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	EUCTR2020-003955-14-DE (EUCTR)	21/12/2020	04/11/2020	A Placebo controlled trial in adult patients with active rheumatoid arthritis with inadequate (partial) response to anti-TNF therapy	A Randomized, Double-blind, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Adults with Active Rheumatoid Arthritis who have demonstrated an inadequate Response to anti-TNF therapy.	Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: AMT -101 Other descriptive name: AMT -101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Germany
3	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
4	EUCTR2019-000878-30-BE (EUCTR)	18/11/2020	21/09/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
5	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
6	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
7	EUCTR2019-002205-22-FR (EUCTR)	01/10/2020	13/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
8	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
9	EUCTR2019-000878-30-BG (EUCTR)	04/09/2020	11/08/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
10	EUCTR2019-004369-42-CZ (EUCTR)	01/09/2020	05/08/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra (R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	United States;Serbia;Hungary;Czech Republic;Slovakia;Spain;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of
No.	TrialID	Date_ enrollment	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	EUCTR2019-002676-14-BG (EUCTR)	20/08/2020	27/05/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
12	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
13	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
14	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
15	EUCTR2019-002205-22-DE (EUCTR)	12/08/2020	07/07/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
No.	TrialID	Date_ enrollment	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	EUCTR2019-002676-14-CZ (EUCTR)	07/07/2020	11/05/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Czechia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
17	EUCTR2019-002676-14-HU (EUCTR)	18/06/2020	14/04/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
18	EUCTR2019-002810-37-PL (EUCTR)	16/06/2020	11/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	Bulgaria;United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Germany
19	EUCTR2019-002810-37-BG (EUCTR)	15/06/2020	28/04/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	United States;Czechia;Estonia;Hungary;Poland;Lithuania;Bulgaria;Germany
20	NCT04584541 (ClinicalTrials.gov)	June 11, 2020	10/6/2020	SarS-Cov-2 Viral Infection (COVID-19) in Patients With Chronic Inflammatory Rheumatism	Study of the Viral Load and Humoral and Cellular B and T Responses in Patients With Rheumatoid Arthritis and Spondyloarthritis Under Immunosuppressive Treatments	Spondyloarthritis;Rheumatoid Arthritis;Covid19	Biological: blood tests;Biological: Nasopharyngeal swabs;Biological: Stools	Assistance Publique - Hôpitaux de Paris	NULL	Recruiting	18 Years	N/A	All	150	N/A	France
No.	TrialID	Date_ enrollment	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	EUCTR2019-002676-14-SE (EUCTR)	01/06/2020	14/04/2020	A STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF 06651600, AND TOFACITINIB. ALONE AND IN COMBINATION IN ACTIVE RHEUMATOID ARTHRITIS	A 24-WEEK RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, ACTIVE COMPARATOR, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PF 06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH MODERATELY-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE	Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint inflammation MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Tofacitinib (Xeljanz®) 11mg Prolonged Release Tablet Product Name: tofacitinib (Xeljanz®) Product Code: CP 690550 MR INN or Proposed INN: Tofacitinib Other descriptive name: TOFACITINIB CITRATE Product Name: IRAK 4 Product Code: PF-06650833 INN or Proposed INN: IRAK 4 Other descriptive name: PF-06650833 Product Name: JAK 3 Product Code: PF-06651600 INN or Proposed INN: JAK 3 Other descriptive name: PF-06651600	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 2	Serbia;Slovakia;Spain;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Canada;Poland;Romania;Bulgaria;Georgia;Sweden;Bosnia and Herzegovina
22	NCT04275206 (ClinicalTrials.gov)	June 1, 2020	14/2/2020	The Anti-inflammatory Effects of Harkány Medicinal Water	The Anti-inflammatory Effects of Harkány Medicinal Water	Rheumatoid Arthritis;Psoriasis	Other: Harkány medicinal water;Other: Tap water (placebo control)	University of Pecs	National Research, Development and Innovation Office, Hungary;Harkány Spa Hospital, Hungary	Recruiting	18 Years	N/A	All	350	N/A	Hungary
23	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
24	EUCTR2019-004369-42-SK (EUCTR)	12/05/2020	09/03/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	United States;Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of
25	EUCTR2019-004078-24-ES (EUCTR)	07/05/2020	21/02/2020	Effect of Sarilumab on atherosclerotic disease in Rheumatoid Arthritis	Effect of Sarilumab on atherosclerotic disease measured by PET/CT (Positron Emission Tomography/Computed Tomography) in Rheumatoid Arthritis - SARIPET	RHEUMATOID ARTHRITIS MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: KEVZARA INN or Proposed INN: SARILUMAB	IDIVAL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 4	Spain
No.	TrialID	Date_ enrollment	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	EUCTR2019-004369-42-PL (EUCTR)	05/05/2020	23/03/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra (R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	United States;Serbia;Czechia;Czech Republic;Hungary;Slovakia;Spain;Poland;Bulgaria;Russian Federation;Georgia;Moldova, Republic of
27	EUCTR2019-002205-22-GB (EUCTR)	01/05/2020	07/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
28	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
29	EUCTR2019-004369-42-HU (EUCTR)	27/04/2020	03/03/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra (R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of
30	EUCTR2019-002810-37-LT (EUCTR)	17/04/2020	03/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany
No.	TrialID	Date_ enrollment	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	EUCTR2019-000867-26-DE (EUCTR)	08/04/2020	04/07/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1800	Phase 3	United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of
32	EUCTR2019-002205-22-ES (EUCTR)	06/04/2020	23/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom
33	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
34	EUCTR2019-002205-22-PL (EUCTR)	29/03/2020	07/02/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom
35	EUCTR2019-000878-30-HU (EUCTR)	26/03/2020	28/02/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	Japan;Serbia;United States;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2019-003700-12-FR (EUCTR)	13/03/2020	04/06/2020	Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients	Association between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug	rheumatoid arthritis MedDRA version: 21.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Methotrexate Product Code: MTX Other descriptive name: METHOTREXATE DISODIUM Product Code: bDMARD INN or Proposed INN: INFLIXIMAB INN or Proposed INN: ETANERCEPT INN or Proposed INN: ADALIMUMAB INN or Proposed INN: CERTOLIZUMAB PEGOL INN or Proposed INN: GOLIMUMAB	CHU Saint-Etienne	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	France
37	EUCTR2019-000868-18-DE (EUCTR)	13/03/2020	08/07/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of
38	EUCTR2019-002810-37-HU (EUCTR)	09/03/2020	20/01/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;Hungary
39	EUCTR2019-000878-30-CZ (EUCTR)	26/02/2020	06/01/2020	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	Serbia;United States;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Japan
40	EUCTR2019-000878-30-LT (EUCTR)	13/02/2020	25/11/2019	A long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK 3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3000	Phase 3	United States;Serbia;Philippines;Estonia;Thailand;Spain;Ukraine;Russian Federation;Colombia;Italy;India;France;Malaysia;Australia;South Africa;Latvia;China;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2019-004468-23-GB (EUCTR)	10/02/2020	26/02/2020	Biologics for RA Pain ( BIORA-PAIN)	Comparison of abatacept with tumor necrosis factor inhibitors in the treatment of rheumatoid arthritis pain: A phase IV trial - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Abatacept Product Name: Abatacept INN or Proposed INN: Abatacept Trade Name: Humira Product Name: Humira INN or Proposed INN: Humira	St George's, University of London	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	United Kingdom
42	EUCTR2018-004558-30-PT (EUCTR)	03/02/2020	21/05/2019	A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.	A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant INN or Proposed INN: BARICITINIB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Ledertrexato Product Name: Metotrexato Product Code: Metotrexato INN or Proposed INN: metotrexato Other descriptive name: METHOTREXATE SODIUM Trade Name: Metex Pen Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	186	Phase 4	Portugal;Spain
43	EUCTR2019-000284-24-CZ (EUCTR)	03/02/2020	17/10/2019	A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.	A RANDOMIZED COMPARATIVE STUDY ASSESSING THE SWITCHING BETWEEN PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.	Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 4	United States;Serbia;Czech Republic;Poland;Ukraine;Lithuania;South Africa;Russian Federation;Bulgaria;Bosnia and Herzegovina
44	EUCTR2018-004429-94-NL (EUCTR)	21/01/2020	17/06/2019	Monitoring of respons to therapy in rheumatoid arthritis with the help of a PET scan.	[18F]PEG-folate PET-CT imaging for monitoring of therapy response in rheumatoid arthritis patients	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: [18F]PEG-Folate	VU Medical Center, department of Rheumatology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	10	Phase 4	Netherlands
45	JPRN-UMIN000042632	2020/01/01	03/12/2020	THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS	THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS - laser effectiveness in rheumatoid arthritis	Rheumatoid arthritis	low level laser therapy. Each patient in group 1 takes 20 sessions of LLLT , in the form of 2 courses, each course contains 10 sessions ,as 3 sessions every week ,10 days free between 2 courses. The laser apparatuses used for therapy in this study were the following, 1.HeNe Laser wavelength 632,8 nm, continuous emission, output power 7.3 mW. 2.GaAIAs diode laser (830 nm, maximum output power 300 mW). 12 patients placebo laser and naproxen Naproxen is given as tablet 500mg twice per day. 12 patients naproxen Naproxen is given as tablet 500mg twice per day. 10 patients	Rheumatology clinic at Al-Kindy Teaching Hospital /Baghdad/Iraq	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	34	Not applicable	Asia(except Japan)
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2019-000284-24-LT (EUCTR)	18/12/2019	07/11/2019	A Comparative Study Between PF-06410293 And Humira in Combination with Methotrexate in Participants with Active Rheumatoid Arthritis.	A RANDOMIZED COMPARATIVE STUDY ASSESSING THE INTERCHANGEABILITY OF PF-06410293 AND HUMIRA® IN COMBINATION WITH METHOTREXATE IN PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS.	Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: Adalimumab -Pfizer Product Code: PF-06410293 INN or Proposed INN: Adalimumab Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA Trade Name: Humira INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB HUMIRA	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420	Phase 3	United States;Serbia;Ukraine;Lithuania;Russian Federation;Czech Republic;Mexico;Argentina;Poland;Peru;South Africa;Bulgaria;Bosnia and Herzegovina
47	EUCTR2018-003351-37-LT (EUCTR)	13/12/2019	29/08/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
48	EUCTR2019-000867-26-GB (EUCTR)	10/12/2019	12/06/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Xeljanz INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1800	Phase 3	United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of
49	EUCTR2019-000868-18-GB (EUCTR)	02/12/2019	11/06/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Kevzara INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colo	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Czechia;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of
50	EUCTR2019-001754-25-NL (EUCTR)	25/11/2019	25/11/2019	Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment	Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch)	rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel , Benepali, Erelzi Product Name: Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab INN or Proposed INN: ETANERCEPT INN or Proposed INN: RITUXIMAB INN or Proposed INN: ABATACEPT INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB INN or Proposed INN: SARILUMAB	Reade	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 4	Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	EUCTR2019-000797-39-GB (EUCTR)	22/11/2019	10/06/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Xeljanz INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China;United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation
52	EUCTR2019-000797-39-PL (EUCTR)	18/11/2019	15/07/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China
53	EUCTR2019-000868-18-PL (EUCTR)	15/11/2019	11/07/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Germany;Netherlands;China;Japan;Korea, Republic of
54	EUCTR2019-000867-26-PL (EUCTR)	15/11/2019	15/07/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1800	Phase 3	United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;China;Japan;Korea, Republic of
55	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
No.	TrialID	Date_ enrollment	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	EUCTR2019-000797-39-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
57	EUCTR2019-000868-18-ES (EUCTR)	14/11/2019	26/07/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;Japan;China;Korea, Republic of
58	EUCTR2019-000868-18-HU (EUCTR)	24/10/2019	28/10/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, incombination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Lithuania;United Kingdom;Italy;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;South Africa;Germany;China;Japan
59	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
60	EUCTR2019-000797-39-HU (EUCTR)	24/10/2019	28/10/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China
No.	TrialID	Date_ enrollment	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	EUCTR2019-000867-26-BG (EUCTR)	11/10/2019	30/07/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1800	Phase 3	Germany;China;Japan;Korea, Republic of;United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria
62	EUCTR2019-000797-39-LT (EUCTR)	11/10/2019	19/07/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) MONOCLONAL Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China
63	EUCTR2019-000867-26-EE (EUCTR)	10/10/2019	01/08/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1800	Phase 3	United States;Estonia;Spain;Thailand;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of
64	JPRN-JapicCTI-194932	01/10/2019	28/08/2019	An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis	An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis	Intervention name : ozoralizumab INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection of TS-152 30mg or TS-152 80mg every 4 weeks Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Taisho Pharmaceutical Co.Ltd	NULL	complete	20		BOTH	505	Phase 3	Japan
65	EUCTR2019-000868-18-CZ (EUCTR)	20/09/2019	20/08/2019	Efficacy and safety of GSK3196165 versus placebo and sarilumab in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors.	A 24-week, phase 3, multicentre, randomised, double-blind, efficacy and safety study, comparing GSK3196165 with placebo and with sarilumab, in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to biological DMARDs and/or Janus Kinase inhibitors. - contRAst-3	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Kevzara Product Name: Sarilumab INN or Proposed INN: SARILUMAB	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Spain;Ukraine;Lithuania;United Kingdom;Italy;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;Japan;China;Korea, Republic of
No.	TrialID	Date_ enrollment	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	EUCTR2019-000797-39-CZ (EUCTR)	19/09/2019	18/09/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: GSK3196165 INN or Proposed INN: Otilimab Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	Serbia;United States;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;South Africa;Latvia;China
67	EUCTR2018-004677-27-BE (EUCTR)	16/09/2019	25/03/2019	Phase IIa study of ABX464 in moderate to severe active Rheumatoid Arthritis patients.	Phase IIa randomized, double blind, placebo controlled, parallel group, multiple dose study on ABX464 in combination with methotrexate (MTX), in patients with moderate to severe active Rheumatoid Arthritis who have inadequate response to MTX or/and to an anti- tumor necrosis factor alpha (TNFa) therapy, or intolerance to anti-TNFa therapy.	Rheumatoid Arthritis MedDRA version: 21.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	Abivax	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	Hungary;Belgium
68	EUCTR2019-000797-39-LV (EUCTR)	13/09/2019	25/06/2019	Efficacy and safety of GSK3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate.	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study comparing GSK3196165 with placebo and with tofacitinib, in combination with methotrexate in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to methotrexate. - contRAst-1	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1700	Phase 3	United States;Serbia;Philippines;Spain;Ukraine;Lithuania;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Malaysia;South Africa;Latvia;China
69	EUCTR2018-003351-37-GR (EUCTR)	13/09/2019	29/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
70	EUCTR2018-003351-37-DK (EUCTR)	29/08/2019	07/08/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;South Africa;Germany;Netherlands
No.	TrialID	Date_ enrollment	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	EUCTR2018-003351-37-NL (EUCTR)	29/08/2019	08/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Germany;Netherlands
72	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
73	EUCTR2018-003351-37-GB (EUCTR)	08/08/2019	16/05/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
74	EUCTR2018-003351-37-DE (EUCTR)	02/08/2019	24/07/2019	A Phase 3b/4 Study in Rheumatoid Arthritis	A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2600	Phase 3;Phase 4	South Africa;Germany;Netherlands;United States;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Australia;Denmark
75	EUCTR2018-003330-32-PL (EUCTR)	19/07/2019	06/05/2019	Efficacy and Safety of Oral SKI-O-703 in Refractory Rheumatoid Arthritis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study to Evaluate the Efficacy and Safety of Oral SKI-O-703 in Patients With Active Rheumatoid Arthritis Despite Treatment With Conventional Therapies	Rheumatoid Arthritis Despite Treatment With Conventional Therapies MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Cevidoplenib Product Code: SKI-O-703 INN or Proposed INN: Cevidoplenib	Oscotec Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	148	Phase 2	United States;Serbia;Czech Republic;Poland;Ukraine;Russian Federation;Korea, Republic of
No.	TrialID	Date_ enrollment	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	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
77	EUCTR2016-003682-26-PL (EUCTR)	11/07/2019	17/05/2018	Phase 3 trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of patients suffering of Early Rheumatoid Arthritis	A Phase 3, Randomized, Double-Blind, Active- and Placebo controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of CF101 Compared to Methotrexate in the Treatment of Early Rheumatoid Arthritis	Early Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CF101 Product Code: CF101 INN or Proposed INN: Piclidenoson Other descriptive name: IB-MECA Product Name: CF101 Product Code: CF101 INN or Proposed INN: Piclidenoson Other descriptive name: IB-MECA Product Name: METHOTREXATE Product Code: METHOTREXATE INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE	Can-Fite BioPharma, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	Serbia;Canada;Poland;Romania;Israel;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
78	EUCTR2019-000660-25-PL (EUCTR)	09/07/2019	20/05/2019	Evaluating Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis	A Phase III, Open-label, Single-arm, Multiple-dose Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients with Moderate to Severe Active Rheumatoid Arthritis	Moderate to Severe Active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CT-P17 Product Code: CT-P17 INN or Proposed INN: ADALIMUMAB	CELLTRION, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 3	Poland
79	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
80	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
No.	TrialID	Date_ enrollment	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	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
82	EUCTR2018-003877-91-DE (EUCTR)	13/06/2019	26/02/2019	B cell therapy followed by T cell therapy to achieve immune tolerance in rheumatoid arthritis with ACPA antiboidies (TOLERA): an unblinded clinical trial in one centre with random assignment to treatment groups in adult patients who failed methotrexate therapy	Sequential B cell/T cell therapy to re-induce humoral immune tolerance in ACPA-positive Rheumatoid Arthritis (TOLERA): a prospective randomized controlled open-label single-centre clinical trial in adult subjects with active ACPA-positive Rheumatoid Arthritis failing Methotrexate - TOLERA	Active rheumatoid arthritis with ACPA antibodies failing methotrexate MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	INN or Proposed INN: RITUXIMAB Trade Name: Orencia INN or Proposed INN: ABATACEPT	Universitätsklinikum Erlangen	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	20	Phase 2	Germany
83	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
84	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
85	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
No.	TrialID	Date_ enrollment	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	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
87	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
88	NCT03938636 (ClinicalTrials.gov)	April 8, 2019	24/4/2019	Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging	Evaluation of the Precision and Sensitivity of Tilmanocept Uptake Value (TUV) on Tc 99m Tilmanocept Planar Imaging	Rheumatoid Arthritis	Drug: TC99m-tilmanocept	Navidea Biopharmaceuticals	NULL	Recruiting	18 Years	N/A	All	105	Phase 2	United States
89	NCT03816345 (ClinicalTrials.gov)	April 4, 2019	24/1/2019	Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer	A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)	Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Neoplasm	Biological: Nivolumab	National Cancer Institute (NCI)	NULL	Recruiting	18 Years	N/A	All	264	Phase 1	United States
90	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
No.	TrialID	Date_ enrollment	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	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
92	EUCTR2018-002202-31-BG (EUCTR)	27/03/2019	30/11/2018	A Phase 3 study to compare BAT1806 with RoActemra in patients with Rheumatoid Arthritis	A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate	Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BAT1806 INN or Proposed INN: BAT1806 Other descriptive name: TOCILIZUMAB Trade Name: RoActemra Product Name: RoActerma INN or Proposed INN: RoActemra Other descriptive name: TOCILIZUMAB	Bio-Thera Solutions, Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	612	Phase 3	Poland;Ukraine;Georgia;Bulgaria;China
93	ChiCTR1900021686	2019-03-15	2019-03-05	A observational study for iguratimod combined with methotrexate in remission or reversion bone erosion of rheumatoid arthritis	A observational study for iguratimod combined with methotrexate in remission or reversion bone erosion of rheumatoid arthritis	Rheumatoid arthritis	Case Series:IGU combined with MTX ;	Nanjing Drum Tower Hospital	NULL	Pending	18	70	Both	Case Series:30;	Phase 4	China
94	EUCTR2018-002306-31-HU (EUCTR)	08/03/2019	11/02/2019	A Phase 2 Long-Term Extension Study in Rheumatoid Arthritis Treated Patients Previously Treated in a Preceding Study with ABBV-105 Given Alone or in Combination with Upadacitinib.	A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial with ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599)	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Code: ABBV-105 Other descriptive name: ABBV-105 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	Czech Republic;Hungary;Canada;Spain;Poland;Belgium;United Kingdom
95	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
No.	TrialID	Date_ enrollment	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	EUCTR2018-000666-10-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
97	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
98	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
99	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
100	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
No.	TrialID	Date_ enrollment	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	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
102	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
103	JPRN-JapicCTI-184031	02/10/2018	09/07/2018	A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy	A Phase III Study of TS-152 in Patients with Active Rheumatoid Arthritis (RA) Without Methotrexate (MTX) Therapy	Rheumatoid Arthritis (RA)	Intervention name : TS-152 INN of the intervention : ozoralizumab Dosage And administration of the intervention : Subcutaneous injection every 4 weeks Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Taisho Pharmaceutical co., LTD	NULL	complete	20		BOTH	135	Phase 3	Japan
104	NCT03699293 (ClinicalTrials.gov)	September 22, 2018	21/9/2018	NSAIDs vs. Coxibs in the Presence of Aspirin	NSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects With Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular Disease	Rheumatoid Arthritis;Cardiovascular Diseases	Drug: celecoxib 200mg capsule;Drug: naproxen sodium 550mg tablet;Drug: Aspirin 81mg tablet	Inova Health Care Services	NULL	Unknown status	18 Years	75 Years	All	30	Phase 4	United States
105	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
No.	TrialID	Date_ enrollment	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	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
107	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
108	EUCTR2017-004079-30-PT (EUCTR)	09/08/2018	29/06/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	207	Phase 3	Portugal;Belgium;Spain;Italy
109	EUCTR2018-002368-18-ES (EUCTR)	25/07/2018	25/07/2018	Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load	Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity inimmunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis Bvaccine with increased antigenic load	1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab.2. breast and lung cancer undertreated by chemotherapy3. HIV4. Haematopoietic progenitor cell transplantation (TCPH). MedDRA version: 20.0;Level: PT;Classification code 10006187;Term: Breast cancer;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 20.0;Classification code 10058467;Term: Lung neoplasm malignant;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1;Classification code 10020161;Term: HIV infection;System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0;Classification code 10063581;Term: Stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Fendrix suspension for injection Product Name: Fendrix Product Code: Fendrix INN or Proposed INN: Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). Other descriptive name: HEPATITIS B VACCINE (RDNA) Trade Name: HBVAXPRO 5 micrograms/0.5 ml Product Name: HBVAXPRO ® 40 micrograms Product Code: HBVAXPRO ® 40 micrograms INN or Proposed INN: HBVAXPRO 5 micrograms/0.5 ml Suspension for injection Hepatitis B vaccine (rDNA) Other descriptive name: HEPATITIS B VIRUS SURFACE ANTIGEN RECOMBINANT (S PROTEIN)	FUNDACIÓ HOSPITAL UNIVERSITARI VALL D’HEBRON – INSTITUT DE RECERCA (VHIR)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	740	Phase 4	Spain
110	EUCTR2017-004079-30-ES (EUCTR)	10/07/2018	21/03/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rhuematoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	207	Phase 3	Portugal;Belgium;Spain;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	EUCTR2016-002344-16-GB (EUCTR)	28/06/2018	29/11/2017	Targeted treatment early with etanercept and methotrexate or methotrexate with treat to target (standard) care for treatment-naive early rheumatoid arthritis patients, based on baseline naive T-cell frequency.	Targeted treatment early with etanercept (biosimilar) plus methotrexate or methotrexate with T2T care for DMARD-naïve early RA patients. A prospective, longitudinal cohort study with an embedded pilot randomised controlled trial to assess treatment rationalisation based on naïve CD4+ T-cell stratification. - TEEMS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		University of Leeds	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	106	Phase 4	United Kingdom
112	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
113	NCT03559686 (ClinicalTrials.gov)	May 30, 2018	5/6/2018	Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Aarthritis (RA)	Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Arthritis (RA) Who Participated in Open Label Studies C87015, C87028 and C87051	Rheumatoid Arthritis	Drug: Certolizumab Pegol	UCB Biopharma S.P.R.L.	NULL	Available	18 Years	N/A	All			NULL
114	EUCTR2017-001944-36-ES (EUCTR)	21/05/2018	10/10/2017	Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis	A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: AMG592 INN or Proposed INN: AMG 592 Other descriptive name: RECOMBINANT FACTOR FC FUSION PROTEIN	Amgen Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	137	Phase 1;Phase 2	United States;Czech Republic;Mexico;Poland;Spain;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom
115	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
No.	TrialID	Date_ enrollment	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	EUCTR2016-000933-37-BG (EUCTR)	09/05/2018	12/01/2018	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Belarus;Portugal;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden
117	EUCTR2016-002569-68-GB (EUCTR)	04/05/2018	18/05/2018	Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease	Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease: A feasibility study - APRIL	Rheumatoid-associated Interstitial Lung Disease (RA-ILD) MedDRA version: 20.0;Level: PT;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	United Kingdom
118	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
119	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
120	NCT03480529 (ClinicalTrials.gov)	March 1, 2018	21/3/2018	Monitoring the IMmUological TOXicity of Drugs	Monitoring the IMmUological TOXicity of Drugs	Arthritis;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Capillary Leak Syndrome;Hepatitis	Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom	Groupe Hospitalier Pitie-Salpetriere	Institut National de la Santé Et de la Recherche Médicale, France	Completed	18 Years	N/A	All	662		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
121	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
122	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
123	EUCTR2017-002878-38-NL (EUCTR)	07/02/2018	12/09/2017	Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis	Abatacept to Silence anti-Citrullinated protein Antibody-expressing B cells in Rheumatoid Arthritis - ASCARA	Patients with early, methotrexate-naïve, ACPA-positive rheumatoid arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000018818;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Orencia 125 mg INN or Proposed INN: ABATACEPT	Leiden University Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	46	Phase 4	Netherlands
124	EUCTR2017-003259-40-ES (EUCTR)	04/01/2018	24/10/2017	Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.	Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial.	Patients with rheumatoid arthritis with high clinical activity and chronical peirodontitis moderate-severe. MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: amoxicilina INN or Proposed INN: AMOXICILLIN Product Name: metronidazol INN or Proposed INN: METRONIDAZOLE Other descriptive name: metronidazol	Dra Beatriz Lozano-Hospital Universitario de Canarias	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 4	Spain
125	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
No.	TrialID	Date_ enrollment	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	NCT03186417 (ClinicalTrials.gov)	December 15, 2017	12/6/2017	Mesenchymal Stem Cells in Early Rheumatoid Arthritis	Cell-Based Therapy in Rheumatoid Arthritis: Proof of Concept Phase 1 Trial	Rheumatoid Arthritis	Biological: 2 million hMSC/kg;Biological: 4 million hMSC/kg;Biological: 6 million hMSC/kg;Biological: placebo	MetroHealth Medical Center	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Recruiting	18 Years	80 Years	All	20	Phase 1	United States
127	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
128	EUCTR2017-001944-36-PL (EUCTR)	23/11/2017	11/10/2017	Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis	A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid Arthritis With Inadequate Response to Standard of Care Therapy	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: AMG 592 INN or Proposed INN: AMG592 Other descriptive name: AMG592	Amgen Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	153	Phase 1;Phase 2	United States;Czech Republic;Mexico;Spain;Poland;Romania;Australia;Bulgaria;Germany;New Zealand;United Kingdom
129	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
130	EUCTR2017-000384-32-BG (EUCTR)	02/11/2017	12/07/2017	Phase IIb in Rheumatoid Arthritis	A Phase IIb, Randomized, Double blind Study in Subjects with Rheumatoid Arthritis Evaluating the Safety and Efficacy of Evobrutinib Compared with Placebo in Subjects with an Inadequate Response to Methotrexate - N/A	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	363	Phase 2	United States;Serbia;Ukraine;Chile;Russian Federation;Colombia;Czech Republic;Mexico;Argentina;Brazil;Poland;Bulgaria;South Africa;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
131	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
132	EUCTR2016-002126-36-IT (EUCTR)	26/10/2017	31/01/2018	A study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO7123520 AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-a INHIBITORS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RO7123520 Product Code: RO7123520 /F03-01	F. Hoffmann - Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	204	Phase 2	United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy
133	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
134	NCT03163966 (ClinicalTrials.gov)	October 5, 2017	8/5/2017	A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis	A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Oral CR6086 Administered at the Doses of 30, 90 or 180 mg Bid for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis	Rheumatoid Arthritis, DMARD-naive and Early Disease Patients	Drug: CR6086;Drug: Methotrexate;Drug: Placebo	Rottapharm Biotech	NULL	Recruiting	18 Years	N/A	All	240	Phase 2	Czechia
135	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
No.	TrialID	Date_ enrollment	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	EUCTR2016-004300-65-BE (EUCTR)	26/09/2017	20/01/2017	Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®).	Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®). - SCINTRA TRIS	rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: 99mTc-S-HYNIC Certolizumab pegol INN or Proposed INN: CERTOLIZUMAB PEGOL	Ghent University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 4	Belgium
137	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
138	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
139	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
140	NCT03241446 (ClinicalTrials.gov)	September 2017	25/7/2017	Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)	A Phase I, Open-Label Study to Investigate the Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis	Arthritis, Rheumatoid	Drug: Tilmanocept	Navidea Biopharmaceuticals	NULL	Withdrawn	30 Years	65 Years	All	0	Phase 1	NULL
No.	TrialID	Date_ enrollment	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	EUCTR2017-000838-64-DK (EUCTR)	25/08/2017	13/06/2017	An early phase study in patients with active Rheumatoid Arthritis to compare the safety and efficacy of AZD9567 and prednisolone	A Phase 2a, Randomised, Double-blind, Parallel Study to Assess the Efficacy, Safety and Tolerability of AZD9567 compared to Prednisolone 20 mg in patients with active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Code: AZD9567 monohydrate INN or Proposed INN: N/A Trade Name: PredniHEXAL INN or Proposed INN: Prednisolone Other descriptive name: -	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	Denmark;Netherlands;Sweden
142	EUCTR2017-000947-41-FR (EUCTR)	18/08/2017	21/06/2017	ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS.	ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTAR	Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor. MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie Trade Name: RoActemra 162 mg solution injectable en seringue préremplie	Groupement des Hôpitaux de l’Institut Catholique de Lille	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	France
143	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
144	EUCTR2016-003630-25-DE (EUCTR)	14/08/2017	13/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
145	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
No.	TrialID	Date_ enrollment	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	EUCTR2016-003630-25-BE (EUCTR)	01/08/2017	12/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
147	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
148	EUCTR2016-003630-25-GB (EUCTR)	19/07/2017	15/08/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
149	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
150	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
No.	TrialID	Date_ enrollment	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	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
152	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
153	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
154	EUCTR2016-000933-37-NL (EUCTR)	19/06/2017	18/04/2017	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	313	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
155	EUCTR2016-003630-25-SK (EUCTR)	15/06/2017	04/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3068	Phase 3	United States;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	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	EUCTR2016-003630-25-ES (EUCTR)	09/06/2017	09/06/2017	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	Serbia;United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan
157	EUCTR2016-003630-25-PL (EUCTR)	07/06/2017	24/04/2017	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	United States;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan;New Zealand
158	EUCTR2016-003630-25-HU (EUCTR)	29/05/2017	12/04/2017	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	2640	Phase 3	Slovakia;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan;United States;Taiwan;Hong Kong
159	EUCTR2015-005309-35-DE (EUCTR)	23/05/2017	24/01/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm International LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1880	Phase 3	United States;Belarus;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
160	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
No.	TrialID	Date_ enrollment	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	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
162	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
163	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
164	EUCTR2016-000933-37-CZ (EUCTR)	02/05/2017	22/11/2016	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: 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 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	313	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;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
165	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
No.	TrialID	Date_ enrollment	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	EUCTR2016-000933-37-DE (EUCTR)	27/04/2017	17/10/2016	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	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
167	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
168	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
169	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
170	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
No.	TrialID	Date_ enrollment	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	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
172	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
173	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
174	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
175	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
No.	TrialID	Date_ enrollment	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	EUCTR2016-000570-37-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
177	EUCTR2015-005309-35-HU (EUCTR)	16/03/2017	02/02/2017	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis	A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4	Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038	R-Pharm	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1880	Phase 3	United States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of
178	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
179	EUCTR2016-000933-37-BE (EUCTR)	14/03/2017	24/11/2016	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	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
180	EUCTR2015-003289-97-DE (EUCTR)	09/03/2017	30/11/2016	A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis	Protocol I8K-MC-JPDA(c)A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY3337641 5 mg Product Code: LY3337641 INN or Proposed INN: Not available Product Name: LY3337641 20 mg Product Code: LY3337641 INN or Proposed INN: Not available	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	276	Phase 2	United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
181	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
182	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
183	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
184	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
185	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
186	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
187	EUCTR2016-000569-21-BE (EUCTR)	30/01/2017	28/10/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	423	Phase 3	Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of;United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary
188	EUCTR2016-000933-37-PT (EUCTR)	30/01/2017	09/11/2016	Study to Compare Upadacitinib to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 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: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	550	Phase 3	United States;Belarus;Portugal;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Latvia;Netherlands;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Norway;New Zealand;Sweden
189	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
190	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
No.	TrialID	Date_ enrollment	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	EUCTR2016-000570-37-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
192	EUCTR2016-000569-21-ES (EUCTR)	13/01/2017	13/01/2017	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	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: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Belgium;Australia;Germany;Japan;Korea, Republic of
193	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
194	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
195	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
No.	TrialID	Date_ enrollment	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	EUCTR2016-000570-37-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
197	NCT02865434 (ClinicalTrials.gov)	January 2017	5/8/2016	Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA	An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and Skeletal Joint Imaging With SPECT in Subjects With Active Rheumatoid Arthritis (RA) and Healthy Controls	Arthritis, Rheumatoid	Drug: Tc99m-tilmanocept;Procedure: SPECT Imaging (60 Minutes post-injection);Procedure: SPECT Imaging (180 Minutes post-injection);Procedure: Whole body planar SPECT imaging (15 Minutes post-injection);Procedure: Whole body planar SPECT imaging (60 Minutes post-injection);Procedure: Whole body planar SPECT imaging (180 Minutes post-injection);Procedure: Whole body planar SPECT imaging (18-20 Hours post-injection);Procedure: Blood Collection for PK Testing (15 Mins Before Injection);Procedure: Blood Collection for PK Testing (after injection);Procedure: Blood Collection for PK Testing (15 minutes post injection);Procedure: Blood Collection for PK Testing (60 minutes post injection);Procedure: Blood Collection for PK Testing (180 minutes post injection);Procedure: Blood Collection for PK Testing (18-20 hours post injection);Procedure: Planar Image with both Hands in Field of View	Navidea Biopharmaceuticals	NULL	Completed	18 Years	N/A	All	39	Phase 1;Phase 2	United States
198	EUCTR2016-000933-37-ES (EUCTR)	28/12/2016	17/11/2016	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: 19.0;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 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 3	United States;Belarus;Spain;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Israel;Colombia;Switzerland;Hungary;Mexico;European Union;Puerto Rico;Canada;Argentina;Brazil;Australia;Latvia;Norway;New Zealand
199	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
200	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
No.	TrialID	Date_ enrollment	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	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
202	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
203	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
204	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
205	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
206	EUCTR2016-000933-37-LV (EUCTR)	06/12/2016	31/10/2016	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: 19.0;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 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 3	United States;Belarus;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Israel;Colombia;Switzerland;Hungary;Mexico;European Union;Puerto Rico;Canada;Argentina;Brazil;Australia;Norway;Latvia;New Zealand
207	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
208	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
209	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
210	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
No.	TrialID	Date_ enrollment	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	EUCTR2016-000933-37-HU (EUCTR)	24/11/2016	12/10/2016	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: 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 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Trade Name: ORENCIA 250mg powder for concentrate for solution for infusion Product Name: Abatacept INN or Proposed INN: ABATACEPT	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	313	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
212	EUCTR2014-005368-13-DE (EUCTR)	22/11/2016	04/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
213	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
214	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
215	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
No.	TrialID	Date_ enrollment	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	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
217	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
218	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
219	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
220	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
No.	TrialID	Date_ enrollment	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	EUCTR2016-002061-54-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
222	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
223	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
224	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
225	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
226	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
227	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
228	EUCTR2012-002535-28-NL (EUCTR)	13/09/2016	01/09/2016	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 19.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Product Code: L01X CO2 Trade Name: RoActemra Product Name: RoActemra Product Code: L04AC07	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	144	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
229	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
230	EUCTR2015-002729-21-PT (EUCTR)	12/09/2016	27/04/2016	A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis	The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria	Rheumatoid artritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	VU University Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Portugal;Hungary;Slovakia;Finland;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
231	EUCTR2015-003335-35-SI (EUCTR)	12/09/2016	28/09/2016	A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	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	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
232	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
233	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
234	NCT02897011 (ClinicalTrials.gov)	September 2016	7/9/2016	2-week dc of MTX and Influenza Vaccination in RA	Effect of Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial	Rheumatoid Arthritis;Influenza;Methotrexate	Drug: Methotrexate	Seoul National University Hospital	NULL	Recruiting	18 Years	65 Years	Both	318	N/A	Korea, Republic of
235	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
236	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
237	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
238	EUCTR2015-003335-35-HU (EUCTR)	18/08/2016	18/03/2016	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Norway;Germany;New Zealand;Sweden
239	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
240	EUCTR2015-003335-35-FI (EUCTR)	10/08/2016	22/04/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
241	NCT02886728 (ClinicalTrials.gov)	August 8, 2016	29/8/2016	Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy	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	Rheumatoid Arthritis	Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: MTX;Drug: Placebo to match MTX	Gilead Sciences	Galapagos NV	Completed	18 Years	N/A	All	1252	Phase 3	United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;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;Czech Republic
242	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
243	EUCTR2016-000064-42-HU (EUCTR)	05/08/2016	06/06/2016	Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis	Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A	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: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	64	Phase 2	Estonia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Romania;Bulgaria;South Africa
244	EUCTR2015-003376-75-BG (EUCTR)	02/08/2016	18/07/2016	A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX	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 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
245	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
No.	TrialID	Date_ enrollment	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	EUCTR2015-003376-75-GR (EUCTR)	28/07/2016	13/05/2016	A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX	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: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Japan;New Zealand;Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary
247	EUCTR2015-003376-75-CZ (EUCTR)	27/07/2016	03/06/2016	A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX	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 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
248	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
249	EUCTR2016-000064-42-SK (EUCTR)	27/07/2016	03/05/2016	Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis	Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A	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: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	64	Phase 2	Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria
250	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
251	EUCTR2015-003333-95-LT (EUCTR)	21/07/2016	09/05/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
252	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
253	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
254	EUCTR2015-003333-95-BG (EUCTR)	13/07/2016	25/03/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Portugal;Belarus;United States;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
255	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
No.	TrialID	Date_ enrollment	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	EUCTR2016-001618-18-FR (EUCTR)	08/07/2016	09/06/2016	Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients	STARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR	glucocorticoid withdrawal in rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Prednisone Product Name: prednisone 5 mg Trade Name: Prednisone Product Name: prednisone 4 mg Trade Name: Prednisone Product Name: prednisone 3 mg Trade Name: Prednisone Product Name: prednisone 2 mg Trade Name: Prednisone Product Name: prednisone 1 mg Trade Name: Hydrocortisone 10mg	CHU Toulouse	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	122	Phase 4	France
257	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
258	EUCTR2015-003376-75-HU (EUCTR)	06/07/2016	09/06/2016	A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX	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 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
259	EUCTR2015-003335-35-GB (EUCTR)	05/07/2016	17/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	499	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
260	EUCTR2015-003335-35-GR (EUCTR)	05/07/2016	26/04/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
261	NCT02683421 (ClinicalTrials.gov)	July 2016	22/1/2016	Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging	Evaluation of Subcutaneous (SC) Injected Tc 99m Tilmanocept Localization in Active Rheumatoid Arthritis (RA) Subjects by SPECT and SPECT/CT Imaging	Rheumatoid Arthritis	Drug: Tilmanocept	Navidea Biopharmaceuticals	NULL	Completed	21 Years	N/A	All	18	Phase 1	United States
262	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
263	EUCTR2015-003376-75-PL (EUCTR)	28/06/2016	08/06/2016	A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX	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 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Belgium;Poland;Australia;Bulgaria;Japan;New Zealand
264	EUCTR2015-003376-75-ES (EUCTR)	23/06/2016	19/01/2016	A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX	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: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Serbia;United States;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;European Union;Mexico;Puerto Rico;Argentina;Australia;Japan;New Zealand
265	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
No.	TrialID	Date_ enrollment	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	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
267	EUCTR2016-000064-42-CZ (EUCTR)	21/06/2016	08/06/2016	Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis	Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A	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: M2951 Product Code: M2951 INN or Proposed INN: N/A Other descriptive name: M2951	Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	64	Phase 2	Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria
268	EUCTR2015-003376-75-PT (EUCTR)	17/06/2016	09/06/2016	A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX	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 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	United States;Portugal;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
269	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
270	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
No.	TrialID	Date_ enrollment	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	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
272	EUCTR2015-003332-13-BG (EUCTR)	15/06/2016	25/03/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
273	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
274	EUCTR2015-003332-13-LT (EUCTR)	10/06/2016	29/04/2016	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: 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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
275	EUCTR2015-003376-75-AT (EUCTR)	10/06/2016	28/06/2016	A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
No.	TrialID	Date_ enrollment	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	EUCTR2015-005307-83-HU (EUCTR)	09/06/2016	28/04/2016	Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy	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: 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; 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	R-Pharm	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1575	Phase 3	United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of
277	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
278	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
279	EUCTR2015-001275-50-NL (EUCTR)	08/06/2016	10/12/2015	Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive	Early Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	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	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
280	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
No.	TrialID	Date_ enrollment	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	EUCTR2015-002887-17-BE (EUCTR)	07/06/2016	16/02/2016	Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	610	Phase 2	United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of
282	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
283	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
284	EUCTR2015-003376-75-BE (EUCTR)	07/06/2016	06/06/2016	A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX	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 INN or Proposed INN: ABT-494 Trade Name: Methotrexate 2.5 mg tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Product Name: ABT-494 INN or Proposed INN: ABT-494 Trade Name: MTX HEXAL 2,5 mg Tabletten Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Methotrexate 2.5mg Tablets Product Name: Methotrexate INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand
285	EUCTR2015-003332-13-GR (EUCTR)	06/06/2016	24/05/2016	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: 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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
No.	TrialID	Date_ enrollment	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	EUCTR2015-003335-35-LV (EUCTR)	03/06/2016	13/04/2016	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Norway;Germany;New Zealand;Sweden
287	EUCTR2015-003335-35-PT (EUCTR)	31/05/2016	30/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
288	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
289	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
290	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
No.	TrialID	Date_ enrollment	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	EUCTR2016-002035-15-FI (EUCTR)	20/05/2016	12/05/2016	Outcome after total knee endoprosthesis under general or regional anesthesia, a randomized study	Outcome after total knee arthroplasty under general or spinal anesthesia, a randomized study - Outcome after total knee arthroplasty under general or spinal anesthesia	Patients undego total knee arthroplasty operation in general or spinal anaesthesia because of osteoarthritis, rheumatoid arthritis or other degenerative condition of the knee MedDRA version: 19.0;Level: LLT;Classification code 10031174;Term: Osteoarthrosis;System Organ Class: 100000004859 MedDRA version: 19.0;Classification code 10031158;Term: Osteo arthritis knees;System Organ Class: 100000004859;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]	Trade Name: Bicain spinal INN or Proposed INN: bupivacaine hydrochloride Other descriptive name: BUPIVACAINE HYDROCHLORIDE Trade Name: Propolipid INN or Proposed INN: propofol Other descriptive name: PROPOFOL	Helsinki University Central Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Finland
292	EUCTR2015-003335-35-SK (EUCTR)	19/05/2016	22/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
293	EUCTR2015-003333-95-HU (EUCTR)	18/05/2016	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: 19.0;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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
294	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
295	EUCTR2015-003335-35-IE (EUCTR)	13/05/2016	10/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
296	EUCTR2015-003333-95-GR (EUCTR)	12/05/2016	10/05/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
297	EUCTR2015-003335-35-CZ (EUCTR)	11/05/2016	15/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
298	EUCTR2015-003333-95-CZ (EUCTR)	11/05/2016	22/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
299	EUCTR2015-003332-13-CZ (EUCTR)	11/05/2016	06/04/2016	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: 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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
300	EUCTR2015-003332-13-HR (EUCTR)	11/05/2016	06/07/2016	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: 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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
No.	TrialID	Date_ enrollment	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	EUCTR2015-003332-13-HU (EUCTR)	10/05/2016	05/05/2016	A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)	A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs	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 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
302	EUCTR2015-003335-35-SE (EUCTR)	10/05/2016	16/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
303	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
304	EUCTR2015-003332-13-ES (EUCTR)	09/05/2016	19/01/2016	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;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Kazakhstan;Norway;New Zealand
305	EUCTR2015-003333-95-PT (EUCTR)	06/05/2016	08/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Serbia;Belarus;United States;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
No.	TrialID	Date_ enrollment	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	EUCTR2015-003333-95-ES (EUCTR)	06/05/2016	19/01/2016	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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Kazakhstan;Germany;New Zealand
307	EUCTR2015-002729-21-HU (EUCTR)	04/05/2016	11/02/2016	A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis	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: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: prednisolone Labesfal Product Name: prednisolone INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE	VU University Medical Center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Hungary;Slovakia;Germany
308	EUCTR2015-003335-35-BE (EUCTR)	04/05/2016	10/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
309	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
310	EUCTR2015-003335-35-DE (EUCTR)	03/05/2016	09/03/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;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
311	EUCTR2015-003335-35-ES (EUCTR)	29/04/2016	11/03/2016	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: 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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	United States;Hong Kong;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Korea, Republic of;Turkey;Austria;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Norway;Germany;New Zealand;Sweden
312	NCT02603146 (ClinicalTrials.gov)	April 27, 2016	10/11/2015	Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis	Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis	Healthy Participants;Rheumatoid Arthritis (RA) Prevention	Drug: Hydroxychloroquine;Drug: HCQ Placebo	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence	Recruiting	18 Years	N/A	All	200	Phase 2	United States
313	EUCTR2015-003333-95-DE (EUCTR)	25/04/2016	14/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Portugal;Belarus;United States;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
314	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
315	EUCTR2015-003332-13-IE (EUCTR)	22/04/2016	08/04/2016	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: 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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
No.	TrialID	Date_ enrollment	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	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
317	EUCTR2015-003332-13-PT (EUCTR)	22/04/2016	08/04/2016	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: 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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Hong Kong;United States;Belarus;Portugal;Serbia
318	EUCTR2015-003333-95-IE (EUCTR)	22/04/2016	08/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
319	EUCTR2015-003333-95-LV (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: 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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Kazakhstan;Germany;New Zealand
320	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
No.	TrialID	Date_ enrollment	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	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
322	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
323	EUCTR2015-003332-13-LV (EUCTR)	20/04/2016	12/04/2016	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: 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 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
324	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
325	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
326	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
327	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
328	EUCTR2015-003333-95-GB (EUCTR)	14/04/2016	11/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
329	EUCTR2015-003332-13-GB (EUCTR)	14/04/2016	11/04/2016	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: 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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
330	EUCTR2015-003332-13-BE (EUCTR)	13/04/2016	07/04/2016	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: 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	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand
No.	TrialID	Date_ enrollment	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	EUCTR2015-003333-95-BE (EUCTR)	13/04/2016	07/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
332	EUCTR2015-003333-95-HR (EUCTR)	05/04/2016	28/04/2016	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Portugal;Belarus;United States;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
333	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
334	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
335	EUCTR2015-002523-26-HU (EUCTR)	08/03/2016	13/11/2015	Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects(investigator-initiated grant proposal)	Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects(investigator-initiated grant proposal)	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tofacitinib Product Code: CP -690,55-10	Arthritis Alapítvány	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Hungary
No.	TrialID	Date_ enrollment	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	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
337	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
338	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
339	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
340	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
No.	TrialID	Date_ enrollment	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	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
342	EUCTR2015-001275-50-RO (EUCTR)	10/02/2016	22/02/2016	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]	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	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3B	United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
343	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
344	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
345	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
No.	TrialID	Date_ enrollment	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	EUCTR2015-002809-12-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
347	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
348	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
349	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
350	EUCTR2015-003332-13-SK (EUCTR)	12/01/2016	04/11/2015	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: 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: ABT-494 INN or Proposed INN: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	600	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;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
No.	TrialID	Date_ enrollment	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	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
352	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
353	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
354	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
355	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
No.	TrialID	Date_ enrollment	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	EUCTR2015-004173-32-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
357	EUCTR2015-003333-95-SK (EUCTR)	18/12/2015	04/11/2015	A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)	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 Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500	Phase 3	Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand
358	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
359	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
360	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
No.	TrialID	Date_ enrollment	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	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
362	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)	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
363	EUCTR2015-001275-50-SE (EUCTR)	09/12/2015	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: 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;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
364	EUCTR2015-001275-50-FI (EUCTR)	08/12/2015	08/12/2015	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;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden
365	NCT02680067 (ClinicalTrials.gov)	December 8, 2015	7/12/2015	NIR Fluorescence Imaging of Lymphatic Transport Using ICG	Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green	Rheumatoid Arthritis	Drug: Indocyanine Green;Device: MultiSpectral Imaging System	University of Rochester	National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Recruiting	18 Years	89 Years	All	30	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
366	EUCTR2015-001275-50-GB (EUCTR)	04/12/2015	26/11/2015	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;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
367	EUCTR2015-001275-50-DE (EUCTR)	01/12/2015	24/11/2015	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;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
368	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	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
369	EUCTR2015-001275-50-FR (EUCTR)	30/11/2015	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: 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: 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	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
370	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	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;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
371	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	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: 19.1;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: 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
372	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	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: 18.1;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: 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;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
373	EUCTR2013-002777-22-IT (EUCTR)	19/11/2015	04/12/2013	Targeted Ultrasound in Rheumatoid Arthritis (TURA)	Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: Humira INN or Proposed INN: ADALIMUMAB	University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 4	France;Hungary;Spain;Denmark;Germany;Japan;United Kingdom;Italy
374	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	80	Phase 4	United States;Canada;Mexico;Algeria
375	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	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	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
376	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
377	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.	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: 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: 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	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
378	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	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: 19.1;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: 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
379	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	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]		Sun Pharma Global FZE	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 3	Belgium;Netherlands
380	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
381	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	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: 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: 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
382	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	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;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
383	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
384	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	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;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Latvia;Germany
385	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	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;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
386	EUCTR2015-001275-50-CZ (EUCTR)	21/10/2015	29/09/2015	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
387	EUCTR2015-001246-28-BE (EUCTR)	19/10/2015	23/07/2015	Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study)	Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study) - TOVERA	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]	Trade Name: RoActemra Product Name: RoActemra	Cliniques Universitaires Saint-Luc, Université catholique de Louvain	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Belgium
388	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
389	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	40	Phase 4	Czech Republic
390	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	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: 19.1;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: GP2015 INN or Proposed INN: ETANERCEPT Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe Product Name: Enbrel 50 mg solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	366	Phase 3	Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
391	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.	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: 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	210	Phase 2	Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
392	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
393	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.	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	Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
394	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
395	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.	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: 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: 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
No.	TrialID	Date_ enrollment	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	NCT02748785 (ClinicalTrials.gov)	September 2015	8/9/2015	MTX Discontinuation and Vaccine Response	Effect of Methotrexate Discontinuation on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial	Arthritis, Rheumatoid	Drug: Methotrexate;Biological: Seasonal Influenza vaccine	Seoul National University Hospital	NULL	Completed	18 Years	N/A	Both	277	Phase 4	Korea, Republic of
397	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
398	NCT02504268 (ClinicalTrials.gov)	August 31, 2015	20/7/2015	Effects of Abatacept in Patients With Early Rheumatoid Arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive	Rheumatoid Arthritis	Drug: Abatacept;Drug: Methotrexate;Other: Abatacept Placebo;Other: Methotrexate Placebo	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	All	1067	Phase 3	United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Monaco;Netherlands;Peru;Poland;Qatar;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom;Czech Republic;Puerto Rico;Saudi Arabia;United Arab Emirates
399	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	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: 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
400	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	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: 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	United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
401	JPRN-JapicCTI-153081	01/8/2015	26/11/2015	Effects of Abatacept in Patients With Early Rheumatoid Arthritis	A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive	Rheumatoid Arthritis	Intervention name : Abatacept + Methotrexate Dosage And administration of the intervention : Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week Control intervention name : Methotrexate Dosage And administration of the control intervention : Methotrexate at least 15mg per week tablet or capsule orally Control intervention name : Abatacept Placebo Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week Control intervention name : Methotrexate Placebo Dosage And administration of the control intervention : Placebo to match Methotrexate capsule orally once per week	Bristol-Myers Squibb K.K.	NULL	complete	18		BOTH	1000	Phase 3	NULL
402	NCT02451748 (ClinicalTrials.gov)	August 2015	6/5/2015	IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA	IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA	Rheumatoid Arthritis	Other: Lab Work;Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg);Drug: Certolizumab pegol (CDP870, tradename Cimzia);Drug: Hydroxychloroquine;Drug: Sulfasalazine;Drug: Medrol;Drug: Prednisone;Drug: Triamcinolone;Drug: Naproxen;Drug: Leflunomide;Drug: Methotrexate;Drug: humira	University of Illinois at Chicago	UCB Pharma	Completed	18 Years	N/A	All	32	Phase 4	United States
403	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
404	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	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: 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
405	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
No.	TrialID	Date_ enrollment	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	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	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
407	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.	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: 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	210	Phase 2	Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany
408	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
409	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	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: 19.0;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
410	EUCTR2015-000833-64-FR (EUCTR)	17/07/2015	02/07/2015	N/A	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
No.	TrialID	Date_ enrollment	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	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	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: 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
412	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
413	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.	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: 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]	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
414	NCT02467504 (ClinicalTrials.gov)	July 1, 2015	4/6/2015	Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis	A Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Methotrexate (MTX)-Naive Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: hrIL-2 active;Drug: hrIL-2 placebo;Drug: MTX;Drug: Folic Acid;Drug: Loxoprofen	Peking University People's Hospital	Monash University;Beijing ShuangLu Pharmaceutical Co., Ltd.	Completed	18 Years	70 Years	All	47	Phase 2	China
415	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	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: 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	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
416	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	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 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
417	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	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: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: Not available Other descriptive name: ALX-0061	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 2	Serbia;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

