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	EUCTR2020-002507-19-NL (EUCTR)	07/09/2020	03/09/2020	Research into administration of lower dosed rituximab with an injection	Comparison of subcutaneous and intravenous continued treatment with ultra-low dose Rituximab in rheumatoid arthritis: a randomised open-label non-inferiority trial - RTX-SC	rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: rituximab Trade Name: Rixathon Product Name: rituximab	Sint Maartenskliniek	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	36	Phase 4	Netherlands
2	EUCTR2019-002810-37-PL (EUCTR)	16/06/2020	11/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	Bulgaria;United States;Hungary;Estonia;Czech Republic;Poland;Lithuania;Germany
3	EUCTR2019-002810-37-BG (EUCTR)	15/06/2020	28/04/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	United States;Czechia;Estonia;Hungary;Poland;Lithuania;Bulgaria;Germany
4	EUCTR2019-002810-37-LT (EUCTR)	17/04/2020	03/03/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;Czechia;Hungary;Poland;Lithuania;Bulgaria;Germany
5	NCT04268771 (ClinicalTrials.gov)	April 8, 2020	31/1/2020	A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products	A Randomized, Double-blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis	Biological: Experimental: Arm A: DRL_RI;Biological: Arm B: Rituxan®/Mabthera®	Dr. Reddy's Laboratories Limited	PPD	Recruiting	18 Years	N/A	All	140	Phase 3	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2019-002810-37-HU (EUCTR)	09/03/2020	20/01/2020	A study to assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	A Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Immunogenicity and Safety of Transitioning Subjects With Rheumatoid Arthritis to Biosimilar Rituximab (DRL_RI) or Continued Treatment With Rituxan® or MabThera®	Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 100mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 100mg INN or Proposed INN: RITUXIMAB Trade Name: Reditux Product Name: Dr. Reddy’s Rituximab (DRL_RI) 500mg Product Code: DRL_RI INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	Dr. Reddy’s Laboratories S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	United States;Estonia;Czech Republic;Poland;Lithuania;Bulgaria;Germany;Hungary
7	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
8	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
9	EUCTR2013-005543-90-EE (EUCTR)	07/08/2017	02/06/2017	This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 Biosimilar to Rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
10	EUCTR2014-005368-13-IT (EUCTR)	10/05/2017	16/02/2018	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB	ARCHIGEN BIOTECH LIMITED	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	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	NCT03161457 (ClinicalTrials.gov)	February 27, 2017	21/4/2017	A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis	A Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Efficacy of JHL1101 Versus EU-sourced MabThera® in Anti TNF Inadequate Responder Patients With Moderate to Severe Rheumatoid Arthritis (RA) on Background Methotrexate (MTX) Therapy	Rheumatoid Arthritis;Arthritis, Rheumatoid	Biological: JHL1101;Biological: MabThera	JHL Biotech, Inc.	NULL	Terminated	18 Years	80 Years	All	153	Phase 1	Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;Lithuania;Poland;Russian Federation;Taiwan;Ukraine;United Kingdom
12	EUCTR2014-005368-13-DE (EUCTR)	22/11/2016	04/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
13	NCT03061838 (ClinicalTrials.gov)	October 27, 2016	20/2/2017	Safety, Tolerability, PK and PD of Biosimilar Drug Ritumax® Compared to Original Drug MabThera®	Multicenter Double-blind Randomized Clinical Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Biosimilar Drug Ritumax® Compared to Original Drug MabThera® in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: MabThera ®;Drug: Ritumax®	Biointegrator LLC	NULL	Terminated	18 Years	N/A	All	8	Phase 1	Russian Federation
14	NCT02819726 (ClinicalTrials.gov)	October 11, 2016	20/6/2016	PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Biological: SAIT101;Biological: MabThera;Biological: Rituxan	Archigen Biotech Limited	NULL	Completed	18 Years	80 Years	All	294	Phase 1	United States;Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;India;Korea, Republic of;Mexico;Poland;Spain
15	EUCTR2014-005368-13-ES (EUCTR)	23/09/2016	15/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2014-005368-13-HU (EUCTR)	19/09/2016	11/07/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	India;Hungary;Czech Republic;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of;United States;Spain;Russian Federation;Italy
17	EUCTR2014-005368-13-CZ (EUCTR)	13/09/2016	13/09/2016	A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).	Severe Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: SAIT101 (proposed rituximab biosimilar) Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB	Archigen Biotech Limited	NULL	Not Recruiting			Female: yes Male: yes	282	Phase 1;Phase 3	United States;Spain;Russian Federation;Italy;India;Czech Republic;Hungary;Mexico;Poland;Bulgaria;Germany;Bosnia and Herzegovina;Korea, Republic of
18	EUCTR2012-002535-28-NL (EUCTR)	13/09/2016	01/09/2016	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 19.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Product Code: L01X CO2 Trade Name: RoActemra Product Name: RoActemra Product Code: L04AC07	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	144	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
19	EUCTR2012-003876-38-PL (EUCTR)	10/11/2015	16/11/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® Product Name: MabThera ® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
20	EUCTR2015-000581-58-CZ (EUCTR)	14/10/2015	16/06/2015	A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action	A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra INN or Proposed INN: tocilizumabum Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Revmatologicky ustav Praha	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	Czech Republic
No.	TrialID	Date_ enrollment	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	EUCTR2012-003876-38-HU (EUCTR)	28/07/2015	22/05/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® Product Name: MabThera ® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
22	EUCTR2012-002535-28-ES (EUCTR)	22/07/2015	10/07/2015	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 4	Portugal;Belgium;Spain;Netherlands;Italy;United Kingdom
23	EUCTR2012-003876-38-DE (EUCTR)	21/07/2015	29/04/2015	Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past	A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT	Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GP2013 Product Code: GP2013 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® Product Name: MabThera ® INN or Proposed INN: RITUXIMAB	Hexal AG (a Sandoz company)	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	United States;Hungary;Poland;Germany
24	EUCTR2015-000833-64-FR (EUCTR)	17/07/2015	02/07/2015	N/A	N/A	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: ORENCIA Trade Name: MABTHERA Trade Name: ROACTEMRA	CHU Amiens-Picardie	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 4	France
25	NCT02514772 (ClinicalTrials.gov)	July 2015	30/7/2015	GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®	A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®	Rheumatoid Arthritis	Biological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ®	Sandoz	Hexal AG	Completed	18 Years	N/A	All	107	Phase 3	United States;Germany;Hungary;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	EUCTR2014-003255-54-CZ (EUCTR)	21/01/2015	24/10/2014	A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid Arthritis	A Double-blind, Randomised, Comparative Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Evaluation of RGB-03 and MabThera® Combined with Methotrexate in Rheumatoid Arthritis Patients	Rheumatoid arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: RGB-03 INN or Proposed INN: RITUXIMAB Trade Name: MabThera INN or Proposed INN: RITUXIMAB	Gedeon Richter Plc	NULL	Not Recruiting			Female: yes Male: yes	142	Phase 1;Phase 3	Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany
27	EUCTR2012-002535-28-IT (EUCTR)	16/01/2015	04/11/2014	Not applicable	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180		Portugal;Belgium;United Kingdom;Italy
28	EUCTR2013-005543-90-BG (EUCTR)	06/01/2015	22/10/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
29	NCT02371096 (ClinicalTrials.gov)	January 2015	5/2/2015	Comparative Pharmacokinetic Trial of RGB-03 and MabThera		Rheumatoid Arthritis	Drug: MabThera (rituximab);Drug: RGB-03	Gedeon Richter Plc.	NULL	Not yet recruiting	18 Years	75 Years	Both		Phase 1	NULL
30	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
No.	TrialID	Date_ enrollment	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	EUCTR2013-005543-90-DE (EUCTR)	19/11/2014	16/06/2014	This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: RITUXIMAB Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
32	NCT02296775 (ClinicalTrials.gov)	November 2014	18/11/2014	Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis		Rheumatoid Arthritis	Biological: DRL_RI;Biological: Rituxan;Biological: MabThera	Dr. Reddy's Laboratories Limited	NULL	Completed	18 Years	65 Years	All	276	Phase 1;Phase 2	India;Ukraine
33	EUCTR2014-000859-91-FR (EUCTR)	03/10/2014	18/06/2015	Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde.	Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde. - LYRITUX	Cette étude portera donc sur une population de patients atteints de polyarthrite rhumatoïde (PR) actives et ayant présenté un échec ou une contre-indication à au moins un anti-TNFa, et n’ayant jamais reçu de rituximab. MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MABTHERA INN or Proposed INN: RITUXIMAB	CHRU de TOURS	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 4	France
34	EUCTR2013-004555-21-GR (EUCTR)	22/09/2014	21/03/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
35	EUCTR2013-005543-90-PL (EUCTR)	09/09/2014	11/07/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Hungary;Estonia;Canada;Poland;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2013-005543-90-HU (EUCTR)	26/08/2014	13/05/2014	This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body, and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.	A Randomized, Double-Blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis - Not applicable	Rheumatoid arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: ABP 798 Product Code: ABP 798 INN or Proposed INN: rituximab Other descriptive name: ABP 798 - Biosimilar to rituximab Trade Name: Rituxan INN or Proposed INN: RITUXIMAB Other descriptive name: Rituxan Trade Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera	Amgen Inc	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 1;Phase 3	United States;Estonia;Hungary;Canada;Poland;Bulgaria;Germany
37	NCT02149121 (ClinicalTrials.gov)	August 2014	23/5/2014	PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety Between CT-P10, Rituxan and MabThera in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: CT-P10;Drug: Rituxan;Drug: MabThera	Celltrion	NULL	Completed	18 Years	75 Years	All	384	Phase 3	Austria;Korea, Republic of
38	EUCTR2012-002535-28-PT (EUCTR)	06/06/2014	25/02/2014	Not applicable	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
39	EUCTR2013-004555-21-AT (EUCTR)	07/04/2014	02/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of
40	EUCTR2013-004555-21-SK (EUCTR)	07/04/2014	23/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2013-004555-21-HU (EUCTR)	02/04/2014	23/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 18.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Korea, Republic of;Bosnia and Herzegovina;Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Latvia;Germany
42	EUCTR2013-004555-21-DE (EUCTR)	31/03/2014	17/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Bosnia and Herzegovina;Korea, Republic of
43	EUCTR2013-004555-21-PT (EUCTR)	24/03/2014	07/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Latvia;Germany;Korea, Republic of;Bosnia and Herzegovina
44	EUCTR2012-003194-25-HR (EUCTR)	17/03/2014	03/09/2014	Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Mabion S.A.	NULL	Not Recruiting			Female: yes Male: yes	863	Phase 3	Serbia;Poland;Ukraine;Romania;Lithuania;Croatia;Russian Federation;Georgia
45	EUCTR2013-004555-21-LV (EUCTR)	03/03/2014	02/01/2014	This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: CT- P10 Product Code: CT- P10 INN or Proposed INN: RITUXIMAB Trade Name: MabThera Product Name: MabThera Product Code: L01XC02 INN or Proposed INN: RITUXIMAB Trade Name: Rituxan Product Name: Rituxan INN or Proposed INN: RITUXIMAB	CELLTRION, Inc.	NULL	Not Recruiting			Female: yes Male: yes	361	Phase 3	Portugal;Slovakia;Greece;Spain;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;Hungary;Mexico;Brazil;Poland;Romania;Peru;Bulgaria;Germany;Latvia;Korea, Republic of;Bosnia and Herzegovina
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2012-003223-38-DE (EUCTR)	01/07/2013	08/04/2013	Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.	EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04	RHEUMATOID ARTHRITIS MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab -Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	157	Phase 2	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
47	NCT01873443 (ClinicalTrials.gov)	May 2013	22/5/2013	Long-Term Efficacy and Safety of CT-P10 in Patients With RA	An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1	Rheumatoid Arthritis	Drug: Rituximab , MTX, folic acid	Celltrion	NULL	Completed	18 Years	75 Years	Both	87	Phase 1	Korea, Republic of
48	NCT02468791 (ClinicalTrials.gov)	May 2013	9/6/2015	MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis	A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Rituximab	Mabion SA	NULL	Completed	18 Years	80 Years	All	709	Phase 3	Bosnia and Herzegovina;Georgia;Poland;Serbia;Ukraine
49	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
50	EUCTR2011-002896-40-PL (EUCTR)	29/03/2013	11/02/2013	A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01	RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab -Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195		United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
No.	TrialID	Date_ enrollment	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	EUCTR2012-003223-38-ES (EUCTR)	27/02/2013	04/03/2013	Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.	EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04	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]	Product Name: Rituximab -Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	157		United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany
52	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
53	EUCTR2012-003194-25-LT (EUCTR)	04/02/2013	24/09/2012	Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis	Active Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: MabionCD20 INN or Proposed INN: Rituximab Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB	Mabion S.A.	NULL	Not Recruiting			Female: yes Male: yes	863		Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia
54	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
55	EUCTR2012-002535-28-GB (EUCTR)	21/01/2013	14/12/2012	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActemra Product Name: RoActemra	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	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
57	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
58	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
59	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
60	EUCTR2011-002896-40-DE (EUCTR)	23/10/2012	02/07/2012	A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01	RHEUMATOID ARTHRITIS MedDRA version: 16.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Rituximab -Pfizer Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017 US	NULL	Not Recruiting			Female: yes Male: yes	195		United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	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
62	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
63	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
