DDrare: Database of Drug Development for Rare Diseases

46. 悪性関節リウマチ
［臨床試験数：4,183，薬物数：2,538（DrugBank：401），標的遺伝子数：183，標的パスウェイ数：219］

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	NCT04539964 (ClinicalTrials.gov)	January 2021	31/8/2020	Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid Arthritis	A Randomized, Sham-Controlled, Double-Blind Study of Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid Arthritis: The RESET-RA Study	Rheumatoid Arthritis	Procedure: Implant Procedure;Drug: Conventional Synthetic DMARD;Device: Active stimulation;Device: Sham stimulation	SetPoint Medical Corporation	NULL	Not yet recruiting	22 Years	75 Years	All	250	Phase 3	NULL
2	NCT04286789 (ClinicalTrials.gov)	November 2020	25/2/2020	Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Study in RA Patients Managed With DMARDs	A Randomized, Double-blind, Parallel, Vehicle Controlled, Repeat Dose Comparative Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ORTD-1 in Rheumatoid Arthritis Patients With Mild Disease Managed With DMARDs	Rheumatoid Arthritis	Drug: Low dose ORTD-1;Drug: Low dose vehicle control;Drug: High dose ORTD-1;Drug: High dose vehicle control	Oryn Therapeutics, LLC	NULL	Recruiting	18 Years	N/A	All	16	Phase 1	United States
3	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
4	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
5	NCT04251741 (ClinicalTrials.gov)	March 1, 2020	8/1/2020	Using Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment	Using Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment: a Blinded Randomized Superiority Trial	Rheumatoid Arthritis	Diagnostic Test: Adalimumab trough concentration;Other: Usual care	Reade Rheumatology Research Institute	ZonMw: The Netherlands Organisation for Health Research and Development;Sint Maartenskliniek	Recruiting	18 Years	N/A	All	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
6	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
7	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
8	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
9	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
10	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
11	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
12	NCT04134728 (ClinicalTrials.gov)	October 31, 2019	18/10/2019	Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) 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	Arthritis, Rheumatoid	Biological: GSK3196165;Biological: Sarilumab;Drug: Placebo to GSK3196165/ Sarilumab;Drug: csDMARDs	GlaxoSmithKline	Iqvia Pty Ltd	Recruiting	18 Years	N/A	All	525	Phase 3	United States;Argentina;Belgium;Canada;Czechia;Germany;Hungary;Italy;Japan;Korea, Republic of;Lithuania;Poland;South Africa;Spain;United Kingdom
13	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
14	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
15	EUCTR2019-000867-26-BG (EUCTR)	11/10/2019	30/07/2019	Efficacy and safety study, comparing GSK3196165 (study drug) with placebo and with tofacitinib in combination with conventional synthetic antirheumatic drugs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic/biologic antirheumatic drugs	A 52-week, phase 3, multicentre, randomised, double blind, efficacy and safety study, comparing GSK3196165 with placebo and with tofacitinib in combination with conventional synthetic DMARDs, in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs - contRAst-2	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Trade Name: Xeljanz Product Name: Tofacitinib INN or Proposed INN: Tofacitinib citrate Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal Product Name: otilimab Product Code: GSK3196165 INN or Proposed INN: OTILIMAB Other descriptive name: Anti human granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1800	Phase 3	Germany;China;Japan;Korea, Republic of;United States;Estonia;Thailand;Spain;Russian Federation;Colombia;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Brazil;Australia;Bulgaria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	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
17	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
18	NCT04464642 (ClinicalTrials.gov)	July 10, 2019	6/7/2020	Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis	Tofacitinib Versus Methotrexate as the First Line DMARD in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Tofacitinib	Dr. Mohammad Mamun Khan	NULL	Active, not recruiting	18 Years	N/A	All	110	Phase 4	Bangladesh
19	NCT03970837 (ClinicalTrials.gov)	June 5, 2019	16/5/2019	Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)	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	Arthritis, Rheumatoid	Biological: GSK3196165;Drug: Tofacitinib;Drug: Placebo to GSK3196165;Drug: Placebo to Tofacitinib;Drug: csDMARDs	GlaxoSmithKline	Iqvia Pty Ltd	Recruiting	18 Years	N/A	All	1500	Phase 3	United States;Argentina;Australia;Bulgaria;Colombia;Estonia;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Russian Federation;Spain;United Kingdom
20	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
21	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
22	EUCTR2018-000666-10-ES (EUCTR)	23/01/2019	22/01/2019	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Hungary;Czech Republic;Canada;Poland;Belgium;Spain;Germany;United Kingdom
23	NCT03863405 (ClinicalTrials.gov)	January 9, 2019	4/3/2019	Metformin Use in Rheumatoid Arthritis	The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Metformin;Drug: Conventional DMARDs;Drug: Placebo Oral Tablet	Ain Shams University	Future University in Egypt	Recruiting	18 Years	N/A	All	60	Phase 2	Egypt
24	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
25	EUCTR2018-000666-10-GB (EUCTR)	17/12/2018	24/10/2018	A Phase 2 study to investigate the safety and efficacy of ABBV-105 given alone or in combination with ABT-494 (Upadacitinib) in patients with active rheumatoid arthritis who have failed prior treatment with biologic therapy	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination with Upadacitinib (ABBV-599 Combination) with a Background of Conventional Synthetic DMARDs in Subjects with Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 Other descriptive name: ABBV-105 , A-1519938.0 Product Code: ABBV-105 Other descriptive name: ABBV-105 , A-1519938.0 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Hungary;Czech Republic;Puerto Rico;Canada;Spain;Poland;Belgium;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	NCT03980639 (ClinicalTrials.gov)	November 20, 2018	18/1/2019	Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase	Abatacept and the Risk of Cancer: a Case Non-case Analysis in VigiBase	Rheumatoid Arthritis	Drug: patient treated with DMARD	University Hospital, Toulouse	NULL	Recruiting	18 Years	N/A	All	594226		France
27	NCT03682705 (ClinicalTrials.gov)	October 8, 2018	21/9/2018	A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis.	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599 Combination) With a Background of Conventional Synthetic DMARDs in Subjects With Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs	Rheumatoid Arthritis (RA)	Drug: Upadacitinib;Drug: ABBV-105;Drug: Upadacitinib placebo;Drug: ABBV-105 placebo	AbbVie	NULL	Completed	18 Years	N/A	All	242	Phase 2	United States;Belgium;Canada;Czechia;Hungary;Poland;Puerto Rico;Spain;United Kingdom;Germany;Ireland
28	NCT03660059 (ClinicalTrials.gov)	September 27, 2018	26/8/2018	A Study to Assess Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)	A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTX	Rheumatoid Arthritis (RA)	Drug: Peficitinib;Drug: Plaebo;Drug: Disease-modifying antirheumatic drugs (DMARDs)	Astellas Pharma China, Inc.	NULL	Active, not recruiting	18 Years	N/A	All	385	Phase 3	China;Korea, Republic of;Taiwan
29	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
30	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
No.	TrialID	Date_ enrollment	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	NCT04066803 (ClinicalTrials.gov)	August 1, 2018	11/12/2018	Optimal MTX Dose With Folic Acid Randomized Case-control Trial	Safety and Efficacy of Optimal Methotrexate With Folic Acid in Patients With Rheumatoid Arthritis in Meizhou, Guangdong: a Randomized Case-control Study	Rheumatoid Arthritis	Drug: MTX;Drug: Folic Acid;Drug: DMARDs	Sun Yat-sen University	Shanghai Pharmaceuticals Holding Co., Ltd	Recruiting	18 Years	70 Years	All	160	Phase 4	China
32	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
33	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
34	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
35	EUCTR2017-004054-41-BE (EUCTR)	07/05/2018	15/03/2018	COBRA-Slim with or without fast access to TNF blockade for remission induction in early RA	CareRA2020: Effectiveness of a combination of Methotrexate and a step down glucocorticoid regimen (COBRA-Slim) for remission induction in patients with early Rheumatoid Arthritis (RA), with or without fast access to 24 weeks of Tumor Necrosis Factor (TNF) blockade in insufficient responders, a randomized, multicenter, pragmatic trial. - CareRA2020	early active Rheumatoid Arthritis, previously untreated with DMARDs MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		University Hospitals Leuven	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	440	Phase 4	Belgium
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	NCT03449758 (ClinicalTrials.gov)	March 5, 2018	8/2/2018	Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis	Effect of Sarilumab on Patient-reported Outcomes in Patients With Moderately to Severely Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor Inhibitors	Rheumatoid Arthritis	Drug: SARILUMAB;Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	84	Phase 4	France
37	EUCTR2017-004079-30-BE (EUCTR)	19/02/2018	19/02/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	219	Phase 3	Portugal;Spain;Belgium;Italy
38	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
39	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
40	NCT03254589 (ClinicalTrials.gov)	October 1, 2017	16/8/2017	Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis	Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis	Rheumatoid Arthritis;Stiffness, Aortic;Endothelial Dysfunction;Cardiovascular Risk Factor	Drug: Methotrexate;Drug: Sulfasalazine;Drug: Other DMARDs	Flinders University	University of South Australia;medac GmbH	Recruiting	18 Years	N/A	All	124	Phase 4	Australia
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	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
42	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
43	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
44	NCT03155347 (ClinicalTrials.gov)	August 2, 2017	15/5/2017	An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy	A Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD Therapy	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to Tocilizumab	Hoffmann-La Roche	NULL	Recruiting	18 Years	70 Years	All	340	Phase 3	China
45	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
46	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
47	ChiCTR-INR-17011772	2017-06-27	2017-06-28	The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents	The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents	Rheumatoid Arthritis	test group:Metformin tablets, 0.25g, 3 / day, oral, atorvastatin tablets 10mg, 1 / night, oral;;Control group:Traditional DMARDs group;	Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated Hospital	NULL	Recruiting	18	65	Both	test group:80;Control group:40;		China
48	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
49	EUCTR2016-000933-37-SK (EUCTR)	15/06/2017	24/04/2017	Study to Compare ABT-494 to Abatacept in Subjects with Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE)	A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing ABT-494 to Abatacept in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	313	Phase 3	Portugal;Belarus;United States;Slovakia;Greece;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Puerto Rico;Australia;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Norway;Germany;New Zealand;Sweden
50	EUCTR2016-000569-21-FR (EUCTR)	08/06/2017	04/11/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	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	NCT03086343 (ClinicalTrials.gov)	May 9, 2017	20/3/2017	A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs	A Phase 3, Randomized, Active-Controlled, Double-Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)	Rheumatoid Arthritis (RA)	Drug: Abatacept;Drug: Placebo for abatacept;Drug: Upadacitinib;Drug: Placebo for upadacitinib	AbbVie	NULL	Active, not recruiting	18 Years	N/A	All	613	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;Germany;Greece;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Chile;Colombia
52	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
53	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
54	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
55	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
No.	TrialID	Date_ enrollment	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	NCT03082573 (ClinicalTrials.gov)	March 3, 2017	13/3/2017	Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel	Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Were Treated With H.P. Acthar Gel After an Incomplete Response to Combinations of DMARDs and Biologic DMRADs	Rheumatoid Arthritis	Drug: H.P. Acthar gel	Iraj Sabahi Research Inc.	Mallinckrodt	Recruiting	21 Years	N/A	All	30	Phase 4	United States
57	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
58	ChiCTR-IPR-17010325	2017-01-31	2017-01-04	The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial	The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial	rheumatic disease;M05.901	Metformin Group:Metformin combined Glucocorticoids and DMARDs;Non-Metformin Group:Glucocorticoids and DMARDs;Metformin combined with Coenzyme Q10 Group:Metformin and Coenzyme Q10 combined Glucocorticoids and DMARDs;	the Second Hospital of Shanxi Medical University	NULL	Pending	18	65	Both	Metformin Group:100;Non-Metformin Group:100;Metformin combined with Coenzyme Q10 Group:100;		China
59	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
60	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
No.	TrialID	Date_ enrollment	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	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
62	ChiCTR-IPR-17010307	2017-01-01	2017-01-01	The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China	The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China	Rheumatoid Arthritis;M05.901	Rapamycin group:Rapamycin;Non-rapamycin group :conventional glucocorticoids and DMARDs;	the Second Hospital of Shanxi Medical University	NULL	Recruiting	18	65	Both	Rapamycin group:200;Non-rapamycin group :100;		China
63	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
64	EUCTR2016-000569-21-GB (EUCTR)	23/12/2016	01/11/2016	Filgotinib in Combination With Conventional Anti-rheumatic Drugs in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD treatment.	A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment	Moderately to severely active rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	423	Phase 3	United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Japan;Korea, Republic of
65	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
No.	TrialID	Date_ enrollment	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	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
67	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
68	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
69	NCT02919761 (ClinicalTrials.gov)	November 7, 2016	26/9/2016	Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis	A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment	Arthritis, Rheumatoid	Drug: Acthar Gel;Drug: Placebo	Mallinckrodt	NULL	Completed	18 Years	N/A	All	259	Phase 4	United States;Argentina;Mexico;Peru;Puerto Rico;Colombia
70	ChiCTR-INR-16009546	2016-11-01	2016-10-21	The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis	The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis	rheumatoid arthritis;M05.901	IL-2 group:lL-2;IL-2 + IL-6 antagonist group:Tocilizumab;non IL-2 or IL-6 antagonist group:glucocorticoids and DMARDs;	the Second Hospital of Shanxi Medical University	NULL	Recruiting	18	65	Both	IL-2 group:15;IL-2 + IL-6 antagonist group:15;non IL-2 or IL-6 antagonist group:15;		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	NCT02037737 (ClinicalTrials.gov)	September 30, 2016	21/11/2013	Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting	Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION Study	Rheumatoid Arthritis	Drug: Abatacept	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	All	153		NULL
72	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
73	NCT02930343 (ClinicalTrials.gov)	September 2016	13/9/2016	Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy	Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: Sulfasalazine	Jawaharlal Institute of Postgraduate Medical Education & Research	NULL	Completed	18 Years	65 Years	All	136	Phase 3	India
74	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
75	EUCTR2015-004386-91-DE (EUCTR)	22/08/2016	18/05/2016	Study to explore and compare the effects of a new drug in combination with methotrexate therapy in people with early and established rheumatoid arthritis.	A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		GlaxoSmithKline Research & Development Limited	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	United States;Poland;Germany
No.	TrialID	Date_ enrollment	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	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
77	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
78	NCT02873936 (ClinicalTrials.gov)	July 27, 2016	17/8/2016	Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) 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	Rheumatoid Arthritis	Drug: Filgotinib;Drug: Placebo to match filgotinib;Drug: csDMARDs	Gilead Sciences	Galapagos NV	Completed	18 Years	N/A	All	449	Phase 3	United States;Argentina;Australia;Belgium;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Poland;Spain;Switzerland;United Kingdom;Italy;Netherlands
79	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
80	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
No.	TrialID	Date_ enrollment	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	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
82	NCT02799472 (ClinicalTrials.gov)	June 15, 2016	26/5/2016	Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active 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	Arthritis, Rheumatoid	Drug: GSK3196165;Drug: Placebo;Drug: MTX;Drug: Folic (or folinic) acid	GlaxoSmithKline	Parexel	Completed	18 Years	N/A	All	39	Phase 2	United States;Germany;Poland
83	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
84	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
85	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
86	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
87	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
88	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
89	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
90	EUCTR2015-003335-35-AT (EUCTR)	04/05/2016	14/04/2016	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: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Portugal;United States;Hong Kong;Slovakia;Greece;Spain;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;Switzerland;Puerto Rico;Australia;Denmark;Latvia;Korea, Republic of;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	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	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
92	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
93	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
94	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
95	NCT02706847 (ClinicalTrials.gov)	March 15, 2016	18/2/2016	A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs	A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)	Rheumatoid Arthritis	Drug: Upadacitinib;Drug: Placebo	AbbVie	NULL	Active, not recruiting	18 Years	99 Years	All	499	Phase 3	United States;Australia;Austria;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Korea, Republic of;Latvia;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Argentina;Brazil;Bulgaria;Chile;Colombia;Czech Republic;Denmark;Hong Kong;Italy;Mexico;Norway;Slovenia
No.	TrialID	Date_ enrollment	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	NCT03355872 (ClinicalTrials.gov)	February 2016	22/11/2017	A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs	A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs	Rheumatoid Arthritis	Drug: HLX01	Shanghai Henlius Biotech	NULL	Completed	18 Years	65 Years	All	194	Phase 1;Phase 2	NULL
97	NCT02643823 (ClinicalTrials.gov)	January 2016	23/12/2015	Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis	Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: hUC-MSC + DMARDs;Drug: DMARDs	Shenzhen Hornetcorn Bio-technology Company, LTD	Futian People's Hospital	Recruiting	18 Years	80 Years	Both	40	Phase 1	China
98	NCT02644499 (ClinicalTrials.gov)	December 31, 2015	30/12/2015	Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis	Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid	Jawaharlal Institute of Postgraduate Medical Education & Research	NULL	Completed	18 Years	N/A	All	186	Phase 4	India
99	EUCTR2013-000337-13-PT (EUCTR)	13/11/2015	11/11/2015	Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled study Prediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA)	Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled study Prediction of response to Certolizumab-Pegol in RA (PreCePRA) - PreCePRA	Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Universitätsklinikum Erlangen	NULL	Not Recruiting			Female: yes Male: yes	156	Phase 3	Serbia;United States;Portugal;Germany
100	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
No.	TrialID	Date_ enrollment	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	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
102	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	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
103	EUCTR2010-021184-32-GB (EUCTR)	25/03/2015	12/06/2015	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	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 and one 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]		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
104	NCT02373202 (ClinicalTrials.gov)	February 2015	12/2/2015	A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)	A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: Mizoribine	Sanofi	Regeneron Pharmaceuticals	Completed	20 Years	N/A	All	91	Phase 3	Japan
105	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	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: 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: NA Product Code: GP2013 INN or Proposed INN: rituximab Other descriptive name: NA Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 1;Phase 2	United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	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	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 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
107	NCT02308163 (ClinicalTrials.gov)	August 8, 2014	2/12/2014	A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs	Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs	Rheumatoid Arthritis	Drug: Peficitinib;Drug: Placebo;Biological: Etanercept	Astellas Pharma Inc	NULL	Completed	20 Years	N/A	All	509	Phase 3	Japan;Korea, Republic of;Taiwan
108	NCT02219347 (ClinicalTrials.gov)	August 2014	15/8/2014	Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)	Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)	Rheumatoid Arthritis	Drug: DMARD cessation	Newcastle-upon-Tyne Hospitals NHS Trust	Newcastle University;Wellcome Trust	Completed	18 Years	N/A	All	74	N/A	United Kingdom
109	NCT02011334 (ClinicalTrials.gov)	July 2014	4/12/2013	A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.	A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICA	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	285	Phase 3	Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay
110	NCT02046616 (ClinicalTrials.gov)	May 28, 2014	24/1/2014	A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)	Tocilizumab SC in Patients With Active Rheumatoid Arthritis and Inadequate Response to DMARDs. A Single-Arm, Open-Label Study to Evaluate Safety, Tolerability and Efficacy. In a Subgroup of Patients Inflammation Will Be Measured by Ultrasound.	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Methotrexate;Drug: Non-Biologic DMARDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	133	Phase 3	Denmark;Finland;Norway;Sweden
No.	TrialID	Date_ enrollment	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	EUCTR2010-020992-21-DE (EUCTR)	25/03/2014	08/07/2011	Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis	A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable Trade Name: Methotrexate Product Name: Methotrexate Product Code: not applicable INN or Proposed INN: METHOTREXATE Other descriptive name: not applicable Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: masitinib mesylate Other descriptive name: not applicable	AB Science	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 2b;Phase 3	Serbia;United States;Philippines;Taiwan;Morocco;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Monaco;India;Czech Republic;Mexico;Argentina;Poland;Romania;South Africa;Germany;Tunisia;Bosnia and Herzegovina
112	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	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	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
