182

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

1183

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

1184

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

1185

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

1186

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

1187

NCT01579006
(ClinicalTrials.gov)

May 2012

16/4/2012

Observational 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

Clalit Health Services

Completed

18 Years

N/A

All

184

N/A

Israel

1188

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

1189

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

1190

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

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]

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

No.

TrialID

Date_
enrollment

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

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

1192

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

1193

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

1194

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

1195

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

No.

TrialID

Date_
enrollment

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

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

1197

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

1198

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

1199

NCT01557374
(ClinicalTrials.gov)

April 2012

16/3/2012

TOward the Lowest Effective DOse of Abatacept or Tocilizumab

Tapering Abatacept or Tocilizumab in Rheumatoid Arthritis in Remission. An Evaluation of Disease Activity, Relapse Risk, Structural Progression and the Economic Impact of a Tapering Strategy

Rheumatoid Arthritis

Drug: Tocilizumab , Abatacept;Drug: Decrease Tocilizumab, Abatacept

Assistance Publique - Hôpitaux de Paris

Ministry of Health, France

Active, not recruiting

18 Years

N/A

All

232

Phase 4

France

1200

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

No.

TrialID

Date_
enrollment

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

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

1202

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

1203

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

1204

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

1205

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

No.

TrialID

Date_
enrollment

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

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

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]

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

1207

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

1208

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

1209

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

1210

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

No.

TrialID

Date_
enrollment

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

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

1212

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

1213

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

1214

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

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]

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

1215

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

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]

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

No.

TrialID

Date_
enrollment

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

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

1217

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

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]

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

1218

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

1219

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

1220

JPRN-UMIN000006702

2012/02/01

11/11/2011

A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis

rheumatoid arthritis

Intensive treatment group
Period: 24 weeks
In the intensive treatment group, a patient starts treatment with MTX at 8mg/week. Dosage is increased to 0.25mg/kg/week by week 8 and is further increased to his or her maximum tolerable dosage by week 12. The maximum tolerable dosage is maintained until week 24. If a patient shows inadequate response to MTX and does not achieve SDAI(simplified disease activity index)emission or CDAI (linical disease activity index)remission by week 16, additional treatment with tacrolimus, bucillamine, sarazosulfapyridine, or biologics will be started as scheduled in the protocol.
After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.
Conventional treatment group
Period: 24 weeks
In the control group, a patient starts treatment with MTX, tacrolimus, bucillamine, sarazosulfapyridine, or biologics by attending rheumatologists' discretion by week 24. Biologics are allowed on and after week 12. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72.

Tokyo Medical and Dental University

Department of Pharmacovigilance

Complete: follow-up continuing

20years-old

70years-old

Male and Female

290

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

1221

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

1222

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

1223

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

1224

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

1225

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

No.

TrialID

Date_
enrollment

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

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

1227

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

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]

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

1228

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

1229

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

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]

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

1230

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

No.

TrialID

Date_
enrollment

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

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

1232

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

1233

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

1234

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

1235

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

1236

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

1237

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

1238

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

1239

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

1240

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

1241

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

1242

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

1243

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

1244

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

1245

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

1246

NCT01408602
(ClinicalTrials.gov)

November 2011

2/8/2011

A Study of Two Doses of MRC375 in Moderate to Severe Rheumatoid Arthritis Patients

A 24-week, Phase 2, Double-blind, Placebo-controlled, Randomized Study to Assess the Safety and Efficacy of 2 Doses of MRC375 in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MRC375;Drug: Matching Placebo;Drug: MRC375 150mg

Molecular Research Center, Inc.

Camargo Pharmaceutical Services;Clin Data Services;Harrison Clinical Research;BARC Global Central Laboratory;Bilcare Global Clinical Supplies

Active, not recruiting

18 Years

N/A

Both

300

Phase 2

United States

1247

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

1248

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

1249

NCT02243800
(ClinicalTrials.gov)

November 2011

16/9/2014

Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency

Rheumatoid Arthritis;Vitamin D Deficiency

Other: cholecalciferol versus placebo

University Hospital, Clermont-Ferrand

CRINEX Laboratory;BP 337 - 3 rue de Gentilly;92541 MONTROUGE Cedex FRANCE

Recruiting

18 Years

N/A

Both

164

Phase 3

France

1250

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.

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]

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

No.

TrialID

Date_
enrollment

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

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

1252

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

1253

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

1254

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

1255

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

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 - BrevActa

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

1256

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

1257

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

1258

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

1259

NCT04169100
(ClinicalTrials.gov)

September 28, 2011

14/11/2019

Novel Form of Acquired Long QT Syndrome

Long QT Syndrome;Connective Tissue Diseases;Rheumatoid Arthritis

Drug: Prednisone

Narrows Institute for Biomedical Research

VA New York Harbor Healthcare System

Recruiting

18 Years

89 Years

All

Phase 4

United States

1260

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

No.

TrialID

Date_
enrollment

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

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

1262

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

1263

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

1264

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

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: 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

1265

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-023587-40-NL
(EUCTR)

06/09/2011

11/05/2011

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.

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

1267

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

1268

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

1269

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

1270

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

1271

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

1272

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

1273

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

1274

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

1275

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

1276

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

1277

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

1278

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

1279

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

1280

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

No.

TrialID

Date_
enrollment

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

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

1282

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

1283

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

1284

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

1285

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]

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

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

1286

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

1287

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

1288

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

1289

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

1290

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

No.

TrialID

Date_
enrollment

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

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

1292

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

1293

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

1294

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)

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: 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

1295

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

No.

TrialID

Date_
enrollment

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

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

1297

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

1298

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

1299

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

1300

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

No.

TrialID

Date_
enrollment

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

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

1302

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

1303

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

1304

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

1305

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

No.

TrialID

Date_
enrollment

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

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

1307

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

1308

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

1309

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

1310

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

No.

TrialID

Date_
enrollment

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

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

1312

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

1313

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

1314

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

1315

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

No.

TrialID

Date_
enrollment

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

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

1317

EUCTR2010-022207-22-DE
(EUCTR)

08/06/2011

03/12/2010

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: 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

1318

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

1319

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

1320

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

No.

TrialID

Date_
enrollment

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

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

1322

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

1323

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

1324

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

1325

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

No.

TrialID

Date_
enrollment

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

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

1327

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

1328

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

1329

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

1330

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

No.

TrialID

Date_
enrollment

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

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

1332

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

1333

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

1334

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

1335

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

No.

TrialID

Date_
enrollment

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

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

1337

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

1338

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

1339

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

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 ®
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

1340

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

1341

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

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: 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

1342

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

1343

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

1344

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

1345

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

1346

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

1347

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

1348

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

1349

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

1350

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

No.

