46. Malignant rheumatoid arthritis Clinical trials / Disease details
Clinical trials : 4,356 / Drugs : 2,567 - (DrugBank : 415) / Drug target genes : 192 - Drug target pathways : 228
| No. | TrialID | Date_ enrollment | 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 | NCT05622175 (ClinicalTrials.gov) | March 31, 2023 | 3/11/2022 | Safety and Preliminary Signs of Efficacy of F8IL10 for Intra-articular Treatment | A Dose-finding Phase I Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: F8IL10 | Philogen S.p.A. | NULL | Not yet recruiting | 18 Years | 80 Years | All | 32 | Phase 1 | NULL |
| 2 | NCT05604885 (ClinicalTrials.gov) | November 30, 2022 | 31/10/2022 | A Dose-range Study of the Safety and Efficacy of Treatment in Adult Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate | A Two-part, Randomized, Double-blind, Multi-center, Placebo-controlled Study of the Dose-range, Safety and Efficacy of 4 and 12 Weeks of Treatment With AP1189 in Adult Rheumatoid Arthritis (RA) Patients With an Inadequate Response to Methotrexate (MTX) Alone - (RESOLVE) | Rheumatoid Arthritis | Drug: AP1189, 60 mg;Drug: AP1189, 80 mg;Drug: AP1189, 100 mg;Drug: Placebo | SynAct Pharma Aps | NBCD A/S | Recruiting | 18 Years | 85 Years | All | 420 | Phase 2 | Moldova, Republic of |
| 3 | NCT05427942 (ClinicalTrials.gov) | June 3, 2022 | 17/6/2022 | Yuflyma® (Adalimumab), Patient Experience After Switching | YUflyma® (Adalimumab), Patient Experience After Switching to adaliMumab biosimilAr High concenTration, Low Volume (40mg/0.4mL) (Yuflyma®) by Taking Patient pERception of Treatment Into Account: The YU-MATTER Study | Rheumatoid Arthritis;Ankylosing Spondylarthritis;Axial Spondyloarthritis Without Radiographic Evidence of Ankylosing Spondylitis;Psoriatic Arthritis;Crohn Disease;Ulcerative Colitis | Drug: Adalimumab | Celltrion HealthCare France | NULL | Recruiting | 18 Years | N/A | All | 300 | France | |
| 4 | NCT05626348 (ClinicalTrials.gov) | December 22, 2021 | 15/11/2022 | The Clinical Efficacy of Immunomodulators in RA Patients | The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Patients for 6 Months Treatment in China | Arthritis, Rheumatoid | Drug: Iguratimod;Drug: Methotrexate;Drug: Adalimumab Injection;Drug: Leflunomide;Drug: Hydroxychloroquine | Qilu Hospital of Shandong University | NULL | Recruiting | 18 Years | 80 Years | All | 400 | Phase 4 | China |
| 5 | EUCTR2019-002205-22-NL (EUCTR) | 15/06/2021 | 11/02/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom | ||
| 6 | EUCTR2019-002205-22-FR (EUCTR) | 01/10/2020 | 13/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 7 | EUCTR2019-002205-22-DE (EUCTR) | 12/08/2020 | 07/07/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 8 | NCT05659407 (ClinicalTrials.gov) | July 24, 2020 | 13/12/2022 | BAFF-var as a Biomarker of Response to B-depletive Treatment in Systemic Lupus Erythematosus and Rheumatoid Arthritis | The BAFF-var Polymorphism as a Biomarker of Response to B-depletive Treatment in Patients Affected by Systemic Lupus Erythematosus and Rheumatoid Arthritis: a Prospective Study | Systemic Lupus Erythematosus;Rheumatoid Arthritis;BLyS Polymorphism | Drug: Belimumab in SLE patients / Rituximab in RA patients | University of Cagliari | Azienda Ospedaliero Universitaria di Cagliari | Recruiting | 18 Years | N/A | All | 60 | Italy | |
| 9 | EUCTR2019-002205-22-BE (EUCTR) | 05/05/2020 | 21/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 10 | EUCTR2019-002205-22-GB (EUCTR) | 01/05/2020 | 07/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 11 | EUCTR2019-002205-22-ES (EUCTR) | 06/04/2020 | 23/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 12 | EUCTR2019-002205-22-PL (EUCTR) | 29/03/2020 | 07/02/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | France;United States;Mexico;Argentina;Belgium;Spain;Poland;Germany;Netherlands;United Kingdom | ||
| 13 | NCT03895879 (ClinicalTrials.gov) | March 1, 2020 | 26/3/2019 | Use of Tocilizumab Drug Levels to Optimize Treatment in RA | Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA) | Rheumatoid Arthritis | Drug: Tocilizumab | Reade Rheumatology Research Institute | ZonMw: The Netherlands Organisation for Health Research and Development | Recruiting | 18 Years | N/A | All | 98 | Phase 4 | Netherlands |