64	NCT01682512 (ClinicalTrials.gov)	September 5, 2012	10/8/2012	Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis	Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial.	Arthritis, Rheumatoid	Drug: BI 695500;Drug: Rituxan ®;Drug: MabThera ®	Boehringer Ingelheim	NULL	Terminated	18 Years	80 Years	All	294	Phase 3	United States;Argentina;Belgium;Bulgaria;Canada;Chile;Germany;Greece;Hungary;Ireland;Mexico;Netherlands;Poland;Portugal;Spain;Ukraine;United Kingdom;Brazil;Estonia;France;Guatemala;Italy;New Zealand;Norway;Peru;Russian Federation;Serbia;South Africa;Sweden
65	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
No.	TrialID	Date_ enrollment	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	EUCTR2011-005021-48-NL (EUCTR)	07/06/2012	05/06/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera ®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
67	EUCTR2011-005021-48-CZ (EUCTR)	23/05/2012	15/02/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera ®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands
68	EUCTR2011-005021-48-ES (EUCTR)	14/05/2012	21/02/2012	A study to investigate and compare the efficacy, safety, tolerability andpharmacodynamic (biochemical and physiological effects of the drug) ofTL011 and MabThera® (rituximab) in patients with severe, activerheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallelgroupstudy to evaluate the efficacy, safety, tolerability andpharmacodynamic profiles of TL011 infusions compared with MabThera®(rituximab) in subjects with severe, active rheumatoid arthritis treatedwith methotrexate (MTX) - ALTO	Sujetos adultos con artritis reumatoide (AR) activa de grado severo tratados con MTX MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera ®, 100 mg Concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
69	EUCTR2012-000139-21-AT (EUCTR)	14/05/2012	23/04/2012	Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action	A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB	Medizinische Universität Wien, Universitätsklinik für Innere Medizin III	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Czech Republic;Slovakia;Austria;Russian Federation;Switzerland
70	EUCTR2011-005021-48-BG (EUCTR)	09/05/2012	20/04/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera ®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	EUCTR2011-005021-48-HU (EUCTR)	04/05/2012	15/02/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera ®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland
72	NCT01638715 (ClinicalTrials.gov)	May 2012	3/7/2012	A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action	A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action	Rheumatoid Arthritis	Drug: Remicade;Drug: Orencia;Drug: Ro-Actemra;Drug: Mabthera	Medical University of Vienna	NULL	Completed	18 Years	75 Years	All	115	Phase 4	Austria;Czechia;Russian Federation;Switzerland;Czech Republic;Saudi Arabia
73	EUCTR2011-005021-48-PL (EUCTR)	10/04/2012	14/03/2012	A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)	A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO	adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: TL011 Product Code: TL011 INN or Proposed INN: TL011 Trade Name: MabThera ®, 100 mg concentrate for solution for infusion INN or Proposed INN: RITUXIMAB	Teva Pharmaceutical Industries	NULL	Not Recruiting			Female: yes Male: yes	544		Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Poland;Macedonia, the former Yugoslav Republic of
74	EUCTR2011-004171-36-ES (EUCTR)	30/03/2012	30/01/2012	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera ® Product Name: MabThera ® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Not Recruiting			Female: yes Male: yes	616		Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of
75	EUCTR2011-004171-36-PL (EUCTR)	29/03/2012	22/02/2012	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera ® Product Name: MabThera ® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	616		Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	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
77	NCT01526057 (ClinicalTrials.gov)	March 20, 2012	1/2/2012	A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES	Rheumatoid Arthritis	Biological: PF-05280586;Biological: MabThera;Biological: Rituxan	Pfizer	NULL	Completed	18 Years	N/A	All	220	Phase 2	United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Taiwan
78	EUCTR2011-006001-10-IT (EUCTR)	19/03/2012	14/03/2012	Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response	Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response -	Rheumatoid arthritis MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MABTHERA EV 1FL 50ML 500MG INN or Proposed INN: RITUXIMAB Other descriptive name: NA Trade Name: MABTHERA EV 1FL 50ML 500MG INN or Proposed INN: RITUXIMAB Other descriptive name: NA	A.O. UNIVERSITARIA INTEGRATA DI VERONA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	48		Italy
79	EUCTR2011-004171-36-GB (EUCTR)	24/02/2012	15/12/2011	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera ® Product Name: MabThera ® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	616		Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
80	EUCTR2011-004171-36-HU (EUCTR)	23/02/2012	16/12/2011	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera ® Product Name: MabThera ® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	616		Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	EUCTR2011-004171-36-CZ (EUCTR)	15/02/2012	30/11/2011	A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)	Severe Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: SAIT101 Product Code: SAIT101 INN or Proposed INN: RITUXIMAB Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody Trade Name: MabThera ® Product Name: MabThera ® INN or Proposed INN: RITUXIMAB	Samsung Electronics Co. Ltd.	NULL	Not Recruiting			Female: yes Male: yes	616		Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland
82	NCT01613027 (ClinicalTrials.gov)	February 2012	25/5/2012	An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis	A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)	Rheumatoid Arthritis	Biological: Rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	135	N/A	Greece
83	NCT01534884 (ClinicalTrials.gov)	February 2012	8/2/2012	Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis	Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: rituximab	Celltrion	NULL	Completed	18 Years	75 Years	Both	154	Phase 1	Korea, Republic of
84	NCT01592292 (ClinicalTrials.gov)	November 2011	11/4/2012	An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy	A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent	Rheumatoid Arthritis	Drug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: Infliximab	Hoffmann-La Roche	NULL	Completed	20 Years	N/A	All	90	N/A	Korea, Republic of
85	NCT01641952 (ClinicalTrials.gov)	October 2011	13/7/2012	An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent	Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program	Rheumatoid Arthritis	Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	505	N/A	Romania
No.	TrialID	Date_ enrollment	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	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
87	NCT01390441 (ClinicalTrials.gov)	July 2011	7/7/2011	A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)	A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed Rituxan® in Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Biological: MK-8808;Biological: MabThera ® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Loratadine	Merck Sharp & Dohme Corp.	NULL	Terminated	18 Years	65 Years	All	100	Phase 1	Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;United States
88	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
89	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
90	EUCTR2010-020499-50-GB (EUCTR)	07/02/2011	31/12/2010	Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis.	Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis.	rheumatoid arthritis MedDRA version: 13;Level: PT;Classification code 10039073;Term: rheumatoid arthritis	Trade Name: MabThera Product Name: rituximab	South Tees Hospitals NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	46	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
91	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
92	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
93	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
94	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
95	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
No.	TrialID	Date_ enrollment	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	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
97	NCT01117129 (ClinicalTrials.gov)	April 2010	4/5/2010	A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)	Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: placebo;Drug: methotrexate;Drug: rituximab [Mabthera/Rituxan]	Hoffmann-La Roche	NULL	Terminated	18 Years	75 Years	Both	2	Phase 4	Spain
98	NCT01123070 (ClinicalTrials.gov)	February 2010	11/5/2010	TL011 in Severe, Active Rheumatoid Arthritis Patients		Rheumatoid Arthritis	Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis;Biological: MabThera infusions	Teva Pharmaceutical Industries	NULL	Completed	18 Years	80 Years	Both	48	Phase 1;Phase 2	Czech Republic;Hungary;Italy;Spain;United Kingdom;Germany
99	NCT01071798 (ClinicalTrials.gov)	January 2010	18/2/2010	An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis	A Prospective, Multi-center, Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months (in Case of Re-therapy the First 12 Months) of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine Care	Rheumatoid Arthritis	Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	1653	N/A	Germany;United States
100	EUCTR2009-011268-13-GB (EUCTR)	31/12/2009	15/03/2010	Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study	Optimal management of rheumatoid arthritis patients who require biologic therapy (ORBIT study) - ORBIT study	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera Product Name: Rituximab Trade Name: Enbrel Product Name: Etanercept Trade Name: Humira Product Name: Adalimumab	NHS Greater Glasgow and Clyde	University of Glasgow	Not Recruiting			Female: yes Male: yes			United Kingdom
No.	TrialID	Date_ enrollment	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	EUCTR2008-005450-20-BE (EUCTR)	29/10/2009	01/10/2009	The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)	The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)	Rheumatoid arthritis MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Remicade (infliximab) INN or Proposed INN: INFLIXIMAB Other descriptive name: remicade Trade Name: Humira (adalimumab) INN or Proposed INN: ADALIMUMAB Trade Name: Enbrel (etanercept) INN or Proposed INN: ETANERCEPT Other descriptive name: Enbrel Trade Name: Mabthera (rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: Mabthera Trade Name: Orencia (abatacept) INN or Proposed INN: ABATACEPT Other descriptive name: Orencia	Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	261		Belgium
102	NCT01075477 (ClinicalTrials.gov)	September 2009	24/2/2010	An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)	Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines	Rheumatoid Arthritis	Drug: rituximab [Mabthera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	151	N/A	Finland;United States
103	EUCTR2008-005525-11-GR (EUCTR)	20/07/2009	17/11/2009	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Greece;Spain;Netherlands;Germany;United Kingdom
104	EUCTR2009-010955-29-NL (EUCTR)	13/07/2009	27/02/2009	Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.	Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.	Pre-clinical RA patients with a high risk on developing the disease.	Trade Name: MabThera 500 mg (10mg/ml) INN or Proposed INN: Rituximab	Division of Clinically Immunology and Rheumatology, AMC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Netherlands
105	EUCTR2008-002381-55-ES (EUCTR)	16/06/2009	01/08/2008	Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR.Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study.	Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR.Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study.	Pacientes con artritis reumatoide (AR) activa refractarios a uno o más fármacos antiTNF (definido por un DAS28>3,2). MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MABTHERA 500 mg concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB	ROCHE FARMA, S.A.	NULL	Not Recruiting			Female: yes Male: yes			Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	EUCTR2008-005525-11-DE (EUCTR)	24/04/2009	09/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81		United Kingdom;Germany;Netherlands;France;Spain
107	EUCTR2008-005525-11-NL (EUCTR)	31/03/2009	12/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81		France;Spain;Germany;Netherlands;United Kingdom
108	NCT00845832 (ClinicalTrials.gov)	March 2009	17/2/2009	A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate	A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate	Rheumatoid Arthritis	Drug: Placebo;Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Terminated	18 Years	65 Years	All	24	Phase 2	France;Germany;Greece;Netherlands;Poland;Spain;Switzerland;United Kingdom;Belgium;Sweden
109	EUCTR2008-005525-11-FR (EUCTR)	06/02/2009	13/03/2009	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Code: RO452294/V02 INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533/F01 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	81		United Kingdom;Germany;Netherlands;France;Spain
110	EUCTR2008-005525-11-ES (EUCTR)	29/01/2009	09/12/2008	Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Artritis reumatoideRheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MABTHERA 500 mg concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	81		United Kingdom;Germany;Netherlands;France;Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	EUCTR2008-005525-11-GB (EUCTR)	29/12/2008	16/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis		F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Greece;Spain;Netherlands;Germany;United Kingdom
112	EUCTR2007-001585-33-DE (EUCTR)	19/08/2008	14/04/2008	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Netherlands;Latvia;Germany
113	EUCTR2007-003647-75-FR (EUCTR)	01/04/2008	07/02/2008	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Finland;United Kingdom;Netherlands;France;Sweden
114	NCT01000610 (ClinicalTrials.gov)	March 17, 2008	21/10/2009	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate	An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: methotrexate;Drug: methylprednisolone	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	18	Phase 4	Tunisia
115	EUCTR2007-003623-20-ES (EUCTR)	12/03/2008	04/02/2008	Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR).Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).	Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR).Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).	Se estudiaran los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: RITUXIMAB	Dr. Juan D. Cañete Crespillo, Hospital Clínic de Barcelona	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Spain
No.	TrialID	Date_ enrollment	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	EUCTR2007-001585-33-GR (EUCTR)	26/02/2008	09/08/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman- La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
117	EUCTR2007-003647-75-NL (EUCTR)	07/02/2008	29/11/2007	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Phase 2	Sweden;France;Finland;United Kingdom;Netherlands
118	EUCTR2007-003647-75-SE (EUCTR)	06/02/2008	04/12/2007	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: MabThera 500 mg (10 mg/ml) concentrate for solution for infusion Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Finland;United Kingdom;Netherlands;France;Sweden
119	EUCTR2007-003647-75-FI (EUCTR)	31/01/2008	19/12/2007	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Trade Name: Mabthera Product Name: Rituximab INN or Proposed INN: rituximab	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	90	Phase 2	Finland;United Kingdom;Netherlands;France;Sweden
120	NCT00576433 (ClinicalTrials.gov)	December 2007	18/12/2007	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.	An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor	Rheumatoid Arthritis	Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	Both	60	Phase 4	Russian Federation
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