TrialID

Date_
enrollment

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

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

1352

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

1353

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

1354

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

1355

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

No.

TrialID

Date_
enrollment

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

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

1357

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

1358

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

1359

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

1360

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

No.

TrialID

Date_
enrollment

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

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

1362

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)

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: 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

1363

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

1364

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

1365

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

No.

TrialID

Date_
enrollment

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

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

1367

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

1368

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

1369

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

1370

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

No.

TrialID

Date_
enrollment

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

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

1372

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

1373

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

1374

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

1375

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

No.

TrialID

Date_
enrollment

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

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

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: 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

1377

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

1378

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

1379

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

1380

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

No.

TrialID

Date_
enrollment

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

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

1382

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

1383

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

1384

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

1385

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

No.

TrialID

Date_
enrollment

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

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

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]

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

1387

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)

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]

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

1388

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

1389

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

1390

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

No.

TrialID

Date_
enrollment

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

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

1392

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

1393

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

1394

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

1395

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

No.

TrialID

Date_
enrollment

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

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

1397

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

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]

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

1398

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

1399

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

1400

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

No.

TrialID

Date_
enrollment

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

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

1402

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

1403

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

1404

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

1405

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

1406

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

1407

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

1408

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

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]

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

1409

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

1410

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

No.

TrialID

Date_
enrollment

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

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

1412

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

1413

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

1414

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

1415

NCT01351805
(ClinicalTrials.gov)

January 2011

4/5/2011

Vitamin D and Fish Oil for Autoimmune Disease, Inflammation and Knee Pain

Autoimmune Diseases;Systemic Inflammatory Process;Knee Pain Chronic;Osteoarthritis;Rheumatoid Arthritis

Drug: Fish Oil;Dietary Supplement: Vitamin D;Other: placebo pill

Brigham and Women's Hospital

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

Active, not recruiting

50 Years

N/A

All

25876

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

1416

NCT01207453
(ClinicalTrials.gov)

January 2011

21/9/2010

Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Milnacipran;Drug: Placebo

Brigham and Women's Hospital

Forest Laboratories;National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Completed

24 Years

N/A

All

Phase 4

United States

1417

NCT01274182
(ClinicalTrials.gov)

January 2011

10/1/2011

GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.

Rheumatoid Arthritis

Biological: GP2013;Biological: MabThera;Biological: Rituxan

Sandoz

Novartis Pharmaceuticals

Completed

18 Years

N/A

All

312

Phase 1;Phase 2

United States;Argentina;Austria;Belgium;Brazil;Estonia;France;Germany;Hungary;India;Italy;Romania;Spain;Turkey

1418

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

1419

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

1420

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

No.

TrialID

Date_
enrollment

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

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

1422

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

1423

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

1424

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

1425

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

1426

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

1427

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

1428

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

1429

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

1430

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

No.

TrialID

Date_
enrollment

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

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

1432

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

1433

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

1434

EUCTR2010-019871-31-GB
(EUCTR)

01/12/2010

08/10/2010

Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.

,NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

Czech Republic;Slovakia;Finland;Belgium;Lithuania;Austria;Germany;United Kingdom

1435

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

No.

TrialID

Date_
enrollment

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

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

1437

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.

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. - SUMMACTA

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

1438

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

1439

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

1440

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

1441

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

1442

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

1443

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

1444

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

1445

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

No.

TrialID

Date_
enrollment

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

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)

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;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden

1447

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)

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]

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

1448

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

1449

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

1450

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

No.

TrialID

Date_
enrollment

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

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

1452

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

1453

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

1454

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

1455

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

1456

NCT01217814
(ClinicalTrials.gov)

November 2010

7/10/2010

Effect of SAR153191 (REGN88) With Methotrexate in Patients With Active Rheumatoid Arthritis Who Failed TNF-a Blockers

A Randomized, Double-blind, Parallel-group, Placebo- and Active Calibrator-controlled Study Assessing the Clinical Benefit of SAR153191 Subcutaneous (SC) on Top of MTX in Patients With Active RA Who Have Failed Previous TNF-a Antagonists

Rheumatoid Arthritis

Drug: Sarilumab;Drug: Placebo;Drug: Golimumab;Drug: methotrexate (MTX);Drug: Folic/folinic acid

Sanofi

Regeneron Pharmaceuticals

Terminated

18 Years

75 Years

All

Phase 2

United States;Colombia;Czechia;Italy;Mexico;Spain;Brazil;Canada;Czech Republic;Germany;Hungary;Norway

1457

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

1458

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

1459

NCT01225991
(ClinicalTrials.gov)

November 2010

20/10/2010

Milnacipran for Treatment of Pain in Older Adults With Rheumatoid Arthritis

An Open-label Trial of Milnacipran for the Treatment of Pain in Rheumatoid Arthritis (RA) in Older Adults

Rheumatoid Arthritis

Drug: Milnacipran

University of California, Los Angeles

Forest Laboratories

Completed

50 Years

N/A

All

Phase 4

United States

1460

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

No.

TrialID

Date_
enrollment

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

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

1462

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

1463

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

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

1464

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

1465

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

No.

TrialID

Date_
enrollment

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

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

1467

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

1468

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

1469

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)

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]

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

1470

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

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]

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

No.

TrialID

Date_
enrollment

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

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

1472

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

1473

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

1474

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

1475

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

No.

TrialID

Date_
enrollment

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

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

1477

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

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 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

1478

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

1479

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

1480

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

No.

TrialID

Date_
enrollment

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

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

1482

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

1483

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

1484

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

1485

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

No.

TrialID

Date_
enrollment

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

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

1487

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

1488

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

1489

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)

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]

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

1490

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

No.

TrialID

Date_
enrollment

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

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

1492

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

1493

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

1494

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

1495

EUCTR2010-018375-22-DE
(EUCTR)

05/10/2010

14/07/2010

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1200

No.

TrialID

Date_
enrollment

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

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

1497

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

1498

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

1499

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

1500

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

1501

NCT01149057
(ClinicalTrials.gov)

October 2010

22/6/2010

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS

An Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDs

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

Clalit Health Services

Completed

18 Years

N/A

All

145

Phase 4

Israel

1502

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

1503

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

1504

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

1505

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

No.

TrialID

Date_
enrollment

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

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

1507

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

1508

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

1509

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

1510

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

No.

TrialID

Date_
enrollment

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

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

1512

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

1513

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

1514

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

1515

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

No.

TrialID

Date_
enrollment

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

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

1517

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

1518

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

1519

NCT01154647
(ClinicalTrials.gov)

September 2010

28/6/2010

Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes

Unraveling Impaired Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes: a Series of Experiments Targeting Brain Neurotransmission

Fatigue Syndrome, Chronic;Fibromyalgia;Arthritis, Rheumatoid

Drug: citalopram;Drug: 1 ml 0.9 % NaCl

Vrije Universiteit Brussel

Research Foundation Flanders;Universiteit Antwerpen;University Hospital, Antwerp;Artesis University College, Antwerp

Not yet recruiting

18 Years

65 Years

Female

N/A

Belgium

1520

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

No.