| 14 | NCT04186871 (ClinicalTrials.gov) | January 7, 2020 | 28/11/2019 | Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis | Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome | Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | 75 Years | All | 112 | Phase 2 | United States;Argentina;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom;Australia |
| 15 | EUCTR2019-001754-25-NL (EUCTR) | 25/11/2019 | 25/11/2019 | Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment | Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch) | rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Enbrel, Benepali, Erelzi Product Name: Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab INN or Proposed INN: ETANERCEPT INN or Proposed INN: RITUXIMAB INN or Proposed INN: ABATACEPT INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB INN or Proposed INN: SARILUMAB | Reade | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 4 | Netherlands | ||
| 16 | EUCTR2018-004605-57-NL (EUCTR) | 06/08/2019 | 24/07/2019 | Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients | Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients: a randomised, multicenter, non-inferiority trial (TODORA) - Use of TOcilizumab Drug levels to Optimize treatment in RA (TODORA) | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: Tocilizumab INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Reade | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 17 | JPRN-UMIN000030584 | 2018/04/18 | 27/12/2017 | MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study | MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study | Rheumatoid Arthritis | Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR). If the dosage of MTX is maintained >= 10 mg/week and remission (SDAI <= 3.3) is achieved at Week 24, the MTX therapy will be continued up to Week 48 (ARM-1). Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 except for dose reduction/interruption due to an adverse drug reaction (ADR). If SDAI remission is not achieved despite the dosage of MTX is maintained >= 10 mg/week at Week 24, a bDMARDs will be added to the treatment in line with EULAR Recommendations 2016. Subjects will subcutaneously receive ADA 40 mg as a bDMARDs every other week up to Week 48, and be randomized to a group in which the MTD of MTX (10 to 25 mg/week) will be maintained (ARM-2) and a group in which the dosage of MTX will be reduced to 6 to 8 mg/week (ARM-3). Then, the efficacy and safety will be evaluated. Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <= 25 mg/week (<= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage | Keio University School of MedicineDivision of Rheumatology, Department of Internal Medicine | Eisai Co., Ltd. | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 300 | Not selected | Japan,Asia(except Japan) |
| 18 | JPRN-jRCTs071180018 | 13/04/2018 | 15/02/2019 | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT. | Rheumatoid arthritis | Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule. | Kawakami Atsushi | NULL | Complete | >= 20age old | Not applicable | Both | 44 | Phase 4 | Japan |
| 19 | JPRN-UMIN000030575 | 2018/03/31 | 26/12/2017 | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. | Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. - Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.An open label randomized controlled trial by HR-pQCT. | Rheumatoid arthritis | Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6. Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule. | Daiichi Sankyo Company, Limited | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 44 | Not applicable | Japan |
| 20 | EUCTR2017-003259-40-ES (EUCTR) | 04/01/2018 | 24/10/2017 | Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial. | Periodontitis treatment in patients with reumatoid arthritis and high clinical activity in the. Randomized clinical trial. | Patients with rheumatoid arthritis with high clinical activity and chronical peirodontitis moderate-severe. MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: amoxicilina INN or Proposed INN: AMOXICILLIN Product Name: metronidazol INN or Proposed INN: METRONIDAZOLE Other descriptive name: metronidazol | Dra Beatriz Lozano-Hospital Universitario de Canarias | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Spain | ||