EUCTR2020-003955-14-DE
(EUCTR)

21/12/2020

04/11/2020

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

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

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

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

Applied Molecular Transport Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

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

EUCTR2019-000878-30-BE
(EUCTR)

18/11/2020

21/09/2020

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

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

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

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

JPRN-jRCTs071200054

18/11/2020

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

Rheumatoid arthritis

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

Kawakami Atsushi

NULL

Recruiting

>= 20age old

Not applicable

Both

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-000658-83-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

EUCTR2019-002205-22-FR
(EUCTR)

01/10/2020

13/01/2020

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

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

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

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

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

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

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

EUCTR2019-000878-30-BG
(EUCTR)

04/09/2020

11/08/2020

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

EUCTR2019-004369-42-CZ
(EUCTR)

01/09/2020

05/08/2020

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

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

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

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

Fresenius Kabi SwissBioSim GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

542

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002676-14-BG
(EUCTR)

20/08/2020

27/05/2020

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

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

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

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

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

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

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

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

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

EUCTR2019-002205-22-DE
(EUCTR)

12/08/2020

07/07/2020

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

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002676-14-CZ
(EUCTR)

07/07/2020

11/05/2020

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

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

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

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

EUCTR2019-002676-14-HU
(EUCTR)

18/06/2020

14/04/2020

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

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

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

EUCTR2019-002810-37-PL
(EUCTR)

16/06/2020

11/03/2020

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

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

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

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

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

EUCTR2019-002810-37-BG
(EUCTR)

15/06/2020

28/04/2020

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

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

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

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

NCT04584541
(ClinicalTrials.gov)

June 11, 2020

10/6/2020

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

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

Spondyloarthritis;Rheumatoid Arthritis;Covid19

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

Assistance Publique - Hôpitaux de Paris

NULL

Recruiting

18 Years

N/A

All

150

N/A

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002676-14-SE
(EUCTR)

01/06/2020

14/04/2020

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

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 2

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

NCT04275206
(ClinicalTrials.gov)

June 1, 2020

14/2/2020

The Anti-inflammatory Effects of Harkány Medicinal Water

Rheumatoid Arthritis;Psoriasis

Other: Harkány medicinal water;Other: Tap water (placebo control)

University of Pecs

National Research, Development and Innovation Office, Hungary;Harkány Spa Hospital, Hungary

Recruiting

18 Years

N/A

All

350

N/A

Hungary

EUCTR2018-003418-41-GB
(EUCTR)

18/05/2020

22/11/2019

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

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

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

Navidea Biopharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;European Union;United Kingdom

EUCTR2019-004369-42-SK
(EUCTR)

12/05/2020

09/03/2020

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

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

Fresenius Kabi SwissBioSim GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

542

Phase 3

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

EUCTR2019-004078-24-ES
(EUCTR)

07/05/2020

21/02/2020

Effect of Sarilumab on atherosclerotic disease in Rheumatoid Arthritis

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

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

Trade Name: KEVZARA
INN or Proposed INN: SARILUMAB

IDIVAL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-004369-42-PL
(EUCTR)

05/05/2020

23/03/2020

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

Fresenius Kabi SwissBioSim GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

542

Phase 3

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

EUCTR2019-002205-22-GB
(EUCTR)

01/05/2020

07/01/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

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

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

EUCTR2019-004369-42-HU
(EUCTR)

27/04/2020

03/03/2020

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

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

Fresenius Kabi SwissBioSim GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

542

Phase 3

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

EUCTR2019-002810-37-LT
(EUCTR)

17/04/2020

03/03/2020

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

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000867-26-DE
(EUCTR)

08/04/2020

04/07/2019

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

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

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Phase 3

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

EUCTR2019-002205-22-ES
(EUCTR)

06/04/2020

23/01/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

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

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

EUCTR2019-002205-22-PL
(EUCTR)

29/03/2020

07/02/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

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

EUCTR2019-000878-30-HU
(EUCTR)

26/03/2020

28/02/2020

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

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003700-12-FR
(EUCTR)

13/03/2020

04/06/2020

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

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

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

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

CHU Saint-Etienne

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France

EUCTR2019-000868-18-DE
(EUCTR)

13/03/2020

08/07/2019

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

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

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

EUCTR2019-002810-37-HU
(EUCTR)

09/03/2020

20/01/2020

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

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

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

EUCTR2019-000878-30-CZ
(EUCTR)

26/02/2020

06/01/2020

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

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

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

EUCTR2019-000878-30-LT
(EUCTR)

13/02/2020

25/11/2019

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-004468-23-GB
(EUCTR)

10/02/2020

26/02/2020

Biologics for RA Pain ( BIORA-PAIN)

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

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

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

St George's, University of London

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

United Kingdom

EUCTR2018-004558-30-PT
(EUCTR)

03/02/2020

21/05/2019

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

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

Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

186

Phase 4

Portugal;Spain

EUCTR2019-000284-24-CZ
(EUCTR)

03/02/2020

17/10/2019

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

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

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

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 4

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

EUCTR2018-004429-94-NL
(EUCTR)

21/01/2020

17/06/2019

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

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

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

Product Name: [18F]PEG-Folate

VU Medical Center, department of Rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

JPRN-UMIN000042632

2020/01/01

03/12/2020

THE EFFECT OF LASER THERAPY ON EARLY ONSET RHEUMATOID ARTHRITIS PATIENTS

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

Rheumatoid arthritis

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

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

NULL

Complete: follow-up complete

20years-old

80years-old

Male and Female

Not applicable

Asia(except Japan)

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000284-24-LT
(EUCTR)

18/12/2019

07/11/2019

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

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

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Phase 3

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

EUCTR2018-003351-37-LT
(EUCTR)

13/12/2019

29/08/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

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

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

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

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

EUCTR2019-000867-26-GB
(EUCTR)

10/12/2019

12/06/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Phase 3

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

EUCTR2019-000868-18-GB
(EUCTR)

02/12/2019

11/06/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

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

EUCTR2019-001754-25-NL
(EUCTR)

25/11/2019

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

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

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

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

Reade

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000797-39-GB
(EUCTR)

22/11/2019

10/06/2019

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

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

EUCTR2019-000797-39-PL
(EUCTR)

18/11/2019

15/07/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

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

EUCTR2019-000868-18-PL
(EUCTR)

15/11/2019

11/07/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

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

EUCTR2019-000867-26-PL
(EUCTR)

15/11/2019

15/07/2019

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Phase 3

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

EUCTR2019-000867-26-ES
(EUCTR)

14/11/2019

09/07/2019

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000797-39-ES
(EUCTR)

14/11/2019

09/07/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

1700

Phase 3

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

EUCTR2019-000868-18-ES
(EUCTR)

14/11/2019

26/07/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

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

EUCTR2019-000868-18-HU
(EUCTR)

24/10/2019

28/10/2019

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

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

EUCTR2019-000867-26-HU
(EUCTR)

24/10/2019

28/10/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Phase 3

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

EUCTR2019-000797-39-HU
(EUCTR)

24/10/2019

28/10/2019

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

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

No.

TrialID

Date_
enrollment

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-BG
(EUCTR)

11/10/2019

30/07/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Phase 3

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

EUCTR2019-000797-39-LT
(EUCTR)

11/10/2019

19/07/2019

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

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

EUCTR2019-000867-26-EE
(EUCTR)

10/10/2019

01/08/2019

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Phase 3

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

JPRN-JapicCTI-194932

01/10/2019

28/08/2019

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

Rheumatoid Arthritis

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

Taisho Pharmaceutical Co.Ltd

NULL

complete

BOTH

505

Phase 3

Japan

EUCTR2019-000868-18-CZ
(EUCTR)

20/09/2019

20/08/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-000797-39-CZ
(EUCTR)

19/09/2019

18/09/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

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

EUCTR2018-004677-27-BE
(EUCTR)

16/09/2019

25/03/2019

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

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

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

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

Abivax

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Belgium

EUCTR2019-000797-39-LV
(EUCTR)

13/09/2019

25/06/2019

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1700

Phase 3

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

EUCTR2018-003351-37-GR
(EUCTR)

13/09/2019

29/07/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

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

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

EUCTR2018-003351-37-DK
(EUCTR)

29/08/2019

07/08/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

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

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

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

No.

TrialID

Date_
enrollment

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-NL
(EUCTR)

29/08/2019

08/07/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

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

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

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

EUCTR2018-003351-37-GB
(EUCTR)

08/08/2019

16/05/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

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

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

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

EUCTR2018-003351-37-DE
(EUCTR)

02/08/2019

24/07/2019

A Phase 3b/4 Study in Rheumatoid Arthritis

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

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2600

Phase 3;Phase 4

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

EUCTR2018-003330-32-PL
(EUCTR)

19/07/2019

06/05/2019

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

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

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

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

Oscotec Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

148

Phase 2

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003933-14-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

EUCTR2016-003682-26-PL
(EUCTR)

11/07/2019

17/05/2018

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

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

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

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

Can-Fite BioPharma, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

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

EUCTR2019-000660-25-PL
(EUCTR)

09/07/2019

20/05/2019

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

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

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

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

CELLTRION, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Poland

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

EUCTR2018-003877-91-DE
(EUCTR)

13/06/2019

26/02/2019

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

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

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

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

Universitätsklinikum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

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

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

EUCTR2018-002306-31-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

No.

TrialID

Date_
enrollment

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

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

NCT03938636
(ClinicalTrials.gov)

April 8, 2019

24/4/2019

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

Rheumatoid Arthritis

Drug: TC99m-tilmanocept

Navidea Biopharmaceuticals

NULL

Recruiting

18 Years

N/A

All

105

Phase 2

United States

NCT03816345
(ClinicalTrials.gov)

April 4, 2019

24/1/2019

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

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

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

Biological: Nivolumab

National Cancer Institute (NCI)

NULL

Recruiting

18 Years

N/A

All

264

Phase 1

United States

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

No.

TrialID

Date_
enrollment

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

EUCTR2018-002202-31-BG
(EUCTR)

27/03/2019

30/11/2018

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

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

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

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

Bio-Thera Solutions, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

612

Phase 3

Poland;Ukraine;Georgia;Bulgaria;China

ChiCTR1900021686

2019-03-15

2019-03-05

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

Rheumatoid arthritis

Case Series:IGU combined with MTX ;

Nanjing Drum Tower Hospital

NULL

Pending

Both

Case Series:30;

Phase 4

China

EUCTR2018-002306-31-HU
(EUCTR)

08/03/2019

11/02/2019

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

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

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

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

No.

TrialID

Date_
enrollment

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-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

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

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

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

100

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

No.

TrialID

Date_
enrollment

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

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

102

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

103

JPRN-JapicCTI-184031

02/10/2018

09/07/2018

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

Rheumatoid Arthritis (RA)

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

Taisho Pharmaceutical co., LTD

NULL

complete

BOTH

135

Phase 3

Japan

104

NCT03699293
(ClinicalTrials.gov)

September 22, 2018

21/9/2018

NSAIDs vs. Coxibs in the Presence of Aspirin

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

Rheumatoid Arthritis;Cardiovascular Diseases

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

Inova Health Care Services

NULL

Unknown status

18 Years

75 Years

All

Phase 4

United States

105

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

No.

TrialID

Date_
enrollment

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

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

107

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

108

EUCTR2017-004079-30-PT
(EUCTR)

09/08/2018

29/06/2018

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

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

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

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

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

207

Phase 3

Portugal;Belgium;Spain;Italy

109

EUCTR2018-002368-18-ES
(EUCTR)

25/07/2018

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

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

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

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

740

Phase 4

Spain

110

EUCTR2017-004079-30-ES
(EUCTR)

10/07/2018

21/03/2018

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

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

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

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

207

Phase 3

Portugal;Belgium;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

111

EUCTR2016-002344-16-GB
(EUCTR)

28/06/2018

29/11/2017

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

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

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

University of Leeds

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

106

Phase 4

United Kingdom

112

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

113

NCT03559686
(ClinicalTrials.gov)

May 30, 2018

5/6/2018

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

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

Rheumatoid Arthritis

Drug: Certolizumab Pegol

UCB Biopharma S.P.R.L.

NULL

Available

18 Years

N/A

All

NULL

114

EUCTR2017-001944-36-ES
(EUCTR)

21/05/2018

10/10/2017

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

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

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

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

137

Phase 1;Phase 2

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

115

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

No.

TrialID

Date_
enrollment

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

EUCTR2016-000933-37-BG
(EUCTR)

09/05/2018

12/01/2018

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

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

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

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

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

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

117

EUCTR2016-002569-68-GB
(EUCTR)

04/05/2018

18/05/2018

Safety of abatacept in Rheumatoid Arthritis associated Interstitial Lung Disease

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

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

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

Cambridge University Hospitals NHS Foundation Trust

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United Kingdom

118

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

Phase 4

Japan

119

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

120

NCT03480529
(ClinicalTrials.gov)

March 1, 2018

21/3/2018

Monitoring the IMmUological TOXicity of Drugs

Arthritis;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Capillary Leak Syndrome;Hepatitis

Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom

Groupe Hospitalier Pitie-Salpetriere

Institut National de la Santé Et de la Recherche Médicale, France

Completed

18 Years

N/A

All

662

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

121

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

122

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

123

EUCTR2017-002878-38-NL
(EUCTR)

07/02/2018

12/09/2017

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

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

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

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

Leiden University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

124

EUCTR2017-003259-40-ES
(EUCTR)

04/01/2018

24/10/2017

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

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

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

Dra Beatriz Lozano-Hospital Universitario de Canarias

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 4

Spain

125

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

No.

TrialID

Date_
enrollment

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

NCT03186417
(ClinicalTrials.gov)

December 15, 2017

12/6/2017

Mesenchymal Stem Cells in Early Rheumatoid Arthritis

Cell-Based Therapy in Rheumatoid Arthritis: Proof of Concept Phase 1 Trial

Rheumatoid Arthritis

Biological: 2 million hMSC/kg;Biological: 4 million hMSC/kg;Biological: 6 million hMSC/kg;Biological: placebo

MetroHealth Medical Center

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

Recruiting

18 Years

80 Years

All

Phase 1

United States

127

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

128

EUCTR2017-001944-36-PL
(EUCTR)

23/11/2017

11/10/2017

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

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

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

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

153

Phase 1;Phase 2

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

129

EUCTR2017-000838-64-NL
(EUCTR)

10/11/2017

13/06/2017

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

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

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

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

130

EUCTR2017-000384-32-BG
(EUCTR)

02/11/2017

12/07/2017

Phase IIb in Rheumatoid Arthritis

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

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

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

363

Phase 2

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

131

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

132

EUCTR2016-002126-36-IT
(EUCTR)

26/10/2017

31/01/2018

A study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO7123520 AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-a INHIBITORS

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

Product Name: RO7123520
Product Code: RO7123520 /F03-01

F. Hoffmann - Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

204

Phase 2

United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy

133

EUCTR2016-004834-11-GB
(EUCTR)

23/10/2017

16/08/2017

A randomized, double blind, placebo-controlled, dose response, phase II, multicentretrial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination withmethotrexate, in DMARD-naïve patients with early rheumatoid arthritis

Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: CR6086
Other descriptive name: CR0686
Product Name: CR6086
Product Code: CR6086Z
INN or Proposed INN: CR6086
Other descriptive name: CR6086
Trade Name: Methotrexate ® 2.5mg Tablets
Product Name: Methotrexate ® 2.5mg Tablets
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE 2.5 mg tablets

Rottapharm Biotech S.r.l.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom

134

NCT03163966
(ClinicalTrials.gov)

October 5, 2017

8/5/2017

A Study of the EP4 Antagonist CR6086 in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis

A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Oral CR6086 Administered at the Doses of 30, 90 or 180 mg Bid for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis, DMARD-naive and Early Disease Patients

Drug: CR6086;Drug: Methotrexate;Drug: Placebo

Rottapharm Biotech

NULL

Recruiting

18 Years

N/A

All

240

Phase 2

Czechia

135

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

No.