TrialID

Date_
enrollment

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

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

1522

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

1523

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

1524

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

1525

EUCTR2010-018375-22-IT
(EUCTR)

29/07/2010

05/07/2010

A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND

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

No.

TrialID

Date_
enrollment

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

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

1527

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

1528

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

1529

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

1530

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

No.

TrialID

Date_
enrollment

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

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

1532

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

1533

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

1534

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

1535

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

1536

JPRN-UMIN000003880

2010/07/01

07/07/2010

Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area

Rheumatoid arthritis

DAS28>3.2 at 24 weeks
Switching to another biologics
DAS28>3.2 at 24 weeks
Dose up of MTX or addition of other DMARDs
DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every two week
DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every four week

Osaka City University Medical School

Higashi Sumiyoshi Morimoto Hospital, Yodogawa Christian Hospital, Kitade Hospital, Shirahama Hamayu Hospital

Recruiting

20years-old

Not applicable

Male and Female

100

Not applicable

Japan

1537

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

1538

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

1539

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

1540

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

No.

TrialID

Date_
enrollment

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

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

1542

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

1543

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

1544

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

1545

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

No.

TrialID

Date_
enrollment

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

EUCTR2009-012759-12-GR
(EUCTR)

15/06/2010

13/11/2009

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

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

1547

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

1548

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

1549

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

1550

EUCTR2009-014296-40-IT
(EUCTR)

08/06/2010

08/02/2010

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 - ND

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

No.

TrialID

Date_
enrollment

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

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

1552

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

1553

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

1554

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

1555

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

No.

TrialID

Date_
enrollment

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

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

1557

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

1558

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

1559

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

1560

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

No.

TrialID

Date_
enrollment

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

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

1562

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

1563

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

1564

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

1565

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

No.

TrialID

Date_
enrollment

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

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

1567

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

1568

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

1569

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

1570

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

No.

TrialID

Date_
enrollment

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

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

1572

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

1573

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

1574

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

1575

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

No.

TrialID

Date_
enrollment

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

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

1577

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

1578

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

1579

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

1580

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

No.

TrialID

Date_
enrollment

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

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

1582

NCT01151644
(ClinicalTrials.gov)

April 2010

25/6/2010

Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases

Rheumatoid Arthritis;Spondyloarthritis;Systemic Lupus Erythematosus (SLE);Dermatomyositis (DM);DMixed Connective Tissue Disease;Systemic Vasculitis;Systemic Sclerosis (SSc);Sjögren's Syndrome;Antiphospholipid Syndrome;Juvenile Idiopathic Arthritis;Juvenile SLE;Juvenile DM

Biological: Anti-pandemic H1N1 influenza vaccine

University of Sao Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

Active, not recruiting

N/A

Both

5000

Phase 4

Brazil

1583

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

1584

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

1585

EUCTR2009-016266-90-FI
(EUCTR)

23/03/2010

29/12/2009

Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients

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: 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

No.

TrialID

Date_
enrollment

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

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

1587

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

1588

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

1589

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

1590

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

No.

TrialID

Date_
enrollment

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

EUCTR2009-016266-90-HU
(EUCTR)

03/03/2010

30/12/2009

Evaluation of SAR153191 (REGN88) on top of methotrexate in rheumatoid arthritis patients

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: 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

1592

EUCTR2009-010516-15-PL
(EUCTR)

03/03/2010

21/08/2009

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: 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

1593

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

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

1595

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

1596

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

1597

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

1598

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

1599

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

1600

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

No.

TrialID

Date_
enrollment

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

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

1602

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

1603

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

1604

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

1605

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

No.

TrialID

Date_
enrollment

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

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

1607

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

1608

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

1609

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

1610

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

No.

TrialID

Date_
enrollment

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

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

1612

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

1613

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

1614

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

1615

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

No.

TrialID

Date_
enrollment

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

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

1617

EUCTR2009-012759-12-SE
(EUCTR)

12/01/2010

17/11/2009

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

1618

EUCTR2009-012759-12-PT
(EUCTR)

12/01/2010

21/10/2009

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

1619

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

1620

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

No.

TrialID

Date_
enrollment

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

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

1622

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

1623

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

1624

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

1625

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

1626

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

1627

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

1628

EUCTR2009-011268-13-GB
(EUCTR)

31/12/2009

15/03/2010

Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study

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: MabThera
Product Name: Rituximab
Trade Name: Enbrel
Product Name: Etanercept
Trade Name: Humira
Product Name: Adalimumab

NHS Greater Glasgow and Clyde

University of Glasgow

Not Recruiting

Female: yes
Male: yes

United Kingdom

1629

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

1630

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

No.

TrialID

Date_
enrollment

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

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

1632

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

1633

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

1634

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

1635

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

1636

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

1637

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

1638

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

1639

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

1640

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

No.

TrialID

Date_
enrollment

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

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

1642

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

1643

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

1644

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

1645

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

1646

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

1647

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

1648

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

1649

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

1650

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

1651

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

1652

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

1653

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

1654

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

1655

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

No.

TrialID

Date_
enrollment

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

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

1657

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

1658

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

1659

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

1660

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

1661

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

1662

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

1663

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)

1664

NCT00844714
(ClinicalTrials.gov)

November 2009

12/2/2009

Cardiovascular Risk Markers in Patients With Rheumatoid Arthritis: Effect of Rituximab Therapy

Endothelial Function;Rheumatoid Arthritis;Inflammation

Drug: Rituxan

University of California, San Francisco

Genentech, Inc.

Completed

18 Years

N/A

All

N/A

United States

1665

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

No.

TrialID

Date_
enrollment

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

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

1667

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

1668

NCT01009879
(ClinicalTrials.gov)

November 2009

5/11/2009

Human Tumor Necrosis Factor Alpha (TNFa)-Induced Pre-B Cell Bone Marrow Emigrants

Human TNFa-Induced Pre-B Cell Bone Marrow Emigrants

Rheumatoid Arthritis

Drug: Etanercept

University of Pittsburgh

Amgen

Withdrawn

18 Years

N/A

Both

Phase 4

United States

1669

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

1670

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

No.

TrialID

Date_
enrollment

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

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

1672

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

1673

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

1674

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

1675

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

1676

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

1677

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

1678

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

1679

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

1680

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

No.

TrialID

Date_
enrollment

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

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

1682

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

1683

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

1684

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

1685

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

No.