113	NCT02046603 (ClinicalTrials.gov)	March 4, 2014	24/1/2014	A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent	Open-Label, Phase IIIb Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic Agent	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	162	Phase 3	United Kingdom
114	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	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: 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
115	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.	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	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 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
No.	TrialID	Date_ enrollment	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	NCT01987479 (ClinicalTrials.gov)	January 30, 2014	8/11/2013	A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis	Multi-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCAR	Rheumatoid Arthritis	Drug: Non-Biologic DMARDs;Drug: Tocilizumab;Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	150	Phase 3	Netherlands
117	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
118	EUCTR2013-002007-34-DK (EUCTR)	09/12/2013	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.	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	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: 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
119	NCT01941095 (ClinicalTrials.gov)	November 20, 2013	30/8/2013	A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis	Multicenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	100	Phase 3	Greece
120	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
No.	TrialID	Date_ enrollment	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	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	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: 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
122	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	A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis;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
123	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		20		BOTH	642	Phase 3	NULL
124	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	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 - ACT-MOVE	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
125	NCT01973569 (ClinicalTrials.gov)	October 2013	25/10/2013	AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment	A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III)	Rheumatoid Arthritis	Drug: denosumab;Drug: placebo	Daiichi Sankyo, Inc.	NULL	Completed	20 Years	N/A	All	679	Phase 3	Japan
No.	TrialID	Date_ enrollment	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	NCT01985464 (ClinicalTrials.gov)	October 2013	31/10/2013	Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis	Feasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Umbilical cord mesenchymal stem cells	Translational Biosciences	NULL	Unknown status	18 Years	N/A	All	20	Phase 1;Phase 2	Panama
127	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
128	NCT01787149 (ClinicalTrials.gov)	September 2013	6/2/2013	A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis	A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis	Combination With DMARDs	Drug: DMARDs	Mycenax Biotech Inc.	NULL	Unknown status	20 Years	N/A	All	98	Phase 3	Taiwan
129	NCT01995201 (ClinicalTrials.gov)	September 2013	1/11/2013	A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis	A Phase IIIb Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous (SC) Tocilizumab (TCZ) Given as Monotherapy or in Combination With Methotrexate (MTX) or Other Non Biologics DMARDs in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Active, not recruiting	18 Years	N/A	Both	401	Phase 3	Ireland;Portugal;Spain
130	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	A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis;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
No.	TrialID	Date_ enrollment	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	EUCTR2013-001569-17-IT (EUCTR)	02/08/2013	04/06/2013	A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients.	A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB	Roche S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 3B	Italy
132	NCT01915537 (ClinicalTrials.gov)	August 2013	30/7/2013	Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients	A Prospective Cohort Study to Observe the Difference of Efficacy Between Infliximab With Methotrexate and Classic DMARDs in the Severe Rheumatoid Arthritis Patients With Poor Prognosis	Rheumatoid Arthritis(RA)	Drug: Infliximab group;Drug: Classic DMARDs treatment group	Zhang, Xiao, M.D.	Central South University;Tianjin Medical University General Hospital;Xijing Hospital	Not yet recruiting	18 Years	70 Years	Both	170	N/A	China
133	NCT01932372 (ClinicalTrials.gov)	July 26, 2013	30/7/2013	Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis	XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)	Rheumatoid Arthritis	Drug: Tofacitinib (Xeljanz);Drug: Etanercept , other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc	Pfizer	NULL	Active, not recruiting	N/A	N/A	All	9968		Japan
134	NCT01881308 (ClinicalTrials.gov)	June 17, 2013	17/6/2013	Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis	REmission in Rheumatoid Arthritis - Assessing WIthrawal of Disease-modifying Antirheumatic Drugs in a Non-inferiority Design	Rheumatoid Arthritis	Drug: TNF inhibitors;Drug: Synthetic DMARD(s);Drug: Co-medication: Synthetic DMARDs	Diakonhjemmet Hospital	The Research Council of Norway;South-Eastern Norway Regional Health Authority	Active, not recruiting	18 Years	80 Years	All	360	Phase 4	Norway
135	NCT01878318 (ClinicalTrials.gov)	June 2013	6/6/2013	A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs	Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs	Rheumatoid Arthritis	Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 4	Venezuela
No.	TrialID	Date_ enrollment	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	NCT01885819 (ClinicalTrials.gov)	June 2013	18/6/2013	Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis	Feasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Autologous stromal vascular fraction cells	Translational Biosciences	NULL	Withdrawn	18 Years	N/A	All	0	Phase 1;Phase 2	Panama
137	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
138	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	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: 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
139	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	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: 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
140	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
141	NCT01547091 (ClinicalTrials.gov)	April 2013	22/2/2012	Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis	Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II	Rheumatoid Arthritis	Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs);Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs);Biological: UC-MSC+DMARDS	Alliancells Bioscience Corporation Limited	NULL	Recruiting	18 Years	70 Years	Both	200	Phase 1;Phase 2	China
142	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)	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	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;United States;Taiwan;Estonia;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
143	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)	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	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: 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		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
144	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	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: 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
145	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)	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	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: SARILUMAB Product Code: SAR153191 INN or Proposed INN: sarilumab Product Name: SARILUMAB Product Code: SAR153191 INN or Proposed INN: sarilumab	SANOFI- AVENTIS RECHERCHE ET DÃ‰VELOPPEMENT	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Colombia;Italy;Switzerland;India;Australia;Peru;Korea, Republic of;Korea, Democratic People's Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
146	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)	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	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Ecuador;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
147	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)	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	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;Japan;New Zealand
148	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)	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	Rheumatoid Arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	522		Portugal;United States;Taiwan;Hong Kong;Slovakia;Ecuador;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Peru;Australia;Korea, Republic of;Guatemala;Lithuania;Turkey;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Germany;New Zealand
149	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	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 DMARD Therapy	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]	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	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
150	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	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: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 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		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
151	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	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 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
152	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)	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	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: 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
153	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	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: 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]	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	Not Recruiting			Female: yes Male: yes	459		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
154	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	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 INN or Proposed INN: Not applicable Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
155	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)	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-? Antagonists - SARIL-RA-TARGET	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 INN or Proposed INN: Sarilumab	sanofi-aventis recherche & développement	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522		United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Australia;Peru;Korea, Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;New Zealand
No.	TrialID	Date_ enrollment	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	NCT01715831 (ClinicalTrials.gov)	January 15, 2013	25/10/2012	A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488	A Multicenter, Open-Label, Single-Arm Extension Study to Describe the Safety of Tocilizumab Treatment In Brazilian Patients With DMARDs Refractory Rheumatoid Arthritis Which Completed Studies ML21530 and MA21488 and Presenting an Indication of Maintaining the Tocilizumab Treatment	Arthritis, Rheumatoid	Drug: DMARDs;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	26	Phase 4	Brazil
157	NCT01965132 (ClinicalTrials.gov)	January 1, 2013	11/10/2013	Korean College of Rheumatology Biologics Registry	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
158	NCT01491815 (ClinicalTrials.gov)	December 14, 2012	8/12/2011	Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction	A Multicenter, Randomized, Open-label, Blinded-assessor, Phase 4 Study in Patients With Early Rheumatoid Arthritis to Compare Active Conventional Therapy Versus Three Biologic Treatments, and Two De-escalation Strategies in Patients Who Respond to Treatment	Rheumatoid Arthritis	Drug: Non-biological DMARD's;Biological: Cimzia;Biological: Orencia;Biological: RoActemra	Karolinska Institutet	NULL	Active, not recruiting	18 Years	N/A	All	812	Phase 4	Denmark;Finland;Iceland;Netherlands;Norway;Sweden
159	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.	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] - Immune System Diseases [C20]	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
160	JPRN-UMIN000009425	2012/12/06	01/12/2012	A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient		Rheumatoid Arthritis	The dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity. Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year. Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year.	Osaka City University Medical School	NULL	Recruiting	20years-old	Not applicable	Male and Female	150	Phase 4	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
161	NCT01717846 (ClinicalTrials.gov)	December 2012	24/10/2012	Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis	In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis	Apoptotic DNA Damage;Rheumatoid Arthritis;T-cell Lymphocytosis	Drug: Group 1 or Orencia treated group;Other: Group 2 (DMARDS treated group)	University of California, Los Angeles	Bristol-Myers Squibb	Withdrawn	18 Years	85 Years	Both	0	Phase 4	United States
162	NCT01759030 (ClinicalTrials.gov)	December 2012	20/12/2012	Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid Arthritis	Double Blind Randomized Clinical Study Evaluating Efficacy and Safety of BCD-020 and MabThera in Patients With Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Other DMARDs Including One or More TNF Inhibitor Therapies	Rheumatoid Arthritis	Drug: Rituximab	Biocad	NULL	Completed	18 Years	80 Years	All	181	Phase 3	Belarus;India;Russian Federation;Ukraine;Colombia
163	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	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;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
164	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	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: 15.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 INN or Proposed INN: No Active Name Specified Trade Name: MabThera 500 mg concentrate for solution for infusion Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300		United States;Serbia;Portugal;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Norway;Germany;New Zealand;Sweden
165	EUCTR2012-001760-30-IT (EUCTR)	05/11/2012	25/07/2012	Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent.	Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB	OSSERVATORIO EPIDEMIOLOGICO GISEA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
166	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	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: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 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	459		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
167	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	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;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
168	NCT01709578 (ClinicalTrials.gov)	October 2012	15/10/2012	To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)	A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-a Antagonists	Rheumatoid Arthritis	Drug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	546	Phase 3	United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic;Hong Kong
169	EUCTR2011-002894-48-GB (EUCTR)	14/09/2012	06/12/2011	Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial	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: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	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
170	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.	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: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 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	459		Serbia;Portugal;United States;Estonia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Italy;France;Peru;South Africa;Netherlands;Guatemala;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Norway;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
171	NCT01661140 (ClinicalTrials.gov)	September 2012	7/8/2012	A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage	Randomized, Phase IV, Placebo-controlled, Comparative Study to Evaluate the Efficacy and Safety of Tapering Methotrexate (MTX) Dosage Versus Maintaining the Dosage in Patients With Severe Active Rheumatoid Arthritis (RA) Who Have Demonstrated an Inadequate Response (IR) to Prior Disease-modifying Anti-rheumatic Drugs (DMARDs) Treatment and Have Initiated RoActemra (RoActemra, TCZ) in Combination With MTX	Rheumatoid Arthritis	Drug: Methotrexate (stable dose);Drug: Tocilizumab;Drug: Methotrexate (tapering dose)	Hoffmann-La Roche	NULL	Terminated	18 Years	N/A	All	427	Phase 4	United Kingdom
172	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	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: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870 MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BI 695500 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	459	Phase 1;Phase 3	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
173	NCT01604343 (ClinicalTrials.gov)	August 2012	21/5/2012	A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)	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 DMARD Therapy	Arthritis, Rheumatoid	Drug: Placebo;Drug: Sirukumab	Janssen Research & Development, LLC	GlaxoSmithKline	Completed	18 Years	N/A	Both	1670	Phase 3	United States;Bulgaria;Canada;Chile;Colombia;Croatia;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa;Taiwan;Ukraine;Argentina;Brazil;India;Peru
174	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	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 DMARD Therapy	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]	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	1650	Phase 3	Serbia;United States;Taiwan;Ukraine;Lithuania;Russian Federation;Chile;Colombia;India;Mexico;Canada;Argentina;Poland;Malaysia;Brazil;Romania;Croatia;Peru;South Africa;Bulgaria;Japan;Korea, Republic of
175	NCT01578850 (ClinicalTrials.gov)	July 2012	12/4/2012	Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening	A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)	Rheumatoid Arthritis	Drug: Etanercept;Drug: placebo	Pfizer	NULL	Completed	18 Years	70 Years	All	491	Phase 4	Brazil;China;Colombia;Czech Republic;Egypt;Hungary;Jordan;Lebanon;Malaysia;Mexico;Philippines;Qatar;Romania;Russian Federation;South Africa;Taiwan;Thailand;Ukraine;United Arab Emirates;Saudi Arabia
No.	TrialID	Date_ enrollment	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	EUCTR2011-005260-20-GB (EUCTR)	28/06/2012	10/05/2012	RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor.	Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER	Adult Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Roche Products Limited	NULL	Not Recruiting			Female: yes Male: yes	618	Phase 4	United Kingdom
177	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
178	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)	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] - Immune System Diseases [C20]	Trade Name: Enbrel ® 50 mg Solution for Injection in Pre-filled Syringe INN or Proposed INN: ETANERCEPT	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	320		United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Hungary;Czech Republic;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China
179	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
180	EUCTR2011-001729-25-GB (EUCTR)	01/06/2012	19/04/2012	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: 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
181	NCT01602302 (ClinicalTrials.gov)	June 2012	16/5/2012	Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis	Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)	Medical University of Graz	NULL	Terminated	18 Years	90 Years	All	40	Phase 4	Austria
182	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	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: 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
183	EUCTR2011-001729-25-SE (EUCTR)	22/05/2012	22/02/2012	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: 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
184	EUCTR2011-005448-87-HU (EUCTR)	14/05/2012	21/03/2012	A STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S)COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITHETANERCEPT PLUS DMARD(S)	A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF THE MAINTENANCE OF EFFICACY OF ETANERCEPT PLUS DMARD(S) COMPARED WITH DMARD(S) ALONE IN SUBJECTS WITH RHEUMATOID ARTHRITIS AFTER ACHIEVING AN ADEQUATE RESPONSE WITH ETANERCEPT PLUS DMARD(S)	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel ® 50 mg Solution for Injection in Pre-filled Syringe INN or Proposed INN: ETANERCEPT	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	320		United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Czech Republic;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China
185	NCT01617005 (ClinicalTrials.gov)	May 2012	8/6/2012	A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)	Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	50	N/A	Montenegro
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
186	EUCTR2011-001729-25-DE (EUCTR)	11/04/2012	10/01/2012	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: 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
187	EUCTR2011-001729-25-CZ (EUCTR)	03/04/2012	03/02/2012	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: 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
188	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	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 and one 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 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
189	EUCTR2011-001729-25-HU (EUCTR)	22/03/2012	26/01/2012	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: 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
190	EUCTR2011-001729-25-ES (EUCTR)	16/03/2012	27/01/2012	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: 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: Trexan Product Name: Methotrexate INN or Proposed INN: METHOTREXATE	UCB Pharma SA	NULL	Not Recruiting			Female: yes Male: yes	800		United States;Spain;Ireland;Turkey;Austria;Colombia;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
191	EUCTR2011-001729-25-IE (EUCTR)	09/03/2012	12/01/2012	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: 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
192	EUCTR2011-001729-25-AT (EUCTR)	08/03/2012	08/02/2012	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: 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
193	NCT01519791 (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;Other: Placebo;Biological: Methotrexate	UCB Pharma SA	NULL	Completed	18 Years	N/A	All	880	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
194	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
195	NCT01511003 (ClinicalTrials.gov)	December 5, 2011	4/1/2012	A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)	An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs	Rheumatoid Arthritis	Drug: Tacrolimus	Astellas Pharma Inc	Astellas Pharma Korea, Inc.	Completed	20 Years	75 Years	All	128	Phase 4	Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
196	NCT01326962 (ClinicalTrials.gov)	November 30, 2011	7/3/2011	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF	Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	28	Phase 3	Saudi Arabia
197	NCT01251120 (ClinicalTrials.gov)	November 2011	30/11/2010	A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis	A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: DMARD	Hoffmann-La Roche	NULL	Terminated	18 Years	N/A	All	2	Phase 4	Finland
198	EUCTR2010-020992-21-SK (EUCTR)	26/10/2011	06/12/2011	Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis	A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to methotrexate, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	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	140	Phase 3	United States;Slovakia;Greece;Spain;Thailand;Turkey;India;France;Czech Republic;Poland;Romania;Tunisia;Germany
199	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.	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: 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	140	Phase 2b;Phase 3	United States;Czech Republic;Slovakia;Greece;Spain;Thailand;Turkey;Germany;India
200	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
201	EUCTR2010-019912-18-BG (EUCTR)	03/10/2011	25/08/2011	A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand
202	NCT01292616 (ClinicalTrials.gov)	October 2011	8/2/2011	Effect of TNF-Inhibition Combined With Conventional DMARDs on Cervical Pannus in Patients With RA and Cervical Spine Involvement		Rheumatoid Arthritis	Drug: therapy with disease-modifying anti rheumatic drugs (DMARD)	University of Zurich	NULL	Recruiting	18 Years	N/A	Both	15	N/A	Switzerland
203	NCT01245439 (ClinicalTrials.gov)	September 2011	17/11/2010	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis	Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	65	Phase 3	Turkey