121	EUCTR2007-001585-33-ES (EUCTR)	15/11/2007	13/09/2007	Estudio clínico multicéntrico, aleatorizado y controlado con placebo para investigar la eficacia de rituximab (MabThera/Rituxan) en la inhibición del daño estructural articular valorado por resonancia magnética nuclear en pacientes con artritis reumatoide y una respuesta inadecuada al metotrexato - estudio SCORE. - SCORE	Estudio clínico multicéntrico, aleatorizado y controlado con placebo para investigar la eficacia de rituximab (MabThera/Rituxan) en la inhibición del daño estructural articular valorado por resonancia magnética nuclear en pacientes con artritis reumatoide y una respuesta inadecuada al metotrexato - estudio SCORE. - SCORE	Artritis reumatoide (AR)Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
122	EUCTR2007-001585-33-LT (EUCTR)	13/11/2007	05/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	Rheumatoid arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
123	NCT00578305 (ClinicalTrials.gov)	November 2007	19/12/2007	A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate	A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate	Rheumatoid Arthritis	Biological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folate	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	185	Phase 3	Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom
124	EUCTR2007-001585-33-DK (EUCTR)	26/10/2007	12/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
125	NCT00502853 (ClinicalTrials.gov)	October 25, 2007	17/7/2007	A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.	Pilot Study to Evaluate the Effect of Mabthera in Combination With MTX in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	75 Years	All	10	Phase 4	Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
126	EUCTR2007-001585-33-EE (EUCTR)	10/10/2007	18/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
127	EUCTR2007-001585-33-FR (EUCTR)	09/10/2007	23/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180		Germany;Netherlands;Denmark;Estonia;France;Spain;Greece;Latvia;Lithuania
128	NCT00934648 (ClinicalTrials.gov)	October 2007	6/7/2009	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate	An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	15	Phase 4	Morocco
129	EUCTR2007-001585-33-NL (EUCTR)	20/09/2007	09/08/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Latvia;Netherlands
130	EUCTR2007-001585-33-CZ (EUCTR)	22/08/2007	04/09/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the SCORE study. - SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 3	France;Estonia;Czech Republic;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
131	EUCTR2007-001754-11-IT (EUCTR)	03/08/2007	02/07/2007	Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND	Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: Mabthera INN or Proposed INN: Rituximab	ROCHE	NULL	Not Recruiting			Female: yes Male: yes			Italy
132	EUCTR2007-001585-33-LV (EUCTR)	26/07/2007	30/07/2007	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE	Rheumatoid arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: MabThera 500mg INN or Proposed INN: RITUXIMAB	F. Hoffman-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	180		France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia
133	NCT00502840 (ClinicalTrials.gov)	July 23, 2007	17/7/2007	A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.	An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070).	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	75 Years	All	193	Phase 3	Germany
134	NCT00504777 (ClinicalTrials.gov)	July 2007	19/7/2007	A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.	An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	36	Phase 4	Taiwan
135	EUCTR2006-006746-33-DE (EUCTR)	28/06/2007	12/03/2007	Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR	Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR	Rheumatoid arthritis MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	Roche Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	240		Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
136	NCT00462345 (ClinicalTrials.gov)	June 2007	18/4/2007	A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.	An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies	Rheumatoid Arthritis	Drug: rituximab;Drug: Methotrexate;Drug: Corticosteroid or NSAID;Dietary Supplement: Folate	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	40	Phase 4	Korea, Republic of
137	NCT00424502 (ClinicalTrials.gov)	January 2007	18/1/2007	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.	An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	20	Phase 4	Hungary
138	EUCTR2006-005386-19-BE (EUCTR)	19/12/2006	03/11/2006	Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini	Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini	Rheumatoid arthritis refractory to TNF blockers patients MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera	Cliniques Universitaires Saint-Luc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Belgium
139	EUCTR2005-003632-22-ES (EUCTR)	22/11/2006	20/03/2012	A study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with rheumatoid arthritis.	An open-label, exploratory study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with active rheumatoid arthritis	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3		Spain
140	NCT02079532 (ClinicalTrials.gov)	November 2006	4/3/2014	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor	An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent	Rheumatoid Arthritis	Drug: rituximab [MabThera]	Hoffmann-La Roche	NULL	Completed	18 Years	75 Years	All	302	Phase 3	Germany
No.	TrialID	Date_ enrollment	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	EUCTR2006-004673-98-HU (EUCTR)	16/10/2006	08/09/2006	Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker	Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker	To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.	Trade Name: MabThera 500 mg concentrate for solution for infusion	Roche (Hungary) Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20		Hungary
142	EUCTR2005-002396-33-HU (EUCTR)	26/09/2006	07/07/2006	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
143	EUCTR2006-001000-37-DE (EUCTR)	19/09/2006	16/06/2006	Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST	Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST	Rheumatoid arthritis MedDRA version: 8.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	Roche Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	300		Germany
144	EUCTR2005-002396-33-SK (EUCTR)	14/09/2006	15/06/2006	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Finland;United Kingdom;Germany;Slovakia;Spain;Italy
145	NCT01126541 (ClinicalTrials.gov)	September 2006	18/5/2010	SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy	A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)	Rheumatoid Arthritis	Drug: rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	224	Phase 3	France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
146	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
147	NCT01272908 (ClinicalTrials.gov)	July 18, 2006	7/1/2011	A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)	Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)	Rheumatoid Arthritis	Drug: rituximab	Hoffmann-La Roche	NULL	Completed	18 Years	80 Years	All	120	Phase 3	Canada;Sweden
148	EUCTR2006-000854-32-AT (EUCTR)	29/05/2006	19/05/2006	Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers	Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers	Rheumatoid Arthritis	Trade Name: Rituximab - MabThera Product Name: Rituximab MabThera Product Code: no	Vienna Medical University	NULL	Not Recruiting			Female: yes Male: yes	20		Austria
149	EUCTR2005-002396-33-DE (EUCTR)	27/04/2006	10/11/2005	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
150	EUCTR2005-002395-15-DE (EUCTR)	27/04/2006	22/11/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
No.	TrialID	Date_ enrollment	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	EUCTR2005-002392-32-DE (EUCTR)	20/04/2006	29/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500		Slovenia;Ireland;Germany;United Kingdom;Sweden
152	EUCTR2005-002396-33-FI (EUCTR)	06/03/2006	22/12/2005	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab Product Name: Methotrexate Product Code: Methotrexate	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		United Kingdom;Germany;Spain;Italy;Hungary;Finland;Slovakia
153	EUCTR2005-002395-15-CZ (EUCTR)	27/02/2006	27/02/2006	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
154	EUCTR2005-002395-15-SE (EUCTR)	13/02/2006	12/12/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
155	NCT00502996 (ClinicalTrials.gov)	February 2006	17/7/2007	A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.	Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)	Rheumatoid Arthritis	Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	246	Phase 3	Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela
No.	TrialID	Date_ enrollment	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	NCT00422383 (ClinicalTrials.gov)	February 2006	15/1/2007	A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)	A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	378	Phase 3	Australia;Belgium;Brazil;Canada;China;Finland;France;Germany;Hungary;Italy;Netherlands;New Zealand;Slovakia;South Africa;Spain;Taiwan;Thailand;United Kingdom;Switzerland;United States
157	EUCTR2005-002395-15-FI (EUCTR)	09/01/2006	26/10/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab Product Name: Methotrexate Product Code: Methotrexate INN or Proposed INN: methotrexate	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853	Phase 3	Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
158	EUCTR2005-002395-15-DK (EUCTR)	06/01/2006	19/06/2007	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853	Phase 3	Czech Republic;Finland;Belgium;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
159	NCT00422942 (ClinicalTrials.gov)	January 2006	15/1/2007	A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)	An Open-label, Exploratory Study of the Pharmacokinetic and Pharmacodynamic Activity of MabThera in Combination With Methotrexate in Synovial Tissue and in Peripheral Blood of Patients With Active Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate	Hoffmann-La Roche	NULL	Terminated	18 Years	80 Years	All	3	Phase 2	Netherlands;Spain
160	EUCTR2005-002395-15-BE (EUCTR)	29/12/2005	24/11/2005	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Czech Republic;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
161	EUCTR2005-002395-15-ES (EUCTR)	29/12/2005	31/10/2005	Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”	Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”	Artritis reumatoide / Rheumatoid arthritis	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	853		Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
162	EUCTR2005-002396-33-ES (EUCTR)	27/12/2005	28/10/2005	Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Artritis Reumatoide (Rheumatoid arthritis)	Trade Name: MabThera 500 mg Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
163	EUCTR2005-002396-33-BE (EUCTR)	27/12/2005	24/11/2005	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid arthritis	Trade Name: MabThera Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375	Phase 3	Hungary;Slovakia;Finland;Spain;Belgium;Germany;United Kingdom;Italy
164	EUCTR2005-002392-32-GB (EUCTR)	07/12/2005	15/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Slovenia;Ireland;Germany;United Kingdom;Sweden
165	EUCTR2005-002395-15-IT (EUCTR)	02/12/2005	02/03/2006	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.	Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: METHOTREXATE 100CPR 2,5MG INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE 25CPR 2,5MG INN or Proposed INN: Methotrexate Trade Name: MabThera INN or Proposed INN: Rituximab	F. Hoffmann - La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	750	Phase 3	Finland;Spain;Czech Republic;Denmark;Germany;United Kingdom;Italy;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
166	EUCTR2005-002396-33-IT (EUCTR)	30/11/2005	01/03/2006	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Mabthera INN or Proposed INN: Rituximab	F. Hoffmann- La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	375		Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy
167	EUCTR2005-002392-32-IE (EUCTR)	23/11/2005	13/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis		F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Slovenia;Ireland;Germany;United Kingdom;Sweden
168	EUCTR2005-002392-32-SE (EUCTR)	12/10/2005	19/09/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500		Slovenia;Ireland;Germany;United Kingdom;Sweden
169	EUCTR2005-002392-32-SI (EUCTR)	11/10/2005	26/10/2005	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.	Active rheumatoid arthritis	Product Name: MabThera Product Code: Ro 45-2294 INN or Proposed INN: Rituximab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	500		Slovenia;Ireland;Germany;United Kingdom;Sweden
170	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
171	NCT02097745 (ClinicalTrials.gov)	June 2004	20/3/2014	A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies	An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies	Rheumatoid Arthritis	Drug: methotrexate;Drug: rituximab [MabThera/Rituxan]	Hoffmann-La Roche	Biogen	Completed	18 Years	80 Years	All	341	Phase 3	United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom
172	NCT00468377 (ClinicalTrials.gov)	March 2004	30/4/2007	Safety and Efficacy Study of Re-treatment With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Respond Poorly to Anti-TNFa Therapies	An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies	Arthritis, Rheumatoid	Drug: Rituximab	Hoffmann-La Roche	Genentech, Inc.	Active, not recruiting	18 Years	80 Years	Both	341	Phase 3	United States
173	NCT00074438 (ClinicalTrials.gov)	June 2003	12/12/2003	Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis	Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placebo	Genentech, Inc.	Roche Pharma AG	Completed	18 Years	80 Years	Both	465	Phase 2	United States
174	NCT00468546 (ClinicalTrials.gov)	May 2003	30/4/2007	A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy	A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies	Rheumatoid Arthritis	Drug: MabThera /Rituxan;Drug: Methotrexate;Other: Placebo	Hoffmann-La Roche	Biogen	Completed	18 Years	80 Years	All	520	Phase 3	United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom
175	NCT02093026 (ClinicalTrials.gov)	August 2002	19/3/2014	Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)	An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic Acid	Hoffmann-La Roche	Genentech, Inc.	Completed	21 Years	N/A	All	465	Phase 2	United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
176	NCT02693210 (ClinicalTrials.gov)	February 2001	23/2/2016	A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis	A Randomised, Double Dummy Controlled, Parallel Group Study of the Efficacy and Safety of MabThera (Rituximab) Alone or in Combination With Either Cyclophosphamide or Methotrexate, in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Cyclophosphamide;Drug: Methotrexate;Other: Placebo Cyclophosphamide;Other: Placebo Methotrexate;Other: Placebo Rituximab;Drug: Rituximab	Hoffmann-La Roche	NULL	Completed	21 Years	N/A	Both	161	Phase 2	Australia;Belgium;Canada;Czech Republic;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
177	EUCTR2011-002896-40-ES (EUCTR)		26/06/2012	A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis	A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES	RHEUMATOID ARTHRITIS MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: PF-05280586 INN or Proposed INN: Not Applicable Other descriptive name: Not Applicable Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable Trade Name: Rituxan ® INN or Proposed INN: RITUXIMAB Other descriptive name: Not Applicable	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	195	Phase 2	United States;Taiwan;Spain;Korea, Democratic People's Republic of;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany
178	EUCTR2015-002156-27-AT (EUCTR)		30/09/2015	Reduced-dose Rituximab in rheumatoid arthritis patients in remission – theREDOREM study	Prospective controlled study of reduced-dose Rituximab in rheumatoidarthritis patients in low disease activity and remission – the REDOREMstudy	rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera INN or Proposed INN: RITUXIMAB	Medical University of Vienna	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-002507-19-NL
(EUCTR)