TrialID

Date_
enrollment

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

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

1687

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

1688

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

1689

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

1690

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

No.

TrialID

Date_
enrollment

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

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

1692

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

1693

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

1694

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

1695

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

No.

TrialID

Date_
enrollment

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

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

1697

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

1698

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

1699

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

1700

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

No.

TrialID

Date_
enrollment

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

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

1702

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

1703

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

1704

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

1705

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

No.

TrialID

Date_
enrollment

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

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

1707

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

1708

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

1709

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

1710

EUCTR2008-008338-35-FI
(EUCTR)

13/08/2009

14/05/2009

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 METHOTREXATE

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

No.

TrialID

Date_
enrollment

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

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

1712

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

1713

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

1714

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

1715

NCT01224041
(ClinicalTrials.gov)

August 2009

18/10/2010

Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study

Rheumatoid Arthritis

Drug: Tacrolimus

Astellas Pharma Inc

Astellas Pharma Korea, Inc.

Completed

18 Years

75 Years

Both

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

1716

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

1717

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

1718

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

1719

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

1720

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

No.

TrialID

Date_
enrollment

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

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

1722

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

1723

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

1724

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

1725

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

No.

TrialID

Date_
enrollment

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

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

1727

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

1728

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

1729

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

1730

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

No.

TrialID

Date_
enrollment

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

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

1732

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

1733

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

1734

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

1735

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

No.

TrialID

Date_
enrollment

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

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

1737

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

1738

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

1739

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

1740

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

No.

TrialID

Date_
enrollment

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

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

1742

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

1743

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

1744

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

1745

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

No.

TrialID

Date_
enrollment

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

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

1747

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

1748

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

1749

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

1750

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

No.

TrialID

Date_
enrollment

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

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

1752

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

1753

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

1754

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

1755

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

No.

TrialID

Date_
enrollment

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

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

1757

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

1758

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

1759

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

1760

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

No.

TrialID

Date_
enrollment

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

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

1762

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

1763

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

1764

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

1765

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

1766

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

1767

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

1768

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

1769

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

1770

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

No.

TrialID

Date_
enrollment

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

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

1772

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

1773

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

1774

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

1775

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

No.

TrialID

Date_
enrollment

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

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

1777

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

1778

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

1779

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

1780

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

No.

TrialID

Date_
enrollment

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

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

1782

NCT01075711
(ClinicalTrials.gov)

April 2009

24/2/2010

Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone)

Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet

Arthritis, Rheumatoid

Drug: Prednisone

Merck KGaA

Merck Serono GmbH, Germany

Completed

18 Years

N/A

Both

2728

N/A

Germany

1783

NCT00931086
(ClinicalTrials.gov)

April 2009

30/6/2009

Expanded Access Trial of Belimumab Antibody in RA Patients Who Were Previously Treated Under HGS Protocol LBRA99

An Expanded Access Trial of Belimumab Antibody (Monoclonal Anti-BLyS Antibody) in Patients With Rheumatoid Arthritis (RA) Who Were Previously Treated Under HGS Protocol LBRA99

Rheumatoid Arthritis

Drug: belimumab

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

No longer available

18 Years

N/A

Both

Phase 4

United States

1784

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

1785

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

No.

TrialID

Date_
enrollment

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

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

1787

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

1788

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

1789

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

1790

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

No.

TrialID

Date_
enrollment

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

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

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]

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

1792

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

1793

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

1794

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

1795

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

1796

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

1797

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

1798

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

1799

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

1800

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

No.

TrialID

Date_
enrollment

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

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

1802

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

1803

EUCTR2008-005320-81-BE
(EUCTR)

16/02/2009

20/02/2009

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 inerleukin-1beta of the IgG1-K-class

Novartis Pharma Services AG

Novartis Pharma Belgium

Not Recruiting

Female: yes
Male: yes

Spain;Belgium;Austria;Germany

1804

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

1805

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

No.

TrialID

Date_
enrollment

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

EUCTR2008-005320-81-DE
(EUCTR)

06/02/2009

17/11/2008

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 interleukin-1beta of the IgG1-Kappa-class

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

213

Germany;Spain;Austria

1807

EUCTR2008-001847-20-SE
(EUCTR)

02/02/2009

23/10/2008

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

Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden

1808

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

1809

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

1810

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

1811

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

1812

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

1813

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

1814

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

1815

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

No.

TrialID

Date_
enrollment

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

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

1817

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

1818

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

1819

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

1820

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

1821

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

1822

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

1823

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

1824

EUCTR2008-001847-20-LV
(EUCTR)

19/12/2008

29/12/2008

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

United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Latvia;Germany;Netherlands;Norway;Sweden

1825

EUCTR2008-001847-20-GB
(EUCTR)

19/12/2008

09/09/2008

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

No.

TrialID

Date_
enrollment

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

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

1827

EUCTR2008-001847-20-DK
(EUCTR)

10/12/2008

21/10/2008

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

Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden

1828

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

1829

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

1830

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

No.

TrialID

Date_
enrollment

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

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

1832

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

1833

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

1834

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

1835

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

No.

TrialID

Date_
enrollment

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

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

1837

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

1838

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

1839

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

1840

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

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]

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

No.

TrialID

Date_
enrollment

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

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

1842

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

1843

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

1844

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

1845

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

No.

TrialID

Date_
enrollment

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

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

1847

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

1848

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

1849

NCT00948610
(ClinicalTrials.gov)

November 2008

28/7/2009

Sleep and Immunity in Rheumatoid Arthritis : Remicade Substudy

Sleep & Immune Mechanisms in Rheumatoid Arthritis: Remicade Substudy

Rheumatoid Arthritis

Drug: Remicade

University of California, Los Angeles

National Heart, Lung, and Blood Institute (NHLBI)

Completed

18 Years

85 Years

All

N/A

United States

1850

NCT00791921
(ClinicalTrials.gov)

November 2008

14/11/2008

Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Pharmacokinetics, and Safety of CDP870 Without Coadministration of MTX in Japanese Active RA Patients in Whom MTX Cannot be Administrated.

Rheumatoid Arthritis

Drug: CDP870;Drug: Placebo of CDP870

Otsuka Pharmaceutical Co., Ltd.

UCB Japan Co. Ltd.

Completed

20 Years

74 Years

All

230

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

1851

NCT00791999
(ClinicalTrials.gov)

November 2008

14/11/2008

Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as add-on Medication to MTX in Japanese Active RA Patients Who Have an Incomplete Response to MTX.

Rheumatoid Arthritis

Drug: CDP870 400mg;Drug: CDP870 200mg;Drug: CDP870 100mg;Drug: Placebo of CDP870

Otsuka Pharmaceutical Co., Ltd.

UCB Japan Co. Ltd.