204	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	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa	Adult Rheumatoid Arthritis (RA) MedDRA version: 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: 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
205	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	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 and one or up to three anti-TNF therapies	Refractory rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	164	Phase 2	Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
206	EUCTR2010-022206-40-PL (EUCTR)	26/07/2011	11/04/2011	A Rheumatoid Arthritis Study in Patients (FLEX-O)	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O)	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: n/a Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: n/a	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1002	Phase 3	United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of
207	NCT01410695 (ClinicalTrials.gov)	July 2011	4/8/2011	Masitinib in Refractory Active Rheumatoid Arthritis	A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs	Rheumatoid Arthritis (RA)	Drug: masitinib 3 mg;Drug: masitinib 6.0 mg;Drug: methotrexate;Drug: Placebo (methotrexate);Drug: Placebo (masitinib)	AB Science	NULL	Terminated	18 Years	N/A	All	324	Phase 2;Phase 3	Czechia;Czech Republic;France;United States
208	EUCTR2010-019262-86-ES (EUCTR)	22/06/2011	21/04/2010	Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)	Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)	Artritis Reumatoide_______________________Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: SAR153191	sanofi-aventis Recherche & Développement	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500		Hungary;Finland;Germany;Netherlands;Estonia;Spain;Greece;Austria;Lithuania
209	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	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 and one or up to three anti- TNF therapies	Refractory rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the 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
210	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
211	EUCTR2010-019912-18-GR (EUCTR)	18/04/2011	01/04/2011	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	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	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
212	EUCTR2010-022206-40-LT (EUCTR)	01/04/2011	28/12/2010	A Rheumatoid Arthritis Study in Patients(FLEX-O)	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O)	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 INN or Proposed INN: not available 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
213	EUCTR2010-022206-40-BG (EUCTR)	30/03/2011	24/02/2011	A Rheumatoid Arthritis Study in Patients (FLEX-O)	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O)	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: LY2127399 Product Code: LY2127399 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
214	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	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: 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
215	EUCTR2010-021577-37-DE (EUCTR)	17/03/2011	29/10/2010	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	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	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: N/A Product Code: MLTA3698A Trade Name: Humira INN or Proposed INN: ADALIMUMAB	GENENTECH, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Spain;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
216	NCT01232569 (ClinicalTrials.gov)	March 2011	1/11/2010	A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab 162 mg;Drug: Placebo	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	656	Phase 3	United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;Greece;Guatemala;Hungary;Israel;Malaysia;Mexico;New Zealand;Panama;Philippines;Poland;Russian Federation;South Africa;Spain;Switzerland;Thailand;Peru
217	NCT01313208 (ClinicalTrials.gov)	March 2011	10/3/2011	Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)	A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy	Rheumatoid Arthritis	Drug: etanercept;Drug: Placebo;Drug: DMARD Therapy	Amgen	NULL	Completed	18 Years	80 Years	All	210	Phase 4	United States;Canada
218	NCT01332994 (ClinicalTrials.gov)	March 2011	18/3/2011	A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis	Efficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI)	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	519	Phase 3	Germany
219	NCT01353859 (ClinicalTrials.gov)	March 2011	13/5/2011	A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs	An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	39	Phase 3	Indonesia;Greece
220	EUCTR2010-022206-40-HU (EUCTR)	23/02/2011	26/11/2010	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	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	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
221	EUCTR2010-020744-35-IT (EUCTR)	18/02/2011	22/12/2010	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 DMARDs. D4300C00002 - OSKIRA-2	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs. D4300C00002 - OSKIRA-2	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
222	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)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	Portugal;Serbia;United States;Spain;Ukraine;Lithuania;Israel;Italy;United Kingdom;India;Czech Republic;Canada;Romania;South Africa;Latvia;Germany
223	NCT01235507 (ClinicalTrials.gov)	February 2011	15/10/2010	A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)	Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDs	Rheumatoid Arthritis	Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	71	Phase 3	Bosnia and Herzegovina
224	NCT01254331 (ClinicalTrials.gov)	February 2011	3/12/2010	An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment	Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	51	Phase 3	Tunisia
225	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	ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS	Artritis reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: N/A Product Code: MLTA3698A Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	GENENTECH, Inc	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 2	Hungary;Germany;Bulgaria;Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
226	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.	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
227	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	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
228	NCT01274182 (ClinicalTrials.gov)	January 2011	10/1/2011	GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy	A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.	Rheumatoid Arthritis	Biological: GP2013;Biological: MabThera;Biological: Rituxan	Sandoz	Novartis Pharmaceuticals	Completed	18 Years	N/A	All	312	Phase 1;Phase 2	United States;Argentina;Austria;Belgium;Brazil;Estonia;France;Germany;Hungary;India;Italy;Romania;Spain;Turkey
229	NCT01202760 (ClinicalTrials.gov)	January 2011	14/9/2010	A Rheumatoid Arthritis Study in Participants	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)	Rheumatoid Arthritis	Drug: LY2127399;Drug: Placebo	Eli Lilly and Company	NULL	Completed	18 Years	N/A	All	1004	Phase 3	United States;Argentina;Australia;Bulgaria;Colombia;Croatia;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Sri Lanka;Taiwan;Ukraine;Peru
230	EUCTR2010-020744-35-PT (EUCTR)	17/12/2010	16/09/2010	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 DMARDs - OSKIRA - 2	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	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
231	EUCTR2010-021577-37-HU (EUCTR)	16/12/2010	27/10/2010	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	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	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
232	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	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
233	EUCTR2010-022206-40-SK (EUCTR)	13/12/2010	27/04/2016	A Rheumatoid Arthritis Study in Patients (FLEX-O)	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O)	Rheumatoid Arthritis MedDRA version: 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: 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;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of
234	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	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 and one or up to three anti-TNF therapies	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]	Product Name: NA Product Code: GP2013 Trade Name: Mabthera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: Rituxan (INN: Rituximab), brand name in the United States Product Name: Rituxan INN or Proposed INN: RITUXIMAB	Hexal AG	NULL	Not Recruiting			Female: yes Male: yes	164	Phase 2	Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany
235	EUCTR2010-018375-22-BG (EUCTR)	25/11/2010	23/09/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	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: 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
No.	TrialID	Date_ enrollment	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	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	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 and one or up to three anti-TNF therapies	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
237	NCT01225393 (ClinicalTrials.gov)	November 2010	18/10/2010	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 the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: MLTA3698A;Drug: adalimumab;Drug: leflunomide;Drug: methotrexate;Drug: placebo	Genentech, Inc.	NULL	Completed	18 Years	75 Years	Both	211	Phase 2	Romania;Spain;Bulgaria;Chile;Germany;Hungary;Mexico;Peru;Poland;United States
238	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	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
239	EUCTR2010-021184-32-FR (EUCTR)	28/10/2010	13/09/2010	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 and one or two anti- TNF therapies	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 and one or two anti- TNF therapies	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
240	NCT01362062 (ClinicalTrials.gov)	October 26, 2010	26/5/2011	Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy	A Study to Observe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti TNF Therapy.	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	110	N/A	India
No.	TrialID	Date_ enrollment	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	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)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	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] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
242	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)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;Czech Republic;Canada;Romania;South Africa;Latvia;Germany
243	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)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
244	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)	A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs - OSKIRA - 2	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] - Immune System Diseases [C20]	Product Name: Fostamatinib disodium Product Code: FosD INN or Proposed INN: Fostamatinib disodium Other descriptive name: Fostamatinib disodium	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia
245	EUCTR2010-018375-22-LT (EUCTR)	11/10/2010	16/08/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	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: 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;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
No.	TrialID	Date_ enrollment	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	EUCTR2010-018375-22-DE (EUCTR)	05/10/2010	14/07/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	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: 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;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
247	NCT01214733 (ClinicalTrials.gov)	October 2010	4/10/2010	A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis	An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	30	Phase 3	South Africa
248	NCT01149057 (ClinicalTrials.gov)	October 2010	22/6/2010	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS	An Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	Clalit Health Services	Completed	18 Years	N/A	All	145	Phase 4	Israel
249	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)	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
250	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	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
251	EUCTR2010-018375-22-GB (EUCTR)	14/09/2010	29/06/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	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
252	NCT01194414 (ClinicalTrials.gov)	September 2010	1/9/2010	A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab SC;Drug: tocilizumab IV;Drug: placebo to tocilizumab SC;Drug: placebo to tocilizumab IV;Drug: Disease-modifying antirheumatic drugs (DMARDs)	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	1262	Phase 3	United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Guatemala;Hong Kong;Italy;Lithuania;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Singapore;South Africa;Spain;Thailand;United Kingdom
253	NCT01197534 (ClinicalTrials.gov)	September 2010	8/9/2010	Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.	(OSKIRA-2): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to DMARDs	Rheumatoid Arthritis	Drug: fostamatinib;Drug: placebo, fostamatinib	AstraZeneca	NULL	Completed	18 Years	N/A	All	913	Phase 3	United States;Canada;Czech Republic;Germany;India;Israel;Italy;Latvia;Lithuania;Portugal;Romania;Serbia;South Africa;Spain;Ukraine;United Kingdom
254	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.	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
255	NCT01195272 (ClinicalTrials.gov)	August 2010	2/9/2010	A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.	A 52 Week, Single Center, Open-label Study to Evaluate Neutrophil Function and Survival Effects of Tocilizumab (TCZ) in Patients With Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	21	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
256	EUCTR2010-018375-22-IT (EUCTR)	29/07/2010	05/07/2010	A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND	A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Trade Name: RoActemra INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1200		Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy
257	JPRN-UMIN000003807	2010/07/01	01/07/2010	A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis		Rheumatoid Arthritis	Combination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate) Combination therapy of TNF-bloking biologics and methotrexate	Japan Association of Rheumatologists in Private Practice	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	160	Not applicable	Japan
258	JPRN-UMIN000003880	2010/07/01	07/07/2010	Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area		Rheumatoid arthritis	DAS28>3.2 at 24 weeks Switching to another biologics DAS28>3.2 at 24 weeks Dose up of MTX or addition of other DMARDs DAS28<=3.2 at 24 weeks 40 mg of Adalimumab every two week DAS28<=3.2 at 24 weeks 40 mg of Adalimumab every four week	Osaka City University Medical School	Higashi Sumiyoshi Morimoto Hospital, Yodogawa Christian Hospital, Kitade Hospital, Shirahama Hamayu Hospital	Recruiting	20years-old	Not applicable	Male and Female	100	Not applicable	Japan
259	NCT01593332 (ClinicalTrials.gov)	July 2010	7/1/2012	Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis		DMARD Resistant Rheumatoid Arthritis	Drug: Rituximab	Mashhad University of Medical Sciences	Roche Pharma AG	Completed	19 Years	75 Years	Both	44	Phase 4	Iran, Islamic Republic of
260	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
No.	TrialID	Date_ enrollment	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	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	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
262	JPRN-UMIN000003615	2010/05/01	14/05/2010	Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA		RA(Rheumatoid Arthritis)	Using 3 DMARDs(Salazosulfapyridine, Bucillamine, and Methotrexate) for 24 months	St Luke's International Hospital	NULL	Recruiting	20years-old	80years-old	Male and Female	20	Not selected	Japan
263	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
264	EUCTR2009-011137-26-GR (EUCTR)	22/03/2010	20/10/2009		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	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
265	EUCTR2009-011137-26-PT (EUCTR)	01/03/2010	09/12/2009	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	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: 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
266	NCT01034397 (ClinicalTrials.gov)	March 2010	16/12/2009	A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs	A Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: placebo;Drug: non-biological DMARDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	54	Phase 4	Portugal
267	NCT01610791 (ClinicalTrials.gov)	March 2010	31/5/2012	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)	A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	121	Phase 3	Morocco
268	NCT01256736 (ClinicalTrials.gov)	March 2010	28/10/2010	To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis	Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: DMARDs	JW Pharmaceutical	NULL	Completed	18 Years	N/A	Both	89	Phase 3	Korea, Republic of
269	NCT01063062 (ClinicalTrials.gov)	February 28, 2010	3/2/2010	A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)	A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	107	Phase 3	Egypt
270	EUCTR2009-011137-26-CZ (EUCTR)	26/02/2010	13/10/2009		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: 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
No.	TrialID	Date_ enrollment	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	EUCTR2009-011137-26-AT (EUCTR)	25/02/2010	04/09/2009		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;Belgium;Denmark;Spain;Greece;Poland
272	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
273	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.	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
274	EUCTR2009-011137-26-BE (EUCTR)	18/01/2010	19/10/2009	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	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	Phase 3	Portugal;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
275	NCT01089023 (ClinicalTrials.gov)	January 2010	8/3/2010	A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	95	Phase 4	Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
276	NCT02731560 (ClinicalTrials.gov)	January 2010	6/3/2016	Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)	Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: Rituximab	Prof. Abid Z. Farooqi	Aga Khan University;Fatima Memorial Hospital;Fauji Foundation Hospital, Rawalpindi	Completed	18 Years	80 Years	Both	74	Phase 4	NULL
277	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
278	EUCTR2009-011137-26-IE (EUCTR)	21/12/2009	15/09/2009	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	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	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
279	EUCTR2009-011137-26-FR (EUCTR)	15/12/2009	10/09/2009	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	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		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
280	EUCTR2009-011137-26-DK (EUCTR)	07/12/2009	02/11/2009		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: 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
281	EUCTR2009-011137-26-NL (EUCTR)	02/12/2009	31/08/2009		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	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
282	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	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: 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
283	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	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
284	EUCTR2009-011137-26-SK (EUCTR)	11/11/2009	19/11/2009	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	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: 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
285	EUCTR2008-006924-68-HU (EUCTR)	11/11/2009	02/09/2009	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	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	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
No.	TrialID	Date_ enrollment	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	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	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
287	NCT00996203 (ClinicalTrials.gov)	October 31, 2009	15/10/2009	A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.	Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: DMARDs (disease-modifying antirheumatic drugs)	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	201	Phase 4	Russian Federation
288	NCT00951275 (ClinicalTrials.gov)	October 31, 2009	30/7/2009	A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	A Single Arm, Open-label Study of Early Improvement of Anemia and Fatigue During Treatment With Tocilizumab (TCZ) in Combination With DMARDs, in Adult Patients With Moderate to Severe Active Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	105	Phase 3	Italy
289	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	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
290	EUCTR2009-011137-26-FI (EUCTR)	22/10/2009	25/08/2009		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;Belgium;Denmark;Spain;Greece;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
291	EUCTR2009-011137-26-HU (EUCTR)	19/10/2009	02/09/2009		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	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
292	EUCTR2009-011137-26-GB (EUCTR)	19/10/2009	18/10/2010	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	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		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
293	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	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
294	EUCTR2009-011137-26-DE (EUCTR)	05/10/2009	03/08/2009	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	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: 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
295	NCT01211834 (ClinicalTrials.gov)	October 2009	29/9/2010	Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy	Rheumatoid Arthritis	Drug: tocilizumab;Drug: DMARDs;Drug: Placebo	JW Pharmaceutical	NULL	Completed	18 Years	N/A	Both	90	Phase 3	Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
296	NCT00996606 (ClinicalTrials.gov)	October 2009	15/10/2009	A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs	Open Label, Multicentric Phase IIIb Study to Evaluate the Effect of Tocilizumab in Combination With DMARDs in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Dedicated Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: DMARDs;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	58	Phase 3	Italy
297	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
298	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	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 ® 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
299	EUCTR2006-006373-25-GB (EUCTR)	03/09/2009	16/11/2010	A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A	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		Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2;Phase 3	Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
300	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
301	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	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
302	EUCTR2008-008338-35-FI (EUCTR)	13/08/2009	14/05/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550 Trade Name: Humira Product Name: Humira	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Finland;Germany;United Kingdom;Czech Republic;Denmark;Bulgaria;Spain
303	NCT00929357 (ClinicalTrials.gov)	August 2009	25/6/2009	Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment	A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.	Rheumatoid Arthritis	Drug: DMARDs or Biologics	Pfizer	NULL	Completed	18 Years	N/A	All	156	N/A	Denmark
304	NCT00966875 (ClinicalTrials.gov)	August 2009	25/8/2009	A Study in Patients With Rheumatoid Arthritis	A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD Therapy	Rheumatoid Arthritis	Biological: LY2439821;Drug: Placebo	Eli Lilly and Company	NULL	Completed	18 Years	75 Years	All	448	Phase 2	United States;Argentina;Chile;Germany;India;Korea, Republic of;Peru;Poland;Romania;Russian Federation;Taiwan;Hungary
305	EUCTR2008-008338-35-DE (EUCTR)	14/07/2009	04/05/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550 Trade Name: Humira Product Name: Humira 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
No.	TrialID	Date_ enrollment	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	JPRN-UMIN000002169	2009/07/01	07/07/2009	Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritis		Rheumatoid Arthritis	Salazosulfapyridine Bucillamine	Higashi-Hiroshima Memorial Hospital	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	60	Phase 4	Japan
307	EUCTR2008-008337-11-GR (EUCTR)	25/06/2009	20/10/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
308	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	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
309	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.	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