TrialID

Date_
enrollment

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

EUCTR2016-004300-65-BE
(EUCTR)

26/09/2017

20/01/2017

Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®).

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

Product Name: 99mTc-S-HYNIC Certolizumab pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL

Ghent University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 4

Belgium

137

EUCTR2017-000838-64-SE
(EUCTR)

11/09/2017

19/05/2017

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

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

Product Name: AZD9567
Product Code: AZD9567 monohydrate
INN or Proposed INN: N/A
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: -

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

138

EUCTR2016-004834-11-PL
(EUCTR)

05/09/2017

17/07/2017

A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis

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

Rottapharm Biotech S.r.l.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of

139

EUCTR2016-004834-11-BG
(EUCTR)

04/09/2017

01/06/2017

A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis

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

Rottapharm Biotech S.r.l.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;United Kingdom;Moldova, Republic of

140

NCT03241446
(ClinicalTrials.gov)

September 2017

25/7/2017

Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)

A Phase I, Open-Label Study to Investigate the Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis

Arthritis, Rheumatoid

Drug: Tilmanocept

Navidea Biopharmaceuticals

NULL

Withdrawn

30 Years

65 Years

All

Phase 1

NULL

No.

TrialID

Date_
enrollment

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

EUCTR2017-000838-64-DK
(EUCTR)

25/08/2017

13/06/2017

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

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

Product Code: AZD9567 monohydrate
INN or Proposed INN: N/A
Trade Name: PredniHEXAL
INN or Proposed INN: Prednisolone
Other descriptive name: -

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Denmark;Netherlands;Sweden

142

EUCTR2017-000947-41-FR
(EUCTR)

18/08/2017

21/06/2017

ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS.

ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTAR

Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor.
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie
Trade Name: RoActemra 162 mg solution injectable en seringue préremplie

Groupement des Hôpitaux de l’Institut Catholique de Lille

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

France

143

EUCTR2016-004834-11-CZ
(EUCTR)

16/08/2017

02/08/2017

A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis

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

Rottapharm Biotech S.r.l.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom

144

EUCTR2016-003630-25-DE
(EUCTR)

14/08/2017

13/04/2017

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

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

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

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

145

EUCTR2013-005543-90-EE
(EUCTR)

07/08/2017

02/06/2017

This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable

Product Name: ABP 798
Product Code: ABP 798
INN or Proposed INN: rituximab
Other descriptive name: ABP 798 Biosimilar to Rituximab
Trade Name: Rituxan
INN or Proposed INN: RITUXIMAB
Other descriptive name: Rituxan
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB
Other descriptive name: MabThera

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

No.

TrialID

Date_
enrollment

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

EUCTR2016-003630-25-BE
(EUCTR)

01/08/2017

12/04/2017

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

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

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

147

EUCTR2016-002126-36-ES
(EUCTR)

31/07/2017

02/06/2017

A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors

A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors

Product Name: RO7123520
Product Code: RO7123520 /F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

204

Phase 2

United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy

148

EUCTR2016-003630-25-GB
(EUCTR)

19/07/2017

15/08/2017

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

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

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

149

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

150

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

No.

TrialID

Date_
enrollment

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

EUCTR2016-004834-11-DK
(EUCTR)

06/07/2017

11/05/2017

A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy, safety and pharmacokinetics of oral CR6086 administered at the doses of 30, 90 or 180 mg bid for 12 weeks in combination with methotrexate, in DMARD-naïve patients with early rheumatoid arthritis

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

Rottapharm Biotech S.r.l.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Argentina;Poland;Romania;Denmark;Bulgaria;Moldova, Republic of;United Kingdom

152

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

153

EUCTR2016-001825-15-IT
(EUCTR)

28/06/2017

16/02/2018

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION - A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREAT

Product Name: Tofacitinb
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE

PFIZER INC

NULL

Not Recruiting

Female: yes
Male: yes

580

Phase 3

Hungary;Czech Republic;Slovakia;Spain;Poland;Bulgaria;Germany;Italy

154

EUCTR2016-000933-37-NL
(EUCTR)

19/06/2017

18/04/2017

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

313

Phase 3

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

155

EUCTR2016-003630-25-SK
(EUCTR)

15/06/2017

04/04/2017

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

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3068

Phase 3

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

No.

TrialID

Date_
enrollment

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

EUCTR2016-003630-25-ES
(EUCTR)

09/06/2017

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

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

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

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

157

EUCTR2016-003630-25-PL
(EUCTR)

07/06/2017

24/04/2017

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

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

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

158

EUCTR2016-003630-25-HU
(EUCTR)

29/05/2017

12/04/2017

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

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2640

Phase 3

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

159

EUCTR2015-005309-35-DE
(EUCTR)

23/05/2017

24/01/2017

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis

A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4

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

Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038

R-Pharm International LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1880

Phase 3

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

160

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

No.

TrialID

Date_
enrollment

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

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

162

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

163

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

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

164

EUCTR2016-000933-37-CZ
(EUCTR)

02/05/2017

22/11/2016

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)

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

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

313

Phase 3

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

165

EUCTR2016-000569-21-DE
(EUCTR)

02/05/2017

04/11/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

EUCTR2016-000933-37-DE
(EUCTR)

27/04/2017

17/10/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

167

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

168

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

169

EUCTR2016-002126-36-DE
(EUCTR)

18/04/2017

23/11/2016

A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors

Product Name: RO7123520
Product Code: RO7123520 /F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

204

Phase 2

United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Colombia;Germany;Italy;United Kingdom

170

EUCTR2016-002337-30-BG
(EUCTR)

11/04/2017

30/01/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

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

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

No.

TrialID

Date_
enrollment

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

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

172

EUCTR2016-001825-15-GB
(EUCTR)

03/04/2017

01/03/2017

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

Product Name: tofacitinib
Product Code: CP 690,550
INN or Proposed INN: tofacitinib
Other descriptive name: TOFACITINIB CITRATE
Trade Name: Methotrexate 2.5mg Tablets BP
Product Name: methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE

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

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3;Phase 4

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

173

EUCTR2016-001825-15-PL
(EUCTR)

29/03/2017

08/03/2017

A PHASE 3B/4 STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG

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

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3;Phase 4

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

174

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

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

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

175

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

No.

TrialID

Date_
enrollment

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

EUCTR2016-000570-37-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

177

EUCTR2015-005309-35-HU
(EUCTR)

16/03/2017

02/02/2017

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis

Moderately to Severely Active Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Olokizumab
Product Code: (CDP6038; L04041)
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038

R-Pharm

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1880

Phase 3

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

178

EUCTR2016-002337-30-HU
(EUCTR)

16/03/2017

06/02/2017

A study to evaluate the safety and efficacy of PF-06650833 in subjects with moderate to severely active rheumatoid arthritis who have an incomplete response to methotrexate treatment

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

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 2

179

EUCTR2016-000933-37-BE
(EUCTR)

14/03/2017

24/11/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

180

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

Product Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

276

Phase 2

United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

181

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

182

EUCTR2016-002126-36-AT
(EUCTR)

01/03/2017

11/11/2016

A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors

A randomized, double-blind, placebo-controlled, multi-center, three-part phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors

Product Name: RO7123520
Product Code: RO7123520 /F03-01
INN or Proposed INN: Not available
Other descriptive name: RO7123520

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

204

Phase 2

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

183

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.

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

184

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

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

185

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

186

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

187

EUCTR2016-000569-21-BE
(EUCTR)

30/01/2017

28/10/2016

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

423

Phase 3

Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of;United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary

188

EUCTR2016-000933-37-PT
(EUCTR)

30/01/2017

09/11/2016

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

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

550

Phase 3

189

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

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

190

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

No.

TrialID

Date_
enrollment

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

EUCTR2016-000570-37-ES
(EUCTR)

13/01/2017

Filgotinib Alone or in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have Not Yet Started Methotrexate Treatment

Moderately to severely active rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

192

EUCTR2016-000569-21-ES
(EUCTR)

13/01/2017

Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.

Moderately to severely active rheumatoid arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

423

Phase 3

United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Belgium;Australia;Germany;Japan;Korea, Republic of

193

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

194

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

195

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

No.

TrialID

Date_
enrollment

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

EUCTR2016-000570-37-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

197

NCT02865434
(ClinicalTrials.gov)

January 2017

5/8/2016

Evaluating Safety of Escalating Doses of Tilmanocept by IV Injection and SPECT Imaging in Subjects With and Without RA

An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and Skeletal Joint Imaging With SPECT in Subjects With Active Rheumatoid Arthritis (RA) and Healthy Controls

Arthritis, Rheumatoid

Drug: Tc99m-tilmanocept;Procedure: SPECT Imaging (60 Minutes post-injection);Procedure: SPECT Imaging (180 Minutes post-injection);Procedure: Whole body planar SPECT imaging (15 Minutes post-injection);Procedure: Whole body planar SPECT imaging (60 Minutes post-injection);Procedure: Whole body planar SPECT imaging (180 Minutes post-injection);Procedure: Whole body planar SPECT imaging (18-20 Hours post-injection);Procedure: Blood Collection for PK Testing (15 Mins Before Injection);Procedure: Blood Collection for PK Testing (after injection);Procedure: Blood Collection for PK Testing (15 minutes post injection);Procedure: Blood Collection for PK Testing (60 minutes post injection);Procedure: Blood Collection for PK Testing (180 minutes post injection);Procedure: Blood Collection for PK Testing (18-20 hours post injection);Procedure: Planar Image with both Hands in Field of View

Navidea Biopharmaceuticals

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

198

EUCTR2016-000933-37-ES
(EUCTR)

28/12/2016

17/11/2016

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 3

United States;Belarus;Spain;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Israel;Colombia;Switzerland;Hungary;Mexico;European Union;Puerto Rico;Canada;Argentina;Brazil;Australia;Latvia;Norway;New Zealand

199

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

200

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

No.

TrialID

Date_
enrollment

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

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

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

202

EUCTR2016-001496-75-PL
(EUCTR)

13/12/2016

03/11/2016

A Clinical Trial to look at the Safety, Tolerability and Efficacy of the Drug Product GS-9876 on patients with Rheumatoid Arthritis who are also being treated with Methotrexate.

Product Name: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
INN or Proposed INN: GS-9876
Product Name: filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Poland;Ukraine;Bulgaria

203

EUCTR2015-003289-97-SK
(EUCTR)

12/12/2016

11/08/2016

A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis

Protocol I8K-MC-JPDAA Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study

Product Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

276

Phase 2

United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of

204

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

205

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

206

EUCTR2016-000933-37-LV
(EUCTR)

06/12/2016

31/10/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 3

United States;Belarus;Korea, Democratic People's Republic of;Turkey;Russian Federation;Chile;Israel;Colombia;Switzerland;Hungary;Mexico;European Union;Puerto Rico;Canada;Argentina;Brazil;Australia;Norway;Latvia;New Zealand

207

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

208

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

209

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

210

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

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Hungary;Czech Republic;Canada;Spain;Poland;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

211

EUCTR2016-000933-37-HU
(EUCTR)

24/11/2016

12/10/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

313

Phase 3

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

212

EUCTR2014-005368-13-DE
(EUCTR)

22/11/2016

04/07/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Product Name: SAIT101 (proposed rituximab biosimilar)
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB

Archigen Biotech Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

213

EUCTR2016-002852-26-HU
(EUCTR)

15/11/2016

29/09/2016

MSB11022 in moderately to severely active rheumatoid arthritis

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

214

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

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

215

EUCTR2015-005800-27-PL
(EUCTR)

08/11/2016

03/10/2016

Study of a new drug’s effect in people with severe rheumatoid arthritis who have not responded sufficiently well to treatment with DMARDs

A randomised, multi-center, double blind (sponsor open), placebo-controlled study to assess the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK3117391 in subjects with moderate to severe, active rheumatoid arthritis

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

Product Name: GSK3117391
Product Code: GSK3117391
INN or Proposed INN: Not applicable
Other descriptive name: GSK3117391

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Romania;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

216

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

217

EUCTR2015-003334-27-FI
(EUCTR)

02/11/2016

17/06/2016

A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

975

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;New Zealand;Japan

218

EUCTR2015-003289-97-PL
(EUCTR)

25/10/2016

17/08/2016

A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, 2-Part Phase 2 Study to Evaluate the Safety and Efficacy of LY3337641 in Adult Subjects with Rheumatoid Arthritis: The RAjuvenate Study - The RAjuvenate Study

Product Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

276

Phase 2

United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of

219

EUCTR2015-003289-97-AT
(EUCTR)

20/10/2016

12/08/2016

A study to determine the safety and efficacy of LY3337641 in Adult Patients with Rheumatoid Arthritis

Product Name: LY3337641 5 mg
Product Code: LY3337641
INN or Proposed INN: Not available
Product Name: LY3337641 20 mg
Product Code: LY3337641
INN or Proposed INN: Not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

276

Phase 2

United States;Slovakia;Spain;Austria;Italy;Mexico;Argentina;Poland;Australia;South Africa;Germany;Japan;Korea, Republic of

220

EUCTR2016-000498-19-BG
(EUCTR)

13/10/2016

19/08/2016

A Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients with Moderate to Severe Rheumatoid Arthritis

A PHASE II OPEN-LABEL EXTENSION STUDY OF PATIENTS PREVIOUSLY ENROLLED IN STUDY GA29350 TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Product Name: GDC-0853
Product Code: RO7010939
INN or Proposed INN: not available
Other descriptive name: GDC-0853 RO7010939

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

580

Phase 2

United States;Serbia;Mexico;Argentina;Poland;Brazil;Ukraine;Russian Federation;Chile;Bulgaria;Colombia;Korea, Republic of

No.

TrialID

Date_
enrollment

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

EUCTR2016-002061-54-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

222

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

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 3

United States;Czech Republic;Hungary;Canada;Poland;Spain;Romania;Australia;Bulgaria;Germany

223

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

224

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

225

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

226

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

227

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

228

EUCTR2012-002535-28-NL
(EUCTR)

13/09/2016

01/09/2016

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Rheumatoid Arthritis
MedDRA version: 19.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: MabThera
Product Name: MabThera
Product Code: L01X CO2
Trade Name: RoActemra
Product Name: RoActemra
Product Code: L04AC07

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

144

Phase 4

Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom

229

EUCTR2014-005368-13-CZ
(EUCTR)

13/09/2016

A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of

230

EUCTR2015-002729-21-PT
(EUCTR)

12/09/2016

27/04/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis - Gloria

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

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Portugal;Hungary;Slovakia;Finland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

231

EUCTR2015-003335-35-SI
(EUCTR)

12/09/2016

28/09/2016

A Study to Compare ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

232

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

233

EUCTR2015-003334-27-SI
(EUCTR)

07/09/2016

14/12/2015

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Japan;New Zealand

234

NCT02897011
(ClinicalTrials.gov)

September 2016

7/9/2016

2-week dc of MTX and Influenza Vaccination in RA

Effect of Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial

Rheumatoid Arthritis;Influenza;Methotrexate

Drug: Methotrexate

Seoul National University Hospital

NULL

Recruiting

18 Years

65 Years

Both

318

N/A

Korea, Republic of

235

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

236

EUCTR2015-003335-35-BG
(EUCTR)

29/08/2016

01/08/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

237

EUCTR2015-003334-27-BG
(EUCTR)

18/08/2016

18/07/2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

975

Phase 3

238

EUCTR2015-003335-35-HU
(EUCTR)

18/08/2016

18/03/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Norway;Germany;New Zealand;Sweden

239

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

240

EUCTR2015-003335-35-FI
(EUCTR)

10/08/2016

22/04/2016

A Study to Compare Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

241

NCT02886728
(ClinicalTrials.gov)

August 8, 2016

29/8/2016

Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy

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

Rheumatoid Arthritis

Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: MTX;Drug: Placebo to match MTX

Gilead Sciences

Galapagos NV

Completed

18 Years

N/A

All

1252

Phase 3

United States;Argentina;Australia;Belgium;Bulgaria;Canada;Chile;Czechia;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;Czech Republic

242

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

243

EUCTR2016-000064-42-HU
(EUCTR)

05/08/2016

06/06/2016

Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis

Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A

Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Estonia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Romania;Bulgaria;South Africa

244

EUCTR2015-003376-75-BG
(EUCTR)

02/08/2016

18/07/2016

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand

245

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

No.

TrialID

Date_
enrollment

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

EUCTR2015-003376-75-GR
(EUCTR)

28/07/2016

13/05/2016

A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Japan;New Zealand;Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary

247

EUCTR2015-003376-75-CZ
(EUCTR)

27/07/2016

03/06/2016

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

248

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

249

EUCTR2016-000064-42-SK
(EUCTR)

27/07/2016

03/05/2016

Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis

Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A

Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria

250

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

251

EUCTR2015-003333-95-LT
(EUCTR)

21/07/2016

09/05/2016

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

252

EUCTR2015-003335-35-IT
(EUCTR)

18/07/2016

28/02/2018

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

ABBVIE DEUTSCHLAND GMBH & CO. KG

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

253

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

254

EUCTR2015-003333-95-BG
(EUCTR)

13/07/2016

25/03/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Belarus;United States;Serbia;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

255

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

No.

TrialID

Date_
enrollment

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

EUCTR2016-001618-18-FR
(EUCTR)

08/07/2016

09/06/2016

Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients

STARComparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR

glucocorticoid withdrawal in rheumatoid arthritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Prednisone
Product Name: prednisone 5 mg
Trade Name: Prednisone
Product Name: prednisone 4 mg
Trade Name: Prednisone
Product Name: prednisone 3 mg
Trade Name: Prednisone
Product Name: prednisone 2 mg
Trade Name: Prednisone
Product Name: prednisone 1 mg
Trade Name: Hydrocortisone 10mg

CHU Toulouse

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

122

Phase 4

France

257

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

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

258

EUCTR2015-003376-75-HU
(EUCTR)

06/07/2016

09/06/2016

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand

259

EUCTR2015-003335-35-GB
(EUCTR)

05/07/2016

17/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

499

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

260

EUCTR2015-003335-35-GR
(EUCTR)

05/07/2016

26/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

261

NCT02683421
(ClinicalTrials.gov)

July 2016

22/1/2016

Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging

Evaluation of Subcutaneous (SC) Injected Tc 99m Tilmanocept Localization in Active Rheumatoid Arthritis (RA) Subjects by SPECT and SPECT/CT Imaging

Rheumatoid Arthritis

Drug: Tilmanocept

Navidea Biopharmaceuticals

NULL

Completed

21 Years

N/A

All

Phase 1

United States

262

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

263

EUCTR2015-003376-75-PL
(EUCTR)

28/06/2016

08/06/2016

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Belgium;Poland;Australia;Bulgaria;Japan;New Zealand

264

EUCTR2015-003376-75-ES
(EUCTR)

23/06/2016

19/01/2016

A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;United States;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;European Union;Mexico;Puerto Rico;Argentina;Australia;Japan;New Zealand

265

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

No.

TrialID

Date_
enrollment

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

EUCTR2015-002729-21-FI
(EUCTR)

21/06/2016

30/03/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

Rheumatoid artritis
MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 4

Portugal;Hungary;Slovakia;Finland;Germany

267

EUCTR2016-000064-42-CZ
(EUCTR)

21/06/2016

08/06/2016

Safety and Efficacy study of M2951 in Subjects with Rheumatoid Arthritis

Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of M2951 in Subjects with Rheumatoid Arthritis on Stable Methotrexate Therapy - N/A

Product Name: M2951
Product Code: M2951
INN or Proposed INN: N/A
Other descriptive name: M2951

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Estonia;Czech Republic;Slovakia;Poland;Ukraine;Romania;South Africa;Bulgaria

268

EUCTR2015-003376-75-PT
(EUCTR)

17/06/2016

09/06/2016

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

United States;Portugal;Serbia;Greece;Spain;Ukraine;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand

269

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

270

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

No.

TrialID

Date_
enrollment

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

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

272

EUCTR2015-003332-13-BG
(EUCTR)

15/06/2016

25/03/2016

A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

273

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

274

EUCTR2015-003332-13-LT
(EUCTR)

10/06/2016

29/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

275

EUCTR2015-003376-75-AT
(EUCTR)

10/06/2016

28/06/2016

A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Methotrexate 2.5 mg tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: MTX HEXAL 2,5 mg Tabletten
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand

No.

TrialID

Date_
enrollment

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

EUCTR2015-005307-83-HU
(EUCTR)

09/06/2016

28/04/2016

Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy

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

R-Pharm

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1575

Phase 3

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

277

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

278

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

279

EUCTR2015-001275-50-NL
(EUCTR)

08/06/2016

10/12/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination with Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults with Early Rheumatoid Arthritis who are Methotrexate Naive

Early Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden

280

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

No.

TrialID

Date_
enrollment

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

EUCTR2015-002887-17-BE
(EUCTR)

07/06/2016

16/02/2016

Efficacy and Safety Study of BMS-986142 in Patients with Moderate to Severe Rheumatoid Arthritis

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

610

Phase 2

United States;Taiwan;Spain;Austria;Russian Federation;Israel;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;South Africa;Netherlands;Germany;Japan;Korea, Republic of

282

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

283

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

284

EUCTR2015-003376-75-BE
(EUCTR)

07/06/2016

06/06/2016

A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to MTX

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;United States;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Argentina;Poland;Belgium;Australia;Bulgaria;Japan;New Zealand

285

EUCTR2015-003332-13-GR
(EUCTR)

06/06/2016

24/05/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

No.

TrialID

Date_
enrollment

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

EUCTR2015-003335-35-LV
(EUCTR)

03/06/2016

13/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Norway;Germany;New Zealand;Sweden

287

EUCTR2015-003335-35-PT
(EUCTR)

31/05/2016

30/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

288

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

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

289

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

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

290

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

No.

TrialID

Date_
enrollment

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

EUCTR2016-002035-15-FI
(EUCTR)

20/05/2016

12/05/2016

Outcome after total knee endoprosthesis under general or regional anesthesia, a randomized study

Outcome after total knee arthroplasty under general or spinal anesthesia, a randomized study - Outcome after total knee arthroplasty under general or spinal anesthesia

Patients undego total knee arthroplasty operation in general or spinal anaesthesia because of osteoarthritis, rheumatoid arthritis or other degenerative condition of the knee
MedDRA version: 19.0;Level: LLT;Classification code 10031174;Term: Osteoarthrosis;System Organ Class: 100000004859
MedDRA version: 19.0;Classification code 10031158;Term: Osteo arthritis knees;System Organ Class: 100000004859;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trade Name: Bicain spinal
INN or Proposed INN: bupivacaine hydrochloride
Other descriptive name: BUPIVACAINE HYDROCHLORIDE
Trade Name: Propolipid
INN or Proposed INN: propofol
Other descriptive name: PROPOFOL

Helsinki University Central Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Finland

292

EUCTR2015-003335-35-SK
(EUCTR)

19/05/2016

22/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

293

EUCTR2015-003333-95-HU
(EUCTR)

18/05/2016

07/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;Austria;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

294

EUCTR2014-004719-36-BG
(EUCTR)

14/05/2016

05/04/2016

Study of the Efficacy and Safety of Olokizumab in Patients withModerately to Severely Active Rheumatoid Arthritis InadequatelyControlled by Methotrexate Therapy

A Randomized, Double-Blind, Parallel-Group, Placebo Controlled,Multicenter Phase III Study of the Efficacy and Safety of Olokizumab inSubjects with Moderately to Severely Active Rheumatoid ArthritisInadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 1

Product Name: Olokizumab
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: CDP6038

R-Pharm

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

Belarus;Turkey;Russian Federation;Bulgaria

295

EUCTR2015-003335-35-IE
(EUCTR)

13/05/2016

10/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

No.

TrialID

Date_
enrollment

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

EUCTR2015-003333-95-GR
(EUCTR)

12/05/2016

10/05/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

297

EUCTR2015-003335-35-CZ
(EUCTR)

11/05/2016

15/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

298

EUCTR2015-003333-95-CZ
(EUCTR)

11/05/2016

22/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

299

EUCTR2015-003332-13-CZ
(EUCTR)

11/05/2016

06/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

300

EUCTR2015-003332-13-HR
(EUCTR)

11/05/2016

06/07/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

No.

TrialID

Date_
enrollment

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

EUCTR2015-003332-13-HU
(EUCTR)

10/05/2016

05/05/2016

A Study Comparing ABT-494 to Placebo in Subjects with Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response to csDMARDs Alone (SELECT-NEXT)

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

302

EUCTR2015-003335-35-SE
(EUCTR)

10/05/2016

16/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

303

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

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

304

EUCTR2015-003332-13-ES
(EUCTR)

09/05/2016

19/01/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Kazakhstan;Norway;New Zealand

305

EUCTR2015-003333-95-PT
(EUCTR)

06/05/2016

08/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Serbia;Belarus;United States;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

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

EUCTR2015-003333-95-ES
(EUCTR)

06/05/2016

19/01/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Turkey;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Kazakhstan;Germany;New Zealand

307

EUCTR2015-002729-21-HU
(EUCTR)

04/05/2016

11/02/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

Rheumatoid artritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 4

Hungary;Slovakia;Germany

308

EUCTR2015-003335-35-BE
(EUCTR)

04/05/2016

10/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

309

EUCTR2015-003335-35-DK
(EUCTR)

03/05/2016

14/03/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden

310

EUCTR2015-003335-35-DE
(EUCTR)

03/05/2016

09/03/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

311

EUCTR2015-003335-35-ES
(EUCTR)

29/04/2016

11/03/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

United States;Hong Kong;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;Puerto Rico;Australia;Denmark;Korea, Republic of;Turkey;Austria;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Norway;Germany;New Zealand;Sweden

312

NCT02603146
(ClinicalTrials.gov)

April 27, 2016

10/11/2015

Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis

Healthy Participants;Rheumatoid Arthritis (RA) Prevention

Drug: Hydroxychloroquine;Drug: HCQ Placebo

National Institute of Allergy and Infectious Diseases (NIAID)

Autoimmunity Centers of Excellence

Recruiting

18 Years

N/A

All

200

Phase 2

United States

313

EUCTR2015-003333-95-DE
(EUCTR)

25/04/2016

14/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

314

EUCTR2015-002729-21-DE
(EUCTR)

25/04/2016

02/02/2016

A study to compare the cost effectiveness and safety of low dose glucocorticoids in elderly patients with rheumatoid arthritis

Trade Name: prednisolone Labesfal
Product Name: prednisolone
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE

VU University Medical Center

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 4

Portugal;Hungary;Slovakia;Finland;Germany

315

EUCTR2015-003332-13-IE
(EUCTR)

22/04/2016

08/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

No.

TrialID

Date_
enrollment

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

EUCTR2015-003332-13-NO
(EUCTR)

22/04/2016

21/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Egypt;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;New Zealand

317

EUCTR2015-003332-13-PT
(EUCTR)

22/04/2016

08/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand;Hong Kong;United States;Belarus;Portugal;Serbia

318

EUCTR2015-003333-95-IE
(EUCTR)

22/04/2016

08/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

319

EUCTR2015-003333-95-LV
(EUCTR)

20/04/2016

12/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

320

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

No.

TrialID

Date_
enrollment

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

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

322

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

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

323

EUCTR2015-003332-13-LV
(EUCTR)

20/04/2016

12/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

324

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

325

EUCTR2015-003333-95-DK
(EUCTR)

15/04/2016

07/04/2016

Product Name: ABT-494
INN or Proposed INN: ABT-494
Trade Name: Humira 40mg/0.8ml solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

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

326

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

327

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

328

EUCTR2015-003333-95-GB
(EUCTR)

14/04/2016

11/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Belgium;Brazil;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

329

EUCTR2015-003332-13-GB
(EUCTR)

14/04/2016

11/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

330

EUCTR2015-003332-13-BE
(EUCTR)

13/04/2016

07/04/2016

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Croatia;Kazakhstan;Bulgaria;Norway;New Zealand

No.

TrialID

Date_
enrollment

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

EUCTR2015-003333-95-BE
(EUCTR)

13/04/2016

07/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;Belarus;Serbia;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

332

EUCTR2015-003333-95-HR
(EUCTR)

05/04/2016

28/04/2016

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

333

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

334

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

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

335

EUCTR2015-002523-26-HU
(EUCTR)

08/03/2016

13/11/2015

Effects of JAK inhibition on rheumatoid arthritis-related comorbidities: link between bone and vascular effects(investigator-initiated grant proposal)

Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Tofacitinib
Product Code: CP -690,55-10

Arthritis Alapítvány

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary

No.

TrialID

Date_
enrollment

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

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.

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

337

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

338

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

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

339

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

340

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

No.

TrialID

Date_
enrollment

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

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

342

EUCTR2015-001275-50-RO
(EUCTR)

10/02/2016

22/02/2016

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3B

United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden

343

EUCTR2015-001275-50-HU
(EUCTR)

09/02/2016

04/12/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Early Rheumatoid Arthritis
MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate Ebewe
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

United Arab Emirates;Qatar;Saudi Arabia;Taiwan;Spain;Russian Federation;Chile;Israel;Colombia;Italy;France;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Germany;Japan;Sweden

344

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.

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

345

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.

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

No.

TrialID

Date_
enrollment

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

EUCTR2015-002809-12-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

347

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

348

EUCTR2015-002634-41-PL
(EUCTR)

20/01/2016

16/12/2015

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;Poland;Malaysia;Bulgaria;Germany;Korea, Republic of

349

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

350

EUCTR2015-003332-13-SK
(EUCTR)

12/01/2016

04/11/2015

Product Name: ABT-494
INN or Proposed INN: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

No.

TrialID

Date_
enrollment

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

EUCTR2014-004673-16-DE
(EUCTR)

12/01/2016

15/07/2015

Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.

Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients

Trade Name: RoActemra 162 mg
Product Code: RO487-7533/F10-04
INN or Proposed INN: tocilizumab
Other descriptive name: TOCILIZUMAB
Trade Name: Prednisone Tablets USP, 5 mg
Product Code: RO001-9265/F04
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: Prednisone Tablets USP, 1 mg
Product Code: RO 001-9265/F02-01
INN or Proposed INN: Prednisone
Other descriptive name: PREDNISONE
Trade Name: RoActemra
Product Code: L04AC07
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

226

Phase 4

Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland

352

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

353

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

354

EUCTR2015-002809-12-ES
(EUCTR)

23/12/2015

30/10/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India

355

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

No.

TrialID

Date_
enrollment

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

EUCTR2015-004173-32-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

357

EUCTR2015-003333-95-SK
(EUCTR)

18/12/2015

04/11/2015

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Phase 3

Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Puerto Rico;Malaysia;Denmark;Australia;South Africa;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Croatia;Kazakhstan;Bulgaria;Germany;New Zealand

358

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

359

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

360

EUCTR2015-002634-41-ES
(EUCTR)

17/12/2015

30/10/2015

Long-term study of BI695501 in patients with active rheumatoid arthritis

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Chile;Russian Federation;Hungary;Malaysia;Poland;Bulgaria;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

361

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

362

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

363

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

364

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

365

NCT02680067
(ClinicalTrials.gov)

December 8, 2015

7/12/2015

NIR Fluorescence Imaging of Lymphatic Transport Using ICG

Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green

Rheumatoid Arthritis

Drug: Indocyanine Green;Device: MultiSpectral Imaging System

University of Rochester

National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Recruiting

18 Years

89 Years

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

366

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

367

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

368

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

369

EUCTR2015-001275-50-FR
(EUCTR)

30/11/2015

04/12/2015

Effects of abatacept in patients who have recently been diagnosed with rheumatoid arthritis

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

370

EUCTR2015-002809-12-CZ
(EUCTR)

27/11/2015

02/10/2015

A Study to Compare YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Product Name: YLB113
Product Code: YLB113
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel
Product Code: Enbrel
INN or Proposed INN: ETANERCEPT

YL Biologics Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Hungary;Czech Republic;Poland;Spain;Ukraine;Romania;Russian Federation;Bulgaria;Latvia;Japan;India

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

371

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

372

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

373

EUCTR2013-002777-22-IT
(EUCTR)

19/11/2015

04/12/2013

Targeted Ultrasound in Rheumatoid Arthritis (TURA)

Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 4

France;Hungary;Spain;Denmark;Germany;Japan;United Kingdom;Italy

374

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

375

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

376

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

377

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

378

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

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

379

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

380

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

381

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

382

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

383

EUCTR2014-003453-34-PL
(EUCTR)

26/10/2015

29/09/2015

Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.

A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate.

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

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Poland;South Africa;Bulgaria;Germany;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina

384

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

385

EUCTR2012-002009-23-PL
(EUCTR)

22/10/2015

08/10/2015

Clinical trial to demonstrate that treatments with GP2015 and Enbrel® are comparable in patients with rheumatoid arthritis

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

366

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Lithuania;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

386

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

387

EUCTR2015-001246-28-BE
(EUCTR)

19/10/2015

23/07/2015

Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study)

Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study) - TOVERA

Trade Name: RoActemra
Product Name: RoActemra

Cliniques Universitaires Saint-Luc, Université catholique de Louvain

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

388

EUCTR2014-000110-61-DE
(EUCTR)

15/10/2015

04/05/2015

Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.

An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE

Product Code: FKB327 PFS
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Code: FKB327 AI
INN or Proposed INN: ADALIMUMAB

Fujifilm Kyowa Kirin Biologics Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

680

Phase 3

United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany

389

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

390

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

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

391

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

392

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

393

EUCTR2014-003453-34-CZ
(EUCTR)

16/09/2015

23/06/2015

Study of a new drug’s effect in people with rheumatoid arthritis who have not responded sufficiently well to treatment with Methotrexate.

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

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Estonia;Spain;Ukraine;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;South Africa;Bulgaria;Germany

394

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

395

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

No.

TrialID

Date_
enrollment

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

NCT02748785
(ClinicalTrials.gov)

September 2015

8/9/2015

MTX Discontinuation and Vaccine Response

Effect of Methotrexate Discontinuation on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial

Arthritis, Rheumatoid

Drug: Methotrexate;Biological: Seasonal Influenza vaccine

Seoul National University Hospital

NULL

Completed

18 Years

N/A

Both

277

Phase 4

Korea, Republic of

397

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

398

NCT02504268
(ClinicalTrials.gov)

August 31, 2015

20/7/2015

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive

Rheumatoid Arthritis

Drug: Abatacept;Drug: Methotrexate;Other: Abatacept Placebo;Other: Methotrexate Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

1067

Phase 3

United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Finland;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Monaco;Netherlands;Peru;Poland;Qatar;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom;Czech Republic;Puerto Rico;Saudi Arabia;United Arab Emirates

399

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

400

EUCTR2013-003177-99-FI
(EUCTR)

12/08/2015

12/02/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

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

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

401

JPRN-JapicCTI-153081

01/8/2015

26/11/2015

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : Abatacept + Methotrexate
Dosage And administration of the intervention : Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
Control intervention name : Methotrexate
Dosage And administration of the control intervention : Methotrexate at least 15mg per week tablet or capsule orally
Control intervention name : Abatacept Placebo
Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week
Control intervention name : Methotrexate Placebo
Dosage And administration of the control intervention : Placebo to match Methotrexate capsule orally once per week

Bristol-Myers Squibb K.K.