| 21 | NCT03387423 (ClinicalTrials.gov) | November 2, 2017 | 7/12/2017 | Observational Study to Determine How Physicians Make Treatment Decisions in Patients Treated With Tofacitinib for Moderate to Severe Active Rheumatoid Arthritis | ESCALATE-RA A NON-INTERVENTIONAL STUDY OF CRITICAL FACTORS FOR ESCALATING DRUG TREATMENT IN PATIENTS TREATED WITH TOFACITINIB FOR MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS | Arthritis, Rheumatoid | Drug: Tofacitinib | Pfizer | NULL | Recruiting | 18 Years | N/A | All | 1500 | Germany | |
| 22 | EUCTR2016-002126-36-IT (EUCTR) | 26/10/2017 | 31/01/2018 | A study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO7123520 AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-a INHIBITORS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 | F. Hoffmann - Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Mexico;Argentina;Spain;Poland;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy | ||
| 23 | EUCTR2012-003655-11-FR (EUCTR) | 18/09/2017 | 28/09/2015 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | moderately to severely active rheumatoid arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: GLPG0634 INN or Proposed INN: Proposed INN - FILGOTINIB Other descriptive name: GLPG0634 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;Guatemala;Ukraine;Austria;Russian Federation;Israel;Chile;Colombia;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany | ||
| 24 | EUCTR2016-002126-36-ES (EUCTR) | 31/07/2017 | 02/06/2017 | A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors | A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Germany;Colombia;United Kingdom;Italy | ||
| 25 | EUCTR2016-002126-36-DE (EUCTR) | 18/04/2017 | 23/11/2016 | A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors | A randomized, double-blind, placebo-controlled, multi-center phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Mexico;Argentina;Poland;Spain;Guatemala;Peru;Austria;Colombia;Germany;Italy;United Kingdom | ||
| 26 | EUCTR2016-002126-36-AT (EUCTR) | 01/03/2017 | 11/11/2016 | A Study to Evaluate the Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-a Inhibitors | A randomized, double-blind, placebo-controlled, multi-center, three-part phase II study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RO7123520 Product Code: RO7123520/F03-01 INN or Proposed INN: Not available Other descriptive name: RO7123520 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 2 | United States;Spain;Guatemala;Austria;Chile;Colombia;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;Germany | ||
| 27 | NCT03001219 (ClinicalTrials.gov) | December 22, 2016 | 20/12/2016 | A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase II Study to Evaluate The Safety and Efficacy of RO7123520 as Adjunct Treatment in Patients With Moderately to Severely Active Rheumatoid Arthritis and an Inadequate Response to TNF-alpha Inhibitors | Rheumatoid Arthritis | Drug: Anti-TNF-alpha;Drug: Methotrexate;Drug: Placebo;Drug: RO7123520 | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 109 | Phase 2 | United States;Argentina;Austria;Colombia;Germany;Guatemala;Italy;Mexico;Peru;Spain;United Kingdom;Czech Republic;Czechia;Poland |
| 28 | NCT02648035 (ClinicalTrials.gov) | September 22, 2016 | 5/1/2016 | EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis | Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study. | Rheumatoid Arthritis | Biological: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 200 | Greece | |
| 29 | NCT02679001 (ClinicalTrials.gov) | March 24, 2016 | 8/2/2016 | A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment. | A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT | Rheumatoid Arthritis | Drug: TNF inhibitor/TCZ | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 200 | Sweden | |
| 30 | NCT03855007 (ClinicalTrials.gov) | January 1, 2016 | 15/2/2019 | The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment | Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China | Arthritis, Rheumatoid | Drug: Iguratimod;Drug: MTX;Drug: HCQ;Drug: Pred | Qilu Hospital of Shandong University | NULL | Active, not recruiting | 16 Years | 90 Years | All | 200 | Phase 4 | China |