07/09/2020

03/09/2020

Research into administration of lower dosed rituximab with an injection

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

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

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

Sint Maartenskliniek

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

EUCTR2019-002810-37-PL
(EUCTR)

16/06/2020

11/03/2020

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

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

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

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

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

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

EUCTR2019-002810-37-BG
(EUCTR)

15/06/2020

28/04/2020

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

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

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

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

EUCTR2019-002810-37-LT
(EUCTR)

17/04/2020

03/03/2020

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

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

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

NCT04268771
(ClinicalTrials.gov)

April 8, 2020

31/1/2020

A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products

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

Rheumatoid Arthritis

Biological: Experimental: Arm A: DRL_RI;Biological: Arm B: Rituxan®/Mabthera®

Dr. Reddy's Laboratories Limited

PPD

Recruiting

18 Years

N/A

All

140

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002810-37-HU
(EUCTR)

09/03/2020

20/01/2020

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

Dr. Reddy’s Laboratories S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

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

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

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

EUCTR2013-005543-90-EE
(EUCTR)

07/08/2017

02/06/2017

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

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

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

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

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

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

EUCTR2014-005368-13-IT
(EUCTR)

10/05/2017

16/02/2018

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

A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA). - A Study Comparing SAIT101 to MabThera® or Rituxan® in Patients with Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

ARCHIGEN BIOTECH LIMITED

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03161457
(ClinicalTrials.gov)

February 27, 2017

21/4/2017

A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis

A Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Efficacy of JHL1101 Versus EU-sourced MabThera® in Anti TNF Inadequate Responder Patients With Moderate to Severe Rheumatoid Arthritis (RA) on Background Methotrexate (MTX) Therapy

Rheumatoid Arthritis;Arthritis, Rheumatoid

Biological: JHL1101;Biological: MabThera

JHL Biotech, Inc.

NULL

Terminated

18 Years

80 Years

All

153

Phase 1

Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;Lithuania;Poland;Russian Federation;Taiwan;Ukraine;United Kingdom

EUCTR2014-005368-13-DE
(EUCTR)

22/11/2016

04/07/2016

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

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

Archigen Biotech Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

282

Phase 1;Phase 3

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

NCT03061838
(ClinicalTrials.gov)

October 27, 2016

20/2/2017

Safety, Tolerability, PK and PD of Biosimilar Drug Ritumax® Compared to Original Drug MabThera®

Multicenter Double-blind Randomized Clinical Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Biosimilar Drug Ritumax® Compared to Original Drug MabThera® in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: MabThera ®;Drug: Ritumax®

Biointegrator LLC

NULL

Terminated

18 Years

N/A

All

Phase 1

Russian Federation

NCT02819726
(ClinicalTrials.gov)

October 11, 2016

20/6/2016

PK, PD, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 Versus MabThera® Versus Rituxan® in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Biological: SAIT101;Biological: MabThera;Biological: Rituxan

Archigen Biotech Limited

NULL

Completed

18 Years

80 Years

All

294

Phase 1

United States;Bosnia and Herzegovina;Bulgaria;Czechia;Germany;Hungary;India;Korea, Republic of;Mexico;Poland;Spain

EUCTR2014-005368-13-ES
(EUCTR)

23/09/2016

15/07/2016

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

Severe Rheumatoid Arthritis (RA)
MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-005368-13-HU
(EUCTR)

19/09/2016

11/07/2016

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

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

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

EUCTR2014-005368-13-CZ
(EUCTR)

13/09/2016

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

Archigen Biotech Limited

NULL

Not Recruiting

Female: yes
Male: yes

282

Phase 1;Phase 3

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

EUCTR2012-002535-28-NL
(EUCTR)