NULL

complete

BOTH

1000

Phase 3

NULL

402

NCT02451748
(ClinicalTrials.gov)

August 2015

6/5/2015

IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA

IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA

Rheumatoid Arthritis

Other: Lab Work;Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg);Drug: Certolizumab pegol (CDP870, tradename Cimzia);Drug: Hydroxychloroquine;Drug: Sulfasalazine;Drug: Medrol;Drug: Prednisone;Drug: Triamcinolone;Drug: Naproxen;Drug: Leflunomide;Drug: Methotrexate;Drug: humira

University of Illinois at Chicago

UCB Pharma

Completed

18 Years

N/A

All

Phase 4

United States

403

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

404

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

405

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

No.

TrialID

Date_
enrollment

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

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

407

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

408

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

409

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

410

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

No.

TrialID

Date_
enrollment

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

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

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: 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

412

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

413

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

414

NCT02467504
(ClinicalTrials.gov)

July 1, 2015

4/6/2015

Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis

A Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Methotrexate (MTX)-Naive Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: hrIL-2 active;Drug: hrIL-2 placebo;Drug: MTX;Drug: Folic Acid;Drug: Loxoprofen

Peking University People's Hospital

Monash University;Beijing ShuangLu Pharmaceutical Co., Ltd.

Completed

18 Years

70 Years

All

Phase 2

China

415

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

416

EUCTR2014-003012-36-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

417

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

418

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

419

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

420

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

No.

TrialID

Date_
enrollment

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

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

422

EUCTR2015-000538-31-DE
(EUCTR)

01/06/2015

07/04/2015

Application into the joint of opioids in chronic arthritis of the knee joint

NEUORIMPA - Intraarticular Application of Opioids in Chronic Arthritis of the knee joint - Neuroimpa - knee joint

chronic arthritis of the knee joint effusion as part of spondyloarthritis (Assessments in SpondyloArthritis international Society, ASAS criteria), Rheumatoid Arthritis, RA (according to American Col-lege of Rheumatology, ACR criteria), undifferentiated mono- or oligoarthritis, Osteoarthritis of the knee, OA.
MedDRA version: 18.0;Level: LLT;Classification code 10067624;Term: Knee arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Morphine Hexal
INN or Proposed INN: Morphinsulfat
Other descriptive name: MORPHINE SULFATE
Trade Name: Triam 40 mg Lichtenstein
INN or Proposed INN: TRIAMCINOLONACETONID
Other descriptive name: TRIAMCINOLONACETONID EP

Charité University medicine Berlin

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

423

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

424

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

425

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

No.

TrialID

Date_
enrollment

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

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

427

EUCTR2014-004904-31-NL
(EUCTR)

19/05/2015

26/01/2015

Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Remsima (infliximab)

Mundipharma Pharmaceuticals B.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

428

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

429

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

430

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

No.

TrialID

Date_
enrollment

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

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

432

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

433

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

434

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

435

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

No.

TrialID

Date_
enrollment

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

EUCTR2014-003033-26-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

437

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

438

EUCTR2014-003307-30-SK
(EUCTR)

16/04/2015

02/02/2015

Multiple dose study of UCB4940 as add-on to Certolizumab Pegol in subjects with rheumatoid arthritis

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

Product Name: BUMEKIZUMAB
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL

UCB Celltech, UK Registered Branch of UCB Pharma SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Czech Republic;Hungary;Slovakia;Russian Federation;Georgia;United Kingdom;Moldova, Republic of

439

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

440

NCT02393378
(ClinicalTrials.gov)

April 8, 2015

15/3/2015

Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate

Rheumatoid Arthritis

Drug: Namilumab;Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid

Takeda

NULL

Terminated

18 Years

N/A

All

Phase 2

Czechia;Estonia;Russian Federation;Spain;United Kingdom;Czech Republic

No.

TrialID

Date_
enrollment

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

EUCTR2014-001471-31-RO
(EUCTR)

08/04/2015

05/10/2015

Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)

Product Name: ABT-122
Product Code: ABT-122
INN or Proposed INN: na
Other descriptive name: ABT-122

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Canada;Poland;Turkey;Romania;Australia;Bulgaria;Germany;New Zealand

442

EUCTR2014-002541-22-DE
(EUCTR)

02/04/2015

09/12/2014

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Humira , 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
INN or Proposed INN: ADALIMUMAB
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 3

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

443

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

444

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

445

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

446

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

447

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

448

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

449

EUCTR2014-002541-22-GB
(EUCTR)

18/03/2015

09/01/2015

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

340

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Czech Republic;Hungary;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

450

EUCTR2012-001176-10-BG
(EUCTR)

16/03/2015

04/11/2014

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE

Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody
Product Name: Sirukumab
Product Code: CNTO136
INN or Proposed INN: Sirukumab
Other descriptive name: Human anti-IL6 monoclonal antibody

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

451

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

452

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

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

453

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

454

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

455

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

456

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

457

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

458

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

459

EUCTR2014-002945-23-GB
(EUCTR)

18/02/2015

04/11/2014

A 24 week Phase 2 study in subjects with moderate to severe early Rheumatoid Arthritis who’s symptoms are not fully controlled by treatment with methotrexate alone. Subjects will be told if they are in the group receiving either 150 mg namilumab injected under the skin or adalimumab. Responses to the medicine will be measured using MRI.

Rheumatoid Arthritis (RA)
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Estonia;Czech Republic;Spain;Russian Federation;United Kingdom

460

EUCTR2014-002945-23-CZ
(EUCTR)

18/02/2015

21/11/2014

Takeda Development Centre Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Estonia;Czech Republic;Spain;Russian Federation;United Kingdom

No.

TrialID

Date_
enrollment

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

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)

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

462

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

463

EUCTR2014-001114-26-NL
(EUCTR)

13/02/2015

24/09/2014

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

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Netherlands;Germany;Sweden

464

EUCTR2014-002541-22-HU
(EUCTR)

11/02/2015

15/12/2014

Efficacy and safety of Sarilumab and Adalimumab monotherapy in patients with Rheumatoid Arthritis

A randomized, double-blind, parallel-group study assessing the efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis - SARIL-RA-MONARCH

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

340

United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Hungary;Czech Republic;Mexico;Puerto Rico;Argentina;Poland;Romania;Peru;South Africa;Germany;Korea, Republic of

465

EUCTR2013-005418-37-DE
(EUCTR)

05/02/2015

24/07/2014

A multicenter, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate.

A multicenter, randomized, double-blind, placebo-controlled phase II study to evaluate safety and clinical efficacy of two different doses of F8IL10 (Dekavil) administered subcutaneously to patients with active rheumatoid arthritis receiving Methotrexate.

Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to at least one anti-TNF treatment.
MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Dekavil
Product Code: F8IL10
INN or Proposed INN: dekavil
Other descriptive name: F8IL10

Philogen S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany;Italy;Switzerland

No.

TrialID

Date_
enrollment

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

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

467

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

468

JPRN-JapicCTI-152979

01/2/2015

Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Intervention name : Namilumab
Dosage And administration of the intervention : Namilumab 20 mg, 80 mg or 150 mg subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study.
Control intervention name : Placebo
Dosage And administration of the control intervention : Namilumab placebo-matching SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study.

TAKEDA PHARMACEUTICAL COMPANY LTD.

NULL

BOTH

108

Phase 2

NULL

469

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

470

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

471

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

472

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

473

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

474

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

475

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

476

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

477

EUCTR2013-003530-33-BE
(EUCTR)

15/01/2015

19/09/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

494

Phase 2

United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;South Africa;Bulgaria;Latvia;Netherlands;New Zealand

478

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

479

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

480

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

No.

TrialID

Date_
enrollment

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

EUCTR2013-003530-33-BG
(EUCTR)

09/01/2015

06/11/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

494

Phase 2

United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand

482

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

483

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.

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

484

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).

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

485

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

No.

TrialID

Date_
enrollment

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

EUCTR2014-000443-33-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

487

NCT02379091
(ClinicalTrials.gov)

December 17, 2014

28/11/2014

Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Namilumab;Drug: Placebo;Drug: Methotrexate;Drug: Folic/folinic acid

Takeda

NULL

Completed

18 Years

N/A

All

108

Phase 2

Bulgaria;Czechia;Japan;Korea, Republic of;Poland;Russian Federation;Spain;United Kingdom;Argentina;Brazil;Colombia;Czech Republic;Germany;Mexico

488

EUCTR2014-003529-16-GB
(EUCTR)

16/12/2014

22/06/2015

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

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

Trade Name: MabThera
Product Name: MabThera
Trade Name: RoActmera
Product Name: RoActmera
Trade Name: Enbrel
Product Name: Enbrel

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

219

Phase 3

United Kingdom

489

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

490

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

No.

TrialID

Date_
enrollment

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

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).

RHEUMATOID ARTHRITIS
MedDRA 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

492

EUCTR2013-003530-33-NL
(EUCTR)

11/12/2014

22/05/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494

Moderately to Severely Active Rheumatoid Arthritis (RA)
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

520

Phase 2

Serbia;United States;Spain;Ukraine;Turkey;Russian Federation;Chile;Israel;Colombia;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Canada;Australia;Bulgaria;South Africa;Latvia;Netherlands;Moldova, Republic of

493

EUCTR2014-001114-26-IE
(EUCTR)

11/12/2014

14/08/2014

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

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

494

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.

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

495

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).

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

496

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

497

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

498

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

499

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

500

EUCTR2013-003530-33-CZ
(EUCTR)

24/11/2014

09/05/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

494

Phase 2

United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Puerto Rico;Belgium;South Africa;Bulgaria;Latvia;Netherlands;New Zealand

No.

TrialID

Date_
enrollment

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

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

502

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.

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

503

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

504

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

505

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

No.

TrialID

Date_
enrollment

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

EUCTR2014-000358-13-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

507

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

508

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

509

EUCTR2014-001114-26-DE
(EUCTR)

10/11/2014

08/08/2014

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

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

510

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).

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

No.

TrialID

Date_
enrollment

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

EUCTR2014-000358-13-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

512

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

513

EUCTR2014-001114-26-AT
(EUCTR)

05/11/2014

10/10/2014

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

150

Phase 4

United States;Greece;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Canada;Australia;Germany;Netherlands;Sweden

514

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

515

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

No.

TrialID

Date_
enrollment

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

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

517

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

518

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

519

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).

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

520

EUCTR2013-004019-37-RO
(EUCTR)

22/10/2014

05/03/2015

A Phase 2 Study to Investigate the Safety and Efficacy of ABT-122 Given with Methotrexate in Subjects with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

160

Phase 2

Hungary;Czech Republic;Canada;Poland;Turkey;Romania;Denmark;Australia;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

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

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

522

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

523

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

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

524

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

525

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

526

EUCTR2014-000706-34-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

527

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

528

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

529

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

530

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

No.

TrialID

Date_
enrollment

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

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

532

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

533

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

534

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

535

EUCTR2013-002358-57-BE
(EUCTR)

18/09/2014

15/07/2014

A Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Failed Anti-TNF Biologic Therapy

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to investigate the Safety and Efficacy of ABT-494 Given with Methotrexate (MTX) in Subjects with Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-TNF Biologic Therapy

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

536

EUCTR2013-005418-37-IT
(EUCTR)

15/09/2014

06/03/2014

Patients with active Rheumatoid Arthritis despite methotrexate therapy that had unsuccessful response to at least one anti-TNF treatment.;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Dekavil
Product Code: F8IL10
INN or Proposed INN: dekavil
Other descriptive name: F8IL10

Philogen S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany;Italy

537

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

538

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

539

EUCTR2013-005543-90-PL
(EUCTR)

09/09/2014

11/07/2014

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany

540

EUCTR2013-003177-99-NL
(EUCTR)

09/09/2014

25/02/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

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

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

541

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

542

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

543

EUCTR2011-005689-39-NL
(EUCTR)

01/09/2014

23/06/2014

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Netherlands;Korea, Republic of

544

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.

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany

545

EUCTR2012-002945-40-BG
(EUCTR)

21/08/2014

05/08/2014

BI695501 compared to adalimumab in patients with active rheumatoid arthritis

Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Product Code: BI 695501
INN or Proposed INN: -
Other descriptive name: BI 695501
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

650

Phase 3

Serbia;United States;Estonia;Spain;Thailand;Ukraine;Russian Federation;Chile;Hungary;Poland;Malaysia;Bulgaria;South Africa;Germany;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

546

EUCTR2012-003655-11-CZ
(EUCTR)

21/08/2014

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

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

Product Name: filgotinib
Product Code: GLPG0634
INN or Proposed INN: INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

739

Phase 2

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

547

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

548

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

549

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

550

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

No.

TrialID

Date_
enrollment

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

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

552

EUCTR2013-003530-33-LV
(EUCTR)

28/07/2014

17/06/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with ABT-494

Product Name: ABT 494 3mg
INN or Proposed INN: ABT 494
Product Name: ABT 494 12mg
INN or Proposed INN: ABT 494
Product Name: ABT-494 30mg
INN or Proposed INN: ABT-494
Product Name: ABT-494 15mg
INN or Proposed INN: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

494

Phase 2

United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;South Africa;Bulgaria;Netherlands;Latvia;New Zealand

553

EUCTR2013-003177-99-GB
(EUCTR)

17/07/2014

11/03/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden

554

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

555

EUCTR2013-003177-99-CZ
(EUCTR)

10/07/2014

05/02/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

Portugal;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

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

EUCTR2012-002945-40-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

557

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

558

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

559

EUCTR2013-004654-13-RO
(EUCTR)

27/06/2014

30/05/2014

The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Moderate to Severe Rheumatoid Arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: ABP 501

Amgen Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

425

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

560

EUCTR2013-005013-13-PL
(EUCTR)

25/06/2014

31/03/2014

A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB5
INN or Proposed INN: ADALIMUMAB
Other descriptive name: SB5
Trade Name: Humira ®
Product Name: Humira ®
INN or Proposed INN: ADALIMUMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

490

Bosnia and Herzegovina;Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;Latvia;United Kingdom;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

561

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

562

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

563

EUCTR2010-019262-86-BE
(EUCTR)

20/06/2014

04/03/2014

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Portugal;United States;Belarus;Philippines;Taiwan;Estonia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

564

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

565

EUCTR2013-003530-33-HU
(EUCTR)

18/06/2014

26/03/2014

Phase 2 Study, Multicenter, Open-Label Extension (OLE) Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial (RCT) with Upadacitinib (ABT-494)

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

494

Phase 2

United States;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Czech Republic;Hungary;European Union;Mexico;Puerto Rico;Belgium;Bulgaria;South Africa;Latvia;Netherlands;New Zealand

No.

TrialID

Date_
enrollment

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

EUCTR2012-003686-17-SI
(EUCTR)

17/06/2014

03/04/2014

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3350

Phase 3

Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden

567

JPRN-JapicCTI-142621

09/6/2014

CHS-0214 Phase III trial

A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate

Rheumatoid Arthritis

Intervention name : CHS-0214
Dosage And administration of the intervention : subcutaneous injection
Control intervention name : Enbrel
INN of the control intervention : Etanercept
Dosage And administration of the control intervention : subcutaneous injection

DAIICHISANKYO Co.,Ltd.

Coherus Biosciences, Inc.

BOTH

620

Phase 3

NULL

568

EUCTR2012-002535-28-PT
(EUCTR)

06/06/2014

25/02/2014

Not applicable

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA

Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: RoActemra
Product Name: RoActemra
INN or Proposed INN: Tocilizumab
Other descriptive name: TOCILIZUMAB

Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 4

Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom

569

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

570

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

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

510

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

571

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

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

572

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

573

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

574

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

575

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

No.

TrialID

Date_
enrollment

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

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

577

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

578

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

579

EUCTR2013-004654-13-DE
(EUCTR)

22/05/2014

03/02/2014

The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: ABP 501
Product Code: ABP 501
INN or Proposed INN: N/A
Other descriptive name: ABP 501

Amgen Inc.

NULL

Not Recruiting

Female: yes
Male: yes

425

Phase 3

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

580

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

581

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

582

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

583

EUCTR2010-019262-86-SE
(EUCTR)

09/05/2014

24/03/2014

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 3

Portugal;Belarus;United States;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

584

EUCTR2013-003177-99-ES
(EUCTR)

07/05/2014

17/03/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

4000

Phase 3B;Phase 4

Portugal;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany;Sweden

585

EUCTR2013-003177-99-SK
(EUCTR)

28/04/2014

10/03/2014

A clinical study to evaluate the safety of two different doses of Tofacitinib for the treatment of rheumatoid arthritis.

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 3;Phase 4

United States;Portugal;Taiwan;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

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

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

587

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

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

588

EUCTR2013-004654-13-BG
(EUCTR)

14/04/2014

18/03/2014

The trial is designed to determine the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis

An Open-Label, Single-arm Extension Study to Evaluate the Long-termSafety and Efficacy of ABP 501 in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: ABP 501
Product Code: ABP 501
Other descriptive name: ABP 501

Amgen Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

425

United States;Spain;Russian Federation;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

589

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

590

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

No.

TrialID

Date_
enrollment

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

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

592

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

593

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

594

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

595

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

No.

TrialID

Date_
enrollment

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

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

597

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

598

EUCTR2013-004555-21-DE
(EUCTR)

31/03/2014

17/01/2014

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis

CELLTRION, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

361

Phase 3

Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of

599

EUCTR2012-003655-11-BG
(EUCTR)

27/03/2014

19/02/2014

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

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

Product Name: filgotinib
Product Code: GLPG0634
INN or Proposed INN: Proposed INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

739

Phase 2

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

600

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

No.

TrialID

Date_
enrollment

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

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.

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

602

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

603

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

604

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

605

EUCTR2010-019262-86-NO
(EUCTR)

24/03/2014

08/10/2010

Long term evaluation of SAR153191 (REGN88, sarilumab) on top of disease modifying anti-rheumatic drugs in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating safety and efficacy of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1940

United States;Portugal;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Malaysia;Australia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Norway;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

606

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

607

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

608

EUCTR2012-003686-17-GR
(EUCTR)

18/03/2014

16/01/2014

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

3350

Phase 3

Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden;United Kingdom;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria

609

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

610

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

No.

TrialID

Date_
enrollment

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

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

612

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

613

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

614

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

615

EUCTR2012-003655-11-HU
(EUCTR)

24/02/2014

11/11/2013

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

Gilead Sciences Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 2

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

616

EUCTR2012-001176-10-DE
(EUCTR)

24/02/2014

05/12/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

617

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

618

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

619

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

620

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

No.

TrialID

Date_
enrollment

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

EUCTR2013-002007-34-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

622

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

623

JPRN-JapicCTI-142505

01/2/2014

Phase III study of MRA-SC 162 mg/week

A Randomized, Double-blind, Parallel-group, Phase III Study of MRA-SC in Rheumatoid Arthritis Patients with Inadequate Response to Tocilizumab Subcutaneous Injection 162 mg every 2 weeks

Rheumatoid arthritis

Intervention name : MRA-SC
INN of the intervention : tocilizumab
Dosage And administration of the intervention : 162 mg QW
Control intervention name : MRA-SC
INN of the control intervention : tocilizumab
Dosage And administration of the control intervention : 162 mg Q2W

Chugai Pharmaceutical Co., Ltd.

NULL

BOTH

Phase 3

NULL

624

NCT02078375
(ClinicalTrials.gov)

February 2014

3/3/2014

The PRESS RA: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis

The PRESS RA Study: Protein and Resistance Exercise Supplementation Study for Rheumatoid Arthritis

Rheumatoid Arthritis

Dietary Supplement: Protein;Dietary Supplement: Carbohydrate (Placebo);Other: Resistance Exercise Program

Johns Hopkins University

National Institute on Aging (NIA);American College of Rheumatology Research and Education Foundation

Terminated

60 Years

95 Years

All

N/A

United States

625

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-003655-11-BE
(EUCTR)

23/01/2014

15/10/2013

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

Product Name: filgotinib
Product Code: GLPG0634
INN or Proposed INN: INN - FILGOTINIB
Other descriptive name: GLPG0634
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

739

Phase 2

627

EUCTR2012-001176-10-IT
(EUCTR)

22/01/2014

28/10/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Janssen-Cilag International N.V.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2165

United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand

628

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

629

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

630

EUCTR2010-019262-86-GB
(EUCTR)

13/01/2014

16/10/2013

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 3

Portugal;Belarus;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

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

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

632

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

633

JPRN-JapicCTI-142497

01/1/2014

Phase 2b, Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects who have Experienced an Inadequate Response to TNF inhibitors.

A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects with Moderate to Severe Active Rheumatoid Arthritis who have Experienced an Inadequate Response to TNF inhibitors.

Rheumatoid Arthritis

Intervention name : Clazakizumab
Dosage And administration of the intervention : Injection, 1 mg, 5 mg, 25 mg
Control intervention name : null

Bristol-Myers K.K.

NULL

BOTH

140

Phase 2

NULL

634

NCT02031471
(ClinicalTrials.gov)

January 2014

16/12/2013

TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment

TOSCARA: An Open-label, Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of Tocilizumab (TCZ) Subcutaneous in TCZ-naïve Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Belgium;Luxembourg

635

NCT02000336
(ClinicalTrials.gov)

January 2014

19/11/2013

Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in 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

Progression of Rheumatoid Arthritis

Drug: Prednisolone;Drug: Placebo

Prof. Dr. rer. nat. H.J. Trampisch

Ruhr University of Bochum

Completed

18 Years

N/A

All

395

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

636

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

637

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

638

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

639

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

640

EUCTR2013-004006-26-DK
(EUCTR)

18/12/2013

OPAL

Optical images for monitoring treatment changes in rheumatoid arthritis – a longitudinal study with Rheumascan

Detection of synovitis and tenosynovitis in the hands of patients with rheumatoid arthritis; Diagnostic performance of optical imaging in comparison with ultrasound and magnetic resonance imaging.
MedDRA version: 16.1;Level: LLT;Classification code 10067132;Term: Synovitis wrist;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: ICG-Pulsion
INN or Proposed INN: 2-{7-[1,1-dimethyl-3-(4-sulfobutyl)-benz[e]indolin-2-ylidene]-1,3,5-heptatrienyl}-1,1-dimethyl-3-(sulfobutyl)-1H-benz[e]-indolium hydroxide,inner salt
Other descriptive name: INDOCYANINE GREEN

Knowledge Centre for Rheumatology and Back Diseases

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

641

EUCTR2012-003655-11-LV
(EUCTR)

18/12/2013

08/11/2013

Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life

A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis

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

Galapagos NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

642

EUCTR2013-002777-22-DE
(EUCTR)

17/12/2013

22/11/2013

Targeted Ultrasound in Rheumatoid Arthritis (TURA)

Targeted Ultrasound in Rheumatoid Arthritis (TURA) - TURA

Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

University of Leeds, Division of Musculoskeletal Disease, Leeds Institute of Molecular Medicine

NULL

Not Recruiting

Female: yes
Male: yes

230

Phase 4

France;Hungary;Spain;Denmark;Germany;Japan;Italy;United Kingdom

643

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

644

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

645

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

No.

TrialID

Date_
enrollment

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

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

647

EUCTR2012-003686-17-HR
(EUCTR)

05/12/2013

01/09/2014

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3350

Phase 3

648

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

649

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

650

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

No.

TrialID

Date_
enrollment

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

EUCTR2013-002777-22-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

652

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

653

EUCTR2012-001176-10-ES
(EUCTR)

31/10/2013

05/09/2013

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

2165

Phase 3

United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand

654

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

655

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

656

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

657

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

658

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

659

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

660

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

661

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

662

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

663

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

664

EUCTR2012-003724-20-RO
(EUCTR)

14/10/2013

28/07/2014

A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.

A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone

Rheumatoid Arthritis
MedDRA version: 17.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: IPI 145
INN or Proposed INN: -
Other descriptive name: IPI-145
Product Code: IPI 145
INN or Proposed INN: -
Other descriptive name: IPI-145
Product Code: IPI 145
INN or Proposed INN: -
Other descriptive name: IPI-145

Infinity Pharmaceuticals, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

316

Phase 2

Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;Colombia;New Zealand

665

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

No.

TrialID

Date_
enrollment

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

EUCTR2013-001999-38-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

667

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

668

JPRN-JapicCTI-132277

01/10/2013

AMG 162 Phase III study (DESIRABLE study)

A Confirmatory Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on DMARDs treatment (Phase III)

rheumatoid arthritis

Intervention name : AMG 162
INN of the intervention : Denosumab
Dosage And administration of the intervention : Administer 60 mg every 6 months or every 3 months as a subcutaneous injection
Control intervention name : Placebo
Dosage And administration of the control intervention : Administer placebo as a subcutaneous injection

DAIICHISANKYO Co.,Ltd.

NULL

BOTH

642

Phase 3

NULL

669

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

670

EUCTR2013-000525-31-HU
(EUCTR)

26/09/2013

30/09/2013

The trial is designed to determine the safety and efficacy of ABP 501 compared with Adalimumab in subjects with moderate to severe rheumatoid arthritis

A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Spain;Russian Federation;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

671

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

672

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

673

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

674

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

675

EUCTR2012-005733-37-GB
(EUCTR)

18/09/2013

23/07/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Rheumatoid Arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade ®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Phase 3

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

676

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

677

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

678

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

679

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

680

EUCTR2012-001984-66-NO
(EUCTR)

11/09/2013

17/10/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX - RA-COMPARE

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: Enbrel 50 mg solution for injection in pre-filled syringe
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Humira
INN or Proposed INN: ADALIMUMAB

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

5910

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

681

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

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

682

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

683

NCT01941940
(ClinicalTrials.gov)

September 5, 2013

2/9/2013

A Study to Evaluate Efficacy of Tocilizumab Administered as Monotherapy or in Combination With Methotrexate and/or Other Disease Modifying Antirheumatic Drugs (DMARDs) in Rheumatoid Arthritis (RA) Participants

A National, Open-Label, Single-Arm, Phase IIIb Study to Evaluate the Efficacy of Weekly Tocilizumab Subcutaneous, Administered as Monotherapy or in Combination With Methotrexate and/or Other DMARDs in Rheumatoid Arthritis (RA) Patients

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: DMARDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

227

Phase 3

Italy

684

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

685

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

No.

TrialID

Date_
enrollment

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

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

687

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

688

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

689

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

690

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-004342-14-DK
(EUCTR)

27/08/2013

19/04/2013

A Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

A Phase 2/3 Open-label Extension Study to Evaluate Long-term Safety and Efficacy With VX 509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs

Product Name: VX-509
Product Code: VX-509
INN or Proposed INN: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2;Phase 3

United States;Estonia;Lithuania;Denmark;South Africa;Netherlands

692

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

693

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

694

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

695

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-005026-30-HU
(EUCTR)

15/08/2013

20/02/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: SB4 (etanercept biosimilar)
Product Code: SB4
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc
Trade Name: Enbrel ®
Product Name: Enbrel ®
INN or Proposed INN: ETANERCEPT
Other descriptive name: TNFR:Fc

Samsung Bioepis Co., Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

498

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

697

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

698

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

699

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

700

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

701

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

702

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

703

EUCTR2013-001569-17-IT
(EUCTR)

02/08/2013

04/06/2013

A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients.

A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients.

Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB

Roche S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3B

Italy

704

EUCTR2012-005733-37-LV
(EUCTR)

02/08/2013

22/05/2013

A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade ®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

584

Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

705

EUCTR2012-003686-17-PL
(EUCTR)

24/07/2013

04/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3350

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

706

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

707

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

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

708

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

709

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

710

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

No.

TrialID

Date_
enrollment

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

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

712

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

713

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

714

EUCTR2011-005648-93-PT
(EUCTR)

05/07/2013

03/04/2013

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

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

715

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

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

716

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

717

EUCTR2012-003686-17-ES
(EUCTR)

04/07/2013

26/06/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib

Lilly S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

Portugal;United States;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden

718

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

719

EUCTR2012-001984-66-IT
(EUCTR)

02/07/2013

07/05/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

720

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

No.

TrialID

Date_
enrollment

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

JPRN-JapicCTI-153073

01/7/2013

18/11/2015

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Rheumatoid arthritis

Intervention name : Sirukumab
Dosage And administration of the intervention : 100 mg
Intervention name : Sirukuma
Dosage And administration of the intervention : 50mg
Control intervention name : null

Janssen Pharmaceutical K.K.

NULL

BOTH

280

Phase 3

NULL

722

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

723

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

724

EUCTR2011-005689-39-ES
(EUCTR)

26/06/2013

24/06/2013

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

Ankylosing Spondylitis (AS)
MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 2

United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Spain;Russian Federation;Germany;Korea, Republic of

725

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

No.

TrialID

Date_
enrollment

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

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

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

727

EUCTR2012-001984-66-LT
(EUCTR)

20/06/2013

23/04/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

728

EUCTR2012-004482-40-ES
(EUCTR)

18/06/2013

16/05/2013

Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapies

Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized.

Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: HUMIRA
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: ENBREL
Product Name: Etanercept
INN or Proposed INN: ETANERCEPT
Trade Name: CIMZIA
Product Name: Certolizumab Pegol
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: SIMPONI
Product Name: Golimumab
INN or Proposed INN: GOLIMUMAB
Trade Name: ORENCIA
Product Name: Abatacept
INN or Proposed INN: ABATACEPT
Trade Name: RoActemra
Product Name: Tocilizumab
INN or Proposed INN: TOCILIZUMAB
Product Name: Infliximab
INN or Proposed INN: INFLIXIMAB

FRANCISCO J. BLANCO GARCÍA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

729

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

730

EUCTR2012-003724-20-DE
(EUCTR)

13/06/2013

04/02/2013

A study of IPI-145 or placebo in combination with methotrexate in patients with rheumatoid arthritis who are currently taking methotrexate.

Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145
Product Code: IPI 145
Other descriptive name: IPI-145

Infinity Pharmaceuticals, Inc

NULL

Not Recruiting

Female: yes
Male: yes

316

Phase 2

Serbia;Hungary;Mexico;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Colombia;Germany;New Zealand

No.

TrialID

Date_
enrollment

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

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

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

732

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

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

733

EUCTR2012-001984-66-HU
(EUCTR)

06/06/2013

14/03/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

734

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

735

EUCTR2012-003686-17-SK
(EUCTR)

05/06/2013

02/05/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

736

EUCTR2012-003686-17-IT
(EUCTR)

29/05/2013

04/04/2013

A Phase 3 Study in Rheumatoid Arthritis

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND

Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

Portugal;United States;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden

737

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

738

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

739

EUCTR2012-005026-30-PL
(EUCTR)

17/05/2013

08/03/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

596

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

740

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

No.

TrialID

Date_
enrollment

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

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

742

EUCTR2012-001984-66-GR
(EUCTR)

15/05/2013

23/04/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

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

743

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

744

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

745

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

No.

TrialID

Date_
enrollment

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

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

747

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

748

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

749

EUCTR2012-001984-66-ES
(EUCTR)

25/04/2013

09/04/2013

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

sanofi-aventis Recherche & Développement

NULL

Not Recruiting

Female: yes
Male: yes

5910

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

750

EUCTR2010-022243-38-NL
(EUCTR)

23/04/2013

13/12/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy - SIRROUND-T

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

840

United States;Serbia;Portugal;Taiwan;Spain;Lithuania;Austria;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

751

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

752

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

753

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

754

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

755

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

No.

TrialID

Date_
enrollment

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

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

757

EUCTR2012-005026-30-BG
(EUCTR)

10/04/2013

05/03/2013

A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.
MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Samsung Bioepis Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

596

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

758

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

759

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

760

EUCTR2012-003536-23-SE
(EUCTR)

08/04/2013

07/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

761

EUCTR2012-003439-41-DK
(EUCTR)

04/04/2013

22/03/2013

A Magnetic Resonance Imaging Study and Arthroscopic Biopsy Substudy in Subjects With Active Rheumatoid Arthritis Receiving VX-509, an Oral JAK3 Inhibitor

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Estonia;Lithuania;Denmark;South Africa;Netherlands

762

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

763

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

764

EUCTR2012-003536-23-ES
(EUCTR)

01/04/2013

04/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

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

765

JPRN-JapicCTI-132121

01/4/2013

Abatacept Post-marketing Clinical Study in Japan

A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Intervention name : Abatacept
Dosage And administration of the intervention : 10 mg/kg IV / month
Control intervention name : Placebo
Dosage And administration of the control intervention : 0 mg/kg IV / month

Bristol-Myers Squibb K.K.

Ono Pharmaceutical Co.,LTD.

BOTH

400

Phase 4

NULL

No.

TrialID

Date_
enrollment

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

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)

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

767

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

768

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

769

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

770

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

No.

TrialID

Date_
enrollment

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

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

772

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

773

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

774

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

775

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

No.

TrialID

Date_
enrollment

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

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

777

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

778

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

779

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

780

EUCTR2012-003536-23-FI
(EUCTR)

13/03/2013

19/02/2013

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: RoActemra
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

200

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-003644-71-ES
(EUCTR)

12/03/2013

21/12/2012

Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

168

France;Hong Kong;Czech Republic;Spain;Australia;Israel;Chile;Russian Federation;Netherlands;Germany;Colombia

782

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

783

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

784

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

785

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

No.

TrialID

Date_
enrollment

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

EUCTR2011-005648-93-SK
(EUCTR)

11/03/2013

06/02/2013

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;Bulgaria;South Africa;Germany

787

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

788

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

789

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

790

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

No.

TrialID

Date_
enrollment

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

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

792

EUCTR2011-006018-15-PL
(EUCTR)

01/03/2013

16/11/2012

Astellas Pharma Global Development, Inc. (APGD)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2b

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

793

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

794

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

795

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-003536-23-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

797

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

798

EUCTR2011-003538-16-AT
(EUCTR)

19/02/2013

14/01/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

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

799

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

800

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

No.

TrialID

Date_
enrollment

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

EUCTR2011-003538-16-GR
(EUCTR)

18/02/2013

14/01/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

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

802

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

803

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)

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

804

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

805

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-002322-73-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

807

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

808

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

809

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

810

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

811

EUCTR2012-002324-32-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

812

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

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

813

EUCTR2012-000439-17-HU
(EUCTR)

05/02/2013

20/11/2012

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;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

814

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

815

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

No.

TrialID

Date_
enrollment

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

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

817

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

818

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

819

NCT01724931
(ClinicalTrials.gov)

February 2013

7/11/2012

Aminopterin Dose Finding Treatment for Methotrexate-Naïve Rheumatoid Arthritis

A Phase 2 Double-Blind, Placebo-Controlled, Randomized Dose Finding Study For The Efficacy And Safety Of Aminopterin In Methotrexate-Naive Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: LD-aminopterin;Drug: placebo

Syntrix Biosystems, Inc.

NULL

Completed

18 Years

N/A

Both

175

Phase 2

Ukraine

820

EUCTR2011-003538-16-SK
(EUCTR)

29/01/2013

08/03/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

522

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

821

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

822

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

823

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

824

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

825

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-002322-73-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

827

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

828

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

829

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

830

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

No.

TrialID

Date_
enrollment

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

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

832

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

833

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

834

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

835

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

No.

TrialID

Date_
enrollment

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

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

837

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

838

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

839

EUCTR2011-003538-16-ES
(EUCTR)

16/01/2013

29/11/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

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

840

EUCTR2012-004631-22-BE
(EUCTR)

15/01/2013

11/12/2012

TapERA:Tapering Etanercept in Reumatoid Artritis.