Completed

20 Years

74 Years

All

316

Phase 2;Phase 3

Japan

1852

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

1853

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

1854

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

1855

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

1856

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

1857

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

1858

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

1859

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

1860

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

No.

TrialID

Date_
enrollment

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

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

1862

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

1863

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

1864

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

1865

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

1866

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

1867

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

1868

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

1869

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

1870

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

No.

TrialID

Date_
enrollment

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

NCT00768053
(ClinicalTrials.gov)

October 2008

3/10/2008

Evaluation of EULAR-RAID Score in Rheumatoid Arthritis Patients

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

Rheumatoid Arthritis

Drug: Etanercept

Wyeth is now a wholly owned subsidiary of Pfizer

Lincoln Medical and Mental Health Center;Umanis;SODIA;depolabo

Completed

18 Years

N/A

All

108

Phase 4

France;Monaco

1872

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

1873

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

1874

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

1875

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

No.

TrialID

Date_
enrollment

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

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

1877

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

1878

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

1879

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

1880

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

No.

TrialID

Date_
enrollment

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

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

1882

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

1883

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

1884

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

1885

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

No.

TrialID

Date_
enrollment

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

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

1887

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

1888

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

1889

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

1890

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

No.

TrialID

Date_
enrollment

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

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

1892

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

1893

EUCTR2007-002951-18-DE
(EUCTR)

16/08/2008

30/06/2008

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 TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist

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

1894

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

1895

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

No.

TrialID

Date_
enrollment

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

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

1897

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

1898

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

1899

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

1900

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

No.

TrialID

Date_
enrollment

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

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

1902

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

1903

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

1904

EUCTR2007-002951-18-GB
(EUCTR)

07/08/2008

14/03/2008

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 TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist

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

1905

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

No.

TrialID

Date_
enrollment

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

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

1907

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

1908

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

1909

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

1910

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

1911

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

1912

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

1913

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

1914

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

1915

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

No.

TrialID

Date_
enrollment

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

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

1917

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

1918

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

1919

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

1920

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

No.

TrialID

Date_
enrollment

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

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

1922

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

1923

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

1924

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

1925

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

No.

TrialID

Date_
enrollment

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

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

1927

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

1928

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

1929

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

1930

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

No.

TrialID

Date_
enrollment

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

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

1932

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

1933

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

1934

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

1935

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

No.

TrialID

Date_
enrollment

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

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

1937

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

1938

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

1939

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

1940

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

No.

TrialID

Date_
enrollment

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

EUCTR2007-002951-18-SE
(EUCTR)

11/06/2008

25/03/2008

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 TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist

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

1942

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

1943

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

1944

EUCTR2007-005464-26-GB
(EUCTR)

05/06/2008

11/04/2008

Devlopment of Heart and blood vessel problems in patients with conditions which cause long-term, widespread, inflammation in the body.

The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II - Inflammatory Biomarkers and Cardiovascular Function - Part II

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] - Immune System Diseases [C20]

Kings College London

Guys and St Thomas'NHS Foundation Trust

Not Recruiting

Female: yes
Male: yes

100

Phase 4

United Kingdom

1945

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

No.

TrialID

Date_
enrollment

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

EUCTR2007-002951-18-DK
(EUCTR)

03/06/2008

23/04/2008

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 TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist

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

1947

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

1948

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

1949

NCT00654368
(ClinicalTrials.gov)

June 2008

3/4/2008

CAMEO: Canadian Methotrexate and Etanercept Outcome Study

Canadian Methotrexate and Etanercept Outcome Study: An Open Label Randomized Trial of Etanercept and Methotrexate Versus Etanercept Alone in the Treatment of Rheumatoid Arthritis (CAMEO)

Rheumatoid Arthritis

Biological: Etanercept;Drug: Methotrexate

Amgen

Wyeth is now a wholly owned subsidiary of Pfizer

Completed

18 Years

N/A

All

258

Phase 4

Canada

1950

EUCTR2008-000327-25-CZ
(EUCTR)

27/05/2008

02/04/2008

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

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

1951

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

1952

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

1953

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

1954

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

1955

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

No.

TrialID

Date_
enrollment

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

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

1957

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

1958

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

1959

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

1960

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

No.

TrialID

Date_
enrollment

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

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

1962

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

1963

NCT00667758
(ClinicalTrials.gov)

May 2008

24/4/2008

Gonadotropin-Releasing Hormone (GnRH)-Antagonist Therapy in Rheumatoid Arthritis

Antagonist to Gonadotropin-Releasing Hormone in Rheumatoid Arthritis (AGRA): A Double-blind, Randomized, Placebo Controlled Trial

Rheumatoid Arthritis

Drug: Cetrorelix;Drug: Placebo

Betanien Hospital

Norwegian Foundation for Health and Rehabilitation;University of Oslo

Completed

18 Years

N/A

Both

104

Phase 2

Norway

1964

NCT01224418
(ClinicalTrials.gov)

May 2008

14/10/2010

A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

Rheumatoid Arthritis

Drug: Tacrolimus

Astellas Pharma Inc

Astellas Pharma Korea, Inc.

Completed

18 Years

75 Years

Both

Phase 4

Korea, Republic of

1965

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

1966

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

1967

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

1968

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

1969

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

1970

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

1971

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

1972

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

1973

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

1974

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

1975

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

No.

TrialID

Date_
enrollment

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

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

1977

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

1978

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

1979

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

1980

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

No.

TrialID

Date_
enrollment

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

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

1982

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

1983

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

1984

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

1985

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

No.

TrialID

Date_
enrollment

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

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

1987

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

1988

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

1989

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

1990

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

No.

TrialID

Date_
enrollment

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

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

1992

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

1993

EUCTR2007-003647-75-GB
(EUCTR)

15/02/2008

10/12/2007

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

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Finland;Netherlands;United Kingdom;Sweden

1994

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

1995

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

No.

TrialID

Date_
enrollment

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

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

1997

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

1998

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

1999

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

2000

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

No.

TrialID

Date_
enrollment

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

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

2002

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

2003

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

2004

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

2005

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

No.

TrialID

Date_
enrollment

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

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

2007

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

2008

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

2009

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

2010

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

2011

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

2012

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

2013

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

2014

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

2015

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

No.

TrialID

Date_
enrollment

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

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

2017

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

2018

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

2019

EUCTR2007-001035-58-PT
(EUCTR)

14/12/2007

16/08/2007

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 METHOTREXATE - N/A

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

2020

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

No.

TrialID

Date_
enrollment

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

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

2022

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

2023

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

2024

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

2025

EUCTR2007-002951-18-NL
(EUCTR)

10/12/2007

09/08/2007

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 TNF-a antagonist therapy - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist

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

2026

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

2027

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

2028

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

2029

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

2030

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

No.