310	EUCTR2008-008337-11-SK (EUCTR)	22/06/2009	09/09/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	795	Phase 3	Slovakia;Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
No.	TrialID	Date_ enrollment	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	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	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
312	EUCTR2008-008337-11-ES (EUCTR)	19/06/2009	27/03/2009	Estudio de fase III, aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP 690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con FARMEsPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Estudio de fase III, aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP 690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con FARMEsPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Artritis reumatoide RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550	Pfizer, S.A.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
313	EUCTR2008-008337-11-DK (EUCTR)	18/06/2009	15/05/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
314	EUCTR2008-008337-11-FI (EUCTR)	17/06/2009	24/04/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	795	Phase 3	Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
315	EUCTR2008-008337-11-DE (EUCTR)	16/06/2009	07/04/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550	Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA	NULL	Not Recruiting			Female: yes Male: yes	795	Phase 3	Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
No.	TrialID	Date_ enrollment	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	EUCTR2008-008338-35-BG (EUCTR)	16/06/2009	22/05/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 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
317	EUCTR2008-008338-35-GB (EUCTR)	11/06/2009	09/04/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550 Trade Name: Humira Product Name: Humira	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Finland;Germany;Czech Republic;United Kingdom;Denmark;Bulgaria;Spain
318	EUCTR2008-008337-11-GB (EUCTR)	10/06/2009	09/04/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550	Pfizer Inc, 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;Germany;United Kingdom;Denmark;Spain;Greece;Poland;Sweden
319	EUCTR2008-008337-11-PL (EUCTR)	09/06/2009	30/04/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550	Pfizer Inc. 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	795	Phase 3	Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden
320	EUCTR2008-008338-35-DK (EUCTR)	03/06/2009	29/04/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550 Trade Name: Humira Product Name: Humira	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	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
321	EUCTR2008-006924-68-GR (EUCTR)	03/06/2009	19/11/2009	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	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	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
322	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
323	NCT00848354 (ClinicalTrials.gov)	June 2009	18/2/2009	Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy	A Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.	Rheumatoid Arthritis	Biological: Phase 1: Etanercept;Drug: Phase 1: Methotrexate;Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX;Drug: Phase 1: Conventiaonal DMARD	Pfizer	Amgen	Completed	18 Years	69 Years	All	429	Phase 4	Argentina;Chile;Colombia;Mexico;Panama;Brazil;Ecuador;Spain;Venezuela
324	NCT00977106 (ClinicalTrials.gov)	June 2009	18/8/2009	TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF	Comparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDO	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: placebo	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	103	Phase 3	France
325	EUCTR2008-008337-11-SE (EUCTR)	27/05/2009	23/03/2009	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
326	EUCTR2008-008338-35-SK (EUCTR)	25/05/2009	09/09/2009	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550 Trade Name: Humira Product Name: Humira	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
327	EUCTR2008-008338-35-CZ (EUCTR)	20/05/2009	18/03/2009	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 METHOTREXATE	PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE	CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: CP -690,550 Trade Name: Humira Product Name: Humira	Pfizer Inc.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 3	Czech Republic;Slovakia;Finland;Spain;Denmark;Bulgaria;Germany;United Kingdom
328	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
329	EUCTR2008-006924-68-PT (EUCTR)	18/05/2009	17/03/2009	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	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	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
330	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	A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: Ro 487-7533 INN or Proposed INN: RoActemra	ROCHE	NULL	Not Recruiting			Female: yes Male: yes			Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
331	NCT00891020 (ClinicalTrials.gov)	May 2009	29/4/2009	A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)	Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Nonbiologic DMARDs of investigator's choice	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	886	Phase 3	United States;Puerto Rico;United Kingdom
332	NCT00856544 (ClinicalTrials.gov)	May 2009	3/3/2009	A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications	Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS	Arthritis, Rheumatoid	Drug: CP -690,550;Drug: Placebo	Pfizer	NULL	Completed	18 Years	N/A	All	795	Phase 3	United States;Australia;Chile;China;Colombia;Croatia;Denmark;Finland;Germany;Greece;Malaysia;Mexico;Poland;Russian Federation;Slovakia;Spain;Sweden;Thailand;United Kingdom;Venezuela
333	NCT00902486 (ClinicalTrials.gov)	May 2009	13/5/2009	INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs	A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics	Rheumatoid Arthritis	Drug: INCB028050;Drug: Placebo	Incyte Corporation	NULL	Completed	18 Years	N/A	All	127	Phase 2	United States;Czechia;Czech Republic
334	EUCTR2008-006924-68-CZ (EUCTR)	28/04/2009	12/02/2009	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	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	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
335	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	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
No.	TrialID	Date_ enrollment	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	EUCTR2008-006924-68-FR (EUCTR)	06/04/2009	19/03/2009	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.	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.	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
337	EUCTR2008-006924-68-IT (EUCTR)	03/04/2009	23/03/2009	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 - extension to study MA21573	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 to study MA21573	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
338	EUCTR2008-006924-68-NL (EUCTR)	02/04/2009	09/02/2009	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	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: 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
339	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	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
340	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	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
No.	TrialID	Date_ enrollment	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	EUCTR2008-006924-68-GB (EUCTR)	06/03/2009	29/04/2009	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	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		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
342	NCT00687193 (ClinicalTrials.gov)	March 2009	22/5/2008	Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD	Arthritis, Rheumatoid	Drug: Placebo;Drug: CP -690,550	Pfizer	NULL	Completed	20 Years	70 Years	All	318	Phase 2	Japan
343	NCT00810199 (ClinicalTrials.gov)	March 2009	16/12/2008	A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment	Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate;Drug: placebo	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	556	Phase 3	United States;Brazil;Croatia;Denmark;Estonia;France;Germany;Greece;Israel;Italy;Latvia;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Sweden;Thailand;United Kingdom;Monaco
344	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
345	EUCTR2008-000587-17-HU (EUCTR)	27/02/2009	28/11/2008	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	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	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
346	EUCTR2008-001847-20-GR (EUCTR)	17/02/2009	06/03/2009	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.	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.	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
347	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	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
348	EUCTR2008-001847-20-SE (EUCTR)	02/02/2009	23/10/2008	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	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra ® INN or Proposed INN: tocilizumab Other descriptive name: 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		Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
349	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	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
350	EUCTR2008-000587-17-GR (EUCTR)	13/01/2009	30/01/2009	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	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	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
No.	TrialID	Date_ enrollment	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	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
352	NCT00843778 (ClinicalTrials.gov)	January 2009	5/1/2009	Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study	A Phase IIIB, Multi-center, Open Label Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With DMARDs in Patients With Active Rheumatoid Arthritis Who Participated in C87076.	Rheumatoid Arthritis	Biological: Certolizumab Pegol	UCB Pharma	NULL	Completed	18 Years	N/A	All	131	Phase 3	Austria;France;Germany;Italy;Poland
353	EUCTR2008-001847-20-LV (EUCTR)	19/12/2008	29/12/2008	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	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra ® INN or Proposed INN: tocilizumab Other descriptive name: 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;Latvia;Germany;Netherlands;Norway;Sweden
354	EUCTR2008-001847-20-GB (EUCTR)	19/12/2008	09/09/2008	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	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470	Phase 3	Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
355	EUCTR2008-001847-20-NL (EUCTR)	10/12/2008	23/10/2008	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. - ACT-RAY	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	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
No.	TrialID	Date_ enrollment	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	EUCTR2008-001847-20-DK (EUCTR)	10/12/2008	21/10/2008	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	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra ® INN or Proposed INN: tocilizumab Other descriptive name: 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		Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
357	EUCTR2007-000830-38-DE (EUCTR)	05/12/2008	29/09/2008	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.	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	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
358	NCT00810277 (ClinicalTrials.gov)	November 30, 2008	16/12/2008	A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs	An Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	14	Phase 3	Finland
359	EUCTR2008-001847-20-EE (EUCTR)	28/11/2008	13/10/2008	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.	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.	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
360	EUCTR2008-001847-20-FR (EUCTR)	17/11/2008	21/10/2008	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.	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.	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
361	NCT00783536 (ClinicalTrials.gov)	November 2008	29/10/2008	A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis	An Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept + Methotrexate;Drug: DMARDS	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Withdrawn	18 Years	80 Years	Both	402	Phase 4	Mexico
362	NCT00773461 (ClinicalTrials.gov)	October 31, 2008	15/10/2008	A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.	A Randomized, Double Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD Therapy	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo	Hoffmann-La Roche	NULL	Completed	18 Years	70 Years	All	209	Phase 3	China
363	EUCTR2008-000587-17-BE (EUCTR)	13/10/2008	19/08/2008	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 - ACT-Sure	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 - ACT-Sure	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
364	EUCTR2007-000830-38-AT (EUCTR)	09/10/2008	09/09/2008	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.	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	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
365	EUCTR2007-000830-38-FR (EUCTR)	07/10/2008	10/07/2008	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.	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	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
366	EUCTR2008-000587-17-DK (EUCTR)	22/09/2008	04/07/2008	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	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	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
367	EUCTR2008-000587-17-CZ (EUCTR)	15/09/2008	20/06/2008	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	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	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
368	EUCTR2008-000587-17-IE (EUCTR)	11/09/2008	05/06/2008	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	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	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
369	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	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
370	NCT00750880 (ClinicalTrials.gov)	September 2008	10/9/2008	An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.	International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	1681	Phase 3	Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Luxembourg;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States
No.	TrialID	Date_ enrollment	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	NCT00780793 (ClinicalTrials.gov)	September 2008	27/10/2008	Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study	Effect of TNF-blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease Activity	Rheumatoid Arthritis	Drug: progressive spacing of TNF-blocker injections;Drug: DMARD maintenance	Assistance Publique - Hôpitaux de Paris	French Society of Rheumatology	Completed	18 Years	N/A	Both	250	Phase 4	France
372	EUCTR2008-000587-17-FI (EUCTR)	20/08/2008	05/06/2008	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	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	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
373	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	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
374	EUCTR2008-000587-17-FR (EUCTR)	12/08/2008	16/07/2008	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	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	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
375	EUCTR2008-000587-17-NL (EUCTR)	12/08/2008	10/09/2008	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	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	Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
376	EUCTR2008-000587-17-PT (EUCTR)	08/08/2008	06/06/2008	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 - ACT-SURE	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 - ACT-SURE	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
377	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	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		Czech Republic;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden
378	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	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
379	EUCTR2008-000587-17-SE (EUCTR)	03/07/2008	21/05/2008	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	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	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
380	JPRN-UMIN000002421	2008/07/01	04/09/2009	Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis		rheumatoid arthritis	tocilizumab Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab	AA amyloidosis clinical research conference	NULL	Recruiting	20years-old	Not applicable	Male and Female	40	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
381	JPRN-UMIN000001281	2008/07/01	31/07/2008	Strategic reduction of joint destruction in rheumatoid arthritis		Rheumatoid arthritis	TNF-inhibitors plus MTX TNF-inhibitors are used for 54 weeks and exchange among them is approved MTX MTX is used for 54 weeks and addition of the other DMARD is approved	School of Medicine, University of Occupational and Environmental Health, Japan	NULL		Not applicable	Not applicable	Male and Female	120	Not selected	Japan
382	EUCTR2007-000830-38-IT (EUCTR)	30/06/2008	21/07/2008	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. - ND	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. - ND	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
383	EUCTR2008-000587-17-AT (EUCTR)	19/06/2008	09/05/2008	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 - ACT-SURE	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 - ACT-SURE	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
384	EUCTR2008-000587-17-GB (EUCTR)	18/06/2008	18/04/2008	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	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	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
385	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	Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER	Patients with a diagnosis of early active rhematoid arthritis in the previous 6 months, naive of previous treatment by DMARD and who need to be treated by DMARD. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ARAVA INN or Proposed INN: Leflunomide Trade Name: ARAVA INN or Proposed INN: Leflunomide Trade Name: ARAVA INN or Proposed INN: Leflunomide	sanofi-aventis Groupe	NULL	Not Recruiting			Female: yes Male: yes	200		Portugal;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
386	NCT00674362 (ClinicalTrials.gov)	June 2008	5/5/2008	Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study	A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: Certolizumab pegol;Biological: Placebo	UCB Pharma	NULL	Completed	18 Years	N/A	All	194	Phase 3	Austria;France;Germany;Italy;Poland
387	EUCTR2007-000828-40-DE (EUCTR)	27/05/2008	10/01/2008	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. - C87076	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. - C87076	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
388	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	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
389	EUCTR2007-000828-40-FR (EUCTR)	26/02/2008	11/12/2007	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. - C87076	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. - C87076	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
390	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	CP 690,550 is being developed as a disease modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA). MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: CP -690,550	Pfizer Inc. 235 East 42nd Street, New York, NY10017	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;United Kingdom;Germany;Czech Republic;Bulgaria;Spain;Greece;Austria;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
391	EUCTR2007-000828-40-AT (EUCTR)	21/02/2008	31/03/2008	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. - C87076	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. - C87076	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
392	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	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
393	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
394	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	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
395	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	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
No.	TrialID	Date_ enrollment	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	EUCTR2007-002945-18-CZ (EUCTR)	15/10/2007	27/08/2007	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 - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs	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 - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs	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
397	NCT00531817 (ClinicalTrials.gov)	October 2007	18/9/2007	A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Placebo;Drug: Permitted DMARDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	619	Phase 3	United States;Puerto Rico
398	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	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	Phase 3	Portugal;Czech Republic;Italy
399	NCT00664716 (ClinicalTrials.gov)	July 2007	21/4/2008	Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Patients	Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.	Rheumatoid Arthritis	Biological: Placebo;Biological: baminercept alfa;Biological: Baminercept alfa	Biogen Idec	NULL	Completed	18 Years	75 Years	Both	391	Phase 2	Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom
400	EUCTR2006-005466-39-HU (EUCTR)	25/06/2007	22/03/2007	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Code: BG9924	Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2b	Hungary;United Kingdom
No.	TrialID	Date_ enrollment	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	NCT00521924 (ClinicalTrials.gov)	June 2007	27/8/2007	Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED)	Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab-therapy	Rheumatoid Arthritis	Biological: infliximab;Drug: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.	Merck Sharp & Dohme Corp.	AESCA Pharma GmbH	Terminated	19 Years	65 Years	All	8	Phase 3	Austria
402	NCT00422227 (ClinicalTrials.gov)	June 2007	11/1/2007	Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region	A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide	Wyeth is now a wholly owned subsidiary of Pfizer	NULL	Completed	18 Years	70 Years	All	300	Phase 4	Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand
403	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	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 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
404	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	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 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
405	EUCTR2006-005466-39-GB (EUCTR)	12/04/2007	07/01/2007	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy	A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis		Biogen Idec Ltd	NULL	Not Recruiting			Female: yes Male: yes	380	Phase 2	Hungary;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
406	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
407	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	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
408	NCT00913432 (ClinicalTrials.gov)	March 2007	3/6/2009	Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis	A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha	Rheumatoid Arthritis	Drug: masitinib	AB Science	NULL	Completed	18 Years	N/A	All	20	Phase 2	NULL
409	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	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 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
410	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	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
411	NCT00484289 (ClinicalTrials.gov)	December 2006	7/6/2007	A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis	A Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101-071, IM101-034, and Also Special DMARD Failures	Rheumatoid Arthritis	Drug: Abatacept	Bristol-Myers Squibb	NULL	Completed	20 Years	N/A	All	217	Phase 3	Japan
412	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	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	72		United Kingdom;Estonia
413	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
414	NCT02006706 (ClinicalTrials.gov)	August 10, 2006	5/12/2013	A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy	An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	15	Phase 3	Serbia
415	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	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	60		Estonia
No.	TrialID	Date_ enrollment	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	EUCTR2004-005102-68-CZ (EUCTR)	14/04/2006	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.	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
417	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	A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA	ACTIVE RHEUMATOID ARTHRITIS	Product Name: N/A Product Code: CRx-139 INN or Proposed INN: Paroxetine & Prednisolone	CombinatoRx, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	Czech Republic;Germany;United Kingdom;Denmark;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04539964
(ClinicalTrials.gov)