| 31 | NCT02878161 (ClinicalTrials.gov) | January 2016 | 12/7/2016 | Predictability Studies on the Efficacy of TNF-a Inhibitors in Chinese RA From Real World | Screening Protein Predictive of Response to Tumor Necrosis Factor-a Inhibitors Treatment in Chinese Rheumatoid Arthritis From Real World and Investigating Its Mechanism Through Signal Pathway | Rheumatoid Arthritis | Drug: methotrexate(necessary);Biological: infliximab;Biological: etanercept;Biological: adalimumab;Drug: leflunomide (permitted, not necessary);Drug: NSAIDs (permitted,not necessary);Drug: Glucocorticoids (permitted,not necessary) | Fen Li | NULL | Enrolling by invitation | 18 Years | 75 Years | Both | 240 | Phase 4 | NULL |
| 32 | NCT02534896 (ClinicalTrials.gov) | November 2015 | 25/8/2015 | To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis | To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis | Active Rheumatoid Arthritis | Drug: Treatment I;Drug: Treatment II;Drug: Treatment III | Sun Pharmaceutical Industries Limited | NULL | Terminated | 18 Years | 90 Years | All | 150 | Phase 3 | Belgium;Netherlands |
| 33 | 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 |
| 34 | EUCTR2014-003012-36-BG (EUCTR) | 19/06/2015 | 12/03/2015 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 35 | EUCTR2014-003012-36-CZ (EUCTR) | 10/06/2015 | 05/01/2015 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 36 | EUCTR2014-003012-36-ES (EUCTR) | 27/05/2015 | 02/02/2015 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 37 | EUCTR2014-003012-36-DE (EUCTR) | 21/05/2015 | 29/12/2014 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 38 | EUCTR2014-003012-36-BE (EUCTR) | 23/03/2015 | 18/12/2014 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 39 | EUCTR2012-001176-10-BG (EUCTR) | 16/03/2015 | 04/11/2014 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand | ||
| 40 | EUCTR2014-003012-36-HU (EUCTR) | 10/03/2015 | 30/12/2014 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis | Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Ablynx NV | NULL | Not Recruiting | Female: yes Male: yes | 228 | Phase 2 | Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 41 | NCT02287922 (ClinicalTrials.gov) | March 2015 | 5/11/2014 | A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis | A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate | Rheumatoid Arthritis | Biological: ALX-0061;Biological: Placebo;Biological: Tocilizumab | Ablynx | NULL | Completed | 18 Years | 74 Years | All | 251 | Phase 2 | United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of |
| 42 | NCT02837978 (ClinicalTrials.gov) | January 2015 | 13/7/2016 | The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment | Prospective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in China | Arthritis, Rheumatoid | Drug: Tacrolimus;Drug: MTX | Qiang Shu | NULL | Recruiting | 18 Years | 80 Years | All | 150 | Phase 4 | China |
| 43 | EUCTR2012-003655-11-CZ (EUCTR) | 21/08/2014 | 21/08/2014 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | moderately to severely active rheumatoid arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: filgotinib Product Code: GLPG0634 INN or Proposed INN: INN - FILGOTINIB Other descriptive name: GLPG0634 Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Gilead Sciences Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 739 | Phase 2 | Spain;Ukraine;Guatemala;Austria;Russian Federation;Chile;Israel;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Peru;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of;United States | ||
| 44 | NCT02234960 (ClinicalTrials.gov) | August 2014 | 5/9/2014 | Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA) | TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL) | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | Both | 102 | N/A | Poland |
| 45 | EUCTR2012-001176-10-PL (EUCTR) | 31/05/2014 | 28/04/2014 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 46 | EUCTR2012-001176-10-HR (EUCTR) | 08/05/2014 | 05/09/2014 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 47 | NCT02157012 (ClinicalTrials.gov) | May 2014 | 1/6/2014 | Evaluation of the Condition of Rheumatoid Arthritis After Treatment | Evaluation of the Condition After Xeljanz Treatment in Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: The effectiveness of Xeljanz in rheumatoid arthritis patients | Shinshu University | Showa Inan General Hospital | Recruiting | 20 Years | 90 Years | All | 100 | Phase 4 | Japan |
| 48 | EUCTR2012-001176-10-NL (EUCTR) | 18/04/2014 | 28/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China | ||