TrialID

Date_
enrollment

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

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

2032

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

2033

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

2034

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

2035

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

2036

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

2037

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

2038

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

2039

NCT00302952
(ClinicalTrials.gov)

November 6, 2007

13/3/2006

Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis

A Double Blind, Placebo Controlled, Phase II, Randomized Study of Lovastatin Therapy in the Treatment of Mildly Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Lovastatin;Drug: Placebo

National Institute of Allergy and Infectious Diseases (NIAID)

Autoimmunity Centers of Excellence

Terminated

18 Years

70 Years

All

Phase 2

United States

2040

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

No.

TrialID

Date_
enrollment

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

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

2042

NCT00554853
(ClinicalTrials.gov)

November 2007

6/11/2007

PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease

Peroxisome Proliferator-activated Receptor-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease

Rheumatoid Arthritis

Drug: pioglitazone;Drug: Sublingual nitroglycerine

University of Michigan

National Heart, Lung, and Blood Institute (NHLBI)

Completed

21 Years

100 Years

All

143

Phase 3

United States

2043

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

2044

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

2045

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

No.

TrialID

Date_
enrollment

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

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

2047

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

2048

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

2049

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

2050

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

No.

TrialID

Date_
enrollment

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

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

2052

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

2053

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

2054

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

2055

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

No.

TrialID

Date_
enrollment

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

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

2057

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

2058

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

2059

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

2060

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

2061

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

2062

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

2063

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

2064

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

2065

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

2066

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

2067

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

2068

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

2069

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

2070

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

No.

TrialID

Date_
enrollment

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

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

2072

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

2073

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

2074

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

2075

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

2076

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

2077

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

2078

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

2079

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

2080

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

No.

TrialID

Date_
enrollment

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

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

2082

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

2083

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

2084

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

2085

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

No.

TrialID

Date_
enrollment

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

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

2087

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

2088

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

2089

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

2090

NCT00523692
(ClinicalTrials.gov)

September 2007

30/8/2007

Remission Induction in Very Early Rheumatoid Arthritis

Remission Induction in Very Early Rheumatoid Arthritis: a Comparison of Etanercept Plus Methotrexate Plus Steroid With Standard Therapy

Rheumatoid Arthritis

Drug: Etanercept , methotrexate and depomedrone;Drug: depemedrone

University Hospital Birmingham

Wyeth is now a wholly owned subsidiary of Pfizer

Not yet 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

2091

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

2092

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

2093

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

2094

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

2095

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

No.

TrialID

Date_
enrollment

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

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

2097

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

2098

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

2099

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

2100

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

No.

TrialID

Date_
enrollment

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

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

2102

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

2103

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

2104

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

2105

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

2106

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

2107

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

2108

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

2109

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

2110

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

No.

TrialID

Date_
enrollment

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

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

2112

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

2113

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

2114

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

2115

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

No.

TrialID

Date_
enrollment

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

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

2117

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

2118

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

2119

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

2120

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

No.

TrialID

Date_
enrollment

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

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

2122

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

2123

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

2124

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

2125

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

No.

TrialID

Date_
enrollment

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

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

2127

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

2128

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

2129

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

2130

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

No.

TrialID

Date_
enrollment

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

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

2132

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

2133

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

2134

NCT00447759
(ClinicalTrials.gov)

June 2007

14/3/2007

The Standard Care Versus Celecoxib Outcome Trial

Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's

Osteoarthritis;Rheumatoid Arthritis

Drug: Celecoxib;Drug: Diclofenac

University of Dundee

University of Glasgow;University of Nottingham

Completed

60 Years

N/A

All

7297

Phase 4

Denmark;Netherlands;United Kingdom

2135

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

No.

TrialID

Date_
enrollment

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

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

2137

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

2138

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

2139

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

2140

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

No.

TrialID

Date_
enrollment

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

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

2142

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

2143

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

2144

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

2145

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

No.

TrialID

Date_
enrollment

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

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

2147

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

2148

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

2149

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

2150

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

No.

TrialID

Date_
enrollment

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

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

2152

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

2153

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

2154

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

2155

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

2156

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

2157

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

2158

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

2159

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

2160

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

No.

TrialID

Date_
enrollment

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

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

2162

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

2163

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

2164

EUCTR2006-006032-22-GB
(EUCTR)

04/04/2007

26/02/2007

TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis - TRACE RA

Rheumatoid arthritis is associated with increased mortality from cardiovascular disease (CVD). Statins have a proven effect in reducing CVD events in at-risk populations, mostly due to their cholesterol-lowering properties, but possibly through anti-inflammatory and immunomodulatory effects. This trial will assess the hypothesis that atorvastatin is more effective than placebo in the primary prevention of cardiovascular events in patients with RA.

University of Manchester

Dudley Group of Hospitals NHS Trust

Not Recruiting

Female: yes
Male: yes

5350

Phase 3

United Kingdom

2165

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

No.

TrialID

Date_
enrollment

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

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

2167

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

2168

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

2169

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

2170

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

No.

TrialID

Date_
enrollment

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

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

2172

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

2173

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

2174

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

2175

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

No.

TrialID

Date_
enrollment

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

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

2177

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

2178

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

2179

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

2180

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

No.

TrialID

Date_
enrollment

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

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

2182

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

2183

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

2184

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

2185

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

No.

TrialID

Date_
enrollment

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

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

2187

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

2188

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

2189

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

2190

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

No.

TrialID

Date_
enrollment

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

NCT00425932
(ClinicalTrials.gov)

February 2007

22/1/2007

Impact of Rituximab on MRI Evidence of Disease Activity in Patients With Moderate to Severe Rheumatoid Arthritis

Impact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Rituximab

Gaylis, Norman B., M.D.

Oklahoma Medical Research Foundation;Genentech, Inc.

Completed

18 Years

80 Years

Both

Phase 2

United States

2192

EUCTR2004-001234-17-GR
(EUCTR)

30/01/2007

18/09/2006

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

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

Pfizer Hellas

Not Recruiting

Female: yes
Male: yes

4402

Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden

2193

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

2194

EUCTR2004-001234-17-EE
(EUCTR)

22/01/2007

29/12/2005

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
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 Inc. New York

Not Recruiting

Female: yes
Male: yes

4402

Portugal;Czech Republic;United Kingdom;Estonia;Ireland;Spain;Greece;Latvia;Lithuania;Sweden

2195

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

2196

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

2197

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

2198

NCT00716248
(ClinicalTrials.gov)

January 2007

8/7/2008

Bucillamine Study of Holding Remission After Infliximab Dose-off

The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate

Rheumatoid Arthritis

Drug: bucillamine;Drug: methotrexate

Saitama Medical University

Keio University

Active, not recruiting

20 Years

N/A

Both

Phase 4

Japan

2199

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

2200

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

No.