13/09/2016

01/09/2016

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

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

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

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

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

144

Phase 4

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

EUCTR2012-003876-38-PL
(EUCTR)

10/11/2015

16/11/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

A randomized, double- blind, controlled, parallel-group, multicenter study to assess the safety and immunogenicity of transitioning to GP2013 or re-treatment with Rituxan® or MabThera® in patients with active rheumatoid arthritis, previously treated with Rituxan® or MabThera® - ASSIST-RT

Rheumatoid Arthritis
MedDRA version: 19.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
Product Name: MabThera ®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

EUCTR2015-000581-58-CZ
(EUCTR)

14/10/2015

16/06/2015

A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action

A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio

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

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
INN or Proposed INN: tocilizumabum
Other descriptive name: TOCILIZUMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB

Revmatologicky ustav Praha

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-003876-38-HU
(EUCTR)

28/07/2015

22/05/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

Rheumatoid Arthritis
MedDRA version: 18.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
Product Name: MabThera ®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

EUCTR2012-002535-28-ES
(EUCTR)

22/07/2015

10/07/2015

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

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

Rheumatoid Arthritis
MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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

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

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 4

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

EUCTR2012-003876-38-DE
(EUCTR)

21/07/2015

29/04/2015

Clinical study to find out if the biologically similar medicine GP2013 is safe in patients with rheumatoid arthritis who have been treated with Rituxan® or MabThera® in the past

Rheumatoid Arthritis
MedDRA version: 19.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GP2013
Product Code: GP2013
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
Product Name: MabThera ®
INN or Proposed INN: RITUXIMAB

Hexal AG (a Sandoz company)

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

United States;Hungary;Poland;Germany

EUCTR2015-000833-64-FR
(EUCTR)

17/07/2015

02/07/2015

N/A

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

Trade Name: ORENCIA
Trade Name: MABTHERA
Trade Name: ROACTEMRA

CHU Amiens-Picardie

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 4

France

NCT02514772
(ClinicalTrials.gov)

July 2015

30/7/2015

GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

Rheumatoid Arthritis

Biological: GP2013 - A Proposed biosimilar rituximab;Biological: Originator rituximab - Rituxan ® or MabThera ®

Sandoz

Hexal AG

Completed

18 Years

N/A

All

107

Phase 3

United States;Germany;Hungary;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-003255-54-CZ
(EUCTR)

21/01/2015

24/10/2014

A study evaluating the effects of RGB-03 and MabThera combined with Methotrexate in patients with Rheumatoid Arthritis

A Double-blind, Randomised, Comparative Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Evaluation of RGB-03 and MabThera® Combined with Methotrexate in Rheumatoid Arthritis Patients

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

Product Name: RGB-03
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
INN or Proposed INN: RITUXIMAB

Gedeon Richter Plc

NULL

Not Recruiting

Female: yes
Male: yes

142

Phase 1;Phase 3

Hungary;Estonia;Czech Republic;Poland;Belgium;Spain;Ukraine;Romania;Austria;Russian Federation;Israel;Germany

EUCTR2012-002535-28-IT
(EUCTR)

16/01/2015

04/11/2014

Not applicable

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

Rheumatoid Arthritis
MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Portugal;Belgium;United Kingdom;Italy

EUCTR2013-005543-90-BG
(EUCTR)

06/01/2015

22/10/2014

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

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

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

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

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

NCT02371096
(ClinicalTrials.gov)

January 2015

5/2/2015

Comparative Pharmacokinetic Trial of RGB-03 and MabThera

Rheumatoid Arthritis

Drug: MabThera (rituximab);Drug: RGB-03

Gedeon Richter Plc.

NULL

Not yet recruiting

18 Years

75 Years

Both

Phase 1

NULL

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-005543-90-DE
(EUCTR)

19/11/2014

16/06/2014

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

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

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

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

NCT02296775
(ClinicalTrials.gov)

November 2014

18/11/2014

Comparative Pharmacokinetic, Pharmacodynamic, Safety and Efficacy Study of Three Anti-CD20 Monoclonal Antibodies in Patients With Moderate to Severe Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: DRL_RI;Biological: Rituxan;Biological: MabThera

Dr. Reddy's Laboratories Limited

NULL

Completed

18 Years

65 Years

All

276

Phase 1;Phase 2

India;Ukraine

EUCTR2014-000859-91-FR
(EUCTR)

03/10/2014

18/06/2015

Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde.

Relation entre la déplétion des LYmphocytes T et la réponse clinique au RITUximab dans la polyarthrite rhumatoïde. - LYRITUX

Cette étude portera donc sur une population de patients atteints de polyarthrite rhumatoïde (PR) actives et ayant présenté un échec ou une contre-indication à au moins un anti-TNFa, et n’ayant jamais reçu de rituximab.
MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MABTHERA
INN or Proposed INN: RITUXIMAB

CHRU de TOURS

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 4

France

EUCTR2013-004555-21-GR
(EUCTR)

22/09/2014

21/03/2014

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

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

Rheumatoid Arthritis
MedDRA version: 16.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: CT- P10
Product Code: CT- P10
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera
Product Name: MabThera
Product Code: L01XC02
INN or Proposed INN: RITUXIMAB
Trade Name: Rituxan
Product Name: Rituxan
INN or Proposed INN: RITUXIMAB

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

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

EUCTR2013-005543-90-PL
(EUCTR)

09/09/2014

11/07/2014

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-005543-90-HU
(EUCTR)

26/08/2014

13/05/2014

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

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 1;Phase 3

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

NCT02149121
(ClinicalTrials.gov)

August 2014

23/5/2014

PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis

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

Rheumatoid Arthritis

Biological: CT-P10;Drug: Rituxan;Drug: MabThera

Celltrion

NULL

Completed

18 Years

75 Years

All

384

Phase 3

Austria;Korea, Republic of

EUCTR2012-002535-28-PT
(EUCTR)

06/06/2014

25/02/2014

Not applicable

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

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

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

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 4

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

EUCTR2013-004555-21-AT
(EUCTR)

07/04/2014

02/01/2014

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

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

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

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

EUCTR2013-004555-21-SK
(EUCTR)

07/04/2014

23/01/2014

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

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

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-004555-21-HU
(EUCTR)

02/04/2014

23/01/2014

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

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

Rheumatoid Arthritis
MedDRA version: 18.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

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

EUCTR2013-004555-21-DE
(EUCTR)

31/03/2014

17/01/2014

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

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

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

CELLTRION, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

361

Phase 3

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

EUCTR2013-004555-21-PT
(EUCTR)

24/03/2014

07/01/2014

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

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

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

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

EUCTR2012-003194-25-HR
(EUCTR)

17/03/2014

03/09/2014

Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

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

Mabion S.A.

NULL

Not Recruiting

Female: yes
Male: yes

863

Phase 3

Serbia;Poland;Ukraine;Romania;Lithuania;Croatia;Russian Federation;Georgia

EUCTR2013-004555-21-LV
(EUCTR)

03/03/2014

02/01/2014

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

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

CELLTRION, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

361

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-003223-38-DE
(EUCTR)

01/07/2013

08/04/2013

Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04

RHEUMATOID ARTHRITIS
MedDRA version: 17.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Rituximab -Pfizer
Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

157

Phase 2

United States;Taiwan;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

NCT01873443
(ClinicalTrials.gov)

May 2013

22/5/2013

Long-Term Efficacy and Safety of CT-P10 in Patients With RA

An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1

Rheumatoid Arthritis

Drug: Rituximab , MTX, folic acid

Celltrion

NULL

Completed

18 Years

75 Years

Both

Phase 1

Korea, Republic of

NCT02468791
(ClinicalTrials.gov)

May 2013

9/6/2015

MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (Rituximab, Roche) in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rituximab

Mabion SA

NULL

Completed

18 Years

80 Years

All

709

Phase 3

Bosnia and Herzegovina;Georgia;Poland;Serbia;Ukraine

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

EUCTR2011-002896-40-PL
(EUCTR)

29/03/2013

11/02/2013

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES - REFLECTIONS B328-01

RHEUMATOID ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-003223-38-ES
(EUCTR)

27/02/2013

04/03/2013

Rheumatoid arthritis extension trial for subjects who have participated in other PF-05280586 trials.

EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS - REFLECTIONS B328-04

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

NULL

Not Recruiting

Female: yes
Male: yes

157

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;South Africa;Germany

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

EUCTR2012-003194-25-LT
(EUCTR)

04/02/2013

24/09/2012

Bioequivalence trial of MabionCD20® (Mabion SA) compared to reference product: MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

Randomized, Double-blind, Parallel-group Comparative Bioequivalence Trial of MabionCD20® (Mabion SA) Compared to MabThera® (rituximab, Roche) in Patients with Rheumatoid Arthritis

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

Product Name: MabionCD20
INN or Proposed INN: Rituximab
Trade Name: MabThera
Product Name: MabThera
INN or Proposed INN: RITUXIMAB

Mabion S.A.

NULL

Not Recruiting

Female: yes
Male: yes

863

Serbia;Poland;Ukraine;Croatia;Romania;Lithuania;Russian Federation;Georgia

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

EUCTR2012-002535-28-GB
(EUCTR)

21/01/2013

14/12/2012

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

Trade Name: MabThera
Product Name: MabThera
Trade Name: RoActemra
Product Name: RoActemra

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

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 4

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

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

EUCTR2011-002896-40-DE
(EUCTR)

23/10/2012

02/07/2012

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

RHEUMATOID ARTHRITIS
MedDRA version: 16.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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

NULL

Not Recruiting

Female: yes
Male: yes

195

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

NCT01682512
(ClinicalTrials.gov)

September 5, 2012

10/8/2012

Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis

Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial.