TapERA:Maintaining remission in RA while tapering Etanercept. - TapERA

reumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Enbrel
Product Name: Enbrel
Product Code: EMEA/H/C000262

University Hospitals Leuven

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

No.

TrialID

Date_
enrollment

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

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

842

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

843

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

844

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

845

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

No.

TrialID

Date_
enrollment

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

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

847

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

848

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

849

EUCTR2012-000439-17-PL
(EUCTR)

10/01/2013

13/11/2012

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: 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

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

850

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

No.

TrialID

Date_
enrollment

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

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

852

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

853

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

854

EUCTR2012-003644-71-NL
(EUCTR)

07/01/2013

Randomized, Double-Blind, Placebo-Controlled Trial of etanercept plus methotrexate in monoclonal antibody (mAb) anti-TNF failure

Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT

Pfizer Inc., 235 EAst 42nd Street, New York, NY 10017, United States

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

France;Hong Kong;Spain;Belgium;Australia;Russian Federation;Israel;Chile;Colombia;Netherlands

855

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

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 anti-TNFa biologics - NN8226-3612

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

856

EUCTR2012-000610-11-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

857

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

858

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

859

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

860

NCT01965132
(ClinicalTrials.gov)

January 1, 2013

11/10/2013

Korean College of Rheumatology Biologics Registry

Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis

Drug: Biologic DMARD

Seoul National University Hospital

NULL

Recruiting

18 Years

N/A

All

7000

Korea, Republic of

No.

TrialID

Date_
enrollment

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

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

862

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

863

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

864

EUCTR2011-006020-20-CZ
(EUCTR)

12/12/2012

03/08/2012

Rheumatoid Arthritis
MedDRA version: 16.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

275

Phase 2b

United States;Hungary;Czech Republic;Mexico;Poland;Ukraine;Bulgaria

865

EUCTR2011-006018-15-CZ
(EUCTR)

12/12/2012

03/08/2012

Astellas Pharma Global Development, Inc. (APGD)

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 2b

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

No.

TrialID

Date_
enrollment

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

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

867

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

868

EUCTR2011-005634-19-PL
(EUCTR)

11/12/2012

06/11/2012

A Phase 2b to investigate the effectiveness of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2b

Serbia;Estonia;Spain;Ukraine;Chile;Russian Federation;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany

869

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

870

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

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

No.

TrialID

Date_
enrollment

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

NCT01772316
(ClinicalTrials.gov)

December 2012

17/1/2013

A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

A Multicenter, Open-label, Long-term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Spain

872

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

873

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

874

EUCTR2011-002894-48-GR
(EUCTR)

16/11/2012

19/10/2012

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United States;Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Ireland;Chile;Russian Federation;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand;Sweden

875

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

No.

TrialID

Date_
enrollment

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

EUCTR2011-001122-18-CZ
(EUCTR)

15/11/2012

10/07/2012

A Study of the Effectiveness and Safety of Ustekinumab (STELARA®) and CNTO 1959 Administered Under the Skin of Patients with Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Korea, Democratic People's Republic of;Turkey;Chile;Russian Federation;Colombia;Czech Republic;Hungary;Mexico;Argentina;Singapore;Peru;Bulgaria

877

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

878

EUCTR2010-022243-38-IT
(EUCTR)

14/11/2012

11/12/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

JANSSEN-CILAG INTERNATIONAL N.V.

NULL

Not Recruiting

Female: yes
Male: yes

990

Portugal;United States;Taiwan;Spain;Lithuania;Austria;United Kingdom;Italy;Canada;Argentina;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China;Japan;Korea, Republic of

879

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

880

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-002181-12-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

882

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

883

EUCTR2010-019262-86-PT
(EUCTR)

09/11/2012

09/08/2012

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 3

United States;Portugal;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

884

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

885

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-002760-27-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

887

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

888

EUCTR2012-001760-30-IT
(EUCTR)

05/11/2012

25/07/2012

Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent.

Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent.

Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB

OSSERVATORIO EPIDEMIOLOGICO GISEA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

889

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

890

EUCTR2011-002840-29-CZ
(EUCTR)

31/10/2012

05/09/2012

A study of multiple different dosages of JNJ-38518168 and placebo in patients with active Rheumatoid Arthritis who are also receiving methotrexate

Product Name: JNJ-38518168-ZBQ - film-coated tablet - 3 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 10 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned
Product Name: JNJ-38518168-ZBQ - film-coated tablet - 30 mg
Product Code: JNJ-38518168-ZBQ
INN or Proposed INN: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

United States;Taiwan;Thailand;Ukraine;Russian Federation;Chile;Colombia;Czech Republic;Hungary;Mexico;Argentina;Poland;Romania;Latvia;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

891

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

892

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

893

EUCTR2011-005634-19-BG
(EUCTR)

24/10/2012

19/10/2012

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany

894

EUCTR2010-021146-22-GB
(EUCTR)

23/10/2012

25/10/2012

Alemtuzumab and rheumatoid arthritis - a study to look at the function of the immune system

Alemtuzumab and rheumatoid arthritis - an immunisation study - Alemtuzumab and rheumatoid arthritis - an immunisation study

Trade Name: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994; manufacturerd by Cambridge Therapeutic Antibody Centre, Burroughs Wellcome, Glaxo Wellcome)
Product Name: Alemtuzumab (already received by alemtuzumab cohort between 1991 and 1994 )

The Newcastle upon Tyne Hospitals NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

895

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

896

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

897

EUCTR2010-022243-38-ES
(EUCTR)

22/10/2012

21/08/2012

A Study of CNTO 136 (sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients with Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

990

United States;Serbia;Portugal;Taiwan;Spain;Lithuania;Austria;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of

898

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

899

EUCTR2012-000535-36-PL
(EUCTR)

18/10/2012

13/09/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

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

900

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

No.

TrialID

Date_
enrollment

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

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

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

902

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

903

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

904

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

905

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

906

EUCTR2011-002894-48-EE
(EUCTR)

08/10/2012

08/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Boehringer Ingelheim International GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

907

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

908

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

909

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

910

JPRN-JapicCTI-132091

01/10/2012

A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFalpha Agents

Rheumatoid Arthritis

Intervention name : AIN457
INN of the intervention : secukinumab
Dosage And administration of the intervention : subcutaneously 75mg, 150mg
Control intervention name : null

Novartis Pharma K.K.

NULL

BOTH

234

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

911

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

912

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

913

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

914

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

915

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

No.

TrialID

Date_
enrollment

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

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

917

JPRN-JapicCTI-152782

12/9/2012

29/01/2015

Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis

Rheumatoid Arthritis

Intervention name : Kolbet
INN of the intervention : Iguratimod
Dosage And administration of the intervention : Oral

Toyama Chemical Co., Ltd. (Current FUJIFILM Toyama Chemical Co., Ltd.)

NULL

BOTH

2000

NULL

918

JPRN-JapicCTI-132051

12/9/2012

23/01/2013

Investigation of the clinical safety and efficacy of iguratimod in patients with rheumatoid arthritis

Rheumatoid Arthritis

Intervention name : iguratimod (Careram)
Dosage And administration of the intervention : Oral

Eisai Co., Ltd.

NULL

BOTH

2000

NULL

919

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

920

EUCTR2011-005648-93-ES
(EUCTR)

10/09/2012

24/05/2012

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis -

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Hungary;Germany;Bulgaria;Chile;France;South Africa;Czech Republic;Russian Federation;Ukraine;Serbia;Argentina;Mexico;Estonia;Spain

No.

TrialID

Date_
enrollment

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

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

922

EUCTR2012-000535-36-DE
(EUCTR)

05/09/2012

15/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

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

923

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

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

840

924

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

925

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

No.

TrialID

Date_
enrollment

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

NCT01694264
(ClinicalTrials.gov)

September 1, 2012

24/9/2012

Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFa

A Randomized, Double-blinded, Phase 3, Multicenter, Investigator-initiated Trial for Entecavir for Prophylaxis of Hepatitis B Virus (HBV) Reactivation in HBV Surface Antigen or Anti-HBc Positive Patients Undergoing Anti-TNFa Treatment

Chronic Hepatitis B;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Juvenile Idiopathic Arthritis

Drug: Entecavir;Drug: Placebo

Seoul National University Hospital

Konkuk University Medical Center;Kyungpook National University;Kyunghee University Medical Center;Kyung Hee University Hospital at Gangdong;Gachon University Gil Medical Center;Daegu Catholic University Medical Center;Eulji University Hospital;SMG-SNU Boramae Medical Center;The Catholic University of Korea;Severance Hospital;Ajou University School of Medicine;Ewha Womans University Mokdong Hospital;Inha University Hospital;Chonnam National University Hospital;Chonbuk National University Hospital;Chungnam National University Hospital;Hallym University Medical Center;Hanyang University;Dong-A University;Korea University Guro Hospital

Terminated

16 Years

85 Years

All

Phase 3

Korea, Republic of

927

EUCTR2012-000535-36-BE
(EUCTR)

28/08/2012

05/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

A multicenter, randomized, double-blind, double dummy, parallel design study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation compared to the currently approved adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

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

928

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

929

EUCTR2012-000535-36-SK
(EUCTR)

23/08/2012

14/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

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

930

EUCTR2011-002067-20-IT
(EUCTR)

23/08/2012

13/09/2012

Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the EU and a n. of other countries worldwide

Trade Name: Cimzia
INN or Proposed INN: CERTOLIZUMAB PEGOL
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

UCB PHARMA SA/NV.

NULL

Not Recruiting

Female: yes
Male: yes

892

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Australia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

931

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

932

EUCTR2012-000535-36-CZ
(EUCTR)

02/08/2012

18/06/2012

A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.

Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.

Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

100

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

933

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

934

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

935

EUCTR2011-005648-93-CZ
(EUCTR)

01/08/2012

24/04/2012

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects with Rheumatoid Arthritis

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

400

Portugal;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;United Kingdom;France;Czech Republic;Hungary;Mexico;Argentina;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

936

NCT01662063
(ClinicalTrials.gov)

August 2012

30/7/2012

A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)

A Multicenter Open-Label, Long-Term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab

Genentech, Inc.

NULL

Completed

18 Years

N/A

All

218

Phase 3

United States;Puerto Rico

937

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

938

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

939

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

940

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

No.

TrialID

Date_
enrollment

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

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

942

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

943

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

944

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

945

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

No.

TrialID

Date_
enrollment

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

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

947

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

948

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

949

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

950

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

No.

TrialID

Date_
enrollment

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

EUCTR2011-002067-20-CZ
(EUCTR)

19/06/2012

25/04/2012

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

Phase 4

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Australia;Bulgaria;Germany

952

EUCTR2010-018485-24-LV
(EUCTR)

15/06/2012

14/05/2012

To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis

Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal

Biotest AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

176

Hungary;Germany;Czech Republic;Spain;Latvia

953

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

954

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

955

EUCTR2011-005634-19-EE
(EUCTR)

13/06/2012

16/04/2012

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2b

Serbia;Estonia;Spain;Ukraine;Russian Federation;Chile;France;Czech Republic;Hungary;Mexico;Argentina;Poland;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

956

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

957

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

958

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

959

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

960

EUCTR2011-004419-22-HU
(EUCTR)

06/06/2012

21/03/2012

Study of VX-509 in Rheumatoid Arthritis Subjects taking Methotrexate

Product Name: VX-509
Product Code: VX-509

Vertex Pharmaceuticals Incorporated

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

Serbia;United States;Estonia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Mexico;Argentina;Poland;Romania;Peru;Bulgaria;Germany

No.

TrialID

Date_
enrollment

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

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

962

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

963

EUCTR2011-002067-20-IE
(EUCTR)

01/06/2012

10/04/2012

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

Phase 4

United States;Portugal;Greece;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;European Union;Mexico;Canada;Australia;Bulgaria;Germany

964

EUCTR2011-004529-28-BG
(EUCTR)

01/06/2012

07/05/2012

A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis

Product Name: JNJ-40346527 -AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Poland;Bulgaria

965

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

No.

TrialID

Date_
enrollment

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

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

967

EUCTR2011-002067-20-HU
(EUCTR)

30/05/2012

20/03/2012

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

968

EUCTR2011-005634-19-HU
(EUCTR)

30/05/2012

11/04/2012

A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects with Moderate-to-Severe Rheumatoid Arthritis.

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab

MedImmune Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2b

Serbia;Estonia;Spain;Ukraine;Chile;Russian Federation;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Bulgaria;South Africa;Germany

969

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

970

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

No.

TrialID

Date_
enrollment

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

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

972

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

973

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

974

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

975

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

976

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

977

EUCTR2011-004529-28-PL
(EUCTR)

14/05/2012

28/03/2012

A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis

Product Name: JNJ-40346527 -AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Hungary;Poland;Bulgaria

978

EUCTR2011-005448-87-HU
(EUCTR)

14/05/2012

21/03/2012

A STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S)

A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S)

Trade Name: Enbrel ® 50 mg Solution for Injection in Pre-filled Syringe
INN or Proposed INN: ETANERCEPT

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

NULL

Not Recruiting

Female: yes
Male: yes

320

United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China

979

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

980

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

No.

TrialID

Date_
enrollment

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

EUCTR2012-000439-17-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

982

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

983

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

984

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

985

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

No.

TrialID

Date_
enrollment

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

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

987

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

988

EUCTR2011-004529-28-HU
(EUCTR)

18/04/2012

01/03/2012

A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis

Product Name: JNJ-40346527 -AAC - capsule - 50 mg
Product Code: JNJ-40346527
INN or Proposed INN: Not assigned
Other descriptive name: Not assigned

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Czech Republic;Hungary;Argentina;Poland;Ukraine;Singapore;Chile;Bulgaria;Russian Federation;Korea, Republic of

989

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

990

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

No.

TrialID

Date_
enrollment

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

EUCTR2011-002392-41-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

992

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

993

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

994

EUCTR2011-004171-36-PL
(EUCTR)

29/03/2012

22/02/2012

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

995

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-021184-32-EE
(EUCTR)

23/03/2012

08/03/2012

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

Product Name: NA
Product Code: GP2013
Trade Name: Mabthera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

Hexal AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

164

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

997

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

998

EUCTR2011-006001-10-IT
(EUCTR)

19/03/2012

14/03/2012

Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response

Rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MABTHERA *EV 1FL 50ML 500MG
INN or Proposed INN: RITUXIMAB
Other descriptive name: NA
Trade Name: MABTHERA *EV 1FL 50ML 500MG
INN or Proposed INN: RITUXIMAB
Other descriptive name: NA

A.O. UNIVERSITARIA INTEGRATA DI VERONA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

999

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

1000

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

No.

TrialID

Date_
enrollment

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

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

1002

EUCTR2011-004468-31-LT
(EUCTR)

14/03/2012

05/01/2012

Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis

An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

1003

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

1004

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

1005

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

No.

TrialID

Date_
enrollment

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

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

1007

EUCTR2011-004171-36-GB
(EUCTR)

24/02/2012

15/12/2011

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

1008

EUCTR2011-004171-36-HU
(EUCTR)

23/02/2012

16/12/2011

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

1009

EUCTR2011-002024-40-ES
(EUCTR)

16/02/2012

14/10/2011

Proof-of-Concept Study with BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults with Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

Product Name: CCR1 Antagonist
Product Code: BMS-817399

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

172

Russian Federation;Mexico;Argentina;Korea, Republic of;Spain;United States;South Africa

1010

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

No.

TrialID

Date_
enrollment

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

EUCTR2011-004468-31-ES
(EUCTR)

10/02/2012

07/12/2011

Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Portugal;Colombia;Bulgaria;Chile;Italy;Latvia;Austria;Lithuania;United Kingdom;Slovakia;Ukraine;Peru;Mexico;Romania;Spain;Bosnia and Herzegovina;Philippines;Poland;Jordan

1012

EUCTR2011-004468-31-PL
(EUCTR)

07/02/2012

10/02/2012

Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

1013

EUCTR2011-004468-31-LV
(EUCTR)

06/02/2012

30/12/2011

Long-term safety and effectivenss CT-P13 together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Portugal;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;United Kingdom;Italy;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of

1014

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

1015

EUCTR2011-004468-31-IT
(EUCTR)

02/02/2012

02/03/2012

Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB
Other descriptive name: NA

CELLTRION, INC.

NULL

Not Recruiting

Female: yes
Male: yes

617

Korea, Republic of;Philippines;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Peru;Latvia;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

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

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

1017

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

1018

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

1019

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

1020

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

No.

TrialID

Date_
enrollment

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

EUCTR2011-004468-31-GB
(EUCTR)

06/01/2012

25/11/2011

Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

617

Phase 3

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

1022

NCT01521923
(ClinicalTrials.gov)

January 2012

19/1/2012

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate for Inducing and Sustaining Clinical Response in the Treatment of DMARD-Naïve Adults With Early Active Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Certolizumab Pegol + Methotrexate (MTX);Biological: Placebo + Methotrexate (MTX)

UCB Pharma

NULL

Completed

18 Years

N/A

All

359

Phase 3

United States;Argentina;Australia;Austria;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Monaco;Netherlands;Poland;Romania;Spain;Sweden;Switzerland;United Kingdom;Czech Republic

1023

NCT01519791
(ClinicalTrials.gov)

January 2012

19/1/2012

Rheumatoid Arthritis

Biological: Certolizumab Pegol;Other: Placebo;Biological: Methotrexate

UCB Pharma SA

NULL

Completed

18 Years

N/A

All

880

Phase 3

1024

EUCTR2011-004468-31-SK
(EUCTR)

30/12/2011

04/01/2012

Comparing the long-term effects of CT-P13 with remicade together with methotrexate in patients with arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Portugal;Philippines;Slovakia;Spain;Ukraine;Lithuania;Austria;Chile;Colombia;Italy;United Kingdom;Mexico;Jordan;Poland;Romania;Peru;Bulgaria;Latvia;Bosnia and Herzegovina

1025

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

1026

EUCTR2011-002633-19-DE
(EUCTR)

21/12/2011

02/08/2011

Prednisolone test for patients with an inflammatory joint disease

Diagnostic value of oral prednisolone test for rheumatoid arthritis - RZR12011-TryCort

rheumatoid arthritis
MedDRA version: 14.0;Level: LLT;Classification code 10062719;Term: Seronegative rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Prednisolone
INN or Proposed INN: PREDNISOLONE
Product Name: Paracetamol
INN or Proposed INN: PARACETAMOL

Rheumazentrum Ruhrgebiet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

1027

EUCTR2010-023782-22-ES
(EUCTR)

16/12/2011

20/07/2011

Rheumatoid Arthritis
MedDRA version: 14.0;Level: LLT;Classification code 10066578;Term: Progression of rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-04171327
Product Code: PF-04171327
Product Code: PF-04171327
Trade Name: Decortin
INN or Proposed INN: PREDNISONE

Pfizer, S.L.U.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

315

Phase 2

Hungary;Colombia;Germany;Malaysia;Bulgaria;South Africa;India;Slovakia;Russian Federation;Czech Republic;Ukraine;Serbia;Canada;Mexico;Korea, Republic of;Romania;Spain;United States;Poland

1028

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

1029

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

1030

EUCTR2011-000436-28-PL
(EUCTR)

07/12/2011

20/06/2011

A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Product Name: Z102
Product Code: Z102
INN or Proposed INN: Z102 (Prednisolone and Dipyridamole).
Product Name: Prednisolone
Product Code: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: Dipyridamole
Product Code: Dipyridamole
INN or Proposed INN: Dipyridamole
Trade Name: Dacortin ®
INN or Proposed INN: PREDNISONE

Zalicus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Hungary;Mexico;Argentina;Brazil;Poland;Ukraine;Peru;Chile;Bulgaria;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1031

EUCTR2010-022208-36-PL
(EUCTR)

05/12/2011

08/04/2011

An Open Label Study for Patients With Rheumatoid Arthritis (FLEX-P)

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) (FLEX-P)

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1505

Phase 3b

Germany;Malaysia;France;Bulgaria;Brazil;Australia;South Africa;New Zealand;Peru;Korea, Republic of;United States;Greece;Croatia;Poland;Hungary;Colombia;Italy;Lithuania;India;Russian Federation;Slovakia;Ukraine;Taiwan;Sri Lanka;Argentina;Mexico;Romania;Spain;Japan

1032

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

1033

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

1034

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

1035

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

No.

TrialID

Date_
enrollment

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

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

1037

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

1038

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

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

1039

EUCTR2010-020992-21-SK
(EUCTR)

26/10/2011

06/12/2011

Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis

A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to methotrexate, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 3

United States;Slovakia;Greece;Spain;Thailand;Turkey;India;France;Czech Republic;Poland;Romania;Tunisia;Germany

1040

EUCTR2009-016266-90-BE
(EUCTR)

25/10/2011

22/08/2011

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

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1594

Phase 2;Phase 3

Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;India;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Romania;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1041

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

1042

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

1043

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

1044

NCT01451203
(ClinicalTrials.gov)

October 11, 2011

25/9/2011

Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis

A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors

Rheumatoid Arthritis

Drug: Placebo;Drug: CZP;Drug: methotrexate (MTX)

Astellas Pharma Inc

UCB Japan Co. Ltd.

Completed

20 Years

64 Years

All

319

Phase 3

Japan

1045

NCT01548768
(ClinicalTrials.gov)

October 10, 2011

6/3/2012

RHYTHM (Formerly Escape II Myocardium)

RHYTHM (RHeumatoid Arthritis studY of THe Myocardium): How Rheumatoid Arthritis (RA) and Tumor Necrosis Factor (TNF) Inhibitors Affect the Myocardial Structure and Function.

Rheumatoid Arthritis

Drug: TNF inhibitors;Drug: DMARDs

Columbia University

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

Completed

18 Years

N/A

All

149

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

1046

EUCTR2011-000436-28-BG
(EUCTR)

07/10/2011

06/10/2011

A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.

Zalicus, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

United States;Serbia;Hungary;Mexico;Argentina;Poland;Brazil;Ukraine;Peru;Russian Federation;Chile;Bulgaria

1047

EUCTR2010-019912-18-BG
(EUCTR)

03/10/2011

25/08/2011

A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Adult Rheumatoid Arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody
Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI)
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

600

United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand

1048

NCT01436370
(ClinicalTrials.gov)

October 2011

15/9/2011

TIV and High Dose TIV in Subjects With Rheumatoid Arthritis

A Phase II Study in Adults With Rheumatoid Arthritis Receiving TNF-alpha-inhibitor Therapy to Assess the Immunogenicity and Safety of Trivalent Inactivated Vaccine (TIV) and High Dose Trivalent Inactivated Vaccine (High-Dose TIV) Administered at Two Dosage Levels

Influenza

Biological: Trivalent inactivated influenza vaccine

National Institute of Allergy and Infectious Diseases (NIAID)

NULL

Completed

18 Years

64 Years

All

102

Phase 2

United States

1049

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

1050

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

No.

TrialID

Date_
enrollment

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

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

1052

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

1053

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

1054

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

1055

EUCTR2011-001220-38-BE
(EUCTR)

19/09/2011

30/08/2011

A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis

A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension

Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

United States;Belgium;Russian Federation;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1056

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

1057

EUCTR2010-023587-40-NL
(EUCTR)

06/09/2011

11/05/2011

Adult Rheumatoid Arthritis (RA)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Humira ®
Product Code: RO 551-6922
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

700

Germany;Netherlands;Italy;Sweden;Greece;Finland;Spain

1058

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

1059

NCT01374971
(ClinicalTrials.gov)

September 2011

14/6/2011

Rheumatoid Arthritis Treatment and Biopsy Study Assessing Certolizumab Pegol (Cimzia)

Open-Label Pre and Post Treatment Arthroscopic Synovial Biopsy Study for the Assessment of Certolizumab Pegol Immunomodulatory Synovial Effects on Select Biomarkers and Gene Expression

Rheumatoid Arthritis

Drug: Certolizumab Pegol (CZP);Procedure: Arthroscopic synovial tissue biopsy

Nathan Wei, MD, FACP, FACR:

University of California, San Diego

Completed

18 Years

N/A

All

Phase 3

United States

1060

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

No.

TrialID

Date_
enrollment

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

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

1062

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

1063

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

1064

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

1065

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

No.

TrialID

Date_
enrollment

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

EUCTR2011-000385-35-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

1067

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

1068

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

1069

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

1070

EUCTR2010-023956-99-HU
(EUCTR)

17/08/2011

18/05/2011

Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to Methotrexate

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

677

Phase 2B

United States;Taiwan;Spain;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Peru;South Africa;Netherlands;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1071

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

1072

EUCTR2010-021184-32-IT
(EUCTR)

03/08/2011

02/02/2011

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

Refractory rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

164

Phase 2

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany

1073

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

1074

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

1075

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

1076

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

1077

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

1078

EUCTR2010-022206-40-PL
(EUCTR)

26/07/2011

11/04/2011

A Rheumatoid Arthritis Study in Patients (FLEX-O)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 3

United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of

1079

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.

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

3080

Phase 4

1080

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

No.

TrialID

Date_
enrollment

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

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

1082

EUCTR2010-022207-22-PL
(EUCTR)

22/07/2011

11/04/2011

A Study in Patients With Rheumatoid Arthritis(FLEX-V)

A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors (FLEX-V)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

555

Phase 3

Germany;Colombia;Malaysia;Italy;Australia;Brazil;Russian Federation;New Zealand;Argentina;Mexico;Taiwan;Korea, Republic of;Spain;Japan;Greece;United States;Poland

1083

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

1084

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

1085

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-022205-17-PL
(EUCTR)

19/07/2011

08/04/2011

A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate (FLEX-M)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Trade Name: Boostrix ®
Product Name: Boostrix ®
Product Code: -
Other descriptive name: DIPHTHERIA TOXOID
Other descriptive name: TETANUS TOXOID
Other descriptive name: PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE
Other descriptive name: PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE
Trade Name: PNEUMOVAX® 23
Product Name: PNEUMOVAX® 23
Product Code: -
Other descriptive name: pneumococcal serotypes

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

990

Phase 3

Hungary;Colombia;Malaysia;Bulgaria;South Africa;Australia;Brazil;Lithuania;India;Slovakia;Russian Federation;Ukraine;New Zealand;Peru;Taiwan;Sri Lanka;Mexico;Argentina;Romania;Korea, Republic of;Japan;United States;Croatia;Poland

1087

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

1088

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

1089

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

1090

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

No.

TrialID

Date_
enrollment

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

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

1092

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

1093

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

1094

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

1095

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

1096

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

1097

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

1098

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

1099

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

1100

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

No.

TrialID

Date_
enrollment

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

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

1102

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

1103

EUCTR2010-022207-22-DE
(EUCTR)

08/06/2011

03/12/2010

A Study in Patients With Rheumatoid Arthritis (FLEX-V)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Other descriptive name: not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Other descriptive name: not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

555

Phase 3

United States;Taiwan;Greece;Spain;Russian Federation;Colombia;Italy;Mexico;Argentina;Poland;Brazil;Malaysia;Australia;Germany;New Zealand;Japan;Korea, Republic of

1104

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

1105

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

No.

TrialID

Date_
enrollment

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

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

1107

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

1108

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

1109

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

1110

EUCTR2011-003016-23-IT
(EUCTR)

11/05/2011

07/03/2012

Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy

Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy (DMARDS)of arthritis management - CIDAI STUDY

Rheumatoid Arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Guna-Anti Interleukin 1
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: Guna-Antiinterleukin 1 alfa
INN or Proposed INN: NA
Other descriptive name: Guna-Antiinterleukin 1 beta
Product Name: Interleukin 10
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: Guna-Interleukin 10
Product Name: Interleukin 4
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: Guna-Interleukin 4

GUNA SPA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

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

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

1112

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

1113

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

1114

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

1115

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

No.

TrialID

Date_
enrollment

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

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

1117

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

1118

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

1119

EUCTR2010-020065-24-IT
(EUCTR)

29/04/2011

20/03/2012

A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel(etanercept) in Patients With Rheumatoid Arthritis and Increased Riskfor Heart Disease.

A clinical outcomes study to evaluate the effects of IL-6 receptorblockade with tocilizumab (TCZ) in comparison with etanercept (ETA) onthe rate of cardiovascular events in patients with moderate to severerheumatoid arthritis (RA). - ENTRACTE

Trade Name: RoActemra ®
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal
Trade Name: Enbrel ®
INN or Proposed INN: ETANERCEPT
Other descriptive name: Etanercept

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

2800

Phase 4

United States;Philippines;Greece;Ecuador;Spain;Chile;Russian Federation;Israel;Italy;India;Malaysia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany

1120

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

1121

EUCTR2010-022224-77-GB
(EUCTR)

27/04/2011

21/12/2010

Open-label study to assess the safety and efficacy of CDP6038 in patients who completed RA0056

Product Name: CDP6038
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: Recombinant human Mab of IgG4 subtype

UCB Biosciences Inc

NULL

Not Recruiting

Female: yes
Male: yes

190

Phase 2

United States;Belgium;United Kingdom

1122

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

1123

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

1124

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

1125

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

1126

EUCTR2010-023587-40-ES
(EUCTR)

13/04/2011

17/02/2011

A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF.

Adult Rheumatoid Arthritis (RA)Artritis reumatoide del adulto (AR)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Finland;Germany;Netherlands;Spain;Italy;Greece;Sweden

1127

EUCTR2010-018485-24-ES
(EUCTR)

12/04/2011

04/11/2010

Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal

Biotest AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

176

Hungary;Germany;Czech Republic;Spain;Latvia

1128

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

1129

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

1130

EUCTR2010-023692-26-GB
(EUCTR)

07/04/2011

18/11/2010

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2

United States;Slovakia;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1131

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

1132

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

1133

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

1134

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

1135

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

No.

TrialID

Date_
enrollment

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

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

1137

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

1138

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

1139

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

1140

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-022208-36-BG
(EUCTR)

24/03/2011

24/02/2011

An Open Label Study for Patients With Rheumatoid Arthritis (FLEX-P)

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) (FLEX-P)

Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: Not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: Not available

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1505

Phase 3b

United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Sri Lanka;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;Lithuania;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

1142

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

1143

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

1144

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

1145

EUCTR2010-022208-36-ES
(EUCTR)

21/03/2011

29/12/2010

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)Estudio en fase 3b, multicéntrico y abierto paraevaluar la seguridad y la eficacia a largo plazo deLY2127399 en pacientes con artritis reumatoide(AR)

Rheumatoid ArthritisArtritis Reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1505

Phase 3b

Hungary;Germany;Bulgaria;Spain;Greece;Poland;Lithuania

No.

TrialID

Date_
enrollment

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

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

1147

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

1148

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

1149

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

1150

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

No.

TrialID

Date_
enrollment

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

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

1152

EUCTR2010-023469-22-NL
(EUCTR)

09/03/2011

02/12/2010

A phase II study of ARA 290 as therapeutic strategy in rheumatoid arthritis - ARA 290 in ARA

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: ARA290
Product Code: ARA290

LUMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Netherlands

1153

EUCTR2009-016055-22-SE
(EUCTR)

09/03/2011

11/01/2011

Hepatitis A vaccine in patients with immunomodulative drugs

Patients with rheumatoid arthritis treated with immunosuppressive medication
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Classification code 10054980;Term: Immunosuppressant drug therapy
MedDRA version: 12.1;Classification code 10063430;Term: Hepatitis A immunisation

Trade Name: Epaxal
Product Name: Epaxal
Other descriptive name: Inactivated hepatitis A virus
Trade Name: Havrix
Product Name: Havrix
Other descriptive name: inactivated hepatitis A virus

HY, HUS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

380

Finland;Sweden

1154

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

1155

NCT01284569
(ClinicalTrials.gov)

March 2011

21/1/2011

Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients

A Phase I/II, Randomised, Double-Blind, Placebo Controlled Study, Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Single and Multiple Intravenous Doses of ALX-0061 in Patients With RA

Rheumatoid Arthritis

Biological: ALX-0061;Biological: Placebo

Ablynx

NULL

Completed

18 Years

80 Years

All

Phase 1;Phase 2

Czechia;Hungary;Poland;Czech Republic;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1156

NCT01317797
(ClinicalTrials.gov)

March 2011

18/2/2011

A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis

A Phase Ib Double-blind, Placebo-controlled, Randomized, Dose-escalating Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Subcutaneous Injections of MT203 in Patients With Mild to Moderate Rheumatoid Arthritis on Treatment With Methotrexate

Rheumatoid Arthritis

Drug: namilumab (MT203);Drug: Placebo

Takeda

NULL

Completed

18 Years

N/A

All

Phase 1

Bulgaria;Netherlands

1157

EUCTR2010-020839-39-GB
(EUCTR)

25/02/2011

12/10/2010

Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with an unsuccessful response to anti-TNF therapy

Product Name: Olikizumab
Product Code: CDP6038
INN or Proposed INN: Olokizumab
Other descriptive name: Recombinant human Mab of IgG4 subtype
Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion.
Product Name: Tocilizumab
INN or Proposed INN: RoActemra ®
Other descriptive name: TOCILIZUMAB

UCB Biosciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

220

United Kingdom;United States

1158

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

1159

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

1160

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

No.

TrialID

Date_
enrollment

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

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

1162

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

1163

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

1164

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

1165

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

1166

EUCTR2010-020892-22-DE
(EUCTR)

17/02/2011

21/07/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

Serbia;Portugal;United States;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;Australia;South Africa;Netherlands;Latvia;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

1167

EUCTR2010-020744-35-DE
(EUCTR)

17/02/2011

21/07/2010

Evaluation of Effectiveness of Two Dosing Regimens of FostamatinibCompared to Placebo in Patients With Rheumatoid Arthritis (RA) WhoAre Taking Disease Modifying Anti-rheumatic Drug (DMARD) But NotResponding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Portugal;Serbia;United States;Spain;Ukraine;Lithuania;Israel;Italy;United Kingdom;India;Czech Republic;Canada;Romania;South Africa;Latvia;Germany

1168

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

1169

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

1170

EUCTR2009-012615-18-FR
(EUCTR)

16/02/2011

05/11/2010

Efficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency - SCORPION

Rheumatoid arthritis (RA)
MedDRA version: 12.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: UVEDOSE
INN or Proposed INN: COLECALCIFEROL

CHU de Clermont-Ferrand

NULL

Not Recruiting

Female: yes
Male: yes

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1171

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

1172

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

1173

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

1174

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

1175

EUCTR2010-020892-22-IT
(EUCTR)

08/02/2011

22/12/2010

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA-X

Patients with active Rheumatoid Arthritis (RA) who have participated in a qualifying study.
MedDRA version: 9.1;Level: PT;Classification code 10039073

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

2000

Portugal;Czech Republic;Estonia;Hungary;Spain;Lithuania;Bulgaria;Latvia;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1176

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

1177

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

1178

EUCTR2010-022504-42-HU
(EUCTR)

04/02/2011

23/11/2010

A study to evaluate the efficacy of different doses of LY3009104 therapy compared to placebo in patients with Rheumatoid Arthritis who are on ongoing methotrexate background therapy.