January 2021

31/8/2020

Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid Arthritis

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

Rheumatoid Arthritis

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

SetPoint Medical Corporation

NULL

Not yet recruiting

22 Years

75 Years

All

250

Phase 3

NULL

NCT04286789
(ClinicalTrials.gov)

November 2020

25/2/2020

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

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

Rheumatoid Arthritis

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

Oryn Therapeutics, LLC

NULL

Recruiting

18 Years

N/A

All

Phase 1

United States

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

EUCTR2019-000868-18-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

NCT04251741
(ClinicalTrials.gov)

March 1, 2020

8/1/2020

Using Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment

Using Adalimumab Serum Concentration to Choose a Subsequent Biological DMARD in Rheumatoid Arthritis Patients Failing Adalimumab Treatment: a Blinded Randomized Superiority Trial

Rheumatoid Arthritis

Diagnostic Test: Adalimumab trough concentration;Other: Usual care

Reade Rheumatology Research Institute

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

Recruiting

18 Years

N/A

All

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

EUCTR2019-000867-26-GB
(EUCTR)

10/12/2019

12/06/2019

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

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

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

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

EUCTR2019-000868-18-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-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

EUCTR2019-000868-18-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

NCT04134728
(ClinicalTrials.gov)

October 31, 2019

18/10/2019

Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) 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

Arthritis, Rheumatoid

Biological: GSK3196165;Biological: Sarilumab;Drug: Placebo to GSK3196165/ Sarilumab;Drug: csDMARDs

GlaxoSmithKline

Iqvia Pty Ltd

Recruiting

18 Years

N/A

All

525

Phase 3

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

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

EUCTR2019-000868-18-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-BG
(EUCTR)

11/10/2019

30/07/2019

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

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1800

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

NCT04464642
(ClinicalTrials.gov)

July 10, 2019

6/7/2020

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

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Tofacitinib

Dr. Mohammad Mamun Khan

NULL

Active, not recruiting

18 Years

N/A

All

110

Phase 4

Bangladesh

NCT03970837
(ClinicalTrials.gov)

June 5, 2019

16/5/2019

Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)

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

Arthritis, Rheumatoid

Biological: GSK3196165;Drug: Tofacitinib;Drug: Placebo to GSK3196165;Drug: Placebo to Tofacitinib;Drug: csDMARDs

GlaxoSmithKline

Iqvia Pty Ltd

Recruiting

18 Years

N/A

All

1500

Phase 3

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

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

EUCTR2018-000666-10-ES
(EUCTR)

23/01/2019

22/01/2019

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

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

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

NCT03863405
(ClinicalTrials.gov)

January 9, 2019

4/3/2019

Metformin Use in Rheumatoid Arthritis

The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Metformin;Drug: Conventional DMARDs;Drug: Placebo Oral Tablet

Ain Shams University

Future University in Egypt

Recruiting

18 Years

N/A

All

Phase 2

Egypt

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03980639
(ClinicalTrials.gov)

November 20, 2018

18/1/2019

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

Rheumatoid Arthritis

Drug: patient treated with DMARD

University Hospital, Toulouse

NULL

Recruiting

18 Years

N/A

All

594226

France

NCT03682705
(ClinicalTrials.gov)

October 8, 2018

21/9/2018

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

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

Rheumatoid Arthritis (RA)

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

AbbVie

NULL

Completed

18 Years

N/A

All

242

Phase 2

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

NCT03660059
(ClinicalTrials.gov)

September 27, 2018

26/8/2018

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

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

Rheumatoid Arthritis (RA)

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

Astellas Pharma China, Inc.

NULL

Active, not recruiting

18 Years

N/A

All

385

Phase 3

China;Korea, Republic of;Taiwan

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04066803
(ClinicalTrials.gov)

August 1, 2018

11/12/2018

Optimal MTX Dose With Folic Acid Randomized Case-control Trial

Safety and Efficacy of Optimal Methotrexate With Folic Acid in Patients With Rheumatoid Arthritis in Meizhou, Guangdong: a Randomized Case-control Study

Rheumatoid Arthritis

Drug: MTX;Drug: Folic Acid;Drug: DMARDs

Sun Yat-sen University

Shanghai Pharmaceuticals Holding Co., Ltd

Recruiting

18 Years

70 Years

All

160

Phase 4

China

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

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

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

EUCTR2017-004054-41-BE
(EUCTR)

07/05/2018

15/03/2018

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

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

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

University Hospitals Leuven

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

440

Phase 4

Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03449758
(ClinicalTrials.gov)

March 5, 2018

8/2/2018

Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

Effect of Sarilumab on Patient-reported Outcomes in Patients With Moderately to Severely Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor Inhibitors

Rheumatoid Arthritis

Drug: SARILUMAB;Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

Phase 4

France

EUCTR2017-004079-30-BE
(EUCTR)

19/02/2018

Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology

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

Joint Research & Development Office (QMUL)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

219

Phase 3

Portugal;Spain;Belgium;Italy

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

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

NCT03254589
(ClinicalTrials.gov)

October 1, 2017

16/8/2017

Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis

Rheumatoid Arthritis;Stiffness, Aortic;Endothelial Dysfunction;Cardiovascular Risk Factor

Drug: Methotrexate;Drug: Sulfasalazine;Drug: Other DMARDs

Flinders University

University of South Australia;medac GmbH

Recruiting

18 Years

N/A

All

124

Phase 4

Australia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

NCT03155347
(ClinicalTrials.gov)

August 2, 2017

15/5/2017

An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy

A Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD Therapy

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to Tocilizumab

Hoffmann-La Roche

NULL

Recruiting

18 Years

70 Years

All

340

Phase 3

China

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

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

ChiCTR-INR-17011772

2017-06-27

2017-06-28

The efficacy and safety of metformin hydrochloride combined with atorvastatin in the treatment of rheumatoid arthritis with poor response to immunosuppressive agents

Rheumatoid Arthritis

test group:Metformin tablets, 0.25g, 3 / day, oral, atorvastatin tablets 10mg, 1 / night, oral;;Control group:Traditional DMARDs group;

Inner Mongolia University of Science and Technology Baotou Medical College First Affiliated Hospital

NULL

Recruiting

Both

test group:80;Control group:40;

China

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

EUCTR2016-000933-37-SK
(EUCTR)

15/06/2017

24/04/2017

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

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

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

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

313

Phase 3

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

EUCTR2016-000569-21-FR
(EUCTR)

08/06/2017

04/11/2016

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

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

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03086343
(ClinicalTrials.gov)

May 9, 2017

20/3/2017

A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs

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

Rheumatoid Arthritis (RA)

Drug: Abatacept;Drug: Placebo for abatacept;Drug: Upadacitinib;Drug: Placebo for upadacitinib

AbbVie

NULL

Active, not recruiting

18 Years

N/A

All

613

Phase 3

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

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

EUCTR2016-000933-37-CZ
(EUCTR)

02/05/2017

22/11/2016

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

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

313

Phase 3

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03082573
(ClinicalTrials.gov)

March 3, 2017

13/3/2017

Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel

Open-label, Pilot Protocol of Patients With Rheumatoid Arthritis Who Were Treated With H.P. Acthar Gel After an Incomplete Response to Combinations of DMARDs and Biologic DMRADs

Rheumatoid Arthritis

Drug: H.P. Acthar gel

Iraj Sabahi Research Inc.

Mallinckrodt

Recruiting

21 Years

N/A

All

Phase 4

United States

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

ChiCTR-IPR-17010325

2017-01-31

2017-01-04

The efficacy and safety of Metformin combined with coenzyme Q10 in refractory rheumatoid arthritis: A multi-center randomized controlled trial

rheumatic disease;M05.901

Metformin Group:Metformin combined Glucocorticoids and DMARDs;Non-Metformin Group:Glucocorticoids and DMARDs;Metformin combined with Coenzyme Q10 Group:Metformin and Coenzyme Q10 combined Glucocorticoids and DMARDs;

the Second Hospital of Shanxi Medical University

NULL

Pending

Both

Metformin Group:100;Non-Metformin Group:100;Metformin combined with Coenzyme Q10 Group:100;

China

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

ChiCTR-IPR-17010307

2017-01-01

The efficacy and safety of rapamycin in refractory rheumatoid arthritis: A multi-center randomized controlled trial in China

Rheumatoid Arthritis;M05.901

Rapamycin group:Rapamycin;Non-rapamycin group :conventional glucocorticoids and DMARDs;

the Second Hospital of Shanxi Medical University

NULL

Recruiting

Both

Rapamycin group:200;Non-rapamycin group :100;

China

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

EUCTR2016-000569-21-GB
(EUCTR)

23/12/2016

01/11/2016

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

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

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

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

EUCTR2016-000569-21-HU
(EUCTR)

12/12/2016

07/11/2016

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

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

423

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

NCT02919761
(ClinicalTrials.gov)

November 7, 2016

26/9/2016

Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

A Multicenter, 2 Part Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Rheumatoid Arthritis With Persistently Active Disease Despite Dual-DMARD Treatment

Arthritis, Rheumatoid

Drug: Acthar Gel;Drug: Placebo

Mallinckrodt

NULL

Completed

18 Years

N/A

All

259

Phase 4

United States;Argentina;Mexico;Peru;Puerto Rico;Colombia

ChiCTR-INR-16009546

2016-11-01

2016-10-21

The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis

rheumatoid arthritis;M05.901

IL-2 group:lL-2;IL-2 + IL-6 antagonist group:Tocilizumab;non IL-2 or IL-6 antagonist group:glucocorticoids and DMARDs;

the Second Hospital of Shanxi Medical University

NULL

Recruiting

Both

IL-2 group:15;IL-2 + IL-6 antagonist group:15;non IL-2 or IL-6 antagonist group:15;

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02037737
(ClinicalTrials.gov)

September 30, 2016

21/11/2013

Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting

Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting in Patients With Inadequate Response to One or Several Conventional DMARDs Including Methotrexate in France. A Database Analysis Based on the ACTION Study

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

153

NULL

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

NCT02930343
(ClinicalTrials.gov)

September 2016

13/9/2016

Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: Sulfasalazine

Jawaharlal Institute of Postgraduate Medical Education & Research

NULL

Completed

18 Years

65 Years

All

136

Phase 3

India

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

EUCTR2015-004386-91-DE
(EUCTR)

22/08/2016

18/05/2016

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

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

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

GlaxoSmithKline Research & Development Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Poland;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

NCT02873936
(ClinicalTrials.gov)

July 27, 2016

17/8/2016

Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) 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

Rheumatoid Arthritis

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

Gilead Sciences

Galapagos NV

Completed

18 Years

N/A

All

449

Phase 3

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

NCT02799472
(ClinicalTrials.gov)

June 15, 2016

26/5/2016

Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active 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

Arthritis, Rheumatoid

Drug: GSK3196165;Drug: Placebo;Drug: MTX;Drug: Folic (or folinic) acid

GlaxoSmithKline

Parexel

Completed

18 Years

N/A

All

Phase 2

United States;Germany;Poland

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

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

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

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

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

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

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

EUCTR2015-003335-35-AT
(EUCTR)

04/05/2016

14/04/2016

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

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

EUCTR2015-003335-35-ES
(EUCTR)

29/04/2016

11/03/2016

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

NCT02706847
(ClinicalTrials.gov)

March 15, 2016

18/2/2016

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

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

Rheumatoid Arthritis

Drug: Upadacitinib;Drug: Placebo

AbbVie

NULL

Active, not recruiting

18 Years

99 Years

All

499

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03355872
(ClinicalTrials.gov)

February 2016

22/11/2017

A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs

Rheumatoid Arthritis

Drug: HLX01

Shanghai Henlius Biotech

NULL

Completed

18 Years

65 Years

All

194

Phase 1;Phase 2

NULL

NCT02643823
(ClinicalTrials.gov)

January 2016

23/12/2015

Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: hUC-MSC + DMARDs;Drug: DMARDs

Shenzhen Hornetcorn Bio-technology Company, LTD

Futian People's Hospital

Recruiting

18 Years

80 Years

Both

Phase 1

China

NCT02644499
(ClinicalTrials.gov)

December 31, 2015

30/12/2015

Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis

Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid

Jawaharlal Institute of Postgraduate Medical Education & Research

NULL

Completed

18 Years

N/A

All

186

Phase 4

India

EUCTR2013-000337-13-PT
(EUCTR)

13/11/2015

11/11/2015

Prediction of response to Certolizumab Pegol treatment with MRI of the brain. A multi-center, randomized double-blind controlled study Prediction of response to Certolizumab-Pegol in Rheumatoid Arthritis (PreCePRA)

Prediction of response to Certolizumab Pegol treatment by functional MRI of the brain. A multi-center, randomized double-blind controlled study Prediction of response to Certolizumab-Pegol in RA (PreCePRA) - PreCePRA

Patients with active Rheumatoid Artrhitis (DAS28 > 3.2) despite DMARD therapy
MedDRA version: 20.0;Level: LLT;Classification code 10040107;Term: Seropositive rheumatoid arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Universitätsklinikum Erlangen

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 3

Serbia;United States;Portugal;Germany

100

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

No.

TrialID

Date_
enrollment

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

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

102

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

103

EUCTR2010-021184-32-GB
(EUCTR)

25/03/2015

12/06/2015

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

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

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 1;Phase 2

United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

104

NCT02373202
(ClinicalTrials.gov)

February 2015

12/2/2015

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

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

Rheumatoid Arthritis

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

Sanofi

Regeneron Pharmaceuticals

Completed

20 Years

N/A

All

Phase 3

Japan

105

EUCTR2010-021184-32-HU
(EUCTR)

09/01/2015

27/10/2014

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

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

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 1;Phase 2

United States;Estonia;Spain;Turkey;Austria;Russian Federation;Italy;United Kingdom;India;France;Hungary;Argentina;Poland;Belgium;Brazil;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

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

107

NCT02308163
(ClinicalTrials.gov)

August 8, 2014

2/12/2014

A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs

Phase 3 Study of ASP015K - A Randomized, Double-blind, Placebo-controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis Who Had an Inadequate Response to DMARDs

Rheumatoid Arthritis

Drug: Peficitinib;Drug: Placebo;Biological: Etanercept

Astellas Pharma Inc

NULL

Completed

20 Years

N/A

All

509

Phase 3

Japan;Korea, Republic of;Taiwan

108

NCT02219347
(ClinicalTrials.gov)

August 2014

15/8/2014

Biomarkers of Remission in Rheumatoid Arthritis (BioRRA)

Rheumatoid Arthritis

Drug: DMARD cessation

Newcastle-upon-Tyne Hospitals NHS Trust

Newcastle University;Wellcome Trust

Completed

18 Years

N/A

All

N/A

United Kingdom

109

NCT02011334
(ClinicalTrials.gov)

July 2014

4/12/2013

A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.