Arthritis, Rheumatoid

Drug: BI 695500;Drug: Rituxan ®;Drug: MabThera ®

Boehringer Ingelheim

NULL

Terminated

18 Years

80 Years

All

294

Phase 3

United States;Argentina;Belgium;Bulgaria;Canada;Chile;Germany;Greece;Hungary;Ireland;Mexico;Netherlands;Poland;Portugal;Spain;Ukraine;United Kingdom;Brazil;Estonia;France;Guatemala;Italy;New Zealand;Norway;Peru;Russian Federation;Serbia;South Africa;Sweden

EUCTR2011-002894-48-BE
(EUCTR)

02/08/2012

18/07/2012

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

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

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

459

Phase 1;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-005021-48-NL
(EUCTR)

07/06/2012

05/06/2012

A study to investigate and compare the efficacy, safety, tolerability and pharmacodynamic (biochemical and physiological effects of the drug) of TL011 and MabThera® (rituximab) in patients with severe, active rheumatoid arthritis treated with methotrexate (MTX)

A multicenter, double-blind, randomized, active controlled, parallel-group study to evaluate the efficacy, safety, tolerability and pharmacodynamic profiles of TL011 infusions compared with MabThera® (rituximab) in subjects with severe, active rheumatoid arthritis treated with methotrexate (MTX) - ALTO

adult patients with severe, active rheumatoid arthritis patients treated with methotrexate (MTX)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland

EUCTR2011-005021-48-CZ
(EUCTR)

23/05/2012

15/02/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands

EUCTR2011-005021-48-ES
(EUCTR)

14/05/2012

21/02/2012

A study to investigate and compare the efficacy, safety, tolerability andpharmacodynamic (biochemical and physiological effects of the drug) ofTL011 and MabThera® (rituximab) in patients with severe, activerheumatoid arthritis treated with methotrexate (MTX)

A multicenter, double-blind, randomized, active controlled, parallelgroupstudy to evaluate the efficacy, safety, tolerability andpharmacodynamic profiles of TL011 infusions compared with MabThera®(rituximab) in subjects with severe, active rheumatoid arthritis treatedwith methotrexate (MTX) - ALTO

Sujetos adultos con artritis reumatoide (AR) activa de grado severo tratados con MTX
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg Concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland

EUCTR2012-000139-21-AT
(EUCTR)

14/05/2012

23/04/2012

Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action

A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio

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

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Other descriptive name: TOCILIZUMAB
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Orencia
Product Name: Orencia
INN or Proposed INN: ABATACEPT
Trade Name: Ro-Actemra
Product Name: Ro Actemra
Other descriptive name: TOCILIZUMAB

Medizinische Universität Wien, Universitätsklinik für Innere Medizin III

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Czech Republic;Slovakia;Austria;Russian Federation;Switzerland

EUCTR2011-005021-48-BG
(EUCTR)

09/05/2012

20/04/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Serbia;Spain;Ukraine;Russian Federation;Czech Republic;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Romania;Bulgaria;Georgia;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-005021-48-HU
(EUCTR)

04/05/2012

15/02/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Macedonia, the former Yugoslav Republic of;Poland

NCT01638715
(ClinicalTrials.gov)

May 2012

3/7/2012

A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action

Rheumatoid Arthritis

Drug: Remicade;Drug: Orencia;Drug: Ro-Actemra;Drug: Mabthera

Medical University of Vienna

NULL

Completed

18 Years

75 Years

All

115

Phase 4

Austria;Czechia;Russian Federation;Switzerland;Czech Republic;Saudi Arabia

EUCTR2011-005021-48-PL
(EUCTR)

10/04/2012

14/03/2012

Product Name: TL011
Product Code: TL011
INN or Proposed INN: TL011
Trade Name: MabThera ®, 100 mg concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB

Teva Pharmaceutical Industries

NULL

Not Recruiting

Female: yes
Male: yes

544

Hungary;Germany;Netherlands;Bulgaria;Czech Republic;Russian Federation;Serbia;Ukraine;Georgia;Romania;Spain;Poland;Macedonia, the former Yugoslav Republic of

EUCTR2011-004171-36-ES
(EUCTR)

30/03/2012

30/01/2012

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

A Randomized, Double-blind, Parallel Group, Multicenter Trial to Compare the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

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

Product Name: SAIT101
Product Code: SAIT101
INN or Proposed INN: RITUXIMAB
Other descriptive name: Chimeric human/mouse anti-CD-20 monoclonal antibody
Trade Name: MabThera ®
Product Name: MabThera ®
INN or Proposed INN: RITUXIMAB

Samsung Electronics Co. Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

616

Taiwan;Spain;Turkey;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Korea, Republic of

EUCTR2011-004171-36-PL
(EUCTR)

29/03/2012

22/02/2012

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

NCT01526057
(ClinicalTrials.gov)

March 20, 2012

1/2/2012

A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)

Rheumatoid Arthritis

Biological: PF-05280586;Biological: MabThera;Biological: Rituxan

Pfizer

NULL

Completed

18 Years

N/A

All

220

Phase 2

United States;Australia;Canada;Colombia;Germany;Israel;Mexico;Russian Federation;South Africa;United Kingdom;Taiwan

EUCTR2011-006001-10-IT
(EUCTR)

19/03/2012

14/03/2012

Efficacy of rituximab at the dose of 500 mg e.v., two infusions two weeks apart, versus rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis, who had been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response

Rheumatoid arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MABTHERA *EV 1FL 50ML 500MG
INN or Proposed INN: RITUXIMAB
Other descriptive name: NA
Trade Name: MABTHERA *EV 1FL 50ML 500MG
INN or Proposed INN: RITUXIMAB
Other descriptive name: NA

A.O. UNIVERSITARIA INTEGRATA DI VERONA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

EUCTR2011-004171-36-GB
(EUCTR)

24/02/2012

15/12/2011

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

EUCTR2011-004171-36-HU
(EUCTR)

23/02/2012

16/12/2011

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Samsung Electronics Co. Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;United Kingdom;Russian Federation;Czech Republic;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-004171-36-CZ
(EUCTR)

15/02/2012

30/11/2011

A study comparing SAIT101 to MabThera® in Subjects with Severe Rheumatoid Arthritis (RA)

Severe Rheumatoid Arthritis (RA)
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Samsung Electronics Co. Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

616

Hungary;Switzerland;Turkey;South Africa;Brazil;Czech Republic;Russian Federation;United Kingdom;Canada;Taiwan;Argentina;Mexico;Romania;Korea, Republic of;Spain;Poland

NCT01613027
(ClinicalTrials.gov)

February 2012

25/5/2012

An Observational Study of MabThera in Participants With Severe Active Rheumatoid Arthritis

A Multicenter Observational Study of the Response to Rituximab (MabThera®) in Seropositive Patients With Rheumatoid Arthritis With Inadequate Response or Intolerance to Treatment With One or More Tumor Necrosis Factor Inhibitors (TNFi)

Rheumatoid Arthritis

Biological: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

135

N/A

Greece

NCT01534884
(ClinicalTrials.gov)

February 2012

8/2/2012

Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Biological: rituximab

Celltrion

NULL

Completed

18 Years

75 Years

Both

154

Phase 1

Korea, Republic of

NCT01592292
(ClinicalTrials.gov)

November 2011

11/4/2012

An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent

Rheumatoid Arthritis

Drug: Rituximab;Drug: Adalimumab;Drug: Etanercept;Drug: Infliximab

Hoffmann-La Roche

NULL

Completed

20 Years

N/A

All

N/A

Korea, Republic of

NCT01641952
(ClinicalTrials.gov)

October 2011

13/7/2012

An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent

Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program

Rheumatoid Arthritis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

505

N/A

Romania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

NCT01390441
(ClinicalTrials.gov)

July 2011

7/7/2011

A Study of the Pharmacokinetics and Safety of MK-8808 (MK-8808-002)

A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed Rituxan® in Patients With Rheumatoid Arthritis (RA)

Rheumatoid Arthritis

Biological: MK-8808;Biological: MabThera ® (rituximab);Drug: Methotrexate;Biological: Rituxan® (rituximab);Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Loratadine

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

65 Years

All

100

Phase 1

Belarus;Bulgaria;Colombia;Georgia;Hungary;Italy;Philippines;Poland;Russian Federation;Singapore;Spain;Ukraine;United Kingdom;United States

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

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

EUCTR2010-020499-50-GB
(EUCTR)

07/02/2011

31/12/2010

Changes in bone density and bone turnover in patients with rheumatoid arthritis treated with rituximab, a B cell depleting monoclonal antibody.An investigator-led, industry supported, multicentre, open-label, single treatment arm, prospective clinical trial. - Effects of B cell depletion on bone turnover in rheumatoid arthritis.

rheumatoid arthritis
MedDRA version: 13;Level: PT;Classification code 10039073;Term: rheumatoid arthritis

Trade Name: MabThera
Product Name: rituximab

South Tees Hospitals NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

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

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

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

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

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

NCT01117129
(ClinicalTrials.gov)

April 2010

4/5/2010

A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)

Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: placebo;Drug: methotrexate;Drug: rituximab [Mabthera/Rituxan]

Hoffmann-La Roche

NULL

Terminated

18 Years

75 Years

Both

Phase 4

Spain

NCT01123070
(ClinicalTrials.gov)

February 2010

11/5/2010

TL011 in Severe, Active Rheumatoid Arthritis Patients

Rheumatoid Arthritis

Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis;Biological: MabThera infusions

Teva Pharmaceutical Industries

NULL

Completed

18 Years

80 Years

Both

Phase 1;Phase 2

Czech Republic;Hungary;Italy;Spain;United Kingdom;Germany

NCT01071798
(ClinicalTrials.gov)

January 2010

18/2/2010

An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis

A Prospective, Multi-center, Non-interventional Observational Study to Evaluate the Safety and Effectiveness of MabThera® (Rituximab) Within the First 6 Months (in Case of Re-therapy the First 12 Months) of Treatment in Patients With Severe Active Rheumatoid Arthritis in Routine Care

Rheumatoid Arthritis

Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

1653

N/A

Germany;United States

100

EUCTR2009-011268-13-GB
(EUCTR)

31/12/2009

15/03/2010

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

Rheumatoid Arthritis
MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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

NHS Greater Glasgow and Clyde

University of Glasgow

Not Recruiting

Female: yes
Male: yes

United Kingdom

No.

TrialID

Date_
enrollment

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

EUCTR2008-005450-20-BE
(EUCTR)

29/10/2009

01/10/2009

The cost-effectiveness of abatacept, rituximab or anti-TNF alpha for patients with rheumatoid artritis. - Dutch Rheumatoid Arthritis Monitoring (DREAM) Targetted Immune Modulator Evaluation (TIME)

Rheumatoid arthritis
MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Remicade (infliximab)
INN or Proposed INN: INFLIXIMAB
Other descriptive name: remicade
Trade Name: Humira (adalimumab)
INN or Proposed INN: ADALIMUMAB
Trade Name: Enbrel (etanercept)
INN or Proposed INN: ETANERCEPT
Other descriptive name: Enbrel
Trade Name: Mabthera (rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: Mabthera
Trade Name: Orencia (abatacept)
INN or Proposed INN: ABATACEPT
Other descriptive name: Orencia

Radboud University Nijmegen Medical Centre, department of Rheumatic Diseases

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

261

Belgium

102

NCT01075477
(ClinicalTrials.gov)

September 2009

24/2/2010

An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)

Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines

Rheumatoid Arthritis

Drug: rituximab [Mabthera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

Both

151

N/A

Finland;United States

103

EUCTR2008-005525-11-GR
(EUCTR)

20/07/2009

17/11/2009

A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

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

Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Greece;Spain;Netherlands;Germany;United Kingdom

104

EUCTR2009-010955-29-NL
(EUCTR)

13/07/2009

27/02/2009

Prevention of clinically manifest rheumatoid arthritis by B cell directed therapy in the earliest phase of the disease.