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients with Active Rheumatoid Arthritis on background Methotrexate Therapy

Product Name: LY3009104
Product Code: LY3009104
INN or Proposed INN: Not available
Other descriptive name: JAK1 / JAK2 Inhibitor
Product Name: LY3009104
Product Code: LY3009104
INN or Proposed INN: Not available
Other descriptive name: JAK1 / JAK2 Inhibtor

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

270

Phase 2b

United States;Czech Republic;Hungary;Mexico;Argentina;Poland;Ukraine;Croatia;Romania;Peru;United Kingdom;India

1179

EUCTR2010-019262-86-NL
(EUCTR)

02/02/2011

24/06/2010

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

1180

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

No.

TrialID

Date_
enrollment

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

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

1182

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

1183

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

1184

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

1185

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-019912-18-ES
(EUCTR)

17/01/2011

19/01/2011

A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.

Rheumatoid arthritis (RA)Artritis Reumatoide (AR)
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: tocilizumab 162mg/0.9ml SC PFS SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6;

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Hungary;Spain;Greece

1187

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

1188

EUCTR2010-020892-22-BG
(EUCTR)

13/01/2011

09/11/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium (FosD) in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

1189

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

1190

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

1191

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

1192

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

1193

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

1194

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

1195

EUCTR2010-019134-27-BG
(EUCTR)

23/12/2010

18/10/2010

A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY

Rhuematoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Product Name: CH-4051
Product Code: CH-4051
INN or Proposed INN: Dipotassium Salt
Trade Name: Methotrexate 10 mg tablets
Product Name: Methotrextate
INN or Proposed INN: Methotrexate
Trade Name: Folimet
Product Name: Folic Acid
INN or Proposed INN: Folic Acid

Chelsea Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2

United States;Czech Republic;Mexico;Argentina;Poland;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1196

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

1197

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

1198

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

1199

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

1200

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

1201

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

1202

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

1203

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

1204

EUCTR2010-020745-27-FR
(EUCTR)

14/12/2010

05/10/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Hungary;Portugal;Czech Republic;Germany;United Kingdom;France;Spain;Italy

1205

EUCTR2010-020743-12-FR
(EUCTR)

14/12/2010

05/10/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

Hungary;Germany;United Kingdom;Bulgaria;Estonia;France;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1206

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

1207

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

1208

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

1209

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

1210

EUCTR2009-015898-12-NL
(EUCTR)

10/12/2010

10/06/2010

Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination with Methotrexate, Administered for 12 Weeks to Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Patients with active rheumatoid arthritis and an inadequate response to Methotrexate
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259
Product Name: GLPG0259
Product Code: GLPG0259

Galápagos NV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Netherlands;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1211

EUCTR2010-021435-14-NL
(EUCTR)

06/12/2010

24/06/2010

Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis

rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667

Academisch Medisch Centrum Amsterdam

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

1212

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

1213

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

1214

EUCTR2010-018375-22-BG
(EUCTR)

25/11/2010

23/09/2010

A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.

Product Name: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody
Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

United States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand

1215

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

No.

TrialID

Date_
enrollment

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

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

1217

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

1218

EUCTR2009-017306-36-NL
(EUCTR)

19/11/2010

19/08/2010

ANTI-IGE THERAPY (OMALIZUMAB) IN IGE-ACPA POSITIVE RA. - TIGER

RHEUMATOID ARTHRITIS
MedDRA version: 12.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid

Trade Name: Xolair
Product Name: OMALIZUMAB
INN or Proposed INN: OMALIZUMAB
Other descriptive name: Xolair

Leiden University Medical Center, Department of Rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

1219

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

1220

EUCTR2009-015019-42-FI
(EUCTR)

17/11/2010

27/09/2010

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

170

United States;Serbia;Finland;Lithuania;Austria;Russian Federation;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1221

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

1222

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

1223

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

1224

EUCTR2010-018674-20-DK
(EUCTR)

05/11/2010

21/09/2010

Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination WithMethotrexate in Adults With Very Early Rheumatoid Arthritis (RA)

A Phase 3b, Randomized, Active Controlled Trial to Evaluate the Efficacy and Safety ofAbatacept SC in Combination with Methotrexate in Inducing Clinical RemissionCompared to Methotrexate Monotherapy in Adults with Very Early RA.Revised protocol 01 incorporating protocol amendment 01

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: METHOTREXATE HOSPIRA 2,5 mg tablety
INN or Proposed INN: METHOTREXATE
Other descriptive name: MTX

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

470

Phase 3b

United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Denmark;Australia;South Africa;Germany;Korea, Republic of;Sweden

1225

EUCTR2010-018646-31-ES
(EUCTR)

05/11/2010

12/08/2010

Estudio de fase 3, aleatorizado, doble ciego y con grupos paralelos para demostrar la equivalencia en eficacia y seguridad de CT-P13 comparado con Remicade cuando se administra con metotrexato a pacientes con artritis reumatoide activa.A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis -

Artritis reumatoide.Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: REMICADE 100 mg polvo para concentrado para solución para perfusión
INN or Proposed INN: INFLIXIMAB
Other descriptive name: INFLIXIMAB

CELLTRION, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

584

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

No.

TrialID

Date_
enrollment

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

EUCTR2010-018674-20-DE
(EUCTR)

05/11/2010

17/08/2010

Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination With Methotrexate in Adults With Very Early Rheumatoid Arthritis (RA)

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

470

Phase 3b

United States;Finland;Russian Federation;Italy;France;Mexico;Canada;Australia;Denmark;South Africa;Germany;Korea, Republic of;Sweden

1227

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

1228

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

1229

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

1230

EUCTR2009-016266-90-NL
(EUCTR)

01/11/2010

16/04/2010

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191
Product Name: SAR153191
Product Code: SAR153191

Sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1740

Portugal;Hungary;Finland;Germany;Czech Republic;Netherlands;Estonia;Spain;Greece;Austria;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1231

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

1232

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

1233

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

1234

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

1235

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

No.

TrialID

Date_
enrollment

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

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

1237

EUCTR2010-020744-35-LV
(EUCTR)

22/10/2010

13/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;Czech Republic;Canada;Romania;South Africa;Latvia;Germany

1238

EUCTR2010-020892-22-LV
(EUCTR)

22/10/2010

13/08/2010

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in theTreatment of Rheumatoid Arthritis (RA) (OSKIRA-X)

A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis - OSKIRA - X

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

2000

United States;Portugal;Serbia;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Peru;South Africa;Latvia;Netherlands;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany

1239

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

1240

EUCTR2010-018485-24-CZ
(EUCTR)

20/10/2010

24/08/2010

To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritis

Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

128

Hungary;Czech Republic;Spain;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1241

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

1242

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

1243

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

1244

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

1245

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

1246

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

1247

EUCTR2007-006129-29-PL
(EUCTR)

14/10/2010

21/04/2010

A multicentre, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, preliminary clinical activity and immunogenicity of multiple doses of MOR103 administered intravenously to patients with active rheumatoid arthritis - MOR103 Rheumatoid Arthritis PoC Study

Product Name: MOR103
Product Code: MOR103
Other descriptive name: Human Recombinant IgG1, lambda

MorphoSys AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Ukraine;Netherlands;Belarus;Bulgaria;Poland

1248

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

1249

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

1250

EUCTR2010-018646-31-LV
(EUCTR)

11/10/2010

29/06/2010

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Level: PT;Term: Rheumatoid arthritis

Product Name: CT-P13
Product Code: CT-P13
INN or Proposed INN: Infliximab
Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB

CELLTRION, Inc

NULL

Not Recruiting

Female: yes
Male: yes

633

Phase 3

Portugal;United Kingdom;Bulgaria;Spain;Italy;Latvia;Austria;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1251

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

1252

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

1253

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

1254

EUCTR2010-020744-35-LT
(EUCTR)

11/10/2010

18/08/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia

1255

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

1256

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

1257

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

1258

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

1259

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

1260

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-018375-22-DE
(EUCTR)

05/10/2010

14/07/2010

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1200

1262

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

1263

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

1264

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

1265

EUCTR2010-021449-28-FR
(EUCTR)

04/10/2010

09/08/2010

Valeur prédictive de la concentration sérique d’Adalimumab (Humira) sur la réponse clinique dans la polyarthrite rhumatoïde - AFORA

Polyarthrite rhumatoïde
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB

CHRU de TOURS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

No.

TrialID

Date_
enrollment

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

EUCTR2010-018646-31-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

1267

EUCTR2006-005035-19-HU
(EUCTR)

01/10/2010

19/09/2007

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TASOCITINIB (CP-690,550) FOR TREATMENT OF RHEUMATOID ARTHRITIS - N/A

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

Product Name: CP -690,550
Product Code: CP -690,550
Product Name: CP -690,550
Product Code: CP -690,550

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

4000

Hungary;Germany;Bulgaria;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Spain;Greece

1268

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

1269

NCT01164579
(ClinicalTrials.gov)

October 2010

15/7/2010

Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tasocitinib plus Methotrexate;Drug: Tofacitinib plus placebo methotrexate;Drug: Placebo tofacitinib plus Methotrexate

Pfizer

NULL

Completed

18 Years

N/A

All

109

Phase 2

United States;Argentina;Chile;Croatia;Czech Republic;Hungary;Mexico;Poland;Puerto Rico

1270

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-019262-86-GR
(EUCTR)

28/09/2010

23/09/2010

A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: N/A
Product Code: SAR153191

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Hungary;Finland;Germany;Netherlands;Estonia;Spain;Greece;Austria;Lithuania

1272

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

1273

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

1274

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

1275

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

No.

TrialID

Date_
enrollment

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

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

1277

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

1278

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

1279

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

1280

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-018646-31-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

1282

EUCTR2010-018674-20-FR
(EUCTR)

10/09/2010

16/08/2010

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

470

Phase 3b

Finland;Germany;Denmark;France;Italy;Sweden

1283

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

1284

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

1285

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

No.

TrialID

Date_
enrollment

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

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

1287

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

1288

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

1289

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

1290

EUCTR2010-018375-22-ES
(EUCTR)

03/08/2010

04/06/2010

A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.

Rheumatoid arthritisArtritis Reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: tocilizumab 162mg/0.9ml jeringa SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Germany;United Kingdom;Bulgaria;Spain;Italy;Lithuania

No.

TrialID

Date_
enrollment

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

JPRN-JapicCTI-101263

01/8/2010

DRIVE

A Dose-response Study of AMG 162 (Denosumab) in Patients with Rheumatoid Arthritis on Methotrexate (MTX) to Validate Inhibitory Effect on Bone Erosion (Phase II)

Rheumatoid Arthritis

Intervention name : AMG 162
INN of the intervention : Denosumab
Dosage And administration of the intervention : AMG 162 60 mg administered subcutaneously - Every 6 months/ Every 3 months/ Every 2 months
Control intervention name : Placebo
Dosage And administration of the control intervention : Subcutaneously for placebo

DAIICHISANKYO Co.,Ltd.

NULL

BOTH

320

Phase 2

NULL

1292

EUCTR2010-018375-22-IT
(EUCTR)

29/07/2010

05/07/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: tocilizumab 162mg/0.9ml syringe SC
Product Code: Ro 487-7533/F10
INN or Proposed INN: tocilizumab
Trade Name: RoActemra
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1200

Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy

1293

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

1294

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

1295

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-019262-86-HU
(EUCTR)

21/07/2010

27/05/2010

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2025

Phase 3

1297

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

1298

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

1299

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

1300

EUCTR2009-017051-10-NL
(EUCTR)

13/07/2010

25/05/2010

Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritis

Patients with rheumatoid arthritis, who suffer from a exacerbation of disease can be included in this study. Exacerbation is defined as a Disease Activity Score of 5.1 or higher.Patients will be excluded if they suffer from diabetes (irrespective of medication) or if they have a contra-indication for dexamethason use.
MedDRA version: 12.0;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up

Trade Name: Dexamethason
Product Name: dexamethason

UMC Utrecht

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

No.

TrialID

Date_
enrollment

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

EUCTR2009-010516-15-GR
(EUCTR)

13/07/2010

21/04/2010

Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate

Rheumatoid arthritis (seropositive)
MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis

Product Name: SBI-087
Product Code: SBI-087
INN or Proposed INN: n/a
Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Hungary;Spain;Greece;Poland

1302

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

1303

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

1304

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

1305

EUCTR2010-019262-86-FI
(EUCTR)

01/07/2010

19/05/2010

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 3

Portugal;United States;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

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

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

1307

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

1308

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

1309

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

1310

EUCTR2010-019262-86-EE
(EUCTR)

18/06/2010

21/05/2010

Long term evaluation of sarilumab in rheumatoid arthritis patients

A multi-center, uncontrolled extension study evaluating the efficacy and safety of sarilumab in patients with active Rheumatoid Arthritis (RA) - RA-EXTEND

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2000

Phase 3

Poland;Belgium;Brazil;Romania;Norway;Germany;New Zealand;Sweden;Portugal;United States;Belarus;Philippines;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina

No.

TrialID

Date_
enrollment

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

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

1312

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

1313

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

1314

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

1315

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

No.

TrialID

Date_
enrollment

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

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

1317

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

1318

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

1319

NCT01132118
(ClinicalTrials.gov)

June 2010

25/5/2010

Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis

Rheumatoid Arthritis;Insulin Resistance

Drug: Hydroxychloroquine

Brigham and Women's Hospital

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

Completed

18 Years

N/A

All

Phase 3

United States

1320

EUCTR2008-007185-33-NL
(EUCTR)

20/05/2010

28/09/2009

A Seamless, Phase 1/2, Multiple Ascending Dose, Proof of Concept Study of ATN-103Administered to Subjects With Active Rheumatoid Arthritis on a Background ofMethotrexate

Rheumatoid arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ATN-103
Product Code: ATN-103

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 1;Phase 2

Hungary;United Kingdom;Germany;Netherlands;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1321

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

1322

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

1323

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

1324

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

1325

EUCTR2010-019438-28-SE
(EUCTR)

17/05/2010

18/03/2010

Vaccination against TBE in patients who use immunosuppressive drugs

TBE vaccin in patients using immunosuppressive drugs
MedDRA version: 12.1;Level: LLT;Classification code 10046859;Term: Vaccination
MedDRA version: 12.1;Classification code 10037153;Term: Psoriasis
MedDRA version: 12.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Classification code 10054980;Term: Immunosuppressant drug therapy

Trade Name: FSME-IMMUN
Other descriptive name: TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED)

Mälarsjukhuset Eskilstuna

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Sweden

No.

TrialID

Date_
enrollment

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

EUCTR2010-018331-18-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

1327

EUCTR2009-015740-42-DE
(EUCTR)

12/05/2010

12/01/2010

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO

Rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Prednisolon
Product Code: Prednisolon
INN or Proposed INN: PREDNISOLONE
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Name: Azathioprin
Other descriptive name: AZATHIOPRINE
Trade Name: Immunosporin
Product Name: Immunosporin
INN or Proposed INN: CICLOSPORIN
Trade Name: Cimzia
Product Name: Cimzia
INN or Proposed INN: GOLIMUMAB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Product Name: Quensyl
Other descriptive name: HYDROXYCHLOROQUINE SULFATE
Trade Name: REMICADE
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Lantarel
Product Name: Lantarel
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Lantarel
Trade Name: Arava
Product Name: Arava
INN or Proposed INN: LEFLUNOMIDE
Other descriptive name: Arava
Product Name: Metex 2,5mg
INN or Proposed INN: METHOTREXATE SODIUM
Other descriptive name: Metex 2,5mg

Universitätsklinkum Erlangen

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Germany

1328

EUCTR2009-015845-21-ES
(EUCTR)

12/05/2010

12/01/2012

A comparison of tocilizumab and adalimumab in patients withrheumatoid arthritis looking at improvement in joint pain, joint swellingand general disease activity.

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Portugal;Germany;Switzerland;Turkey;Sweden;Australia;Brazil;Finland;United Kingdom;Czech Republic;Mexico;Belgium;Spain;Greece;United States

1329

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

1330

EUCTR2009-010516-15-ES
(EUCTR)

11/05/2010

29/07/2009

Ensayo aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de SBI-087 en sujetos seropositivos con artritis reumatoide activa en tratamiento de fondo estable con metotrexatoRandomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate

Rheumatoid arthritis (seropositive)Artritis reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis

Product Name: SBI-087
Product Code: SBI-087
INN or Proposed INN: n/a
Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Hungary;Spain;Greece;Poland

No.

TrialID

Date_
enrollment

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

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

1332

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

1333

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

1334

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

1335

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

1336

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

1337

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

1338

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

1339

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

1340

EUCTR2010-018696-21-FR
(EUCTR)

14/04/2010

15/02/2010

Etude de l’évolution de la réponse immunitaire Th17 chez des patients atteints de polyarthrite rhumatoïde et traités par tocilizumab après échec des autres thérapies - TOCI 17

Polyarthrite rhumatoïde
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoACTEMRA
Product Name: TOCILIZUMAB

CHU DIJON

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

No.

TrialID

Date_
enrollment

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

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

1342

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

1343

EUCTR2009-014296-40-AT
(EUCTR)

07/04/2010

29/12/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE WITH INADEQUATE RESPONSE TO TNF INHIBITORS

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

1344

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

1345

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

No.

TrialID

Date_
enrollment

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

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

1347

EUCTR2009-012566-32-HU
(EUCTR)

31/03/2010

20/11/2009

Rheumatoid arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 827
Product Code: AMG 827
INN or Proposed INN: AMG 827

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Hungary;United Kingdom;Czech Republic;Bulgaria;Latvia;Poland

1348

EUCTR2007-006657-63-HU
(EUCTR)

26/03/2010

15/02/2010

Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA) - DOSERA

Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Enbrel 25 mg powder and solvent for solution for injection
Product Name: Enbrel
Trade Name: Enbrel 50 mg powder and solvent for solution for injection
Product Name: Enbrel

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

186

Finland;Hungary;Iceland;Denmark;Sweden

1349

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

1350

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

No.

TrialID

Date_
enrollment

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

EUCTR2009-016266-90-FI
(EUCTR)

23/03/2010

29/12/2009

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

Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191
INN or Proposed INN: Sarilumab
Product Name: Sar

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1594

Portugal;Belarus;United States;Philippines;Estonia;Taiwan;Greece;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;India;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Finland;Lithuania;Turkey;Austria;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Romania;Germany;New Zealand

1352

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

1353

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

1354

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

1355

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

No.

TrialID

Date_
enrollment

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

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

1357

EUCTR2009-016266-90-HU
(EUCTR)

03/03/2010

30/12/2009

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

Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab
Product Name: Sarilumab
Product Code: SAR153191 (REGN88)
INN or Proposed INN: Sarilumab

sanofi-aventis recherche & développement

NULL

Not Recruiting

Female: yes
Male: yes

1594

1358

EUCTR2009-010516-15-PL
(EUCTR)

03/03/2010

21/08/2009

Rheumatoid arthritis (seropositive)
MedDRA version: 13.1;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: SBI-087
Product Code: SBI-087
INN or Proposed INN: n/a
Other descriptive name: Anti-CD20 small modular immunopharmaceutical, WYE-400087

Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Greece;Spain;Poland

1359

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

1360

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

No.

TrialID

Date_
enrollment

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

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

1362

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

1363

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

1364

EUCTR2009-016789-10-NL
(EUCTR)

19/02/2010

17/11/2009

Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximab

To assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapy

Trade Name: Focetria
Trade Name: Pandemrix,

Div KIR AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

1365

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

No.

TrialID

Date_
enrollment

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

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

1367

EUCTR2009-017325-19-FI
(EUCTR)

11/02/2010

28/12/2009

The effect of Six months Adalimumab Treatment on Sick Leaves and retirement in Patients with rheumatoid Arthritis who are at risk of losing their ability to work”

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 12.1;Term: Rheumatoid arthritis

Trade Name: HUMIRA
INN or Proposed INN: ADALIMUMAB

Helsingin reumakeskus

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Finland

1368

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

1369

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

1370

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

No.

TrialID

Date_
enrollment

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

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

1372

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

1373

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

1374

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

1375

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

No.

TrialID

Date_
enrollment

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

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

1377

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

1378

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

1379

EUCTR2009-012759-12-PT
(EUCTR)

12/01/2010

21/10/2009

A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
Other descriptive name: Methotrexate as methotrexate disodium

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Australia;Denmark;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden

1380

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

No.

TrialID

Date_
enrollment

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

EUCTR2009-012759-12-SE
(EUCTR)

12/01/2010

17/11/2009

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1128

Phase 3

1382

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

1383

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

1384

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

1385

NCT01198509
(ClinicalTrials.gov)

January 2010

8/9/2010

Role of Oral and Intestinal Microbiota in Rheumatoid Arthritis (RA)

Rheumatoid Arthritis;Psoriatic Arthritis;Periodontal Disease

Drug: doxycycline;Drug: vancomycin

New York University School of Medicine

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Memorial Sloan Kettering Cancer Center

Completed

18 Years

70 Years

All

178

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

1386

NCT01034137
(ClinicalTrials.gov)

January 2010

16/12/2009

A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis

U-ACT-EARLY: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Evaluate Remission in DMARD and Biological naïve Early Rheumatoid Arthritis (RA) Subjects Treated With Tocilizumab (TCZ) Plus Tight Control Methotrexate (MTX) , TCZ Monotherapy or Tight Control MTX Monotherapy

Rheumatoid Arthritis

Drug: methotrexate;Drug: placebo MTX;Drug: placebo TCZ;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

317

Phase 3

Netherlands

1387

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

1388

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

1389

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

1390

EUCTR2009-014735-20-EE
(EUCTR)

29/12/2009

27/10/2009

A Clinical Trial to investigate the effects of Mavrilimumab, a drug used in clinical research, in subjects with rheumatoid arthritis, which is a disease causing pain and swelling in joints.

A Phase 2 Randomised, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Efficacy and Safety of CAM-3001 in Subjects with Rheumatoid Arthritis - EARTH

Product Name: mavrilimumab
Product Code: CAM-3001
INN or Proposed INN: mavrilimumab
Other descriptive name: anti-GM-CSF receptor alpha

MedImmune Ltd

NULL

Not Recruiting

Female: yes
Male: yes

264

Phase 2

Hungary;Czech Republic;Estonia;Poland;Ukraine;Lithuania;Romania;Bulgaria;Russian Federation;Latvia;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1391

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

1392

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

1393

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

1394

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

1395

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

No.

TrialID

Date_
enrollment

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

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

1397

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

1398

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

1399

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

1400

EUCTR2009-011137-26-DK
(EUCTR)

07/12/2009

02/11/2009

Active Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: Simponi
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab
Product Name: Golimumab
Product Code: SCH 900259
INN or Proposed INN: Golimumab

Schering-Plough Research Institute, A Division of Schering Corporation

NULL

Not Recruiting

Female: yes
Male: yes

3150

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1401

EUCTR2008-004894-16-HU
(EUCTR)

03/12/2009

17/11/2008

Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Hungary;Czech Republic;Germany;Poland

1402

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

1403

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

1404

EUCTR2009-012759-12-ES
(EUCTR)

01/12/2009

23/09/2009

Estudio multicéntrico, doble ciego, randomizado, con grupos de tratamiento paralelos, para evaluar la seguridad, la remisión de la enfermedad y la prevención del daño estructural articular durante el tratamiento con tocilizumab (TCZ) en monoterapia y en combinación con metotrexato (MTX), frente a metotrexato en monoterapia, en pacientes con artritis reumatoide precoz, moderada a severa. A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.

Artritis ReumatoideRheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium
Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB
Trade Name: ROACTEMRA
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1128

Hungary;Portugal;Finland;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Sweden

1405

EUCTR2009-012041-35-FR
(EUCTR)

27/11/2009

16/10/2009

A phase II, randomized, partially double blind, controlled study to evaluate the immunogenicity, safety, and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis (RA) who have relapsed despite use of an anti-TNFa biological drug, due to anti-drug antibodies

Rheumatoid arthritis
MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: TNF-Kinoid
Product Code: TNF-K

Neovacs SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Bulgaria;France

No.

TrialID

Date_
enrollment

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

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

1407

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

1408

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

1409

EUCTR2009-013223-37-ES
(EUCTR)

25/11/2009

17/09/2009

Estudio en fase 2a, aleatorizado, doble ciego, controlado con un fármaco activo y con placebo, de PF-04171327 en el tratamiento de los signos y síntomas de la artritis reumatoideA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS

ARTRITIS REUMATOIDE
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: PF-04171327
Product Code: PF-04171327
Product Name: PF-04171327
Product Code: PF-04171327
Trade Name: DECORTIN (PREDNISONA) 5 MG COMPRIMIDOS
INN or Proposed INN: Prednisone
Other descriptive name: Decortin®

Pfizer S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

119

Phase 2A

Hungary;Spain

1410

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

1411

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

1412

EUCTR2009-012759-12-FR
(EUCTR)

13/11/2009

09/10/2009

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra ®
Product Code: Ro 487-7533/F01
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' Tablets
Product Code: Ro 002-9893/F02
INN or Proposed INN: Methotrexate Disodium

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1128

Hungary;Portugal;Finland;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Sweden

1413

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

1414

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

1415

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

No.

TrialID

Date_
enrollment

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

EUCTR2009-012759-12-IT
(EUCTR)

12/11/2009

17/11/2009

Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: RoActemra
INN or Proposed INN: Tocilizumab
Trade Name: Methotrexate ``Lederle`` 2.5mg tablets
INN or Proposed INN: Methotrexate

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1128

Hungary;Portugal;Finland;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Sweden

1417

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

1418

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

1419

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

1420

EUCTR2009-013223-37-CZ
(EUCTR)

10/11/2009

17/08/2009

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, ACTIVE AND PLACEBO CONTROLLED STUDY OF PF-04171327 IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: PF-04171327
Product Code: PF-04171327
Product Name: PF-04171327
Product Code: PF-04171327
INN or Proposed INN: Prednisone
Other descriptive name: Decortin®

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

119

Phase 2

Hungary;Czech Republic;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1421

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

1422

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

1423

EUCTR2008-005450-20-BE
(EUCTR)

29/10/2009

01/10/2009

The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)

Rheumatoid arthritis
MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade (infliximab)
INN or Proposed INN: INFLIXIMAB
Other descriptive name: remicade
Trade Name: Humira (adalimumab)
INN or Proposed INN: ADALIMUMAB
Trade Name: Enbrel (etanercept)
INN or Proposed INN: ETANERCEPT
Other descriptive name: Enbrel
Trade Name: Mabthera (rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: Mabthera
Trade Name: Orencia (abatacept)
INN or Proposed INN: ABATACEPT
Other descriptive name: Orencia

Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

261

Belgium

1424

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

1425

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

No.

TrialID

Date_
enrollment

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

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

1427

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

1428

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

1429

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

1430

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

No.

TrialID

Date_
enrollment

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

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

1432

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

1433

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

1434

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

1435

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

No.

TrialID

Date_
enrollment

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

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

1437

NCT00929864
(ClinicalTrials.gov)

October 2009

29/6/2009

Abatacept Versus Adalimumab Head-to-Head

A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Abatacept;Drug: Adalimumab

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

869

Phase 3

United States;Argentina;Canada;Chile;Peru

1438

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

1439

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

1440

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

No.

TrialID

Date_
enrollment

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

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

1442

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

1443

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

1444

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

1445

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

No.

TrialID

Date_
enrollment

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

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

1447

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

1448

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

1449

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

1450

NCT00975130
(ClinicalTrials.gov)

September 2009

20/8/2009

Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)

An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission (Part 2)

Arthritis, Rheumatoid

Biological: SC golimumab;Biological: IV golimumab

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

3366

Phase 3

Argentina;Austria;Belgium;Brazil;Canada;Chile;Colombia;Czech Republic;Denmark;Ecuador;Finland;France;Germany;Greece;Guatemala;Hungary;Ireland;Israel;Italy;Korea, Republic of;Mexico;Monaco;Netherlands;Norway;Panama;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;United Kingdom

No.

TrialID

Date_
enrollment

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

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

1452

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

1453

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

1454

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

1455

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

1456

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

1457

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

1458

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

1459

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

1460

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

No.

TrialID

Date_
enrollment

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

EUCTR2008-008338-35-FI
(EUCTR)

13/08/2009

14/05/2009

CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: Humira
Product Name: Humira

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

NULL

Not Recruiting

Female: yes
Male: yes

700

Phase 3

Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain

1462

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

1463

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

1464

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

1465

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

No.

TrialID

Date_
enrollment

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

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

1467

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

1468

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

1469

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

1470

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

No.

TrialID

Date_
enrollment

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

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

1472

EUCTR2009-010955-29-NL
(EUCTR)

13/07/2009

27/02/2009

Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.

Pre-clinical RA patients with a high risk on developing the disease.

Trade Name: MabThera 500 mg (10mg/ml)
INN or Proposed INN: Rituximab

Division of Clinically Immunology and Rheumatology, AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

1473

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

1474

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

1475

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

No.

TrialID

Date_
enrollment

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

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

1477

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

1478

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

1479

EUCTR2008-008338-35-ES
(EUCTR)

19/06/2009

27/03/2009

PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATEEstudio de fase 3 aleatorizado, doble ciego, con comparador activo y controlado con placebo de la eficacia y la seguridad de dos dosis de CP-690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con metotrexato

CP 690,550 está estudiándose como fármaco antirreumático modificador de la enfermedad (FARME) en el tratamiento de la artritis reumatoide activa moderada o grave en adultosCP-690,550 ins being studied as a DMARD for the treatment of moderate to severe active RA in adults.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB

Pfizer, S.A

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Phase 3

Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain

1480

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

No.

TrialID

Date_
enrollment

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

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

1482

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

1483

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

1484

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

1485

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

1486

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

1487

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

1488

JPRN-JapicCTI-090764

01/6/2009

26/05/2009

Long-Term Treatment Study of Ocrelizumab for Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : Ocrelizumab
Dosage And administration of the intervention : 500 mg will be administered by intravenous infusion on Day 1 and Day 15. Repeat courses of therapy with ocrelizumab may be administered basically every 24 weeks, a minimum interval of 12 weeks, between courses.

Chugai Pharmaceutical Co., Ltd.

NULL

BOTH

200

Phase 3

NULL

1489

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

1490

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

No.

TrialID

Date_
enrollment

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

EUCTR2008-006917-25-CZ
(EUCTR)

22/05/2009

11/03/2009

A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).

Patients with active rheumatoid arthritis who are on a stable dose of methotrexate

Product Name: Tranilast
INN or Proposed INN: Tranilast
Product Name: Tranilast
INN or Proposed INN: Tranilast

Nuon Therapeutics, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 2

United Kingdom;Germany;Czech Republic;Bulgaria;Poland

1492

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

1493

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

1494

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

1495

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

No.

TrialID

Date_
enrollment

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

EUCTR2009-011105-17-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

1497

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

1498

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

1499

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

1500

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

1501

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

1502

EUCTR2008-008309-23-FR
(EUCTR)

24/04/2009

31/03/2009

Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDO

Polyarthrite rhumatoïde active modérée à sévère de moins de 10 ans d'ancienneté, avec réponse inadéquate au méthotrexate (MTX) et/ou à un autre DMARD et/ou à au moins un anti-TNF
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: RoActemra
Product Code: RO487-7533/F01-F05
INN or Proposed INN: tolicizumab

ROCHE

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

1503

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

1504

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

1505

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

No.

TrialID

Date_
enrollment

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

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

1507

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

1508

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

1509

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

1510

EUCTR2008-006075-75-GB
(EUCTR)

14/04/2009

28/04/2009

A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AK106-001616
Trade Name: Naprosyn 500 mg
Product Name: Naprosyn 500 mg
INN or Proposed INN: naproxen

Asahi Kasei Pharma Corporation

NULL

Not Recruiting

Female: yes
Male: yes

130

Phase 2a

Hungary;Czech Republic;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1511

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

1512

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

1513

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

1514

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

1515

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

1516

EUCTR2008-005427-28-FR
(EUCTR)

02/04/2009

19/03/2009

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

UCB Pharma SA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1048

Phase 3b

Germany;Netherlands;France;Spain;Italy

1517

JPRN-JapicCTI-090751

01/4/2009

A study of Adalimumab in Japanese subjects with Rheumatoid Arthritis

A Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects with Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : 40 mg every other week, subcutaneous
Control intervention name : Placebo
Dosage And administration of the control intervention : every other week, subcutaneous

Abbott Japan Co., Ltd.

Eisai Co., Ltd.

BOTH

300

Phase 3

NULL

1518

NCT00763139
(ClinicalTrials.gov)

April 2009

26/9/2008

Inflammation and Insulin Resistance in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Pioglitazone;Drug: Placebo

Vanderbilt University

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

Completed

18 Years

N/A

All

N/A

United States

1519

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

1520

EUCTR2008-004875-23-FR
(EUCTR)

31/03/2009

16/04/2009

An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

236

Hungary;Germany;Belgium;France;Austria;Poland

No.

TrialID

Date_
enrollment

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

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

1522

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

1523

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

1524

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

1525

EUCTR2008-000744-13-BG
(EUCTR)

19/03/2009

26/01/2009

Long Term Follow On Safety Study of Fostamatinib in Patients Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788
Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

800

France;United States;Mexico;Belgium;Poland;Romania;Peru;Bulgaria;Germany;Colombia;Italy

No.

TrialID

Date_
enrollment

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

EUCTR2007-005288-86-FR
(EUCTR)

18/03/2009

30/07/2008

A Phase IIIb, open-label, run-in and double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of certolizumab pegol administered concomitantly with stable-dose methotrexate in patients with active rheumatoid arthritis

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: Anti-TNF humanized antibody Fab' fragment - PEG conjugate

UCB Pharma S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

335

Phase 3b

France

1527

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

1528

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

1529

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

1530

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

1531

NCT00837434
(ClinicalTrials.gov)

March 2009

3/2/2009

Anti-TNF Agents for the Treatment of Rheumatoid Arthritis

A Partially Blinded, Randomized, Multi-Center, Phase IV Trial to Evaluate Mechanism of Action of Anti-TNF Agents in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept;Drug: Adalimumab

National Institute of Allergy and Infectious Diseases (NIAID)

Autoimmunity Centers of Excellence

Completed

18 Years

75 Years

All

Phase 4

United States

1532

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

1533

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

1534

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

1535

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

No.

TrialID

Date_
enrollment

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

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

1537

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

1538

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

1539

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

1540

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

1541

EUCTR2008-000744-13-FR
(EUCTR)

10/02/2009

21/10/2008

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Rigel Pharmaceuticals, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Germany;Bulgaria;France;Italy

1542

EUCTR2008-001523-57-ES
(EUCTR)

09/02/2009

22/10/2008

Estudio abierto y multicéntrico de evaluación de la respuesta temprana a abatacept con metotrexato de fondo mediante ecografía Power-Doppler en pacientes con artritis reumatoide activa y respuesta insuficiente a metotrexato Multicenter, Open-Label Study to Assess Early Reponse to Abatacept with Background Methotrexate Using Power Doppler Ultrasound in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Sujetos adultos con artritis reumatoide activa, de acuerdo con los criterios de la asociación de reumatismo Americana para la clasificación de la AR y con respuesta al metotrexate inadecuada.Adult subjects with Active Rheumatoid Arthritis, in accordance with the American Rheumatology Association criteria for the classification of AR with inadequate response to Metotrexate
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy

1543

EUCTR2008-005525-11-FR
(EUCTR)

06/02/2009

13/03/2009

A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera
Product Code: RO452294/V02
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533/F01
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;France;Spain

1544

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

1545

EUCTR2008-001847-20-SE
(EUCTR)

02/02/2009

23/10/2008

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

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

No.