TrialID

Date_
enrollment

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

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

2202

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

2203

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

2204

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

2205

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

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 Luxembourg SARL Branch Office Estonia

NULL

Not Recruiting

Female: yes
Male: yes

290

Phase 2A

Czech Republic;Estonia;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

2206

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

2207

NCT00413452
(ClinicalTrials.gov)

December 2006

15/12/2006

Etanercept SFP in RA Patients

Open-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: Etanercept

Amgen

Wyeth is now a wholly owned subsidiary of Pfizer

Completed

18 Years

N/A

Both

224

Phase 3

United States;Canada

2208

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

2209

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

2210

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

No.

TrialID

Date_
enrollment

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

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

2212

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

2213

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

2214

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

2215

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

No.

TrialID

Date_
enrollment

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

NCT00589485
(ClinicalTrials.gov)

November 2006

21/12/2007

Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

Osteoarthritis;Rheumatoid Arthritis;Traumatic Arthritis;Knee Arthritis

Device: Simplex® Bone Cement;Device: Cobalt™ Bone Cement

Zimmer Biomet

New Lexington Clinic

Withdrawn

18 Years

N/A

All

N/A

United States

2217

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

2218

NCT00396812
(ClinicalTrials.gov)

November 2006

6/11/2006

Rituximab for the Treatment of Early Rheumatoid Arthritis (RA)

An Open Label, Single Arm, Single Center, Phase I/II Trial of Rituximab (a Monoclonal Antibody to CD20) for the Treatment of Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rituximab

National Institute of Allergy and Infectious Diseases (NIAID)

Autoimmunity Centers of Excellence

Terminated

18 Years

N/A

All

Phase 1;Phase 2

United States

2219

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

2220

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

No.

TrialID

Date_
enrollment

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

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

2222

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

2223

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

2224

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

2225

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

No.

TrialID

Date_
enrollment

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

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

2227

EUCTR2006-000363-28-GB
(EUCTR)

03/10/2006

28/04/2006

DIFFERENTIATING THE MECHANISM OF ACTION OF ANTI TNF-alpha AGENTS - DATA Study

Rheumatoid arthritis and Psoriatic arthritis

Greater Glasgow Health Board

Glasgow University

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

2228

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

2229

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

2230

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

2231

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

2232

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

2233

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

2234

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

2235

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

2236

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

2237

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

2238

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

2239

EUCTR2005-006165-14-CZ
(EUCTR)

18/08/2006

24/08/2006

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: MLN3897
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: AVE9897
Trade Name: Methotrexate (MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol.
Product Name: Methotrexate
Product Code: N/A
INN or Proposed INN: Methotrexate
Other descriptive name: N/A

Millennium Pharmaceuticals Inc

,NULL

Not Recruiting

Female: yes
Male: yes

186

Phase 2a

United Kingdom;Czech Republic;Netherlands

2240

EUCTR2005-006165-14-NL
(EUCTR)

16/08/2006

01/06/2006

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: MLN3897
Product Code: N/A
INN or Proposed INN: N/A
Other descriptive name: AVE9897
Trade Name: Methotrexate (MTX) administration is at the discretion of the rheumatologist and no tradename is fixed by the protocol
Product Name: Methotrexate
Product Code: N/A
INN or Proposed INN: Methotrexate
Other descriptive name: N/A

Millennium Pharmaceuticals Inc

,NULL

Not Recruiting

Female: yes
Male: yes

186

Phase 2a

Czech Republic;United Kingdom;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

2241

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

2242

EUCTR2005-006165-14-GB
(EUCTR)

03/08/2006

11/05/2006

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of the Efficacy, Safety, and Pharmacokinetics of MLN3897 in Patients with Rheumatoid Arthritis Taking Methotrexate - NA

Rheumatoid Arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Millennium Pharmaceuticals Inc

,NULL

Not Recruiting

Female: yes
Male: yes

186

Phase 2

Czech Republic;Netherlands;United Kingdom

2243

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

2244

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

2245

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

No.

TrialID

Date_
enrollment

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

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

2247

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

2248

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

2249

EUCTR2004-001234-17-GB
(EUCTR)

15/06/2006

15/09/2005

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

2250

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

2251

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

2252

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

2253

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

2254

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

2255

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

2256

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

2257

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

2258

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

2259

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

2260

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

2261

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

2262

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

2263

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

2264

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

2265

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

No.

TrialID

Date_
enrollment

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

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

2267

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

2268

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

2269

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

2270

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

No.

TrialID

Date_
enrollment

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

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

2272

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

2273

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

2274

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.

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]

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

2275

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

No.

TrialID

Date_
enrollment

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

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

2277

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

2278

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

2279

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

2280

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

Laboratórios Pfizer, Lda

NULL

Not Recruiting

Female: yes
Male: yes

4402

Portugal;Czech Republic;United Kingdom;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

2281

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

2282

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

2283

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

2284

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

2285

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

No.

TrialID

Date_
enrollment

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

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

2287

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

2288

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

2289

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

2290

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

No.

TrialID

Date_
enrollment

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

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

2292

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

2293

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

2294

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

2295

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

No.

TrialID

Date_
enrollment

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

NCT00603993
(ClinicalTrials.gov)

March 2006

10/1/2008

Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

A Non-Randomized, Open-Label, Roll-Over Study With Self Injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Adalimumab

Abbott

Abbott Japan Co.,Ltd;Eisai Co., Ltd.

Completed

20 Years

N/A

All

Phase 3

Japan

2297

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

2298

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

2299

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

2300

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

2301

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

2302

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

2303

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

2304

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

2305

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

No.

TrialID

Date_
enrollment

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

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

2307

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

2308

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

2309

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

2310

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

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

No.

TrialID

Date_
enrollment

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

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

2312

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

2313

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

2314

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

2315

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

No.

TrialID

Date_
enrollment

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

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

2317

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

2318

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

2319

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

2320

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

No.

TrialID

Date_
enrollment

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

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

2322

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

2323

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

2324

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

2325

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

No.

TrialID

Date_
enrollment

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

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

2327

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

2328

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

2329

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

2330

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

No.

TrialID

Date_
enrollment

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

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

2332

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

2333

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

2334

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

2335

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

No.

TrialID

Date_
enrollment

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

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

2337

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

2338

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

2339

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

2340

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

No.

TrialID

Date_
enrollment

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

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

2342

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

2343

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

2344

EUCTR2005-002396-33-IT
(EUCTR)

30/11/2005

01/03/2006

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]

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

2345

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

No.

TrialID

Date_
enrollment

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

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

2347

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

2348

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

2349

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

2350

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

No.

TrialID

Date_
enrollment

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

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

2352

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

2353

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

2354

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

2355

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

No.