| 49 | EUCTR2012-003655-11-BG (EUCTR) | 27/03/2014 | 19/02/2014 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 739 | Phase 2 | United States;Czechia;Spain;Guatemala;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of | ||
| 50 | NCT02065700 (ClinicalTrials.gov) | February 25, 2014 | 14/2/2014 | Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Patients | A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Filgotinib | Galapagos NV | Gilead Sciences | Completed | 18 Years | N/A | All | 739 | Phase 2 | United States;Argentina;Australia;Belgium;Bulgaria;Chile;Colombia;Czechia;France;Germany;Guatemala;Hungary;Israel;Latvia;Mexico;Moldova, Republic of;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine;Czech Republic |
| 51 | EUCTR2012-001176-10-DE (EUCTR) | 24/02/2014 | 05/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 52 | EUCTR2012-003655-11-HU (EUCTR) | 24/02/2014 | 11/11/2013 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 739 | Phase 2 | United States;Czechia;Spain;Guatemala;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of | ||
| 53 | EUCTR2012-001176-10-PT (EUCTR) | 18/02/2014 | 09/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 54 | EUCTR2012-003655-11-BE (EUCTR) | 23/01/2014 | 15/10/2013 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | Moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 739 | Phase 2 | Ukraine;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of;United States;Czechia;Spain;Guatemala | ||
| 55 | EUCTR2012-001176-10-IT (EUCTR) | 22/01/2014 | 28/10/2013 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Australia;Peru;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 56 | EUCTR2012-001176-10-BE (EUCTR) | 14/01/2014 | 23/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | 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: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 57 | EUCTR2012-001176-10-AT (EUCTR) | 13/01/2014 | 13/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia | ||
| 58 | EUCTR2012-001176-10-GB (EUCTR) | 10/01/2014 | 20/12/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 59 | EUCTR2012-003655-11-LV (EUCTR) | 18/12/2013 | 08/11/2013 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | Moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 739 | Phase 2 | United States;Czechia;Spain;Guatemala;Ukraine;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Latvia;Moldova, Republic of | ||
| 60 | NCT01990157 (ClinicalTrials.gov) | November 2013 | 5/11/2013 | Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis | Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis in Which Methotrexate (MTX) Treatment is Not Effective | Rheumatoid Arthritis | Drug: TAB08 | Theramab LLC | NULL | Completed | 18 Years | 65 Years | All | 18 | Phase 1/Phase 2 | Russian Federation |
| 61 | EUCTR2012-001176-10-ES (EUCTR) | 31/10/2013 | 05/09/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | United States;Serbia;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 62 | EUCTR2013-002341-11-GB (EUCTR) | 25/10/2013 | 26/07/2013 | This is a study in healthy subjects to look at the effect of tocilizumab (RoActemra) on a type of white blood cell | A SINGLE BLIND PHASE IV PHARMACODYNAMIC STUDY TO EVALUATE NEUTROPHIL DISTRIBUTION KINETICS AND FUNCTION FOLLOWING SINGLE-DOSE TOCILIZUMAB TREATMENT IN HEALTHY SUBJECTS | healthy volunteers (intended indication: Rheumatoid Arthritis) MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: no Male: yes | Phase 4 | United Kingdom | |||
| 63 | EUCTR2012-001176-10-LT (EUCTR) | 09/09/2013 | 20/06/2013 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) - SIRROUND-LTE | Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody Product Name: Sirukumab Product Code: CNTO136 INN or Proposed INN: Sirukumab Other descriptive name: Human anti-IL6 monoclonal antibody | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 2165 | Phase 3 | Serbia;Portugal;United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;South Africa;Netherlands;China;Korea, Republic of;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 64 | NCT01856309 (ClinicalTrials.gov) | August 7, 2013 | 15/5/2013 | Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (Sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) | Arthritis, Rheumatoid | Drug: Sirukumab 100 mg;Drug: Sirukumab 50 mg;Drug: Placebo | Janssen Research & Development, LLC | GlaxoSmithKline | Completed | 18 Years | N/A | All | 1820 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;France;Germany;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Ukraine;United Kingdom |