TrialID

Date_
enrollment

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

EUCTR2008-005525-11-ES
(EUCTR)

29/01/2009

09/12/2008

Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

Artritis reumatoideRheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MABTHERA 500 mg concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;France;Spain

1547

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

1548

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

1549

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

1550

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

No.

TrialID

Date_
enrollment

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

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

1552

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

1553

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

1554

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

1555

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

No.

TrialID

Date_
enrollment

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

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

1557

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

1558

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

1559

EUCTR2008-001847-20-LV
(EUCTR)

19/12/2008

29/12/2008

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

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

1560

EUCTR2007-001625-10-IE
(EUCTR)

12/12/2008

07/10/2008

AN OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE RADIOGRAPHIC EFFICACY AND SAFETY OF ENBREL™ (ETANERCEPT) ADDED TO METHOTREXATE IN COMPARISON WITH USUAL TREATMENT IN SUBJECTS WITH MODERATE RHEUMATOID ARTHRITIS DISEASE ACTIVITY

RHEUMATOID ARTHRITIS

Trade Name: Etanercept
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

700

Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Spain;Ireland;Italy;Greece;Poland;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1561

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

1562

EUCTR2008-001847-20-DK
(EUCTR)

10/12/2008

21/10/2008

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

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

1563

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

1564

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

1565

EUCTR2007-003288-36-FR
(EUCTR)

08/12/2008

21/10/2008

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

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1566

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

1567

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

1568

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

1569

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

1570

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

1571

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

1572

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

1573

EUCTR2007-001625-10-IT
(EUCTR)

26/11/2008

01/04/2009

An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) added to Methotrexate in Comparison with Usual Treatment in Subjects with Moderate Rheumatoid Arthritis Disease Activity. - EXTRA

Trade Name: ENBREL
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

700

France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;United Kingdom;Italy

1574

EUCTR2008-006256-22-FR
(EUCTR)

21/11/2008

31/10/2008

Evaluation by high resolution micro computerized tomography of bone microarchitecture changes in patients with rheumatoid arthritis under anti-TNF therapy.

rheumatoid arthritis requiring anti-TNF alpha treatment
MedDRA version: 9.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: remicade
INN or Proposed INN: infliximab
Trade Name: humira
INN or Proposed INN: adalimumab
Trade Name: enbrel
INN or Proposed INN: etanercept

CHU Saint-Etienne

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

1575

EUCTR2008-001847-20-FR
(EUCTR)

17/11/2008

21/10/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab
Product Code: RO04877533/F05/F04
INN or Proposed INN: tocilizumab
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
INN or Proposed INN: Methotrexate

F Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

470

Germany;United Kingdom;Netherlands;Denmark;Estonia;France;Spain;Italy;Greece;Latvia;Sweden

No.

TrialID

Date_
enrollment

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

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

1577

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

1578

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

1579

EUCTR2008-001523-57-FR
(EUCTR)

04/11/2008

21/10/2008

Trade Name: Orencia
Product Name: Abatacept (IV)
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Hungary;Germany;United Kingdom;Denmark;Norway;France;Spain;Italy

1580

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

1581

EUCTR2007-005434-37-GR
(EUCTR)

04/11/2008

06/02/2009

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). - MTX-IR Study

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

1582

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

1583

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

1584

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

1585

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

1586

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

1587

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

1588

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

1589

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

1590

EUCTR2007-003288-36-NL
(EUCTR)

15/10/2008

11/07/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Other descriptive name: Chimeric Human-Murine IgG1

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Finland;United Kingdom;Germany;Netherlands;France;Spain;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1591

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

1592

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

1593

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

1594

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

1595

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

1596

EUCTR2008-001105-42-FR
(EUCTR)

10/10/2008

28/08/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

Germany;Belgium;France;Poland;Austria

1597

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

1598

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

1599

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

1600

EUCTR2007-000830-38-FR
(EUCTR)

07/10/2008

10/07/2008

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol
Other descriptive name: Anti-TNF humanized antibody Fab fragment - PEG conjugate

UCB Pharma S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

132

Phase 3B

Germany;France;Italy;Poland;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1601

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

1602

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

1603

EUCTR2008-001282-28-NL
(EUCTR)

23/09/2008

29/08/2008

Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy - Vaccinations in rheumatic autoimmune diseases

Rheumatic autoimmune diseases including rheumatoid arthritis and poly or dermatomyositis.

Trade Name: Influvac
INN or Proposed INN: Influvac
Trade Name: Pneumovax 23
INN or Proposed INN: Pneumovax 23
Trade Name: HBvaxpro
INN or Proposed INN: HBVAXPRO

Radboud University Nijmegen Medical Centre

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

1604

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

1605

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

No.

TrialID

Date_
enrollment

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

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

1607

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

1608

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

1609

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

1610

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

No.

TrialID

Date_
enrollment

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

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

1612

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

1613

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

1614

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

1615

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

1616

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

1617

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

1618

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

1619

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

1620

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

No.

TrialID

Date_
enrollment

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

EUCTR2007-002951-18-DE
(EUCTR)

16/08/2008

30/06/2008

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

GlaxoSmithKline Research & Development

NULL

Not Recruiting

Female: yes
Male: yes

236

Phase 3

France;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden

1622

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

1623

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

1624

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

1625

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

No.

TrialID

Date_
enrollment

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

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

1627

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

1628

EUCTR2007-005434-37-IE
(EUCTR)

08/08/2008

22/05/2008

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

1629

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

1630

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

No.

TrialID

Date_
enrollment

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

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

1632

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

1633

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

1634

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

1635

EUCTR2007-007888-24-FR
(EUCTR)

31/07/2008

17/07/2008

Open-label Study to Evaluate the EULAR-RAID Score, Rheumatoid Arthritis Impact of Disease Score, in Rheumatoid Arthritis Patients Eligible to Etanercept and Who Will Receive Etanercept. - RAINBOW

RHEUMATOID ARTHRITIS

Trade Name: ENBREL
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

107

France

No.

TrialID

Date_
enrollment

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

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

1637

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

1638

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

1639

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

1640

EUCTR2008-000743-34-FR
(EUCTR)

21/07/2008

17/04/2008

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients with Rheumatoid Arthritis Who Have Failed at Least One Biologic

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: R935788
INN or Proposed INN: Fostamatinib Disodium
Other descriptive name: R788 Sodium, R788 Na, R788

Rigel Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

Germany;France;Italy

No.

TrialID

Date_
enrollment

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

EUCTR2007-005434-37-NL
(EUCTR)

16/07/2008

30/05/2008

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;Germany;Netherlands;Italy;United Kingdom

1642

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

1643

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

1644

EUCTR2007-005434-37-HU
(EUCTR)

09/07/2008

26/05/2008

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 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

1645

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

No.

TrialID

Date_
enrollment

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

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

1647

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

1648

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

1649

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

1650

EUCTR2007-006150-25-FR
(EUCTR)

24/06/2008

05/05/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Wyeth Research Division of Wyeth Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

216

Hungary;Germany;Netherlands;Belgium;France;Austria

No.

TrialID

Date_
enrollment

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

EUCTR2008-000327-25-PL
(EUCTR)

24/06/2008

20/05/2008

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CE-224,535

Pfizer Inc. 235 East 42nd Street NY10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2A

Czech Republic;Spain;Poland

1652

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

1653

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

1654

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

1655

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

No.

TrialID

Date_
enrollment

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

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

1657

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

1658

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

1659

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

1660

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

No.

TrialID

Date_
enrollment

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

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

1662

EUCTR2007-002951-18-SE
(EUCTR)

11/06/2008

25/03/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

236

Phase 3

Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden

1663

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

1664

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

1665

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

No.

TrialID

Date_
enrollment

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

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

1667

EUCTR2007-001625-10-FR
(EUCTR)

03/06/2008

13/05/2008

RHEUMATOID ARTHRITIS

Trade Name: Etanercept
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria

1668

EUCTR2007-002951-18-DK
(EUCTR)

03/06/2008

23/04/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

236

Phase 3

France;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden

1669

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

1670

JPRN-JapicCTI-080587

01/6/2008

Safety, Efficacy and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis

A Multicenter, Open-label Study of Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis (JRA)

Intervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : adalimumab 20 mg for chldren with body weight < 30 kg; adalimumab 40 mg for chldren with body weight >= 30 kg
Control intervention name : null

Abbott Japan Co., Ltd.

Eisai Co., Ltd.

BOTH

Phase 3

NULL

No.

TrialID

Date_
enrollment

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

EUCTR2007-001625-10-ES
(EUCTR)

28/05/2008

24/03/2008

Estudio abierto y aleatorizado para evaluar la eficacia radiológica y la seguridad de Enbrel® (etanercept) añadido a metotrexato en comparación con el tratamiento habitual en pacientes con artritis reumatoide moderadaAn Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra

Artritis reumatoideRHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria

1672

EUCTR2008-000327-25-CZ
(EUCTR)

27/05/2008

02/04/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CE-224,535

Pfizer Inc. 235 East 42nd Street NY10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

Czech Republic;Spain;Poland

1673

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

1674

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

1675

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

No.

TrialID

Date_
enrollment

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

EUCTR2008-000327-25-ES
(EUCTR)

19/05/2008

18/03/2008

ESTUDIO DE FASE 2A ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS DE CE-224,535, UN ANTAGONISTA DEL RECEPTOR P2X7, EN EL TRATAMIENTO DE LOS SIGNOS Y SÍNTOMAS DE LA ARTRITIS REUMATOIDE EN PACIENTES CON UN CONTROL INADECUADO CON METROTEXATOA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OFRHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELYCONTROLLED ON METHOTREXATE

Artritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: CE-224,535

PFIZER S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2A

Czech Republic;Spain;Poland

1677

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

1678

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

1679

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

1680

EUCTR2007-006288-56-AT
(EUCTR)

14/05/2008

14/04/2008

Methotrexat-Polyglutamate als Marker fuer das klinische Outcome in der Therapie der rheumatoiden Arthritis

Rheumatoid Arthritis

Trade Name: Ebetrexat
INN or Proposed INN: METHOTREXATE

Ludwig Boltzmann Cluster für Rheumatologie, Balneologie und Rehabilitation

NULL

Not Recruiting

Female: yes
Male: yes

Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1681

EUCTR2007-002951-18-FR
(EUCTR)

14/05/2008

18/03/2008

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

236

Phase 3

Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden

1682

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

1683

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

1684

EUCTR2007-000896-41-FR
(EUCTR)

07/05/2008

29/02/2008

Rheumatoid arthritis

Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Etanercept
Product Code: 0881
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: ETANERCEPT
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: METHOTREXATE

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Hungary;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

1685

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

No.

TrialID

Date_
enrollment

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

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

1687

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

1688

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

1689

EUCTR2007-005759-41-ES
(EUCTR)

23/04/2008

19/02/2008

Estudio internacional randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab administrado en un régimen de una o dos infusiones, comparado con placebo, en pacientes con artritis reumatoide activa que manifiestan una respuesta inadecuada a tratamiento con metotrexato.A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy

Artritis reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United Kingdom;Germany;France;Spain;Italy

1690

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

No.

TrialID

Date_
enrollment

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

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

1692

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

1693

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

1694

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

1695

EUCTR2007-003647-75-FR
(EUCTR)

01/04/2008

07/02/2008

A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Netherlands;France;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1696

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

1697

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

1698

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

1699

EUCTR2007-005759-41-FR
(EUCTR)

19/03/2008

12/02/2008

A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913/F03
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

United Kingdom;Germany;France;Spain;Italy

1700

EUCTR2007-006539-29-SE
(EUCTR)

14/03/2008

20/12/2007

Effects of different anti-rheumatic treatments of arthritis on antibody response following pneumococcal vaccination using Prevenar

Patients with rheumatic diseases (rheumatoid arthritis and spondyloarthripaties) who are going to be vaccinated with Prevenar vaccine in order to study the serological responses to two pneumococcal serotypes and to study the impact of different treatment modalities on serological responses.

Trade Name: Prevenar vaccine
Product Name: Prevenar vaccine
INN or Proposed INN: 7-valent Pneumococcal Conjugate vaccine

Dept of Rheumatology, Lund University Hospital, Lund, Sweden

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Sweden

No.

TrialID

Date_
enrollment

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

EUCTR2007-003623-20-ES
(EUCTR)

12/03/2008

04/02/2008

Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR).Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).

Se estudiaran los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB

Dr. Juan D. Cañete Crespillo, Hospital Clínic de Barcelona

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

1702

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

1703

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

1704

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

1705

EUCTR2007-002536-29-FR
(EUCTR)

03/03/2008

04/10/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Trade Name: Humira
Product Name: Adalimumab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

No.

TrialID

Date_
enrollment

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

EUCTR2007-000828-40-FR
(EUCTR)

26/02/2008

11/12/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Certolizumab pegol
Product Code: CDP870
INN or Proposed INN: Certolizumab pegol

UCB Pharma S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

170

Phase 3B

Germany;France;Italy;Poland;Austria

1707

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

1708

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

1709

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

1710

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

No.

TrialID

Date_
enrollment

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

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

1712

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

1713

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

1714

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

1715

EUCTR2007-003647-75-NL
(EUCTR)

07/02/2008

29/11/2007

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Sweden;France;Finland;United Kingdom;Netherlands

No.

TrialID

Date_
enrollment

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

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

1717

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

1718

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

1719

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

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

NULL

Not Recruiting

Female: yes
Male: yes

4000

Phase 2;Phase 3

1720

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

1721

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

1722

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

1723

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

1724

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

1725

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

1726

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

1727

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

1728

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

1729

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

1730

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

No.

TrialID

Date_
enrollment

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

EUCTR2007-002536-29-ES
(EUCTR)

18/01/2008

14/02/2008

Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, fase II de atacicept en pacientes con artritis reumatoide moderada a gravemente activa, sin tratamiento previo con anti-TNFa y con respuesta insuficiente a metrotexato.A randomised, double-blind, placebo controlled, multi-centre phase II study of atacicept in anti-TNFa-naïve patients with moderate to severely active rheumatoid arthritis and an inadequate response to methotrexate. - Atacicept en pacientes con AR sin tratamiento previo con anti-TNFa

Artritis ReumatoideRheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

1732

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

1733

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

1734

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

1735

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

1736

ChiCTR-CCC-10001054

2008-01-01

2010-08-25

Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis

1:none;2:Infliximab ;

National Sciences Foundation of China

NULL

Completed

Both

1:39;2:39;

China

1737

EUCTR2006-003577-27-ES
(EUCTR)

21/12/2007

09/10/2007

ESTUDIO DE FASE IIA, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO, DE DOCE SEMANAS DE DURACIÓN PARA EVALUAR LA SEGURIDAD, FARMACOCINÉTICA Y EFICACIA DE PH-797804 ADMINISTRADO POR VIA ORAL UNA VEZ AL DÍA EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - n/a

Tratamiento de artritis reumatoide (AR)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: PH-797804
Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide
Product Code: PH-797804
Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide
Product Code: PH-797804
Other descriptive name: S(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide

Pfizer S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

290

Phase 2A

Czech Republic;Estonia;Spain

1738

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

1739

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

1740

EUCTR2007-001035-58-PT
(EUCTR)

14/12/2007

16/08/2007

RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Maraviroc
Product Code: UK-427,857
INN or Proposed INN: Maraviroc

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

NULL

Not Recruiting

Female: yes
Male: yes

114

Phase 2

Portugal;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1741

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

1742

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

1743

EUCTR2006-005137-38-DK
(EUCTR)

10/12/2007

08/06/2007

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:

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

1744

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

1745

EUCTR2007-002951-18-NL
(EUCTR)

10/12/2007

09/08/2007

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Not Recruiting

Female: yes
Male: yes

236

Phase 3

Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden

No.

TrialID

Date_
enrollment

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

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

1747

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

1748

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

1749

NCT00596206
(ClinicalTrials.gov)

December 2007

4/1/2008

Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid Arthritis

Assessment of the Early Efficacy Response Rate of Leflunomide According to the Initial Dosing Regimen in the Treatment of Naive-DMARD (Disease Modifying Anti-Rheumatic Drug) Early RA (Rheumatoid Arthritis)-Patients

Arthritis, Rheumatoid

Drug: leflunomide

Sanofi

NULL

Completed

18 Years

N/A

Both

124

Phase 3

Czech Republic;Italy;Korea, Republic of;Portugal;Romania

1750

NCT00963703
(ClinicalTrials.gov)

December 2007

20/8/2009

Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes

Rheumatoid Arthritis

Drug: Rituximab

University of Manitoba

Hoffmann-La Roche

Completed

18 Years

N/A

Both

N/A

Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1751

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

1752

EUCTR2007-002951-18-ES
(EUCTR)

27/11/2007

11/10/2007

A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to TNF-a antagonist therapyEstudio Fase III, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, para investigar la eficacia clínica de ofatumumab en pacientes adultos con artritis reumatoide activa y respuesta inadecuada a la terapia con antagonistas TNFa - Investigating efficacy of ofatumumab in RA patients with inadequate response to TNF-a antagonist

Rheumatoid ArthritisArtritis Reumatoide
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab

Genmab A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

236

Phase 3

Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden

1753

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

1754

EUCTR2007-002536-29-FI
(EUCTR)

19/11/2007

15/10/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Humira
Product Name: Adalimumab
INN or Proposed INN: Adalimumab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

264

Phase 2

Portugal;Finland;Germany;Czech Republic;Bulgaria;France;Spain;Italy;Greece;Poland;Austria;Sweden

1755

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

No.

TrialID

Date_
enrollment

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

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

1757

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

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

1758

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

1759

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

1760

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

No.

TrialID

Date_
enrollment

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

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

1762

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

1763

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

1764

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

1765

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

No.

TrialID

Date_
enrollment

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

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

1767

EUCTR2007-001035-58-ES
(EUCTR)

30/10/2007

26/07/2007

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF MARAVIROC (UK-427,857) IN THE TREATMENT OF RHEUMATOID ARTHRITIS IN SUBJECTS RECEIVING METHOTREXATEESTUDIO EN FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y EN GRUPOS PARALELOS PARA EVALUAR LA SEGURIDAD Y LA EFICACIA DE MARAVIROC (UK 427,857) EN EL TRATAMIENTO DE LA ARTRITIS REUMATOIDE EN PACIENTES QUE RECIBEN METOTREXATO - N/A

ARTRITIS REUMATOIDERHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Maraviroc
Product Code: UK-427,857
INN or Proposed INN: Maraviroc

Pfizer, S. A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

114

Phase 2

Portugal;Spain;Italy

1768

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

1769

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

1770

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

No.

TrialID

Date_
enrollment

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

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

1772

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

1773

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

1774

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

1775

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

No.

TrialID

Date_
enrollment

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

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

1777

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

1778

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

1779

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

1780

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

No.

TrialID

Date_
enrollment

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

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

1782

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

1783

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

1784

EUCTR2007-001585-33-FR
(EUCTR)

09/10/2007

23/07/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Germany;Netherlands;Denmark;Estonia;France;Spain;Greece;Latvia;Lithuania

1785

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

1786

NCT00626275
(ClinicalTrials.gov)

October 2007

22/2/2008

Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid Arthritis

A Phase 2a Randomized, Placebo- and Active-Controlled, Single-Dose, 3-Period, Crossover Study Followed by a Randomized, Placebo-Controlled, 14-Day, Parallel-Group Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: ADL5859;Drug: Naproxen;Drug: Placebo

Cubist Pharmaceuticals LLC

NULL

Completed

18 Years

75 Years

All

Phase 2

United States

1787

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

1788

EUCTR2007-002951-18-IT
(EUCTR)

28/09/2007

05/10/2007

Rheumatoid arthritis
MedDRA version: 9.1;Level: HLT;Classification code 10039078;Term: Rheumatoid arthropathies

Product Name: Ofatumumab
Product Code: HuMax-CD20

Genmab A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

236

Phase 3

Germany;United Kingdom;Netherlands;Denmark;France;Spain;Italy;Sweden

1789

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

1790

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

No.

TrialID

Date_
enrollment

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

EUCTR2007-004694-26-BE
(EUCTR)

17/09/2007

10/09/2007

A Comparative Study Of A 6-Month Infliximab (Remicade) Or Placebo Regimen In Undifferentiated Arthritis At High Risk For The Development Of Rheumatoid Arthritis : Clinical, Radiological (MRI) And Synovial Benefit P1200/001. - INFLIXIMAB (REMICADE) in UA

Patient with undifferentiated arthritis and the presence of anti-CCP antibodies are at high risk to develop RA
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade
Product Name: REMICADE® (Infliximab)
Product Code: -

Saint-Luc Universitary Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

1792

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

1793

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

1794

EUCTR2007-002752-42-FR
(EUCTR)

13/09/2007

23/07/2007

FAKIR : Variabilité pharmacocinétique et de la relation pharmacocinétique-phamacodynamique de l'infliximab (Remicade®) dans la polyarthrite rhumatoide - FAKIR

Polyarthrite rhumatoïde
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade ®
INN or Proposed INN: INFLIXIMAB

CHRU de Tours

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

1795

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

No.

TrialID

Date_
enrollment

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

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

1797

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

1798

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

1799

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

1800

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

No.

TrialID

Date_
enrollment

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

EUCTR2007-002976-32-NL
(EUCTR)

06/09/2007

30/08/2007

COBRA-light study, an open randomised trial comparing a modified COBRA therapy with the COBRA therapy according to BeSt in early rheumatoid arthritis.

Patients with early rheumatoid arthritis wil be treated with a combination therapy: COBRA according to BEST or a modified COBRA schedule (COBRA-light).

Trade Name: Prednisone
Trade Name: Methotrexate
Trade Name: Sulphasalazine

TIPharma

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

1802

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

1803

EUCTR2006-004139-31-HU
(EUCTR)

05/09/2007

17/05/2007

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

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden

1804

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

1805

NCT00595413
(ClinicalTrials.gov)

September 2007

7/1/2008

Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)

A Randomised, Double-blind, Placebo Controlled, Multi-centre Phase II Study of Atacicept in Anti-TNFa-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Placebo matched to atacicept;Drug: Atacicept : with loading dose;Drug: Atacicept;Biological: Adalimumab

EMD Serono

Merck KGaA

Completed

18 Years

N/A

All

311

Phase 2

United States;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1806

EUCTR2006-003054-26-CZ
(EUCTR)

31/08/2007

06/08/2007

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 - NA

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

1807

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

1808

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

1809

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

1810

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

1811

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

1812

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

1813

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

1814

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

1815

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

1816

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

1817

NCT00511329
(ClinicalTrials.gov)

August 2007

2/8/2007

Growth Hormone in Children With Juvenile Rheumatoid Arthritis (JRA) and With Crohn's Disease

Growth and the Effect of Genotropin in Chronically Ill Children With Juvenile Rheumatoid Arthritis and With Crohn's Disease

Arthritis, Juvenile Rheumatoid;Crohn Disease

Drug: somatropin [rDNA origin] for injection

Nationwide Children's Hospital

Pfizer

Terminated

5 Years

17 Years

All

Phase 2;Phase 3

United States

1818

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

1819

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

1820

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

No.

TrialID

Date_
enrollment

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

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

1822

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

1823

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

1824

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

1825

EUCTR2006-005330-20-FR
(EUCTR)

16/07/2007

26/03/2007

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-a therapy.

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1000

Phase 3

France;Czech Republic;Hungary;Slovakia;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1826

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

1827

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

1828

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

1829

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

1830

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

No.

TrialID

Date_
enrollment

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

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

1832

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

1833

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

1834

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

1835

EUCTR2006-005137-38-FR
(EUCTR)

19/06/2007

10/04/2007

Rheumatoid Arthritis
MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:

Trade Name: Enbrel
Product Name: Enbrel Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Enbrel Auto Injector
Product Code: Auto Injector
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

724

Finland;Germany;United Kingdom;Denmark;France;Sweden

No.

TrialID

Date_
enrollment

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

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

1837

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

1838

NCT00485589
(ClinicalTrials.gov)

June 11, 2007

11/6/2007

A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)

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- Naive Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Ocrelizumab;Drug: Placebo

Genentech, Inc.

Roche Pharma AG

Terminated

18 Years

N/A

All

613

Phase 3

United States

1839

EUCTR2006-005330-20-BE
(EUCTR)

07/06/2007

28/02/2007

anti TNF-IR phase III

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3A

Hungary;Germany;Netherlands;Slovenia;Belgium;France;Spain;Italy;Sweden

1840

EUCTR2006-004140-23-CZ
(EUCTR)

06/06/2007

18/12/2006

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

Product Name: Atacicept
Product Code: Not Applicable
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono Int, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Bulgaria;Germany;Netherlands;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1841

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

1842

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

1843

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

1844

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

1845

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

No.

TrialID

Date_
enrollment

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

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

1847

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

1848

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

1849

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

1850

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

1851

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

1852

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

1853

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

1854

EUCTR2006-005147-28-FR
(EUCTR)

07/05/2007

06/03/2007

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.

Rheumatoid Arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: ocrelizumab
Product Code: RO 496-4913/F03
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

United Kingdom;Germany;France;Spain;Greece;Austria

1855

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

1856

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

1857

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

1858

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

1859

NCT00443430
(ClinicalTrials.gov)

May 2007

2/3/2007

Trial of Early Aggressive Drug Therapy in Juvenile Idiopathic Arthritis

Trial of Early Aggressive Therapy in Juvenile Idiopathic Arthritis (TREAT in JIA)

Juvenile Chronic Polyarthritis;Juvenile Idiopathic Arthritis;Juvenile Rheumatoid Arthritis

Drug: methotrexate;Drug: methotrexate - etanercept - prednisolone arm

Seattle Children's Hospital

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

Completed

2 Years

17 Years

All

Phase 4

United States

1860

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

No.

TrialID

Date_
enrollment

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

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

1862

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

1863

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

1864

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

1865

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

No.

TrialID

Date_
enrollment

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

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

1867

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

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

1868

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

1869

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

1870

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

No.

TrialID

Date_
enrollment

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

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

1872

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

1873

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

1874

NCT00989235
(ClinicalTrials.gov)

April 2007

2/10/2009

Substudy - Low Dose of Abatacept in Subjects With Rheumatoid Arthritis

A Phase 3B, Multi-Center, Randomized, Double-blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate-naïve Early Erosive Rheumatoid Arthritis Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate - Low Dose Sub-Study

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

108

Phase 3

NULL

1875

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

No.

TrialID

Date_
enrollment

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

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

1877

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

1878

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

1879

EUCTR2006-004139-31-FR
(EUCTR)

12/03/2007

12/02/2007

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

Trade Name: Humira
INN or Proposed INN: Adalimumab
Trade Name: Metex®

Abbott GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden

1880

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

No.

TrialID

Date_
enrollment

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

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

1882

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

1883

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

1884

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

1885

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

1886

EUCTR2006-006380-22-DE
(EUCTR)

22/02/2007

28/12/2006

Biological dosimetry in radiation synovectomy of small finger joints with Erbium [169Er] citrate - ER-MM1 biological dosimetry

Patients with rheumatoid arthritis or seronegative spondylarthropathy with at least one inflamed finger joint (MCP, PIP, DIP) referred for RSO with with Erbium [169Er]citrate
MedDRA version: 8.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions

Trade Name: ERMM-1
INN or Proposed INN: erbium citrate

CIS bio international

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany

1887

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

1888

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

1889

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

1890

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

No.

TrialID

Date_
enrollment

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

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

1892

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

1893

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

1894

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

1895

EUCTR2006-006186-16-NL
(EUCTR)

30/01/2007

16/07/2007

IMPROVED: Induction therapy with Methotrexate and Prednisone in Rheumatoid Or Very Early arthritic DiseaseA randomized clinical trial in patients with recent-onset arthritis to compare the efficacy of DMARD combination therapy including prednisone with combination therapy including adalimumab, a TNF-blocking agent - IMPROVED

rheumatoid arthritis and undifferentiated arthritis
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Methotrexate
Product Code: MTX
INN or Proposed INN: METHOTREXATE
Product Name: Prednisone
INN or Proposed INN: PREDNISONE
Product Name: Sulfasalazine
INN or Proposed INN: SULFASALAZINE
Trade Name: hydroxychloroquine
Product Name: hydroxychloroquine
Product Code: HCQ
INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE
Trade Name: Humira
Product Name: adalimumab

Leiden University Medical Center, department of rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

No.

TrialID

Date_
enrollment

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

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

1897

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

1898

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

1899

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

1900

NCT02886689
(ClinicalTrials.gov)

January 2007

29/8/2016

C.O.R.P.U.S.: Observational Cohort of Adult and Child Inflammatory Arthritis in France

C.O.R.P.U.S. : Observational Cohort of Active Rheumatoid Arthritis, Spondylarthropathy and Idiopathic Juvenile Arthritis in France

Arthritis, Rheumatoid;Spondylitis, Ankylosing;Arthritis, Psoriatic;Arthitis, Juvenile Idiopathic

Drug: TNF-alpha antagonist and other biotherapy

Central Hospital, Nancy, France

NULL

Completed

3 Years

75 Years

Both

5400

N/A

France

No.

TrialID

Date_
enrollment

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

EUCTR2006-005386-19-BE
(EUCTR)

19/12/2006

03/11/2006

Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini

Rheumatoid arthritis refractory to TNF blockers patients
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera

Cliniques Universitaires Saint-Luc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

1902

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

1903

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

1904

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

1905

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

No.

TrialID

Date_
enrollment

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

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

1907

EUCTR2006-003577-27-EE
(EUCTR)

01/12/2006

29/09/2006

A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOIDARTHRITIS. - na

Treatment of rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Pfizer Luxembourg SARL Branch Office Estonia

NULL

Not Recruiting

Female: yes
Male: yes

290

Phase 2A

Czech Republic;Estonia;Spain

1908

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

1909

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

1910

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

No.

TrialID

Date_
enrollment

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

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

1912

EUCTR2005-003632-22-ES
(EUCTR)

22/11/2006

20/03/2012

A study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with rheumatoid arthritis.

An open-label, exploratory study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with active rheumatoid arthritis

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

Trade Name: MabThera
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

1913

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

1914

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

1915

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

No.

TrialID

Date_
enrollment

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

EUCTR2006-003843-22-IT
(EUCTR)

24/10/2006

30/08/2006

prospeCtive study on intensive early rheumatoid arthritis treatment with adalimUmab: induction of REmission and maintenance - 'CURE'A Phase IV multicenter, randomized, double-blind study

rheumatoid arthritis
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: HUMIRA *SC 2SIR+F 40MG 0,8ML+2T
INN or Proposed INN: Adalimumab
Trade Name: METHOTREXATE *100CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: DELTACORTENE FORTE*10CPR 25MG
INN or Proposed INN: Prednisone

OSPEDALE POLICLINICO S. MATTEO

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Italy

1917

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

1918

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

1919

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

1920

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

1921

EUCTR2006-003698-29-FR
(EUCTR)

05/10/2006

14/09/2006

A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

Rheumatoid arthritis (RA)
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: AMG 108
Product Code: AMG 108

Amgen Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

784

Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden

1922

NCT00346216
(ClinicalTrials.gov)

October 4, 2006

28/6/2006

Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen

Arthritis, Rheumatoid

Drug: celecoxib;Drug: Ibuprofen;Drug: Naproxen

Pfizer

The Cleveland Clinic

Completed

18 Years

N/A

All

24081

Phase 4

United States;Australia;Brazil;Canada;Colombia;Costa Rica;Hong Kong;Mexico;Panama;Peru;Philippines;Taiwan;Ukraine

1923

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

1924

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

1925

NCT00749645
(ClinicalTrials.gov)

October 2006

7/9/2008

Efficacy Study of FANG(30) for Active Rheumatoid Arthritis in Adult Patients

Clinical Phase II Pilot Study of the Efficacy of FANG(30) to Treat Active Rheumatoid Arthritis in Adult Patients

Arthritis, Rheumatoid

Drug: FANG(30);Drug: Placebo

Juan C. Bertoglio, MD

Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Completed

18 Years

70 Years

Both

Phase 2

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

1926

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

1927

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

1928

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

1929

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

1930

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

No.

TrialID

Date_
enrollment

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

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

1932

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

1933

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

1934

NCT01308255
(ClinicalTrials.gov)

September 2006

3/3/2011

Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA)

A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: Infliximab;Drug: Methylprednisolone;Drug: Methotrexate;Dietary Supplement: Folic acid

University of Leeds

NULL

Completed

18 Years

80 Years

All

112

Phase 4

United Kingdom

1935

NCT00367211
(ClinicalTrials.gov)

September 2006

18/8/2006

Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis

Drug: PN 200 tablets (500 mg naproxen and 20 mg omeprazole);Drug: Naproxen 500 mg tablets (PN 200 minus omeprazole)

POZEN

NULL

Completed

18 Years

N/A

Both

400

Phase 3

United States

No.

TrialID

Date_
enrollment

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

EUCTR2006-002645-37-HU
(EUCTR)

25/08/2006

13/06/2006

A Phase II randomized double-blind placebo-controlled Study of KC706 in patients with rheumatoid arthritis inadequately controlled with a stable dose of methotrexate

Active rheumatoid arthritis (RA), patients taking stable doses of methotrexate
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: KC706
Product Code: KR002524

Kémia, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Hungary

1937

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

1938

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

1939

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

1940

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

No.

TrialID

Date_
enrollment

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

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

1942

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

1943

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

1944

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

1945

EUCTR2006-001359-36-NL
(EUCTR)

02/06/2006

29/03/2006

Effects of low-dose aspirin taken at bedtime on pathophysiologic mechanisms underlying hypertension in subjects with grade 1 essential hypertension: the Aspirin In Reduction of Tension (ASPIRETENSION) study - ASPIRETENSION

Patients should have grade 1 essential hypertension (140/90-159/99 mmHg), but free of history of any cardiovascular events, diabetes mellitus type 1 or 2 or rheumatoid arthritis.

Trade Name: Ascal(r) / carbasalate calcium

Leiden University Medical Center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

No.

TrialID

Date_
enrollment

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

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

1947

NCT00439062
(ClinicalTrials.gov)

June 2006

20/2/2007

Treatment of Rheumatoid Arthritis With Roxithromycin

Rheumatoid Arthritis

Drug: Roxithromycin

Nazilli State Hospital

NULL

Completed

18 Years

70 Years

Both

100

Phase 4

Turkey

1948

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

1949

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

1950

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

No.

TrialID

Date_
enrollment

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

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

1952

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

1953

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

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

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

1954

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

1955

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

No.

TrialID

Date_
enrollment

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

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

1957

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

1958

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

1959

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

1960

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

No.

TrialID

Date_
enrollment

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

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

1962

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

1963

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

1964

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

1965

EUCTR2005-002909-23-IT
(EUCTR)

11/04/2006

14/03/2006

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.

Trade Name: RoActemra
INN or Proposed INN: Ro Actemra

F. Hoffmann - La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

2420

Sweden;Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

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

EUCTR2005-001633-14-SE
(EUCTR)

11/04/2006

27/02/2006

Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira[R]) 40 mg s.c. eow versus infliximab (Remicade[R]) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study

Rheumatoid arthritis

Trade Name: Humira
Product Name: Humira
Trade Name: Remicade
Product Name: Remicade

Hvidovre Hospital, Dept. Rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

112

Denmark;Sweden

1967

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

1968

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

1969

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

1970

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

No.