Pre-clinical RA patients with a high risk on developing the disease.

Trade Name: MabThera 500 mg (10mg/ml)
INN or Proposed INN: Rituximab

Division of Clinically Immunology and Rheumatology, AMC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

105

EUCTR2008-002381-55-ES
(EUCTR)

16/06/2009

01/08/2008

Evaluación de la Eficacia de Rituximab en pacientes con Artritis Reumatoide a través de la medición, por Resonancia Magnética de Mano, de los parámetros clínicos de la enfermedad. Estudio RESONAR.Efficacy of rituximab in patients with Rheumatoid Arthritis, by measurement of disease parameters through magnetic resonance of the hand. RESONAR study.

Pacientes con artritis reumatoide (AR) activa refractarios a uno o más fármacos antiTNF (definido por un DAS28>3,2).
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MABTHERA 500 mg concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB

ROCHE FARMA, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

EUCTR2008-005525-11-DE
(EUCTR)

24/04/2009

09/12/2008

A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

Rheumatoid Arthritis
MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;France;Spain

107

EUCTR2008-005525-11-NL
(EUCTR)

31/03/2009

12/12/2008

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

Trade Name: MabThera 500mg
Product Name: rituximab
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

France;Spain;Germany;Netherlands;United Kingdom

108

NCT00845832
(ClinicalTrials.gov)

March 2009

17/2/2009

A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate

A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate

Rheumatoid Arthritis

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

Hoffmann-La Roche

NULL

Terminated

18 Years

65 Years

All

Phase 2

France;Germany;Greece;Netherlands;Poland;Spain;Switzerland;United Kingdom;Belgium;Sweden

109

EUCTR2008-005525-11-FR
(EUCTR)

06/02/2009

13/03/2009

A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

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

Trade Name: MabThera
Product Code: RO452294/V02
INN or Proposed INN: Rituximab
Product Name: tocilizumab
Product Code: RO4877533/F01
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;France;Spain

110

EUCTR2008-005525-11-ES
(EUCTR)

29/01/2009

09/12/2008

Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

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

Trade Name: MABTHERA 500 mg concentrado para solución para perfusión
INN or Proposed INN: RITUXIMAB
Other descriptive name: RITUXIMAB
Product Name: tocilizumab
Product Code: RO4877533
INN or Proposed INN: tocilizumab

F Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;France;Spain

No.

TrialID

Date_
enrollment

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

EUCTR2008-005525-11-GB
(EUCTR)

29/12/2008

16/12/2008

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

F Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Greece;Spain;Netherlands;Germany;United Kingdom

112

EUCTR2007-001585-33-DE
(EUCTR)

19/08/2008

14/04/2008

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera/Rituxan) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - RA-SCORE

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

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Netherlands;Latvia;Germany

113

EUCTR2007-003647-75-FR
(EUCTR)

01/04/2008

07/02/2008

A randomised, double-blind, placebo controlled, multi-centre, exploratory, pilot, phase II trial of 150 mg atacicept given subcutaneously in combination with rituximab in subjects with rheumatoid arthritis. - Atacicept in combination with rituximab in subjects with rheumatoid arthritis

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

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Netherlands;France;Sweden

114

NCT01000610
(ClinicalTrials.gov)

March 17, 2008

21/10/2009

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate

Rheumatoid Arthritis

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

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Tunisia

115

EUCTR2007-003623-20-ES
(EUCTR)

12/03/2008

04/02/2008

Estudio de los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide (Estudio TESICE-AR).Study of the B-cell-targeted therapy (rituximab) effects on the synovial tissue inmunopathology and peripheral blood B cells in rheumatoid arthritis (TESICE-AR study).

Se estudiaran los efectos de la terapia anti-célula B (rituximab) sobre la inmunopatología del tejido sinovial y las células B de sangre periférica en artritis reumatoide.
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: RITUXIMAB

Dr. Juan D. Cañete Crespillo, Hospital Clínic de Barcelona

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

No.

TrialID

Date_
enrollment

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

EUCTR2007-001585-33-GR
(EUCTR)

26/02/2008

09/08/2007

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

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman- La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

117

EUCTR2007-003647-75-NL
(EUCTR)

07/02/2008

29/11/2007

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

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Sweden;France;Finland;United Kingdom;Netherlands

118

EUCTR2007-003647-75-SE
(EUCTR)

06/02/2008

04/12/2007

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

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: MabThera 500 mg (10 mg/ml) concentrate for solution for infusion
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Netherlands;France;Sweden

119

EUCTR2007-003647-75-FI
(EUCTR)

31/01/2008

19/12/2007

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

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Trade Name: Mabthera
Product Name: Rituximab
INN or Proposed INN: rituximab

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Finland;United Kingdom;Netherlands;France;Sweden

120

NCT00576433
(ClinicalTrials.gov)

December 2007

18/12/2007

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor

Rheumatoid Arthritis

Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

Both

Phase 4

Russian Federation

No.

TrialID

Date_
enrollment

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

EUCTR2007-001585-33-ES
(EUCTR)

15/11/2007

13/09/2007

Estudio clínico multicéntrico, aleatorizado y controlado con placebo para investigar la eficacia de rituximab (MabThera/Rituxan) en la inhibición del daño estructural articular valorado por resonancia magnética nuclear en pacientes con artritis reumatoide y una respuesta inadecuada al metotrexato - estudio SCORE. - SCORE

Artritis reumatoide (AR)Rheumatoid arthritis (RA)
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

122

EUCTR2007-001585-33-LT
(EUCTR)

13/11/2007

05/07/2007

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis and inadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE

Rheumatoid arthritis (RA)
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

123

NCT00578305
(ClinicalTrials.gov)

November 2007

19/12/2007

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

A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Biological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folate

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

185

Phase 3

Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom

124

EUCTR2007-001585-33-DK
(EUCTR)

26/10/2007

12/07/2007

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

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

125

NCT00502853
(ClinicalTrials.gov)

October 25, 2007

17/7/2007

A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.

Pilot Study to Evaluate the Effect of Mabthera in Combination With MTX in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

All

Phase 4

Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

126

EUCTR2007-001585-33-EE
(EUCTR)

10/10/2007

18/07/2007

A randomized, placebo controlled, multicenter clinical study investigating efficacy of rituximab (MabThera®/Rituxan®) in the inhibition of joint structural damage assessed by magnetic resonance imaging in patients with rheumatoid arthritis andinadequate response to methotrexate - the R.A. SCORE study. - R.A. SCORE

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

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

127

EUCTR2007-001585-33-FR
(EUCTR)

09/10/2007

23/07/2007

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

Trade Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Germany;Netherlands;Denmark;Estonia;France;Spain;Greece;Latvia;Lithuania

128

NCT00934648
(ClinicalTrials.gov)

October 2007

6/7/2009

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate

Rheumatoid Arthritis

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

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Morocco

129

EUCTR2007-001585-33-NL
(EUCTR)

20/09/2007

09/08/2007

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

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Latvia;Netherlands

130

EUCTR2007-001585-33-CZ
(EUCTR)

22/08/2007

04/09/2007

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

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 3

France;Estonia;Czech Republic;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

131

EUCTR2007-001754-11-IT
(EUCTR)

03/08/2007

02/07/2007

Pilot study to evaluate the effect of Rituximab in combination with MTX in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis. - ND

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

Trade Name: Mabthera
INN or Proposed INN: Rituximab

ROCHE

NULL

Not Recruiting

Female: yes
Male: yes

Italy

132

EUCTR2007-001585-33-LV
(EUCTR)

26/07/2007

30/07/2007

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

Trade Name: MabThera 500mg
Product Name: MabThera 500mg
INN or Proposed INN: RITUXIMAB

F. Hoffman-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

180

France;Estonia;Greece;Spain;Lithuania;Denmark;Germany;Netherlands;Latvia

133

NCT00502840
(ClinicalTrials.gov)

July 23, 2007

17/7/2007

A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.

An Open Label Study to Evaluate the Safety of Re-treatment With MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent (Extension Study to ML19070).

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

All

193

Phase 3

Germany

134

NCT00504777
(ClinicalTrials.gov)

July 2007

19/7/2007

A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Agents.

An Open Label Study to Evaluate the Safety, and Effect on Treatment Response, of MabThera in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One or More Anti-TNF Agents.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Taiwan

135

EUCTR2006-006746-33-DE
(EUCTR)

28/06/2007

12/03/2007

Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR

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

Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

Roche Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

240

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

136

NCT00462345
(ClinicalTrials.gov)

June 2007

18/4/2007

A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.

An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies

Rheumatoid Arthritis

Drug: rituximab;Drug: Methotrexate;Drug: Corticosteroid or NSAID;Dietary Supplement: Folate

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

Phase 4

Korea, Republic of

137

NCT00424502
(ClinicalTrials.gov)

January 2007

18/1/2007

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.

An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

Phase 4

Hungary

138

EUCTR2006-005386-19-BE
(EUCTR)

19/12/2006

03/11/2006

Cytokines and inflammatory proteins gene expression study in synovial biopsies from rheumatoid arthritis patients refractory to anti-TNF therapy treated with Rituximab - Anti TNF resistant RA / RTX / mini

Rheumatoid arthritis refractory to TNF blockers patients
MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis

Trade Name: MabThera

Cliniques Universitaires Saint-Luc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium

139

EUCTR2005-003632-22-ES
(EUCTR)

22/11/2006

20/03/2012

A study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with rheumatoid arthritis.

An open-label, exploratory study of the pharmacokinetic and pharmacodynamic activity of rituximab in combination with methotrexate (MTX) in synovial tissue and in peripheral blood of patients with active rheumatoid arthritis

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

Trade Name: MabThera
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

140

NCT02079532
(ClinicalTrials.gov)

November 2006

4/3/2014

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor

An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent

Rheumatoid Arthritis

Drug: rituximab [MabThera]

Hoffmann-La Roche

NULL

Completed

18 Years

75 Years

All

302

Phase 3

Germany

No.

TrialID

Date_
enrollment

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

EUCTR2006-004673-98-HU
(EUCTR)

16/10/2006

08/09/2006

Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker

To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.