A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICA

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

285

Phase 3

Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay

110

NCT02046616
(ClinicalTrials.gov)

May 28, 2014

24/1/2014

A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Tocilizumab SC in Patients With Active Rheumatoid Arthritis and Inadequate Response to DMARDs. A Single-Arm, Open-Label Study to Evaluate Safety, Tolerability and Efficacy. In a Subgroup of Patients Inflammation Will Be Measured by Ultrasound.

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Methotrexate;Drug: Non-Biologic DMARDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

133

Phase 3

Denmark;Finland;Norway;Sweden

No.

TrialID

Date_
enrollment

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

EUCTR2010-020992-21-DE
(EUCTR)

25/03/2014

08/07/2011

Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritis

A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.

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

Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: not applicable
INN or Proposed INN: METHOTREXATE
Other descriptive name: not applicable
Product Name: Masitinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: not applicable

AB Science

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 2b;Phase 3

Serbia;United States;Philippines;Taiwan;Morocco;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Monaco;India;Czech Republic;Mexico;Argentina;Poland;Romania;South Africa;Germany;Tunisia;Bosnia and Herzegovina

112

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

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

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

113

NCT02046603
(ClinicalTrials.gov)

March 4, 2014

24/1/2014

A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent

Open-Label, Phase IIIb Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic Agent

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

162

Phase 3

United Kingdom

114

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

115

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.

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 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

No.

TrialID

Date_
enrollment

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

NCT01987479
(ClinicalTrials.gov)

January 30, 2014

8/11/2013

A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis

Multi-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCAR

Rheumatoid Arthritis

Drug: Non-Biologic DMARDs;Drug: Tocilizumab;Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

150

Phase 3

Netherlands

117

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

118

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

119

NCT01941095
(ClinicalTrials.gov)

November 20, 2013

30/8/2013

A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis

Multicenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

100

Phase 3

Greece

120

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

No.

TrialID

Date_
enrollment

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

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

122

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

123

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

124

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

125

NCT01973569
(ClinicalTrials.gov)

October 2013

25/10/2013

AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment

A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III)

Rheumatoid Arthritis

Drug: denosumab;Drug: placebo

Daiichi Sankyo, Inc.

NULL

Completed

20 Years

N/A

All

679

Phase 3

Japan

No.

TrialID

Date_
enrollment

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

NCT01985464
(ClinicalTrials.gov)

October 2013

31/10/2013

Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis

Feasibility Study of Umbilical Cord Tissue Derived Mesenchymal Stem Cells (UC-MSC) in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Umbilical cord mesenchymal stem cells

Translational Biosciences

NULL

Unknown status

18 Years

N/A

All

Phase 1;Phase 2

Panama

127

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

128

NCT01787149
(ClinicalTrials.gov)

September 2013

6/2/2013

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis

Combination With DMARDs

Drug: DMARDs

Mycenax Biotech Inc.

NULL

Unknown status

20 Years

N/A

All

Phase 3

Taiwan

129

NCT01995201
(ClinicalTrials.gov)

September 2013

1/11/2013

A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis

A Phase IIIb Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous (SC) Tocilizumab (TCZ) Given as Monotherapy or in Combination With Methotrexate (MTX) or Other Non Biologics DMARDs in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Active, not recruiting

18 Years

N/A

Both

401

Phase 3

Ireland;Portugal;Spain

130

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

No.

TrialID

Date_
enrollment

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

EUCTR2013-001569-17-IT
(EUCTR)

02/08/2013

04/06/2013

A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients.

A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients.

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
INN or Proposed INN: TOCILIZUMAB
Other descriptive name: TOCILIZUMAB

Roche S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3B

Italy

132

NCT01915537
(ClinicalTrials.gov)

August 2013

30/7/2013

Infliximab and Classic DMARDs in the Rheumatoid Arthritis Patients

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

Rheumatoid Arthritis(RA)

Drug: Infliximab group;Drug: Classic DMARDs treatment group

Zhang, Xiao, M.D.

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

Not yet recruiting

18 Years

70 Years

Both

170

N/A

China

133

NCT01932372
(ClinicalTrials.gov)

July 26, 2013

30/7/2013

Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)

Rheumatoid Arthritis

Drug: Tofacitinib (Xeljanz);Drug: Etanercept , other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc

Pfizer

NULL

Active, not recruiting

N/A

All

9968

Japan

134

NCT01881308
(ClinicalTrials.gov)

June 17, 2013

17/6/2013

Assessing Withdrawal of Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis

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

Rheumatoid Arthritis

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

Diakonhjemmet Hospital

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

Active, not recruiting

18 Years

80 Years

All

360

Phase 4

Norway

135

NCT01878318
(ClinicalTrials.gov)

June 2013

6/6/2013

A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs

Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs

Rheumatoid Arthritis

Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Withdrawn

18 Years

N/A

Both

Phase 4

Venezuela

No.

TrialID

Date_
enrollment

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

NCT01885819
(ClinicalTrials.gov)

June 2013

18/6/2013

Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis

Feasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Autologous stromal vascular fraction cells

Translational Biosciences

NULL

Withdrawn

18 Years

N/A

All

Phase 1;Phase 2

Panama

137

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

138

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

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: 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

139

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

140

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

141

NCT01547091
(ClinicalTrials.gov)

April 2013

22/2/2012

Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis

Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II

Rheumatoid Arthritis

Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs);Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs);Biological: UC-MSC+DMARDS

Alliancells Bioscience Corporation Limited

NULL

Recruiting

18 Years

70 Years

Both

200

Phase 1;Phase 2

China

142

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

143

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)

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: 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

144

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

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: 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

145

EUCTR2011-003538-16-IT
(EUCTR)

08/03/2013

14/01/2013

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Product Name: SARILUMAB
Product Code: SAR153191
INN or Proposed INN: sarilumab
Product Name: SARILUMAB
Product Code: SAR153191
INN or Proposed INN: sarilumab

SANOFI- AVENTIS RECHERCHE ET DÃ‰VELOPPEMENT

NULL

Not Recruiting

Female: yes
Male: yes

522

Portugal;United States;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Colombia;Italy;Switzerland;India;Australia;Peru;Korea, Republic of;Korea, Democratic People's Republic of;Guatemala;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

146

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

147

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

148

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

149

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

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 DMARD Therapy

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

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

150

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

No.

TrialID

Date_
enrollment

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

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

152

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

153

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

154

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

155

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

No.

TrialID

Date_
enrollment

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

NCT01715831
(ClinicalTrials.gov)

January 15, 2013

25/10/2012

A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488

A Multicenter, Open-Label, Single-Arm Extension Study to Describe the Safety of Tocilizumab Treatment In Brazilian Patients With DMARDs Refractory Rheumatoid Arthritis Which Completed Studies ML21530 and MA21488 and Presenting an Indication of Maintaining the Tocilizumab Treatment

Arthritis, Rheumatoid

Drug: DMARDs;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Brazil

157

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

158

NCT01491815
(ClinicalTrials.gov)

December 14, 2012

8/12/2011

Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction

A Multicenter, Randomized, Open-label, Blinded-assessor, Phase 4 Study in Patients With Early Rheumatoid Arthritis to Compare Active Conventional Therapy Versus Three Biologic Treatments, and Two De-escalation Strategies in Patients Who Respond to Treatment

Rheumatoid Arthritis

Drug: Non-biological DMARD's;Biological: Cimzia;Biological: Orencia;Biological: RoActemra

Karolinska Institutet

NULL

Active, not recruiting

18 Years

N/A

All

812

Phase 4

Denmark;Finland;Iceland;Netherlands;Norway;Sweden

159

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

160

JPRN-UMIN000009425

2012/12/06

01/12/2012

A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient

Rheumatoid Arthritis

The dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity.
Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year.
Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year.

Osaka City University Medical School

NULL

Recruiting

20years-old

Not applicable

Male and Female

150

Phase 4

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

161

NCT01717846
(ClinicalTrials.gov)

December 2012

24/10/2012

Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis

In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis

Apoptotic DNA Damage;Rheumatoid Arthritis;T-cell Lymphocytosis

Drug: Group 1 or Orencia treated group;Other: Group 2 (DMARDS treated group)

University of California, Los Angeles

Bristol-Myers Squibb

Withdrawn

18 Years

85 Years

Both

Phase 4

United States

162

NCT01759030
(ClinicalTrials.gov)

December 2012

20/12/2012

Study of Safety and Efficacy of BCD-020 Comparing to MabThera in Patients With Rheumatoid Arthritis

Double Blind Randomized Clinical Study Evaluating Efficacy and Safety of BCD-020 and MabThera in Patients With Rheumatoid Arthritis Who Had an Inadequate Response or Intolerance to Other DMARDs Including One or More TNF Inhibitor Therapies

Rheumatoid Arthritis

Drug: Rituximab

Biocad

NULL

Completed

18 Years

80 Years

All

181

Phase 3

Belarus;India;Russian Federation;Ukraine;Colombia

163

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

164

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

165

EUCTR2012-001760-30-IT
(EUCTR)

05/11/2012

25/07/2012

Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent.

Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent.

Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB
Trade Name: RoActemra
INN or Proposed INN: TOCILIZUMAB

OSSERVATORIO EPIDEMIOLOGICO GISEA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

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

167

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

168

NCT01709578
(ClinicalTrials.gov)

October 2012

15/10/2012

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-a Antagonists

Rheumatoid Arthritis

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

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

546

Phase 3

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

169

EUCTR2011-002894-48-GB
(EUCTR)

14/09/2012

06/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

170

EUCTR2011-002894-48-NL
(EUCTR)

10/09/2012

14/12/2011

Efficacy, pharmacokinetics, and safety of BI 695500 in patients with rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Moderately to severely active Rheumatoid Arthritis that has had an inadequate response or intolerance to conventional DMARD therapy including at least one TNF inhibitor
MedDRA version: 17.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

171

NCT01661140
(ClinicalTrials.gov)

September 2012

7/8/2012

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage

Randomized, Phase IV, Placebo-controlled, Comparative Study to Evaluate the Efficacy and Safety of Tapering Methotrexate (MTX) Dosage Versus Maintaining the Dosage in Patients With Severe Active Rheumatoid Arthritis (RA) Who Have Demonstrated an Inadequate Response (IR) to Prior Disease-modifying Anti-rheumatic Drugs (DMARDs) Treatment and Have Initiated RoActemra (RoActemra, TCZ) in Combination With MTX

Rheumatoid Arthritis

Drug: Methotrexate (stable dose);Drug: Tocilizumab;Drug: Methotrexate (tapering dose)

Hoffmann-La Roche

NULL

Terminated

18 Years

N/A

All

427

Phase 4

United Kingdom

172

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

173

NCT01604343
(ClinicalTrials.gov)

August 2012

21/5/2012

A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)

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 DMARD Therapy

Arthritis, Rheumatoid

Drug: Placebo;Drug: Sirukumab

Janssen Research & Development, LLC

GlaxoSmithKline

Completed

18 Years

N/A

Both

1670

Phase 3

United States;Bulgaria;Canada;Chile;Colombia;Croatia;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;South Africa;Taiwan;Ukraine;Argentina;Brazil;India;Peru

174

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

175

NCT01578850
(ClinicalTrials.gov)

July 2012

12/4/2012

Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)

Rheumatoid Arthritis

Drug: Etanercept;Drug: placebo

Pfizer

NULL

Completed

18 Years

70 Years

All

491

Phase 4

Brazil;China;Colombia;Czech Republic;Egypt;Hungary;Jordan;Lebanon;Malaysia;Mexico;Philippines;Qatar;Romania;Russian Federation;South Africa;Taiwan;Thailand;Ukraine;United Arab Emirates;Saudi Arabia

No.

TrialID

Date_
enrollment

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

EUCTR2011-005260-20-GB
(EUCTR)

28/06/2012

10/05/2012

RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor.

Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER

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

Roche Products Limited

NULL

Not Recruiting

Female: yes
Male: yes

618

Phase 4

United Kingdom

177

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

178

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)

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] - Immune System Diseases [C20]

Trade Name: Enbrel ® 50 mg Solution for Injection in Pre-filled Syringe
INN or Proposed INN: ETANERCEPT

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

NULL

Not Recruiting

Female: yes
Male: yes

320

United Arab Emirates;Philippines;Saudi Arabia;Taiwan;Slovakia;Thailand;Ukraine;Turkey;Russian Federation;Colombia;India;Egypt;Hungary;Czech Republic;Mexico;Argentina;Malaysia;Brazil;Poland;Romania;South Africa;China

179

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

180

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

181

NCT01602302
(ClinicalTrials.gov)

June 2012

16/5/2012

Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis

Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)

Medical University of Graz

NULL

Terminated

18 Years

90 Years

All

Phase 4

Austria

182

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

183

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

184

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

185

NCT01617005
(ClinicalTrials.gov)

May 2012

8/6/2012

A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

N/A

Montenegro

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

186

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

187

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

188

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

189

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

190

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

No.

TrialID

Date_
enrollment

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

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

192

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

193

NCT01519791
(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;Other: Placebo;Biological: Methotrexate

UCB Pharma SA

NULL

Completed

18 Years

N/A

All

880

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

194

NCT01521923
(ClinicalTrials.gov)

January 2012

19/1/2012

Rheumatoid Arthritis

Biological: Certolizumab Pegol + Methotrexate (MTX);Biological: Placebo + Methotrexate (MTX)

UCB Pharma

NULL

Completed

18 Years

N/A

All

359

Phase 3

195

NCT01511003
(ClinicalTrials.gov)

December 5, 2011

4/1/2012

A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)

An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs

Rheumatoid Arthritis

Drug: Tacrolimus

Astellas Pharma Inc

Astellas Pharma Korea, Inc.

Completed

20 Years

75 Years

All

128

Phase 4

Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

196

NCT01326962
(ClinicalTrials.gov)

November 30, 2011

7/3/2011

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF

Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Saudi Arabia

197

NCT01251120
(ClinicalTrials.gov)

November 2011

30/11/2010

A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis

A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: DMARD

Hoffmann-La Roche

NULL

Terminated

18 Years

N/A

All

Phase 4

Finland

198

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

199

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

200

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

201

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

202

NCT01292616
(ClinicalTrials.gov)

October 2011

8/2/2011

Effect of TNF-Inhibition Combined With Conventional DMARDs on Cervical Pannus in Patients With RA and Cervical Spine Involvement

Rheumatoid Arthritis

Drug: therapy with disease-modifying anti rheumatic drugs (DMARD)

University of Zurich

NULL

Recruiting

18 Years

N/A

Both

N/A

Switzerland

203

NCT01245439
(ClinicalTrials.gov)

September 2011

17/11/2010

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Turkey

204

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

205

EUCTR2010-021184-32-IT
(EUCTR)

03/08/2011

02/02/2011

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

Refractory rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Hexal AG

NULL

Not Recruiting

Female: yes
Male: yes

164

Phase 2

Estonia;Spain;Turkey;Austria;United Kingdom;Italy;India;France;Hungary;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

206

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

207

NCT01410695
(ClinicalTrials.gov)

July 2011

4/8/2011

Masitinib in Refractory Active Rheumatoid Arthritis

A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs

Rheumatoid Arthritis (RA)

Drug: masitinib 3 mg;Drug: masitinib 6.0 mg;Drug: methotrexate;Drug: Placebo (methotrexate);Drug: Placebo (masitinib)

AB Science

NULL

Terminated

18 Years

N/A

All

324

Phase 2;Phase 3

Czechia;Czech Republic;France;United States

208

EUCTR2010-019262-86-ES
(EUCTR)

22/06/2011

21/04/2010

Estudio de extensión multicéntrico no controlado que evalúa la eficacia y seguridad de SAR153191 junto con Fármacos Anti-Reumáticos Modificadores de la Enfermedad (FARMEs) en pacientes con Artritis Reumatoide (AR) activa______________________________________________A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)

Artritis Reumatoide_______________________Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: SAR153191

sanofi-aventis Recherche & Développement

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Hungary;Finland;Germany;Netherlands;Estonia;Spain;Greece;Austria;Lithuania

209

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

210

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

211

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

212

EUCTR2010-022206-40-LT
(EUCTR)

01/04/2011

28/12/2010

A Rheumatoid Arthritis Study in Patients(FLEX-O)

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: 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

213

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

214

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

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: 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

215

EUCTR2010-021577-37-DE
(EUCTR)

17/03/2011

29/10/2010

Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: N/A
Product Code: MLTA3698A
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

GENENTECH, Inc

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Hungary;Spain;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

216

NCT01232569
(ClinicalTrials.gov)

March 2011

1/11/2010

A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Tocilizumab 162 mg;Drug: Placebo

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

656

Phase 3

United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;Greece;Guatemala;Hungary;Israel;Malaysia;Mexico;New Zealand;Panama;Philippines;Poland;Russian Federation;South Africa;Spain;Switzerland;Thailand;Peru

217

NCT01313208
(ClinicalTrials.gov)

March 2011

10/3/2011

Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy

Rheumatoid Arthritis

Drug: etanercept;Drug: Placebo;Drug: DMARD Therapy

Amgen

NULL

Completed

18 Years

80 Years

All

210

Phase 4

United States;Canada

218

NCT01332994
(ClinicalTrials.gov)

March 2011

18/3/2011

A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis

Efficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI)

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

519

Phase 3

Germany

219

NCT01353859
(ClinicalTrials.gov)

March 2011

13/5/2011

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Indonesia;Greece

220

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

221

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

222

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

223

NCT01235507
(ClinicalTrials.gov)

February 2011

15/10/2010

A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)

Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDs

Rheumatoid Arthritis

Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Bosnia and Herzegovina

224

NCT01254331
(ClinicalTrials.gov)

February 2011

3/12/2010

An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment

Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Tunisia

225

EUCTR2010-021577-37-ES
(EUCTR)

27/01/2011

23/11/2010

ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, DE GRUPOS PARALELOS PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE MLTA3698A COMBINADO CON UN FÁRMACO ANTIRREUMÁTICO MODIFICADOR DE LA ENFERMEDAD (FARME) EN COMPARACIÓN CON ADALIMUMAB COMBINADO CON UN FARME EN PACIENTES CON ARTRITIS REUMATOIDE ACTIVAA PHASE II, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THEEFFICACY AND SAFETY OF MLTA3698A IN COMBINATION WITH A DISEASE-MODIFYINGANTI-RHEUMATIC DRUG (DMARD) COMPARED WITH ADALIMUMAB IN COMBINATION WITH A DMARD IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS

Artritis reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: N/A
Product Code: MLTA3698A
Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB

GENENTECH, Inc

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

Hungary;Germany;Bulgaria;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

226

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

227

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

228

NCT01274182
(ClinicalTrials.gov)

January 2011

10/1/2011

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

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

Rheumatoid Arthritis

Biological: GP2013;Biological: MabThera;Biological: Rituxan

Sandoz

Novartis Pharmaceuticals

Completed

18 Years

N/A

All

312

Phase 1;Phase 2

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

229

NCT01202760
(ClinicalTrials.gov)

January 2011

14/9/2010

A Rheumatoid Arthritis Study in Participants

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)

Rheumatoid Arthritis

Drug: LY2127399;Drug: Placebo

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

1004

Phase 3

United States;Argentina;Australia;Bulgaria;Colombia;Croatia;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Sri Lanka;Taiwan;Ukraine;Peru

230

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

231

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

232

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

233

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

234

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

235

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

No.