TrialID

Date_
enrollment

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

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

1972

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

1973

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

1974

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

1975

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

No.

TrialID

Date_
enrollment

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

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

1977

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

1978

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

1979

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

1980

EUCTR2005-002909-23-LT
(EUCTR)

07/03/2006

11/01/2006

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.

Rheumatoid arthritis

Trade Name: RoActemra
INN or Proposed INN: tocilizumab

F Hoffmann La-Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

2420

Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1981

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

1982

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

1983

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

1984

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

1985

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

No.

TrialID

Date_
enrollment

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

EUCTR2005-003495-38-GR
(EUCTR)

27/02/2006

30/06/2006

Part A: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.Part B: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 1 dose of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

440

United Kingdom;Germany;Estonia;Spain;Ireland;Greece

1987

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

1988

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

1989

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

1990

EUCTR2004-003295-10-IT
(EUCTR)

20/02/2006

29/11/2006

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNF 945; Monoclonal Antibody, Administered Subcutaneously, in Methotrexatena ve Subjects with Active Rheumatoid Arthritis - CNTO148 T05

RA in subjects who are naive to metotrexate
MedDRA version: 8.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders

Product Name: golimumab
Product Code: CNTO148
INN or Proposed INN: Methotrexate
Product Name: golimumab
Product Code: CNTO148

CENTOCOR

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Hungary;United Kingdom;Spain;Italy

No.

TrialID

Date_
enrollment

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

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

1992

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

1993

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

1994

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

1995

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

No.

TrialID

Date_
enrollment

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

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

1997

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

1998

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

1999

EUCTR2005-003694-25-ES
(EUCTR)

27/01/2006

28/11/2005

Ensayo randomizado, doble ciego, con doble enmascaramiento, de grupos paralelos para evaluar la eficacia y seguridad de RO4402257 como monoterapia en comparación con la monoterapia de metotrexato para pacientes con artritis reumatoide activa (AR)A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis (RA).

Artritis ReumatoideRheumatoid Arthritis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Czech Republic;Spain;Italy

2000

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

No.

TrialID

Date_
enrollment

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

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

2002

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

2003

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

2004

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

2005

EUCTR2004-001234-17-IE
(EUCTR)

16/01/2006

02/11/2006

Treatment of osteoarthritis (OA) and/or rheumatoid arthritis (RA) in high GI risk patients
MedDRA version: 8.0;Level: LLT;Classification code 10039073

Pfizer Healthcare Ireland

NULL

Not Recruiting

Female: yes
Male: yes

4402

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2006

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

2007

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

2008

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

2009

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

2010

EUCTR2005-002395-15-DK
(EUCTR)

06/01/2006

19/06/2007

Rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Phase 3

Czech Republic;Finland;Belgium;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2011

NCT00299104
(ClinicalTrials.gov)

January 2006

2/3/2006

A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

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-Naive Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: placebo;Drug: rituximab

Genentech, Inc.

Hoffmann-La Roche

Completed

18 Years

80 Years

All

755

Phase 3

United States

2012

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

2013

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

2014

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

2015

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

2016

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

2017

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

2018

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

2019

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

2020

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

2021

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

2022

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

2023

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

2024

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

2025

EUCTR2005-002395-15-IT
(EUCTR)

02/12/2005

02/03/2006

Trade Name: METHOTREXATE *100CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *25CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: MabThera
INN or Proposed INN: Rituximab

F. Hoffmann - La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;Spain;Czech Republic;Denmark;Germany;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2026

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

2027

NCT00264537
(ClinicalTrials.gov)

December 2005

11/12/2005

A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive

A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Placebo injections;Drug: Placebo capsules;Drug: Methotrexate capsules;Biological: Golimumab 50 mg injections;Biological: Golimumab 100 mg injections

Centocor, Inc.

Schering-Plough

Completed

18 Years

N/A

All

637

Phase 3

United States;Argentina;Australia;Austria;Belgium;Canada;Chile;Hungary;India;Korea, Republic of;Malaysia;New Zealand;Philippines;Poland;Russian Federation;Singapore;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Brazil;Mexico;Turkey

2028

EUCTR2005-002396-33-IT
(EUCTR)

30/11/2005

01/03/2006

Trade Name: Mabthera
INN or Proposed INN: Rituximab

F. Hoffmann- La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

2029

EUCTR2005-003495-38-ES
(EUCTR)

25/11/2005

06/10/2005

Rheumatoid Arthritis

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

United Kingdom;Germany;Estonia;Ireland;Spain;Greece

2030

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

2031

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

2032

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

2033

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

2034

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

2035

EUCTR2004-005102-68-BE
(EUCTR)

15/11/2005

25/07/2005

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability andSafety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis onBackground Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNFTherapy and Have Limited Therapeutic Options.Revised Protocol 3, incorporating Amendments 2, 3 and 8. + Protocol Amendments 1 & 5.+ Protocol Amendment 11 - Site specific: All sites in Belgium (v1.0, dated 23-Sep-2008)

RHEUMATOID ARTHRITIS,NOS

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Germany;United Kingdom;Belgium;Spain;Ireland;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2036

EUCTR2005-002219-26-IT
(EUCTR)

11/11/2005

16/03/2007

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
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

2037

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

2038

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

2039

EUCTR2004-004995-35-IT
(EUCTR)

08/11/2005

02/02/2007

Evaluate the difference in ACR-20 response between rheumatoid arthritis subjects treated with each of two doses of CRx-139 plus DMARD therapy and subjects treated with steroid plus DMARD therapy after 8 weeks of treatment.
MedDRA version: 6.1;Level: PT;Classification code 10039073

INN or Proposed INN: Paroxetine
INN or Proposed INN: Paroxetine
Trade Name: Prednisolene tablets BP 1 mg
INN or Proposed INN: Prednisolone

COMBINATORX, INC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 2

Czech Republic;Germany;United Kingdom;Denmark;Italy

2040

EUCTR2004-001825-69-IT
(EUCTR)

04/11/2005

14/12/2005

A Multi Center, Open label, Extension study of RA 1 using Extracoproreal photoimmune therapy with Uvadex

Rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073

Trade Name: UVADEX
INN or Proposed INN: Methoxsalen

THERAKOS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2041

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

2042

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

2043

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

2044

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

2045

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

No.

TrialID

Date_
enrollment

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

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

2047

EUCTR2005-001319-23-IT
(EUCTR)

21/10/2005

30/09/2005

Rheumatoid arthritis
MedDRA version: 6.1;Level: PT;Classification code 10039073

Product Name: ERB-041
Product Code: ERB-041
Other descriptive name: NA
Product Name: ERB-041
Product Code: ERB-041
Other descriptive name: NA
Product Name: ERB-041
Product Code: ERB-041
Other descriptive name: NA

WYETH LEDERLE

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Spain;Italy

2048

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

2049

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

2050

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

No.

TrialID

Date_
enrollment

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

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

2052

EUCTR2005-001319-23-ES
(EUCTR)

14/10/2005

22/06/2005

A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy.Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, dirigido a evaluar la eficacia y la seguridad de 3 dosis orales distintas de ERB-041 en sujetos con artritis reumatoide en tratamiento de fondo con metotrexato

Rheumatoid arthritis

Product Name: ERB-041
Product Code: ERB-041
Product Name: ERB-041
Product Code: ERB-041
Product Name: ERB-041
Product Code: ERB-041

Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and Development

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Hungary;Spain;Italy

2053

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

2054

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

2055

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

No.

TrialID

Date_
enrollment

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

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

2057

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

2058

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

2059

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

2060

EUCTR2005-002423-13-IT
(EUCTR)

28/09/2005

04/11/2005

Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA 17822

Trade Name: RoActemra
INN or Proposed INN: RoActemra

F.Hoffmann La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Slovakia;Bulgaria;Germany;Italy

No.

TrialID

Date_
enrollment

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

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

2062

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

2063

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

2064

EUCTR2005-002219-26-ES
(EUCTR)

21/09/2005

10/10/2005

Rheumatoid arthritis (RA)

Product Name: SB-681323 Tablets
Product Code: SB-681323
Product Name: SB-681323 Tablets
Product Code: SB-681323

GlaxoSmithKline S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Norway;Spain;Italy;Sweden

2065

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

No.

TrialID

Date_
enrollment

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

EUCTR2005-002421-31-GB
(EUCTR)

16/09/2005

26/07/2005

A phase II randomized, double-blind, multicentre, placebo-controlled, dose-ranging, parallel group study to compare the efficacy, safety and tolerability of 3 strengths of AD 452 in adult subjects with active rheumatoid arthritis who are currently taking methotrexate

Rheumatoid arthritis
Level: PTClassification code 10039073

Product Name: AD 452 4.5 mg Tablet
Other descriptive name: (+) erythromefloquine
Product Name: AD 452 9 mg tablet
Other descriptive name: (+)erythromefloquine
Product Name: AD 452 18 mg tablet
Other descriptive name: (+)erythromefloquine

Arakis Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

292

Phase 2

Germany;United Kingdom

2067

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

2068

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

2069

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

2070

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

No.

TrialID

Date_
enrollment

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

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

2072

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

2073

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

2074

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

2075

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

No.

TrialID

Date_
enrollment

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

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

2077

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

2078

EUCTR2005-001633-14-DK
(EUCTR)

17/08/2005

30/06/2005

Randomised, multi-center, open-label, parallel-group study comparing adalimumab (Humira?) 40 mg s.c. eow versus infliximab (Remicade?) 3 mg/kg i.v. every 6. week in RA patients with unsustainable clinical response to infliximab 3 mg/kg every 8. week - The SWITCH Study

Rheumatoid arthritis

Trade Name: Humira
Product Name: Humira
Trade Name: Remicade
Product Name: Remicade

Hvidovre Hospital, Dept. Rheumatology

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

112

Denmark;Sweden

2079

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

2080

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

No.

TrialID

Date_
enrollment

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

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

2082

EUCTR2005-000158-61-ES
(EUCTR)

09/08/2005

09/06/2005

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLT;Classification code 10039073

Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Product Name: GW406381
Product Code: GW406381X
Other descriptive name: GW406381X
Trade Name: Artilog
Product Name: Celecoxib
INN or Proposed INN: Celecoxib

GlaxoSmithKline s.a.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

2210

Phase 3

Hungary;Germany;Czech Republic;United Kingdom;Denmark;Estonia;Ireland;Spain;Italy;Latvia;Lithuania

2083

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

2084

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

2085

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

No.

TrialID

Date_
enrollment

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

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

2087

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

2088

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

2089

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

2090

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

No.

TrialID

Date_
enrollment

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

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

2092

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

2093

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

2094

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

2095

EUCTR2005-001138-33-ES
(EUCTR)

05/07/2005

16/05/2006

A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.

Rheumatoid Arthritis

F. Hoffmann La-Roche AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

650

Portugal;Denmark;Slovenia;Norway;Spain;Italy

No.

TrialID

Date_
enrollment

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

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

2097

NCT00122382
(ClinicalTrials.gov)

July 2005

19/7/2005

Remission and Joint Damage Progression in Early Rheumatoid Arthritis

A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

Rheumatoid Arthritis

Drug: Abatacept;Drug: placebo;Drug: methotrexate

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

1052

Phase 3

United States;Australia;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Russian Federation;South Africa;Spain;United Kingdom;Austria;Ireland

2098

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

2099

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

2100

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

No.

TrialID

Date_
enrollment

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

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

2102

EUCTR2004-003741-40-SK
(EUCTR)

16/06/2005

07/12/2004

A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

630

Phase 3

Hungary;Slovakia;Austria;Germany;Italy

2103

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

2104

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

2105

EUCTR2004-002993-49-DE
(EUCTR)

10/06/2005

25/01/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

No.

TrialID

Date_
enrollment

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

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

2107

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

2108

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

2109

EUCTR2004-002993-49-GB
(EUCTR)

17/05/2005

23/02/2005

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;United Kingdom;Estonia;Latvia;Sweden;Lithuania

2110

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

2111

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

2112

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

2113

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

2114

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

2115

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

No.

TrialID

Date_
enrollment

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

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

2117

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

2118

EUCTR2004-003741-40-HU
(EUCTR)

15/04/2005

07/02/2005

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Germany;Italy

2119

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

2120

EUCTR2004-002846-36-ES
(EUCTR)

12/04/2005

24/01/2006

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTERSTUDY TO COMPARE 3 DOSE LEVELS OF CP 690,550 VERSUS PLACEBO, DMINISTERED ORALLY TWICE DAILY (BID) FOR 6 WEEKS, IN THE TREATMENT OF THE IGNS AND SYMPTOMS OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS

Rheumatoid Arthritis
MedDRA version: 7.1;Level: LLD;Classification code 10039073

Product Name: CP690,550
Product Code: CP690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,
Product Name: CP690,550
Product Code: CP690,550
Other descriptive name: (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile,

Pfizer, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

312

Phase 2A

Germany;Spain;Italy

No.

TrialID

Date_
enrollment

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

EUCTR2004-005210-37-ES
(EUCTR)

29/03/2005

04/11/2005

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Finland;Czech Republic;Germany;Spain;Sweden

2122

EUCTR2004-002993-49-FI
(EUCTR)

29/03/2005

16/12/2004

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870

Celltech R&D Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 3

Hungary;Finland;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

2123

EUCTR2004-003733-14-FI
(EUCTR)

23/03/2005

17/11/2004

A study investigating whether tocilizumab (study drug) prevents joint damage, and how safe it is, in patients with moderate to severe rheumatoid arthritis randomly divided to groups receiving treatment with tocilizumab and methotrexate or methotrexate and placebo.

A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. - LITHE

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

Trade Name: RoActemra
Product Name: Tocilizumab
Product Code: RO4877533
INN or Proposed INN: Tocilizumab
Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody

F. Hoffmann La-Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1170

France;Norway;Italy;Australia;Brazil;South Africa;Finland;Denmark;Mexico;China;Spain;United States;Greece;Poland

2124

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

2125

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

No.

TrialID

Date_
enrollment

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

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

2127

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

2128

EUCTR2004-004302-24-CZ
(EUCTR)

09/03/2005

04/02/2005

A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety and Tolerability of L-000883191 in Rheumatoid Arthritis - Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis

Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA
Trade Name: PARALEN 500
Product Name: PARALEN 500
Product Code: 8594739041288
INN or Proposed INN: paracetamol
Other descriptive name: NA

Merck & Co., Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Finland;Germany;Czech Republic;Spain;Italy

2129

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

2130

EUCTR2004-003741-40-DE
(EUCTR)

28/02/2005

01/12/2004

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

630

Hungary;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2131

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

2132

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

2133

EUCTR2004-004302-24-ES
(EUCTR)

16/02/2005

04/11/2005

Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Product Name: L-000883191
Product Code: L-000883191
INN or Proposed INN: NA
Other descriptive name: NA
Trade Name: Paracetamol
Product Name: Paracetamol
Product Code: NA
INN or Proposed INN: NA
Other descriptive name: NA

Merck & Co. Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

Finland;Czech Republic;Germany;Spain;Italy

2134

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

2135

EUCTR2004-002993-49-HU
(EUCTR)

11/02/2005

15/12/2004

Rheumatoid Arthritis
Classification code 10039073

Product Name: CDP870
Product Code: CDP870
INN or Proposed INN: certolizumab pegol

Celltech R&D Ltd

NULL

Not Recruiting

Female: yes
Male: yes

950

Phase 3

Finland;Hungary;Czech Republic;Germany;Estonia;Latvia;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2136

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

2137

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

2138

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

2139

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

2140

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

2141

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

2142

NCT00423358
(ClinicalTrials.gov)

February 2005

17/1/2007

Treatment of Hypovitaminosis D in Rheumatoid Arthritis

Rheumatoid Arthritis;Hypovitaminosis D

Dietary Supplement: Vitamin D;Dietary Supplement: placebo

University of Wisconsin, Madison

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

Completed

18 Years

90 Years

All

N/A

United States

2143

EUCTR2004-003733-14-ES
(EUCTR)

28/01/2005

07/12/2005

Rheumatoid Arthritis

Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA

F. Hoffmann La-Roche AG

NULL

Not Recruiting

Female: yes
Male: yes

1170

Finland;Denmark;Spain;Italy

2144

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

2145

EUCTR2004-000012-13-EE
(EUCTR)

20/01/2005

A Double-Blind, Placebo-Controlled, Parallel, Randomized Study To Evaluate The Efficacy And Safety Of 3 Oral Dose Levels Of TMI-005 In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate -

Rheumatoid Arthritis

Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development

NULL

Not Recruiting

Female: yes
Male: yes

360

Czech Republic;Estonia;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2146

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

2147

EUCTR2004-004302-24-FI
(EUCTR)

18/01/2005

17/11/2004

Rheumatoid Arthritis
MedDRA version: 7.0;Level: LLT;Classification code 10039073

Suomen MSD Oy

NULL

Not Recruiting

Female: yes
Male: yes

136

Finland;Czech Republic;Germany;Spain;Italy

2148

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

2149

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

2150

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

2151

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

2152

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

2153

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

2154

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

2155

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

No.

TrialID

Date_
enrollment

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

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

2157

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

2158

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

2159

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

2160

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

No.

TrialID

Date_
enrollment

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

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

2162

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

2163

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

2164

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

2165

NCT00831649
(ClinicalTrials.gov)

September 2004

27/1/2009

A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201

Rheumatoid Arthritis

Drug: natalizumab

Biogen

Elan Pharmaceuticals

Terminated

18 Years

75 Years

Both

Phase 2

NULL

No.

TrialID

Date_
enrollment

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

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

2167

EUCTR2004-000074-31-SE
(EUCTR)

06/07/2004

21/05/2004

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

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

2168

NCT00094562
(ClinicalTrials.gov)

June 2004

20/10/2004

A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss

AAFA™ Fish Oil Nutritional Supplementation to Maintain Body Weight in Patients With Disease-Related Weight Loss

Cancer;Cancer Cachexia;Chronic Obstructive Pulmonary Disease;Chronic Heart Failure;Rheumatoid Arthritis

Drug: Fish oil supplement

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

National Center for Complementary and Integrative Health (NCCIH)

Completed

18 Years

90 Years

All

Phase 2

United States

2169

NCT00083759
(ClinicalTrials.gov)

May 2004

1/6/2004

Natalizumab in the Treatment of Rheumatoid Arthritis in Subjects Receiving Methotrexate

A Phase II, Multicenter, Double-blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Natalizumab (300 mg) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Receiving Concomitant Treatment With Methotrexate (MTX)

Rheumatoid Arthritis

Drug: natalizumab;Drug: placebo

Biogen

Elan Pharmaceuticals

Terminated

18 Years

75 Years

All

299

Phase 2

United States;Canada

2170

NCT00157872
(ClinicalTrials.gov)

January 7, 2004

7/9/2005

A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)

A Multicenter, Randomized, Parallel-Group, 8-Week, Double-Blind, and Active Comparator-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Rofecoxib Tablet 25 mg Once Daily Versus Naproxen Table 500 mg Twice Daily in the Treatment of Chinese Patient With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MK0966; rofecoxib;Drug: Comparator: naproxen tablet 500 mg

Merck Sharp & Dohme Corp.

NULL

Completed

18 Years

N/A

All

150

Phase 4

China

No.

TrialID

Date_
enrollment

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

NCT00095173
(ClinicalTrials.gov)

December 2003

1/11/2004

BMS-188667 in Children and Adolescents With Juvenile Rheumatoid Arthritis

A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)

Juvenile Rheumatoid Arthritis

Drug: Abatacept;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

6 Years

17 Years

All

214

Phase 3

United States;Austria;Brazil;France;Germany;Italy;Mexico;Peru;Portugal;Spain;Switzerland

2172

NCT00062465
(ClinicalTrials.gov)

June 2003

5/6/2003

Treating Rheumatoid Arthritis With Tripterygium Wilfordi Hook F or Sulfasalazine

A 24-Week, Double Blind, Randomized Study to Determine the Effects of 24 Weeks of Dosing With Tripterygium Wilfordii Hook F (TwHF) or Sulfasalazine, in Subjects With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: TwHF

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

NULL

Completed

N/A

Both

157

Phase 2

United States

2173

NCT00563849
(ClinicalTrials.gov)

May 2003

21/11/2007

Leflunomide + Methotrexate in Rheumatoid Arthritis

An Open-Label, Multi-Center Study to Evaluation of Leflunomide Plus Methotexate for the Treatment of Rheumatoid Arthritis in DMARDs:(Disease-Modifying Antirheumatic Drug) na¿ve or Restart (Skip DMARDs More Than 4 Weeks) Subjects.

Rheumatoid Arthritis

Drug: Leflunomide

Sanofi

NULL

Completed

18 Years

75 Years

Both

Phase 4

Korea, Republic of

2174

NCT00650455
(ClinicalTrials.gov)

February 2003

28/3/2008

Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients

Clinical Protocol for a Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Bextra® (Valdecoxib) 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe RA Population

Arthritis, Rheumatoid

Drug: valdecoxib;Drug: naproxen;Drug: placebo

Pfizer

NULL

Completed

18 Years

N/A

Both

489

Phase 4

United States;Canada

2175

NCT00034060
(ClinicalTrials.gov)

April 2002

19/4/2002

The Role of Cytokines on Growth Hormone Suppression in Premenopausal Women With Rheumatoid Arthritis and the Effect of Treatment With Etanercept

Suppression of the Growth Hormone/ Insulin-Like Growth Factor-1 (GH/IGF-1) Axis in Women With Rheumatoid Arthritis

Rheumatoid Arthritis;Healthy

Drug: Etanercept

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

NULL

Completed

N/A

Female

Phase 2

United States

No.

TrialID

Date_
enrollment

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

NCT00959439
(ClinicalTrials.gov)

March 2002

13/8/2009

Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)

A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg.

Rheumatoid Arthritis;Osteoarthritis

Drug: Naproxen Delayed Release Tables, 375 (Gevena Pharmaceuticals, Inc.);Drug: Naproxen (EC-Narosyn) Delayed Release Tables, 375 (Syntex (USA), Inc.)

Sandoz

NULL

Completed

21 Years

50 Years

All

Phase 1

NULL

2177

NCT00029042
(ClinicalTrials.gov)

January 2002

4/1/2002

Infliximab to Treat Children With Juvenile Rheumatoid Arthritis

A Randomized Double Blind Controlled Intra-Patient Dose Escalation Phase II Trial of Infliximab in Pediatric Patients With Refractory Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis

Drug: Infliximab

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

NULL

Terminated

N/A

Both

Phase 2

United States

2178

NCT00014794
(ClinicalTrials.gov)

April 2001

11/4/2001

Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate Synovial Blood Flow in Rheumatoid Arthritis Patients

H215O Positron Emission Tomography (PET) in the Assessment of Synovial Blood Flow in Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Drug: 15-O labeled water

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

NULL

Completed

N/A

Both

Phase 1

United States

2179

NCT00034853
(ClinicalTrials.gov)

December 2000

2/5/2002

Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis

Arthritis, Juvenile Rheumatoid

Drug: meloxicam oral suspension;Drug: naproxen oral suspension

Boehringer Ingelheim

NULL

Completed

2 Years

17 Years

Both

180

Phase 3

United States;Brazil;Mexico;Ukraine;Argentina

2180

NCT00279747
(ClinicalTrials.gov)

September 2000

19/1/2006

A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)

A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension 0.25mg/kg and 0.125 mg/kg Administered Once Daily in Comparison to Naproxen Oral Suspension 5mg/kg Administered Twice Daily in Children With Juvenile Rheumatoid Arthritis.

Arthritis, Juvenile Rheumatoid

Drug: meloxicam 0.25 mg/kg;Drug: meloxicam 0.125 mg/kg;Drug: naproxen 10 mg/kg

Boehringer Ingelheim

NULL

Completed

2 Years

16 Years

Both

226

Phase 3

Austria;Belgium;France;Germany;Italy;Russian Federation;United Kingdom

No.

TrialID

Date_
enrollment

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

NCT00006292
(ClinicalTrials.gov)

September 2000

23/9/2000

Infliximab for the Treatment of Early Rheumatoid Arthritis

Randomized Double Blind Active Treatment Controlled Trial of the Anti-TNF-Alpha Antibody Infliximab in Patients With Erosive Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Infliximab

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

NULL

Completed

N/A

Both

Phase 2

United States

2182

NCT00012506
(ClinicalTrials.gov)

October 1999

10/3/2001

The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis

Uveitis;Arthritis, Juvenile Rheumatoid

Drug: TNFR:Fc

National Eye Institute (NEI)

NULL

Recruiting

2 Years

18 Years

Both

Phase 3

United States

2183

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

2184

NCT00000401
(ClinicalTrials.gov)

July 1999

3/11/1999

Oral Collagen for Rheumatoid Arthritis

Open Label Multicenter Induction of CII Tolerance in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Oral bovine type II collagen

University of Tennessee

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

Completed

18 Years

80 Years

Both

110

Phase 2

United States

2185

NCT00001862
(ClinicalTrials.gov)

February 1999

3/11/1999

TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis

The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis;Uveitis

Drug: Enbrel

National Eye Institute (NEI)

NULL

Completed

N/A

Both

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2186

NCT00001677
(ClinicalTrials.gov)

June 1998

3/11/1999

Methotrexate Alone Versus Combination of Methotrexate and Subcutaneous Fludarabine for Severe Rheumatoid Arthritis: Safety, Tolerance and Efficacy

Arthritis, Rheumatoid;Synovitis

Drug: Methotrexate;Drug: Fludarabine

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

NULL

Completed

N/A

Both

Phase 2

United States

2187

NCT00001614
(ClinicalTrials.gov)

July 1997

3/11/1999

The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis

Arthritis, Juvenile Rheumatoid;Uveitis

Drug: Chicken type II collagen

National Eye Institute (NEI)

NULL

Completed

N/A

Both

Phase 1

United States

2188

NCT00000395
(ClinicalTrials.gov)

September 1996

3/11/1999

Antifolate Effectiveness in Arthritis

Mechanisms of Antifolate Efficacy in Arthritis

Rheumatoid Arthritis;Adjuvant Arthritis

Drug: Methotrexate;Dietary Supplement: Folinic acid;Dietary Supplement: Folic acid

University of Alabama at Birmingham

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Dietary Supplements (ODS)

Completed

18 Years

85 Years

Both

Phase 2

United States

2189

NCT00000429
(ClinicalTrials.gov)

June 1996

18/1/2000

Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis

Calcium Supplementation for Bone Mineralization in Juvenile Rheumatoid Arthritis (JRA)

Juvenile Rheumatoid Arthritis

Drug: Calcium carbonate

Children's Hospital Medical Center, Cincinnati

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

Completed

6 Years

18 Years

Both

192

Phase 2

United States

2190

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

No.

TrialID

Date_
enrollment

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

EUCTR2016-003630-25-BG
(EUCTR)

17/07/2017

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

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3068

Phase 3

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

2192

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

2193

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

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

2194

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

2195

EUCTR2019-000878-30-EE
(EUCTR)

12/05/2020

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

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3000

Phase 3

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

No.

TrialID

Date_
enrollment

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

JPRN-JapicCTI-132125

14/05/2013

A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

Rheumatoid Arthritis

Intervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 52
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous injection every 2 weeks through Week 50
Control intervention name : Adalimumab
Dosage And administration of the control intervention : Adalimumab administered by SC injection every 2 weeks through Week 50

Eli Lilly Japan K.K.

NULL

BOTH

Phase 3

NULL

2197

EUCTR2009-015019-42-Outside-EU/EEA
(EUCTR)

08/03/2012

Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Childrenwith Juvenile Idiopathic Arthritis (JIA) and Multiple Joint InvolvementWho Have Poor Response to Methotrexate (GO KIDS)

Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 14.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO148
INN or Proposed INN: Golimumab
Other descriptive name: Human anti-TNF-alpha monoclonal antibody

Janssen Biologics B.V.

NULL

Female: yes
Male: yes

170

Peru;Russian Federation;United States;Argentina;Brazil;Canada;Mexico

2198

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

2199

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

2200

JPRN-JapicCTI-132156

12/06/2013

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

Rheumatoid Arthritis

Intervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.

Eli Lilly Japan K.K.

NULL

recruiting

BOTH

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2201

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

2202

JPRN-JapicCTI-121843

28/05/2012

OSKIRA-Asia-1

A Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose Ranging Study in Asia Evaluating Efficacy and Safety of Fostamatinib in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate Therapy

Rheumatoid Arthritis

Intervention name : Fostamatinib
Dosage And administration of the intervention : 100mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 75mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 50mg twice daily for 12 weeks
Intervention name : Fostamatinib
Dosage And administration of the intervention : 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12
Control intervention name : Placebo
Dosage And administration of the control intervention : twice daily for 12 weeks

AstraZeneca

NULL

BOTH

Phase 2

NULL

2203

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

2204

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

2205

EUCTR2019-000868-18-LT
(EUCTR)

19/07/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

600

Phase 3

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

No.

TrialID

Date_
enrollment

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

EUCTR2011-001661-40-Outside-EU/EEA
(EUCTR)

07/02/2012

A multicenter study of the safety, efficacy effects on the body of Humira (adalimumab) in children with polyarticular Juvenile Rheumatoid Arthritis (a form of reheumatoid arthritis in children / young people with unknown cause).

A Multicenter, Randomized, Double-blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Juvenile Rheumatiod Arthritis

Polyarticular Juvenile Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10036039;Term: Polyarticular juvenile rheumatoid arthritis, chronic or unspecified;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Trade Name: Humira 40mg/0.8 ml solution for injection for paediatric use
INN or Proposed INN: ADALIMUMAB

Abbott Laboratories

NULL

Female: yes
Male: yes

171

United States

2207

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

2208

JPRN-JapicCTI-050016

02/09/2005

A controlled, randomized trial of MRA monotherapy in patients with rheumatoid arthritis(RA)

Intervention name : MRA (tocilizumab)
Dosage And administration of the intervention : Intravenous infusion

Chugai Pharmaceutical Co., Ltd.

NULL

Phase 3

NULL

2209

EUCTR2014-004558-33-Outside-EU/EEA
(EUCTR)

09/12/2014

A Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

Abbott Japan Co., Ltd.

NULL

Female: yes
Male: yes

Japan

2210

JPRN-JapicCTI-050018

02/09/2005

Double-blind, parallel-group, controlled Phase 3 study of MRA in rheumatoid arthritis(RA)

Intervention name : MRA (tocilizumab)
Dosage And administration of the intervention : Intravenous infusion

Chugai Pharmaceutical Co., Ltd.

NULL

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2211

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

2212

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

2213

JPRN-JapicCTI-080650

23/10/2008

Dose-Response Study of Ocrelizumab for Rheumatoid Arthritis.

Rheumatoid Arthritis

Intervention name : Ocrelizumab
Dosage And administration of the intervention : 50mg,200mg,500mg twice as an IV infusion on Days1 and 15
Control intervention name : Placebo
Dosage And administration of the control intervention : administered twice as an IV infusion on Days1 and 15

Chugai Pharmaceutical Co., Ltd.

NULL

BOTH

Phase 2

NULL

2214

EUCTR2015-002466-22-Outside-EU/EEA
(EUCTR)

23/12/2015

A Randomized, Multi-center, Blinded, Placebo-controlled Study With an Openlabel Run-in Period to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHuiL-1ra (Anakinra) in Polyarticular-Course Juvenile Rheumatoid Arthritis

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

Product Name: anakinra
INN or Proposed INN: ANAKINRA

Amgen Inc

NULL

Female: yes
Male: yes

United States;Australia;Canada;Costa Rica;New Zealand

2215

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

2216

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

2217

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

2218

EUCTR2015-002156-27-AT
(EUCTR)

30/09/2015

Reduced-dose Rituximab in rheumatoid arthritis patients in remission – theREDOREM study

Prospective controlled study of reduced-dose Rituximab in rheumatoidarthritis patients in low disease activity and remission – the REDOREMstudy

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

Trade Name: MabThera
INN or Proposed INN: RITUXIMAB

Medical University of Vienna

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Austria

2219

JPRN-JapicCTI-050146

12/10/2005

Clinical Study to assess the efficacy and safety of increased dose of TA-650 in patients with Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : TA-650 (Infliximab)
Dosage And administration of the intervention : Intravenous drip infusion

Mitsubishi Tanabe Pharma Corporation

NULL

BOTH

Phase 3

NULL

2220

JPRN-JapicCTI-132138

28/05/2013

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis

Rheumatoid Arthritis

Eli Lilly Japan K.K.

NULL

BOTH

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

2221

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

2222

EUCTR2005-000443-28-Outside-EU/EEA
(EUCTR)

22/09/2011

A Phase III Study of BMS-188667 in Children and Adolescents with Juvenile Rheumatoid Arthritis

A Phase III, Multi-Center, Multi-National, Randomized, Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents with Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)

Juvenile Rheumatoid Arthritis
MedDRA version: 14.0;Level: LLT;Classification code 10023267;Term: Juvenile rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: abatacept

Bristol Myers Squibb International Corporation

NULL

Female: yes
Male: yes

200

Phase 3

Austria;Brazil;France;Germany;Italy;Mexico;Peru;Portugal;Spain;Switzerland;United States

2223

EUCTR2012-001171-37-Outside-EU/EEA
(EUCTR)

07/03/2012

Study evaluating safety and effectiveness in children with childhood arthritis

A Phase IV Registry of Etanercept in Children With Juvenile Rheumatoid Arthritis

Juvenile idiopathic arthritis (JIA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT
Trade Name: Enbrel
Product Name: Enbrel (Etanercept)
INN or Proposed INN: ETANERCEPT

Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320

NULL

Female: yes
Male: yes

594

Phase 4

Canada;United States

2224

JPRN-JapicCTI-142405

06/01/2014

A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis

Rheumatoid Arthritis

Intervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily
Intervention name : placebo
Dosage And administration of the intervention : Placebo administered orally once daily

Eli Lilly Japan K.K.

NULL

other

BOTH

Phase 3

NULL

2225

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

No.

TrialID

Date_
enrollment

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

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

2227

EUCTR2015-005450-36-Outside-EU/EEA
(EUCTR)

01/08/2016

Pilot to Evaluate the Safety and Efficacy of Abatacept in Adults and Children Over the Age of 6 With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

A Phase II Randomized, Placebo-Controlled, Double-Blind, Parallel Arms With Switchover, Pilot Study to Evaluate the Efficacy and Safety of Intravenous Abatacept in Treatment Resistant Nephrotic Syndrome (Focal Segmental Glomerulosclerosis/ Minimal Change)

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT

Bristol-Myers Squibb Company

NULL

Female: yes
Male: yes

100

Phase 2

United States

2228

JPRN-JapicCTI-121990

22/10/2012

OSKIRA-Asia-1X

A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Rheumatoid Arthritis

Intervention name : Fostamatinib
Dosage And administration of the intervention : 100mg once daily

AstraZeneca

NULL

BOTH

Phase 2

NULL

2229

JPRN-JapicCTI-070479

26/11/2007

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy.

Rheumatoid arthritis

Intervention name : Ocrelizumab
Dosage And administration of the intervention : Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26.

Chugai Pharmaceutical Co., Ltd.

NULL

BOTH

Phase 3

NULL