Trade Name: MabThera 500 mg concentrate for solution for infusion

Roche (Hungary) Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary

142

EUCTR2005-002396-33-HU
(EUCTR)

26/09/2006

07/07/2006

A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

143

EUCTR2006-001000-37-DE
(EUCTR)

19/09/2006

16/06/2006

Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST

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

Trade Name: MabThera 500 mg Konzentrat zur Herstellung einer Infusionslösung
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

Roche Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

300

Germany

144

EUCTR2005-002396-33-SK
(EUCTR)

14/09/2006

15/06/2006

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Finland;United Kingdom;Germany;Slovakia;Spain;Italy

145

NCT01126541
(ClinicalTrials.gov)

September 2006

18/5/2010

SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy

A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)

Rheumatoid Arthritis

Drug: rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

224

Phase 3

France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

146

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

147

NCT01272908
(ClinicalTrials.gov)

July 18, 2006

7/1/2011

A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

Rituximab Phase IIIb Open-label, Multi-centre Assessment of Safety and Effectiveness in Patients With RA Following an Inadequate Response to One Prior Anti-TNF Inhibitor (RESET)

Rheumatoid Arthritis

Drug: rituximab

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

120

Phase 3

Canada;Sweden

148

EUCTR2006-000854-32-AT
(EUCTR)

29/05/2006

19/05/2006

Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers

Rheumatoid Arthritis

Trade Name: Rituximab - MabThera
Product Name: Rituximab MabThera
Product Code: no

Vienna Medical University

NULL

Not Recruiting

Female: yes
Male: yes

Austria

149

EUCTR2005-002396-33-DE
(EUCTR)

27/04/2006

10/11/2005

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

150

EUCTR2005-002395-15-DE
(EUCTR)

27/04/2006

22/11/2005

A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.

Rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

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

EUCTR2005-002392-32-DE
(EUCTR)

20/04/2006

29/09/2005

A randomised, placebo controlled, double-blind, parallel group, international study to evaluate the safety and efficacy of rituximab (MabThera/Rituxan) in combination with methotrexate, compared to methotrexate monotherapy, in patients with active rheumatoid arthritis.

Active rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Slovenia;Ireland;Germany;United Kingdom;Sweden

152

EUCTR2005-002396-33-FI
(EUCTR)

06/03/2006

22/12/2005

Rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
Product Name: Methotrexate
Product Code: Methotrexate

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

United Kingdom;Germany;Spain;Italy;Hungary;Finland;Slovakia

153

EUCTR2005-002395-15-CZ
(EUCTR)

27/02/2006

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

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

154

EUCTR2005-002395-15-SE
(EUCTR)

13/02/2006

12/12/2005

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

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

155

NCT00502996
(ClinicalTrials.gov)

February 2006

17/7/2007

A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

Multicenter Non-Comparative Expanded Access Program of to Assess Safety of Rituximab (Mab Anti Cd-20) in Patients With Rheumatoid Arthritis (Ser)

Rheumatoid Arthritis

Drug: Methotrexate;Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

246

Phase 3

Argentina;Brazil;Chile;Colombia;Ecuador;El Salvador;Mexico;Peru;Uruguay;Venezuela

No.

TrialID

Date_
enrollment

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

NCT00422383
(ClinicalTrials.gov)

February 2006

15/1/2007

A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)

A Randomized, Double-blind Study to Evaluate the Effect of Various Re-treatment Regimens of MabThera in Combination With Methotrexate on Treatment Response in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan]

Hoffmann-La Roche

NULL

Completed

18 Years

N/A

All

378

Phase 3

Australia;Belgium;Brazil;Canada;China;Finland;France;Germany;Hungary;Italy;Netherlands;New Zealand;Slovakia;South Africa;Spain;Taiwan;Thailand;United Kingdom;Switzerland;United States

157

EUCTR2005-002395-15-FI
(EUCTR)

09/01/2006

26/10/2005

Rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab
Product Name: Methotrexate
Product Code: Methotrexate
INN or Proposed INN: methotrexate

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Phase 3

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

158

EUCTR2005-002395-15-DK
(EUCTR)

06/01/2006

19/06/2007

Rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Phase 3

Czech Republic;Finland;Belgium;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

159

NCT00422942
(ClinicalTrials.gov)

January 2006

15/1/2007

A Pharmacokinetic and Pharmacodynamic Study of MabThera (Rituximab) Plus Methotrexate in Patients With Rheumatoid Arthritis (RA)

An Open-label, Exploratory Study of the Pharmacokinetic and Pharmacodynamic Activity of MabThera in Combination With Methotrexate in Synovial Tissue and in Peripheral Blood of Patients With Active Rheumatoid Arthritis.

Rheumatoid Arthritis

Drug: rituximab [MabThera/Rituxan];Drug: Methotrexate

Hoffmann-La Roche

NULL

Terminated

18 Years

80 Years

All

Phase 2

Netherlands;Spain

160

EUCTR2005-002395-15-BE
(EUCTR)

29/12/2005

24/11/2005

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

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Czech Republic;Finland;Spain;Belgium;Denmark;Germany;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

161

EUCTR2005-002395-15-ES
(EUCTR)

29/12/2005

31/10/2005

Estudio fase III, multicéntrico, randomizado, controlado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y eficacia de Rituximab en combinación con metotrexato (MTX), en comparación con metotrexato sólo en pacientes con artritis reumatoide activa no tratados previamente con metotrexato”

Artritis reumatoide / Rheumatoid arthritis

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

853

Czech Republic;Finland;Spain;Denmark;Germany;United Kingdom;Italy;Sweden

162

EUCTR2005-002396-33-ES
(EUCTR)

27/12/2005

28/10/2005

Estudio internacional, randomizado, doble ciego, para evaluar la eficacia y seguridad de diversos regímenes de retratamiento con rituximab en combinación con metotrexato, en pacientes con AR que manifiestan una respuesta inadecuada a metotrexato.A randomised, double-blind, international study to evaluate the efficacy and safety of various re-treatment regimens of rituximab in combination with methotrexate in RA patients with an inadequate response to methotrexate.

Artritis Reumatoide (Rheumatoid arthritis)

Trade Name: MabThera 500 mg
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

163

EUCTR2005-002396-33-BE
(EUCTR)

27/12/2005

24/11/2005

Rheumatoid arthritis

Trade Name: MabThera
Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 3

Hungary;Slovakia;Finland;Spain;Belgium;Germany;United Kingdom;Italy

164

EUCTR2005-002392-32-GB
(EUCTR)

07/12/2005

15/09/2005

Active rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Slovenia;Ireland;Germany;United Kingdom;Sweden

165

EUCTR2005-002395-15-IT
(EUCTR)

02/12/2005

02/03/2006

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

Trade Name: METHOTREXATE *100CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE *25CPR 2,5MG
INN or Proposed INN: Methotrexate
Trade Name: MabThera
INN or Proposed INN: Rituximab

F. Hoffmann - La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

750

Phase 3

Finland;Spain;Czech Republic;Denmark;Germany;United Kingdom;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

EUCTR2005-002396-33-IT
(EUCTR)

30/11/2005

01/03/2006

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

Trade Name: Mabthera
INN or Proposed INN: Rituximab

F. Hoffmann- La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

375

Hungary;Slovakia;Finland;Spain;Germany;United Kingdom;Italy

167

EUCTR2005-002392-32-IE
(EUCTR)

23/11/2005

13/09/2005

Active rheumatoid arthritis

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Slovenia;Ireland;Germany;United Kingdom;Sweden

168

EUCTR2005-002392-32-SE
(EUCTR)

12/10/2005

19/09/2005

Active rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Slovenia;Ireland;Germany;United Kingdom;Sweden

169

EUCTR2005-002392-32-SI
(EUCTR)

11/10/2005

26/10/2005

Active rheumatoid arthritis

Product Name: MabThera
Product Code: Ro 45-2294
INN or Proposed INN: Rituximab

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

500

Slovenia;Ireland;Germany;United Kingdom;Sweden

170

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

171

NCT02097745
(ClinicalTrials.gov)

June 2004

20/3/2014

A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

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

Rheumatoid Arthritis

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

Hoffmann-La Roche

Biogen

Completed

18 Years

80 Years

All

341

Phase 3

United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom

172

NCT00468377
(ClinicalTrials.gov)

March 2004

30/4/2007

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

Arthritis, Rheumatoid

Drug: Rituximab

Hoffmann-La Roche

Genentech, Inc.

Active, not recruiting

18 Years

80 Years

Both

341

Phase 3

United States

173

NCT00074438
(ClinicalTrials.gov)

June 2003

12/12/2003

Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: methotrexate;Drug: rituximab;Drug: corticosteroids;Drug: placebo

Genentech, Inc.

Roche Pharma AG

Completed

18 Years

80 Years

Both

465

Phase 2

United States

174

NCT00468546
(ClinicalTrials.gov)

May 2003

30/4/2007

A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies

Rheumatoid Arthritis

Drug: MabThera /Rituxan;Drug: Methotrexate;Other: Placebo

Hoffmann-La Roche

Biogen

Completed

18 Years

80 Years

All

520

Phase 3

United States;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Norway;United Kingdom

175

NCT02093026
(ClinicalTrials.gov)

August 2002

19/3/2014

Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)

An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic Acid

Hoffmann-La Roche

Genentech, Inc.

Completed

21 Years

N/A

All

465

Phase 2

United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

176

NCT02693210
(ClinicalTrials.gov)

February 2001

23/2/2016

A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis

A Randomised, Double Dummy Controlled, Parallel Group Study of the Efficacy and Safety of MabThera (Rituximab) Alone or in Combination With Either Cyclophosphamide or Methotrexate, in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: Cyclophosphamide;Drug: Methotrexate;Other: Placebo Cyclophosphamide;Other: Placebo Methotrexate;Other: Placebo Rituximab;Drug: Rituximab

Hoffmann-La Roche

NULL

Completed

21 Years

N/A

Both

161

Phase 2

Australia;Belgium;Canada;Czech Republic;Germany;Israel;Italy;Netherlands;Poland;Spain;United Kingdom

177

EUCTR2011-002896-40-ES
(EUCTR)

26/06/2012

A study comparing the pharmacokinetics and pharmacodynamics, and assessing the safety of PF-05280586 in subjects with active rheumatoid arthritis

RHEUMATOID ARTHRITIS
MedDRA version: 14.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Code: PF-05280586
INN or Proposed INN: Not Applicable
Other descriptive name: Not Applicable
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable
Trade Name: Rituxan ®
INN or Proposed INN: RITUXIMAB
Other descriptive name: Not Applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

195

Phase 2

United States;Taiwan;Spain;Korea, Democratic People's Republic of;Israel;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Brazil;Peru;Australia;South Africa;Germany

178

EUCTR2015-002156-27-AT
(EUCTR)

30/09/2015

Reduced-dose Rituximab in rheumatoid arthritis patients in remission – theREDOREM study

Prospective controlled study of reduced-dose Rituximab in rheumatoidarthritis patients in low disease activity and remission – the REDOREMstudy

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

Trade Name: MabThera
INN or Proposed INN: RITUXIMAB

Medical University of Vienna

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Austria