TrialID

Date_
enrollment

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

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

237

NCT01225393
(ClinicalTrials.gov)

November 2010

18/10/2010

A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MLTA3698A;Drug: adalimumab;Drug: leflunomide;Drug: methotrexate;Drug: placebo

Genentech, Inc.

NULL

Completed

18 Years

75 Years

Both

211

Phase 2

Romania;Spain;Bulgaria;Chile;Germany;Hungary;Mexico;Peru;Poland;United States

238

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

239

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

240

NCT01362062
(ClinicalTrials.gov)

October 26, 2010

26/5/2011

Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy

A Study to Observe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti TNF Therapy.

Rheumatoid Arthritis

Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

110

N/A

India

No.

TrialID

Date_
enrollment

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

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)

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] - Immune System Diseases [C20]

Product Name: Fostamatinib disodium
Product Code: FosD
INN or Proposed INN: Fostamatinib disodium
Other descriptive name: Fostamatinib disodium

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Portugal;Serbia;Spain;Ukraine;Lithuania;Israel;United Kingdom;Italy;India;Czech Republic;Canada;Romania;South Africa;Germany;Latvia

242

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

243

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

244

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

245

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

No.

TrialID

Date_
enrollment

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

EUCTR2010-018375-22-DE
(EUCTR)

05/10/2010

14/07/2010

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]

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

1200

247

NCT01214733
(ClinicalTrials.gov)

October 2010

4/10/2010

A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis

An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

Phase 3

South Africa

248

NCT01149057
(ClinicalTrials.gov)

October 2010

22/6/2010

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

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

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

Clalit Health Services

Completed

18 Years

N/A

All

145

Phase 4

Israel

249

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

250

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

251

EUCTR2010-018375-22-GB
(EUCTR)

14/09/2010

29/06/2010

Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

252

NCT01194414
(ClinicalTrials.gov)

September 2010

1/9/2010

A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis

A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: tocilizumab SC;Drug: tocilizumab IV;Drug: placebo to tocilizumab SC;Drug: placebo to tocilizumab IV;Drug: Disease-modifying antirheumatic drugs (DMARDs)

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

1262

Phase 3

United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Guatemala;Hong Kong;Italy;Lithuania;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Singapore;South Africa;Spain;Thailand;United Kingdom

253

NCT01197534
(ClinicalTrials.gov)

September 2010

8/9/2010

Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.

(OSKIRA-2): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to DMARDs

Rheumatoid Arthritis

Drug: fostamatinib;Drug: placebo, fostamatinib

AstraZeneca

NULL

Completed

18 Years

N/A

All

913

Phase 3

United States;Canada;Czech Republic;Germany;India;Israel;Italy;Latvia;Lithuania;Portugal;Romania;Serbia;South Africa;Spain;Ukraine;United Kingdom

254

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

255

NCT01195272
(ClinicalTrials.gov)

August 2010

2/9/2010

A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.

A 52 Week, Single Center, Open-label Study to Evaluate Neutrophil Function and Survival Effects of Tocilizumab (TCZ) in Patients With Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

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

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

257

JPRN-UMIN000003807

2010/07/01

01/07/2010

A study for comparison of triple combination therapy (bucillamine, salazosulphapiridine and methotrexate) with TNF-blocking biologics and methotrexate combination therapy concerning efficacy and tolerability for rheumatoid arthritis

Rheumatoid Arthritis

Combination therapy of three DMARDs (bucillamine, salazosulphapyridine and methotrexate)
Combination therapy of TNF-bloking biologics and methotrexate

Japan Association of Rheumatologists in Private Practice

NULL

Complete: follow-up complete

Not applicable

Male and Female

160

Not applicable

Japan

258

JPRN-UMIN000003880

2010/07/01

07/07/2010

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

Rheumatoid arthritis

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

Osaka City University Medical School

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

Recruiting

20years-old

Not applicable

Male and Female

100

Not applicable

Japan

259

NCT01593332
(ClinicalTrials.gov)

July 2010

7/1/2012

Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis

DMARD Resistant Rheumatoid Arthritis

Drug: Rituximab

Mashhad University of Medical Sciences

Roche Pharma AG

Completed

19 Years

75 Years

Both

Phase 4

Iran, Islamic Republic of

260

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

No.

TrialID

Date_
enrollment

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

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

262

JPRN-UMIN000003615

2010/05/01

14/05/2010

Evaluation of the effectiveness of three nonbiologic DMARDs [salazosulfapyridine(SSZ), bucillamine(BUC), methotrexate(MTX)] combination therapy for early RA

RA(Rheumatoid Arthritis)

Using 3 DMARDs(Salazosulfapyridine, Bucillamine, and Methotrexate) for 24 months

St Luke's International Hospital

NULL

Recruiting

20years-old

80years-old

Male and Female

Not selected

Japan

263

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

264

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

265

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

266

NCT01034397
(ClinicalTrials.gov)

March 2010

16/12/2009

A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs

A Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDs

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: placebo;Drug: non-biological DMARDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Portugal

267

NCT01610791
(ClinicalTrials.gov)

March 2010

31/5/2012

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)

A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

121

Phase 3

Morocco

268

NCT01256736
(ClinicalTrials.gov)

March 2010

28/10/2010

To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: DMARDs

JW Pharmaceutical

NULL

Completed

18 Years

N/A

Both

Phase 3

Korea, Republic of

269

NCT01063062
(ClinicalTrials.gov)

February 28, 2010

3/2/2010

A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)

A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

107

Phase 3

Egypt

270

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

No.

TrialID

Date_
enrollment

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

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

272

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

273

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

274

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

275

NCT01089023
(ClinicalTrials.gov)

January 2010

8/3/2010

A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

276

NCT02731560
(ClinicalTrials.gov)

January 2010

6/3/2016

Rituximab (RTX) for Disease Modifying Anti Rheumatic Drug (DMARD) Non-responders in Pakistan: The Pakistan Rituximab Study (PARIS)

Efficacy and Safety of Rituximab in Pakistani Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Rituximab

Prof. Abid Z. Farooqi

Aga Khan University;Fatima Memorial Hospital;Fauji Foundation Hospital, Rawalpindi

Completed

18 Years

80 Years

Both

Phase 4

NULL

277

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

278

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

279

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

280

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

281

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

282

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

283

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

284

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

285

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

No.

TrialID

Date_
enrollment

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

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

287

NCT00996203
(ClinicalTrials.gov)

October 31, 2009

15/10/2009

A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: DMARDs (disease-modifying antirheumatic drugs)

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

201

Phase 4

Russian Federation

288

NCT00951275
(ClinicalTrials.gov)

October 31, 2009

30/7/2009

A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Single Arm, Open-label Study of Early Improvement of Anemia and Fatigue During Treatment With Tocilizumab (TCZ) in Combination With DMARDs, in Adult Patients With Moderate to Severe Active Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

105

Phase 3

Italy

289

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

290

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

No.

TrialID

Date_
enrollment

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

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

292

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

293

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

294

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

295

NCT01211834
(ClinicalTrials.gov)

October 2009

29/9/2010

Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy

Rheumatoid Arthritis

Drug: tocilizumab;Drug: DMARDs;Drug: Placebo

JW Pharmaceutical

NULL

Completed

18 Years

N/A

Both

Phase 3

Korea, Republic of

No.

TrialID

Date_
enrollment

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

NCT00996606
(ClinicalTrials.gov)

October 2009

15/10/2009

A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs

Open Label, Multicentric Phase IIIb Study to Evaluate the Effect of Tocilizumab in Combination With DMARDs in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Dedicated Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: DMARDs;Drug: Tocilizumab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Italy

297

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

298

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

299

EUCTR2006-006373-25-GB
(EUCTR)

03/09/2009

16/11/2010

A PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE LONG TERM SAFETY AND FUNCTIONAL STATUS OF SUBJECTS WITH RHEUMATOID ARTHRITIS PREVIOUSLY ENROLLED IN STUDIES OF CP-690,550 - N/A

Pfizer Inc. 235 East 42nd Street, New York, NY10017

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2;Phase 3

Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Bulgaria;Germany;United Kingdom;Sweden

300

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

301

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

302

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

303

NCT00929357
(ClinicalTrials.gov)

August 2009

25/6/2009

Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.

Rheumatoid Arthritis

Drug: DMARDs or Biologics

Pfizer

NULL

Completed

18 Years

N/A

All

156

N/A

Denmark

304

NCT00966875
(ClinicalTrials.gov)

August 2009

25/8/2009

A Study in Patients With Rheumatoid Arthritis

A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD Therapy

Rheumatoid Arthritis

Biological: LY2439821;Drug: Placebo

Eli Lilly and Company

NULL

Completed

18 Years

75 Years

All

448

Phase 2

United States;Argentina;Chile;Germany;India;Korea, Republic of;Peru;Poland;Romania;Russian Federation;Taiwan;Hungary

305

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

No.

TrialID

Date_
enrollment

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

JPRN-UMIN000002169

2009/07/01

07/07/2009

Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritis

Rheumatoid Arthritis

Salazosulfapyridine
Bucillamine

Higashi-Hiroshima Memorial Hospital

NULL

Complete: follow-up complete

20years-old

80years-old

Male and Female

Phase 4

Japan

307

EUCTR2008-008337-11-GR
(EUCTR)

25/06/2009

20/10/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden

308

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

309

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

310

EUCTR2008-008337-11-SK
(EUCTR)

22/06/2009

09/09/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

795

Phase 3

Slovakia;Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

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

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

312

EUCTR2008-008337-11-ES
(EUCTR)

19/06/2009

27/03/2009

Estudio de fase III, aleatorizado, doble ciego y controlado con placebo de la seguridad y la eficacia de dos dosis de CP 690,550 en pacientes con artritis reumatoide activa que reciben tratamiento de base con FARMEsPHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Artritis reumatoide RHEUMATOID ARTHRITIS
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden

313

EUCTR2008-008337-11-DK
(EUCTR)

18/06/2009

15/05/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden

314

EUCTR2008-008337-11-FI
(EUCTR)

17/06/2009

24/04/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

795

Phase 3

Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden

315

EUCTR2008-008337-11-DE
(EUCTR)

16/06/2009

07/04/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

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

NULL

Not Recruiting

Female: yes
Male: yes

795

Phase 3

Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

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

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

317

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

318

EUCTR2008-008337-11-GB
(EUCTR)

10/06/2009

09/04/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

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

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;Germany;United Kingdom;Denmark;Spain;Greece;Poland;Sweden

319

EUCTR2008-008337-11-PL
(EUCTR)

09/06/2009

30/04/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

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

NULL

Not Recruiting

Female: yes
Male: yes

795

Phase 3

Finland;United Kingdom;Germany;Denmark;Spain;Greece;Poland;Sweden

320

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

No.

TrialID

Date_
enrollment

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

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

322

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

323

NCT00848354
(ClinicalTrials.gov)

June 2009

18/2/2009

Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

A Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.

Rheumatoid Arthritis

Biological: Phase 1: Etanercept;Drug: Phase 1: Methotrexate;Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX;Drug: Phase 1: Conventiaonal DMARD

Pfizer

Amgen

Completed

18 Years

69 Years

All

429

Phase 4

Argentina;Chile;Colombia;Mexico;Panama;Brazil;Ecuador;Spain;Venezuela

324

NCT00977106
(ClinicalTrials.gov)

June 2009

18/8/2009

TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF

Comparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDO

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: placebo

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

103

Phase 3

France

325

EUCTR2008-008337-11-SE
(EUCTR)

27/05/2009

23/03/2009

PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS

Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: CP -690,550

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Greece;Finland;Poland;Spain;Denmark;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

326

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

327

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

328

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

329

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

330

EUCTR2009-011105-17-IT
(EUCTR)

17/05/2009

27/03/2009

A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue

Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: Tocilizumab
Product Code: Ro 487-7533
INN or Proposed INN: RoActemra

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

331

NCT00891020
(ClinicalTrials.gov)

May 2009

29/4/2009

A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)

Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Nonbiologic DMARDs of investigator's choice

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

886

Phase 3

United States;Puerto Rico;United Kingdom

332

NCT00856544
(ClinicalTrials.gov)

May 2009

3/3/2009

A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS

Arthritis, Rheumatoid

Drug: CP -690,550;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

795

Phase 3

United States;Australia;Chile;China;Colombia;Croatia;Denmark;Finland;Germany;Greece;Malaysia;Mexico;Poland;Russian Federation;Slovakia;Spain;Sweden;Thailand;United Kingdom;Venezuela

333

NCT00902486
(ClinicalTrials.gov)

May 2009

13/5/2009

INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs

A Randomized, Double-blind, Placebo Controlled, Dose Ranging, Parallel Group, Phase 2 Study of INCB028050 Compared to Background Therapy in Patients With Active RA With Inadequate Response to Any Disease Modifying Anti-Rheumatic Drugs (DMARD) Therapy Including Biologics

Rheumatoid Arthritis

Drug: INCB028050;Drug: Placebo

Incyte Corporation

NULL

Completed

18 Years

N/A

All

127

Phase 2

United States;Czechia;Czech Republic

334

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

335

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

No.

TrialID

Date_
enrollment

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

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

337

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

338

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

339

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

340

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

No.

TrialID

Date_
enrollment

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

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

342

NCT00687193
(ClinicalTrials.gov)

March 2009

22/5/2008

Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD

Arthritis, Rheumatoid

Drug: Placebo;Drug: CP -690,550

Pfizer

NULL

Completed

20 Years

70 Years

All

318

Phase 2

Japan

343

NCT00810199
(ClinicalTrials.gov)

March 2009

16/12/2008

A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate;Drug: placebo

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

556

Phase 3

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

344

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

345

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

No.

TrialID

Date_
enrollment

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

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

347

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

348

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

349

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

350

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

No.

TrialID

Date_
enrollment

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

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

352

NCT00843778
(ClinicalTrials.gov)

January 2009

5/1/2009

Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

A Phase IIIB, Multi-center, Open Label Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With DMARDs in Patients With Active Rheumatoid Arthritis Who Participated in C87076.

Rheumatoid Arthritis

Biological: Certolizumab Pegol

UCB Pharma

NULL

Completed

18 Years

N/A

All

131

Phase 3

Austria;France;Germany;Italy;Poland

353

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

354

EUCTR2008-001847-20-GB
(EUCTR)

19/12/2008

09/09/2008

Rheumatoid Arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

F Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

470

Phase 3

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

355

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

No.