| 65 | JPRN-JapicCTI-153073 | 01/7/2013 | 18/11/2015 | Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003 | A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T) | Rheumatoid arthritis | Intervention name : Sirukumab Dosage And administration of the intervention : 100 mg Intervention name : Sirukuma Dosage And administration of the intervention : 50mg Control intervention name : null | Janssen Pharmaceutical K.K. | NULL | 18 | BOTH | 280 | Phase 3 | NULL | ||
| 66 | NCT01846975 (ClinicalTrials.gov) | May 2013 | 19/4/2013 | Introducing a Single IV Abatacept Treatment in RA Patients Currently Receiving Weekly SC Abatacept to Simulate a Holiday | A Phase IV, Open Label Study Introducing a Single IV Treatment With Abatacept in Patients With Rheumatoid Arthritis Currently Receiving Weekly Injections of SC Abatacept to Simulate a Holiday or Patient Vacation | Rheumatoid Arthritis | Drug: IV Abatacept | Rüdiger B. Müller | Bristol-Myers Squibb | Completed | 18 Years | N/A | Both | 49 | Phase 4 | Switzerland |
| 67 | JPRN-UMIN000010126 | 2013/02/25 | 26/02/2013 | Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease | Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD | Interstitial lung disease related to rheumatoid arthritis | In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on. In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases. | Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 34 | Not applicable | Japan |
| 68 | NCT01768858 (ClinicalTrials.gov) | February 5, 2013 | 14/1/2013 | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis;Crohn´s Disease;Ulcerative Colitis;Plaque Psoriasis | Drug: Adalimumab | AbbVie | Raffeiner GmbH | Completed | 18 Years | 99 Years | All | 96 | Austria | |
| 69 | NCT01715831 (ClinicalTrials.gov) | January 15, 2013 | 25/10/2012 | A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488 | A Multicenter, Open-Label, Single-Arm Extension Study to Describe the Safety of Tocilizumab Treatment In Brazilian Patients With DMARDs Refractory Rheumatoid Arthritis Which Completed Studies ML21530 and MA21488 and Presenting an Indication of Maintaining the Tocilizumab Treatment | Arthritis, Rheumatoid | Drug: DMARDs;Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 26 | Phase 4 | Brazil |
| 70 | JPRN-UMIN000009425 | 2012/12/06 | 01/12/2012 | A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient | A validity inspection study of the treat-to-target strategy with golimumab for the treatment of rheumatoid arthritis patient - Go-Go trial | Rheumatoid Arthritis | The dose of golimumab should be fixed as 50 mg/month for all period. Treat-to-target strategy might be achieved by MTX or other DMARDs for one year. The goal of treatment is low disease activity. Treat-to-target strategy will be started with 50 mg of golimumab for first 3 months and then 100 mg golimumab can be used for tight control of rheumatoid arthritis to achieve low disease activity (LDA). Also MTX or other DMARDs might be used for tight control. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is allowed. Total period is one year. Treat-to-target strategy will be started with 100 mg of golimumab for first 3 months. If the LDA is achieved, reduction of dose from 100 to 50 mg/month is performed. If not, physicians should control the disease activity using MTX or other DMARDs. Total period is one year. | Osaka City University Medical School | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Phase 4 | Japan |
| 71 | NCT01664104 (ClinicalTrials.gov) | June 2012 | 7/8/2012 | A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting | CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 151 | N/A | Italy |
| 72 | EUCTR2011-006040-79-DK (EUCTR) | 25/05/2012 | 25/05/2012 | A clinical trial with the aim to explore the efficacy and safety of adding tocilizumab to standard of care in patients withearly rheumatoid arth | The efficacy and safety of adding tocilizumab to methotrexate and intra-articular glucocorticosteroid treatment in early rheumatoid arthritis.A randomized, double-blinded, placebo-controlled trial. - DanACT Early | Adult Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra® | Aarhus University Hospital, Department of Rheumatology U | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Denmark | ||