TrialID

Date_
enrollment

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

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

2357

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

2358

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

2359

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

2360

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

No.

TrialID

Date_
enrollment

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

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

2362

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

2363

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

2364

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

2365

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

No.

TrialID

Date_
enrollment

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

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

2367

EUCTR2005-001319-23-IT
(EUCTR)

21/10/2005

30/09/2005

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

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

2368

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

2369

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

2370

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

No.

TrialID

Date_
enrollment

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

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

2372

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

2373

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

2374

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

2375

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

No.

TrialID

Date_
enrollment

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

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

2377

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

2378

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

2379

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

2380

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

No.

TrialID

Date_
enrollment

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

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

2382

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

2383

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

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]

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

2384

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

2385

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

No.

TrialID

Date_
enrollment

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

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

2387

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

2388

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

2389

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

2390

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

No.

TrialID

Date_
enrollment

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

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

2392

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

2393

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

2394

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

2395

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

No.

TrialID

Date_
enrollment

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

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

2397

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

2398

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

2399

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

2400

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

No.

TrialID

Date_
enrollment

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

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

2402

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

2403

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

2404

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

2405

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

2406

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

2407

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

2408

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

2409

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

2410

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

No.

TrialID

Date_
enrollment

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

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

2412

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

2413

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

2414

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

2415

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

No.

TrialID

Date_
enrollment

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

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

2417

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

2418

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

2419

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

2420

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

2421

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

2422

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

2423

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

2424

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

2425

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

No.

TrialID

Date_
enrollment

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

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

2427

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

2428

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

2429

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

2430

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

No.

TrialID

Date_
enrollment

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

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

2432

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

2433

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

2434

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

2435

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

No.

TrialID

Date_
enrollment

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

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

2437

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

2438

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

2439

EUCTR2004-003741-40-HU
(EUCTR)

15/04/2005

07/02/2005

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

Not Recruiting

Female: yes
Male: yes

630

Hungary;Germany;Italy

2440

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

2441

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

2442

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

2443

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

2444

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

2445

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

No.

TrialID

Date_
enrollment

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

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

2447

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

2448

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

2449

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

2450

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

No.

TrialID

Date_
enrollment

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

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

2452

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

2453

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

2454

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

2455

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

No.

TrialID

Date_
enrollment

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

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

2457

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

2458

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

2459

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

2460

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

No.

TrialID

Date_
enrollment

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

NCT00522184
(ClinicalTrials.gov)

February 2005

27/8/2007

Intra-Articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-Blind Randomized Study

Intra-Articular Injection of Etanercept in Patient Suffering From Rheumatoid Arthritis : a Double-Blind Randomized Study for Evaluation of Efficacy and Safety of Etanercept Versus Intra-Articular Steroid Injection in Acute Synovitis

Rheumatoid Arthritis

Procedure: intra-articular injection of etanercept;Procedure: intra-articular injection of steroid

Centre Hospitalier Universitaire de Nice

Wyeth is now a wholly owned subsidiary of Pfizer

Completed

18 Years

N/A

Both

Phase 3

France

2462

EUCTR2004-003733-14-ES
(EUCTR)

28/01/2005

07/12/2005

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.

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

2463

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

2464

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

2465

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

No.

TrialID

Date_
enrollment

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

EUCTR2004-004302-24-FI
(EUCTR)

18/01/2005

17/11/2004

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

Suomen MSD Oy

NULL

Not Recruiting

Female: yes
Male: yes

136

Finland;Czech Republic;Germany;Spain;Italy

2467

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

2468

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

2469

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

2470

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

2471

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

2472

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

2473

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

2474

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

2475

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

No.

TrialID

Date_
enrollment

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

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

2477

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

2478

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

2479

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

2480

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

2481

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

2482

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

2483

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

2484

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

2485

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

No.

TrialID

Date_
enrollment

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

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

2487

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

2488

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

2489

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

2490

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

2491

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

2492

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

2493

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

2494

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

2495

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

No.

TrialID

Date_
enrollment

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

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

2497

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

2498

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

2499

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

2500

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

No.

TrialID

Date_
enrollment

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

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

2502

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

2503

NCT00468377
(ClinicalTrials.gov)

March 2004

30/4/2007

Safety and Efficacy Study of Re-treatment With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Respond Poorly to Anti-TNFa Therapies

An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies

Arthritis, Rheumatoid

Drug: Rituximab

Hoffmann-La Roche

Genentech, Inc.

Active, not recruiting

18 Years

80 Years

Both

341

Phase 3

United States

2504

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

2505

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

No.

TrialID

Date_
enrollment

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

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

2507

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

2508

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

2509

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

2510

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

No.

TrialID

Date_
enrollment

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

NCT00908089
(ClinicalTrials.gov)

March 2003

22/5/2009

TNF-blocking Therapy in Combination With Disease-modifying Antirheumatic Drugs in Early Rheumatoid Arthritis

Use of TNF-blocking Therapy in Combination With DMARDs in Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Trexan +Salazopyrin+Oxiklorin+prednisolone + infliximab;Drug: Trexan +Salazopyrin+Oxiklorin+prednisolone + placebo

Helsinki University

Seinajoki Central Hospital;Oulu University Hospital;Jyväskylä Central Hospital;Kuopio University Hospital;Satakunta Central Hospital;University of Turku;Rheumatism Foundation Hospital;Orton Invalid Foundation;South Karelia central hospital;Lappi Central Hospital;Central Hospital of Kanta-Hame

Active, not recruiting

18 Years

60 Years

Both

100

Phase 4

Finland

2512

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

2513

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

2514

NCT00116727
(ClinicalTrials.gov)

October 2002

30/6/2005

Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 2)

Rheumatoid Arthritis

Drug: ENBREL ®

Amgen

Immunex Corporation;Wyeth is now a wholly owned subsidiary of Pfizer

Completed

18 Years

N/A

Both

5103

N/A

United States

2515

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

No.

TrialID

Date_
enrollment

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

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

2517

NCT00116714
(ClinicalTrials.gov)

October 2001

30/6/2005

Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudy

Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 1)

Rheumatoid Arthritis

Drug: DMARD

Amgen

Immunex Corporation;Wyeth is now a wholly owned subsidiary of Pfizer

Completed

18 Years

N/A

Both

4968

N/A

United States

2518

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

2519

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

2520

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

No.

TrialID

Date_
enrollment

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

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

2522

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

2523

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

2524

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

2525

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

No.

TrialID

Date_
enrollment

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

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

2527

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

2528

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

2529

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

2530

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

No.

TrialID

Date_
enrollment

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

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

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

2532

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

2533

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

2534

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

2535

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

No.

TrialID

Date_
enrollment

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

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

2537

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

2538

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

2539

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