TrialID

Date_
enrollment

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

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

357

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

358

NCT00810277
(ClinicalTrials.gov)

November 30, 2008

16/12/2008

A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs

An Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 3

Finland

359

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

360

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

361

NCT00783536
(ClinicalTrials.gov)

November 2008

29/10/2008

A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis

An Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept + Methotrexate;Drug: DMARDS

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Withdrawn

18 Years

80 Years

Both

402

Phase 4

Mexico

362

NCT00773461
(ClinicalTrials.gov)

October 31, 2008

15/10/2008

A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.

A Randomized, Double Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD Therapy

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo

Hoffmann-La Roche

NULL

Completed

18 Years

70 Years

All

209

Phase 3

China

363

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

364

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

365

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

366

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

367

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

368

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

369

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

370

NCT00750880
(ClinicalTrials.gov)

September 2008

10/9/2008

An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.

International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.

Rheumatoid Arthritis

Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

1681

Phase 3

Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Luxembourg;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States

No.

TrialID

Date_
enrollment

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

NCT00780793
(ClinicalTrials.gov)

September 2008

27/10/2008

Spacing of TNF-blocker Injections in Rheumatoid Arthritis Study

Effect of TNF-blocker Injections Spacing on Rheumatoid Arthritis Inflammatory Activity in Patients in Clinical Remission or Low Disease Activity

Rheumatoid Arthritis

Drug: progressive spacing of TNF-blocker injections;Drug: DMARD maintenance

Assistance Publique - Hôpitaux de Paris

French Society of Rheumatology

Completed

18 Years

N/A

Both

250

Phase 4

France

372

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

373

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

374

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

375

EUCTR2008-000587-17-NL
(EUCTR)

12/08/2008

10/09/2008

Rheumatoid arthritis.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Product Name: RoActemra
Product Code: RO4877533 (TCZ)
INN or Proposed INN: tocilizumab

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1500

Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

376

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

377

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

378

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

379

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

380

JPRN-UMIN000002421

2008/07/01

04/09/2009

Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis

rheumatoid arthritis

tocilizumab
Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab

AA amyloidosis clinical research conference

NULL

Recruiting

20years-old

Not applicable

Male and Female

Not selected

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

381

JPRN-UMIN000001281

2008/07/01

31/07/2008

Strategic reduction of joint destruction in rheumatoid arthritis

Rheumatoid arthritis

TNF-inhibitors plus MTX
TNF-inhibitors are used for 54 weeks and exchange among them is approved

MTX
MTX is used for 54 weeks and addition of the other DMARD is approved

School of Medicine, University of Occupational and Environmental Health, Japan

NULL

Not applicable

Male and Female

120

Not selected

Japan

382

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

383

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

384

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

385

EUCTR2007-000886-40-IT
(EUCTR)

04/06/2008

21/03/2008

Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER

Patients with a diagnosis of early active rhematoid arthritis in the previous 6 months, naive of previous treatment by DMARD and who need to be treated by DMARD.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide
Trade Name: ARAVA
INN or Proposed INN: Leflunomide

sanofi-aventis Groupe

NULL

Not Recruiting

Female: yes
Male: yes

200

Portugal;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

386

NCT00674362
(ClinicalTrials.gov)

June 2008

5/5/2008

Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

A Phase IIIB, Multi-center, Double-blind, Placebo-controlled, Parallel Group, 52-week Study to Evaluate the Safety and Efficacy of Certolizumab Pegol, Administered With DMARDs, in Patients With Low to Moderate Disease Activity Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: Certolizumab pegol;Biological: Placebo

UCB Pharma

NULL

Completed

18 Years

N/A

All

194

Phase 3

Austria;France;Germany;Italy;Poland

387

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

388

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

389

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

390

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

No.

TrialID

Date_
enrollment

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

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

392

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

393

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

394

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

395

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

No.

TrialID

Date_
enrollment

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

EUCTR2007-002945-18-CZ
(EUCTR)

15/10/2007

27/08/2007

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 - Clinical efficacy and safety of ofatumumab in RA patients receiving background nonbiologic DMARDs

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

397

NCT00531817
(ClinicalTrials.gov)

October 2007

18/9/2007

A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Tocilizumab;Drug: Placebo;Drug: Permitted DMARDs

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

619

Phase 3

United States;Puerto Rico

398

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

399

NCT00664716
(ClinicalTrials.gov)

July 2007

21/4/2008

Assessment Of The Safety And Efficacy Of BG9924 In Rheumatoid Arthritis (RA) Patients

Assessment Of Safety, Efficacy, PK&PD Of BG9924 in RA Patients Who Have Had An Inadequate Response To Conventional DMARD Therapy.

Rheumatoid Arthritis

Biological: Placebo;Biological: baminercept alfa;Biological: Baminercept alfa

Biogen Idec

NULL

Completed

18 Years

75 Years

Both

391

Phase 2

Argentina;Brazil;Hungary;Mexico;Poland;Romania;Russian Federation;United Kingdom

400

EUCTR2006-005466-39-HU
(EUCTR)

25/06/2007

22/03/2007

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Conventional DMARD Therapy

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Product Code: BG9924

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2b

Hungary;United Kingdom

No.

TrialID

Date_
enrollment

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

NCT00521924
(ClinicalTrials.gov)

June 2007

27/8/2007

Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED)

Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab-therapy

Rheumatoid Arthritis

Biological: infliximab;Drug: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.

Merck Sharp & Dohme Corp.

AESCA Pharma GmbH

Terminated

19 Years

65 Years

All

Phase 3

Austria

402

NCT00422227
(ClinicalTrials.gov)

June 2007

11/1/2007

Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Etanercept , Methotrexate;Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Completed

18 Years

70 Years

All

300

Phase 4

Hong Kong;India;Korea, Republic of;Malaysia;Philippines;Singapore;Taiwan;Thailand

403

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

404

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

405

EUCTR2006-005466-39-GB
(EUCTR)

12/04/2007

07/01/2007

Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

380

Phase 2

Hungary;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

406

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

407

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

408

NCT00913432
(ClinicalTrials.gov)

March 2007

3/6/2009

Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha

Rheumatoid Arthritis

Drug: masitinib

AB Science

NULL

Completed

18 Years

N/A

All

Phase 2

NULL

409

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

410

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

411

NCT00484289
(ClinicalTrials.gov)

December 2006

7/6/2007

A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis

A Phase III, Multi-center, Open-label, Uncontrolled, Long-term Study to Evaluate the Safety of Abatacept (BMS-188667) in Japanese Subjects With Rheumatoid Arthritis Having Completed Clinical Studies IM101-071, IM101-034, and Also Special DMARD Failures

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

20 Years

N/A

All

217

Phase 3

Japan

412

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

413

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

414

NCT02006706
(ClinicalTrials.gov)

August 10, 2006

5/12/2013

A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Disease Activity in Patients With Active Rheumatoid Arthritis After DMARD Treatment Failure

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

Phase 3

Serbia

415

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

No.

TrialID

Date_
enrollment

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

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

417

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

418

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

419

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

420

EUCTR2005-003436-21-CZ
(EUCTR)

15/02/2006

07/11/2005

A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114

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

Product Name: SMP-114
Product Code: SMP-114
INN or Proposed INN: rimacalib

Dainippon Sumitomo Pharma Europe Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Hungary;Germany;United Kingdom;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

421

NCT00296257
(ClinicalTrials.gov)

February 2006

22/2/2006

Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114

A Phase 2, Multi-Centre, Randomised, Double Blind, Placebo Controlled Study Evaluating the Efficacy, Safety and Pharmacokinetics of Two Doses of a Candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg Once Daily), Administered in Combination With Ongoing Methotrexate Treatment in Patients With Active Rheumatoid Arthritis.

Rheumatoid Arthritis (RA)

Drug: SMP-114

Dainippon Sumitomo Pharma Europe LTd.

NULL

Terminated

18 Years

N/A

Both

312

Phase 2

Czech Republic;Germany;Hungary;Netherlands;Poland;United Kingdom

422

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

423

NCT02922192
(ClinicalTrials.gov)

January 2006

28/9/2016

Incidence of Hospitalizations for Serious Infections in Patients Receiving Biologic Anti-Inflammatories for Rheumatologic, Psoriatic, and Gastrointestinal Conditions: A Descriptive Analysis

Rheumatoid Arthritis;Inflammatory Bowel Disease;Psoriasis;Psoriatic Arthritis;Ankylosing Spondylitis

Drug: TNF-a antagonists, non-TNFs, DMARD non-biologics

Biologics & Biosimilars Collective Intelligence Consortium

HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMC;HealthCore, Inc.;Aetna, Inc.;University of Alabama; Rheumatologist and Healthcare Research;AbbVie;Amgen;Boehringer Ingelheim;Group Health Cooperative;Harvard Pilgrim Health Care;Merck Sharp & Dohme Corp.;Momenta;Pfizer;UPMC

Active, not recruiting

18 Years

N/A

Both

100000

N/A

NULL

424

NCT00254293
(ClinicalTrials.gov)

January 2006

15/11/2005

Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA)

A Study to Assess the Steady-State Trough Serum Concentration, Safety, and Immunogenicity of Abatacept (BMS-188667) Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Who Are Receiving Disease Modifying Ant-Rheumatic Drugs (DMARDs)

Rheumatoid Arthritis

Drug: Abatacept or Placebo (both as IV & SC Solution);Drug: Abatacept or Placebo (both as IV & SC solution);Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States

425

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

426

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

427

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

428

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

429

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

430

NCT00292422
(ClinicalTrials.gov)

November 2005

15/2/2006

Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis

A Randomized, Blinded, Placebo-Controlled, Multicenter, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD Therapy

Rheumatoid Arthritis

Drug: BG9924

Biogen Idec

NULL

Completed

18 Years

75 Years

Both

Phase 2

United States;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

431

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

432

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

433

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

434

EUCTR2004-005102-68-GB
(EUCTR)

01/09/2005

27/05/2005

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options. Revised Protocol 3 incorporating amendments 2, 3 and 8. Protocol Amendments 1 & 5.

RHEUMATOID ARTHRITIS,NOS

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Belgium;Spain;Ireland;Germany;Italy;United Kingdom

435

EUCTR2004-004995-35-CZ
(EUCTR)

30/08/2005

ACTIVE RHEUMATOID ARTHRITIS

Trade Name: Prednisolone Tablets BP 1 mg
Product Name: N/A
Product Code: CRx-139
INN or Proposed INN: Paroxetine & Prednisolone

CombinatoRx, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

Germany;United Kingdom;Czech Republic;Denmark;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

436

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

437

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

438

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

439

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

440

NCT00503425
(ClinicalTrials.gov)

June 30, 2005

17/7/2007

A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy.

An Open Label Study to Assess the Safety and Effect on Disease Activity of MabThera in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With DMARDs and/or One Anti-TNF Alpha Agent

Rheumatoid Arthritis

Drug: Rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

215

Phase 3

Israel

No.

TrialID

Date_
enrollment

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

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

442

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

443

NCT00106574
(ClinicalTrials.gov)

April 2005

25/3/2005

A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

Rheumatoid Arthritis

Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

1220

Phase 3

United States;Argentina;Australia;Brazil;Canada;China;Costa Rica;Czech Republic;Finland;France;Germany;Hong Kong;Mexico;Panama;Russian Federation;South Africa;Spain;Sweden;Thailand

444

NCT00124982
(ClinicalTrials.gov)

April 2005

30/6/2005

Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options

Rheumatoid Arthritis

Drug: Abatacept;Drug: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD);Drug: Anti-Tumor Necrosing Factor (TNF) Therapy

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

1286

Phase 3

United States;Belgium;Czech Republic;France;Germany;Ireland;Italy;Mexico;Spain;United Kingdom;Canada

445

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

No.

TrialID

Date_
enrollment

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

NCT00747214
(ClinicalTrials.gov)

November 2004

3/9/2008

A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA

A Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RA

Rheumatoid Arthritis

Drug: CRx-102;Drug: Placebo;Drug: DMARD Therapy

Zalicus

NULL

Completed

18 Years

N/A

All

Phase 2

NULL

447

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

448

NCT00117091
(ClinicalTrials.gov)

September 2004

30/6/2005

Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)

An Open-Label Multicentre Study of Anakinra (Kineret®) in Combination With DMARDS in Subjects With Active Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Drug: Anakinra (Kineret®)

Amgen

NULL

Completed

18 Years

N/A

Both

Phase 3

NULL

449

NCT00831922
(ClinicalTrials.gov)

September 2004

28/1/2009

Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis

A Multicenter, Open Label, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis With Inadequate Response to at Least One Disease Modifying Anti Rheumatic Drugs (DMARD)

Rheumatoid Arthritis

Drug: masitinib (AB1010)

AB Science

NULL

Completed

18 Years

N/A

All

Phase 2

NULL

450

NCT00089921
(ClinicalTrials.gov)

July 2004

17/8/2004

SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate

A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine

Arthritis, Rheumatoid

Drug: SCIO-469;Drug: Placebo

Scios, Inc.

NULL

Completed

18 Years

N/A

Both

302

Phase 2

United States

No.

TrialID

Date_
enrollment

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

NCT00162201
(ClinicalTrials.gov)

October 2003

9/9/2005

An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy

Rheumatoid Arthritis

Drug: Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

Phase 1

United Kingdom

452

NCT00548834
(ClinicalTrials.gov)

June 2003

15/10/2007

Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis

Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD

Rheumatoid Arthritis

Drug: CDP870

UCB Pharma

NULL

Completed

18 Years

75 Years

Both

220

Phase 3

NULL

453

NCT02214888
(ClinicalTrials.gov)

May 2003

12/8/2014

Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets in Patients With Active Rheumatoid Arthritis

A 12 Week Double-blind, Randomized, Placebo-controlled Trial to Investigate Efficacy, Safety and Pharmacokinetics of BIRB 796 BS Tablets at Doses of 50 and 70 mg Administered Twice a Day in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARD

Arthritis, Rheumatoid

Drug: BIRB 796 BS, low dose;Drug: BIRB 796 BS, high dose;Drug: Placebo

Boehringer Ingelheim

NULL

Terminated

18 Years

75 Years

Both

170

Phase 2

NULL

454

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

455

NCT00908089
(ClinicalTrials.gov)

March 2003

22/5/2009

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

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

Rheumatoid Arthritis

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

Helsinki University

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

Active, not recruiting

18 Years

60 Years

Both

100

Phase 4

Finland

No.

TrialID

Date_
enrollment

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

NCT00764725
(ClinicalTrials.gov)

December 2002

1/10/2008

Comparison of MTX+Anti-TNF to MTX+Conventional DMARDs in Patients With Early Rheumatoid Arthritis (RA) Who Failed MTX Alone (SWEFOT)

A Prospective Randomized, Open, Multi-Center Trial Comparing TNF-Blockade + MTX to MTX+SSZ+HCQ in Patients With Early RA With an Inadequate Response to MTX

Rheumatoid Arthritis

Drug: conventional DMARD combination;Biological: MTX plus anti-TNF

Karolinska Institutet

NULL

Completed

18 Years

N/A

Both

487

Phase 4

NULL

457

NCT00048581
(ClinicalTrials.gov)

December 2002

2/11/2002

Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.

A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background Disease Modifying Anti-Rheumatic Drugs (DMARDS) Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy

Rheumatoid Arthritis

Drug: Abatacept;Drug: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

738

Phase 3

United States

458

NCT00116727
(ClinicalTrials.gov)

October 2002

30/6/2005

Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

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

Rheumatoid Arthritis

Drug: ENBREL ®

Amgen

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

Completed

18 Years

N/A

Both

5103

N/A

United States

459

NCT00116714
(ClinicalTrials.gov)

October 2001

30/6/2005

Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudy

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

Rheumatoid Arthritis

Drug: DMARD

Amgen

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

Completed

18 Years

N/A

Both

4968

N/A

United States

460

NCT02209779
(ClinicalTrials.gov)

May 2001

5/8/2014

Efficacy and Safety of Different Doses of BIRB 796 BS in Patients With Active Rheumatoid Arthritis

A Randomised, Parallel, Double-blind, Placebo-controlled Study to Investigate Efficacy and Safety of Different Doses (5, 10, 20 and 30 mg) of BIRB 796 BS Administered Twice a Day Orally Over 4 Weeks in Patients With Active Rheumatoid Arthritis Who Have Failed at Least One DMARD

Arthritis, Rheumatoid

Drug: BIBR 796 BS;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

18 Years

75 Years

Both

167

Phase 2

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

461

NCT00579878
(ClinicalTrials.gov)

December 1999

17/12/2007

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations (Leflunomide-Hydroxychloroquine-Sulfasalazine or Methotrexate-Hydroxychloroquine-Sulfasalazine) in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Leflunomide;Drug: Methotrexate -Sulfasalazine-Hydroxychloroquine;Drug: Leflunomide -Sulfasalazine-Hydroxychloroquine

University of Nebraska

NULL

Completed

19 Years

80 Years

All

Phase 3

United States

462

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

463

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