| 73 | NCT01724268 (ClinicalTrials.gov) | May 2012 | 7/11/2012 | Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient | Randomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot Study | RHEUMATOID ARTHRITIS | Drug: Pred + Meth;Drug: Anti TNF + Meth | Hamad Medical Corporation | NULL | Recruiting | 18 Years | N/A | Both | 80 | Phase 3 | Qatar |
| 74 | JPRN-UMIN000007432 | 2012/04/01 | 02/03/2012 | Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody. | Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody. - PRISM Study | rheumatoid arthritis | Infliximab and Methotrexate. Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks (indispensable), and if SDAI Score 3.3 or more, it will change into of 3mg/kg 4week or 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. If not remission(SDAI Score 3.3 or more), after change into of 3mg/kg 4week interval medication, it will change into of 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. | Keio University | NULL | Complete: follow-up continuing | 20years-old | 75years-old | Male and Female | 100 | Not selected | Japan |
| 75 | NCT02818361 (ClinicalTrials.gov) | April 2012 | 15/6/2016 | Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis | Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: Topical tripterygium gel;Drug: Placebo gel | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | NULL | Completed | 18 Years | 65 Years | All | 70 | N/A | China |
| 76 | 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 |
| 77 | NCT01469013 (ClinicalTrials.gov) | November 2011 | 8/11/2011 | Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of Baricitinib (LY3009104) in Japanese Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy | Arthritis, Rheumatoid | Drug: Placebo;Drug: Baricitinib;Drug: Methotrexate | Eli Lilly and Company | NULL | Completed | 20 Years | 75 Years | All | 145 | Phase 2 | Japan |
| 78 | NCT01404429 (ClinicalTrials.gov) | May 2011 | 26/7/2011 | Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis | Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate | Postgraduate Institute of Medical Education and Research | NULL | Completed | 18 Years | 65 Years | All | 100 | Phase 4 | India |
| 79 | EUCTR2009-016119-38-BG (EUCTR) | 05/10/2010 | 18/08/2010 | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | United Kingdom;Bulgaria;Latvia;Poland | |||
| 80 | NCT01034306 (ClinicalTrials.gov) | October 2010 | 16/12/2009 | Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis | A Phase IIB Study of the Efficacy and Safety of Daily CF101 in Patients With Active Rheumatoid Arthritis and Elevated Baseline Expression Levels of Peripheral Blood Mononuclear Cell A3 Adenosine Receptors | Rheumatoid Arthritis | Drug: CF101;Drug: Placebo control | Can-Fite BioPharma | NULL | Completed | 18 Years | 75 Years | All | 79 | Phase 2 | Bulgaria;Israel |
| 81 | EUCTR2009-016119-38-LV (EUCTR) | 13/08/2010 | 28/05/2010 | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | United Kingdom;Bulgaria;Latvia;Poland | |||
| 82 | EUCTR2009-016119-38-CZ (EUCTR) | 01/07/2010 | 02/07/2010 | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | Czech Republic;Poland;Bulgaria;Latvia;United Kingdom | |||
| 83 | EUCTR2009-016119-38-PL (EUCTR) | 23/06/2010 | 30/04/2010 | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | United Kingdom;Bulgaria;Latvia;Poland | |||
| 84 | EUCTR2009-016119-38-GB (EUCTR) | 19/05/2010 | 17/03/2010 | Safety and Efficacy of AMG 827 in Subjects With RA | A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis. | Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: AMG 827 Product Code: AMG 827 INN or Proposed INN: AMG 827 | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | Czech Republic;United Kingdom;Bulgaria;Latvia;Poland;Australia | |||
| 85 | 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 | ||||
| 86 | NCT01059448 (ClinicalTrials.gov) | May 2010 | 28/1/2010 | Safety and Efficacy of AMG 827 in Subjects With RA | A Long-Term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AMG 827 | Amgen | NULL | Terminated | N/A | N/A | Both | 211 | Phase 2 | United States;Bulgaria;Canada;Czech Republic;Latvia;Mexico;Poland;United Kingdom |
| 87 | EUCTR2009-015653-20-NL (EUCTR) | 08/03/2010 | 10/03/2010 | Prospective study on the effects of etanercept treatment in patients with rheumatoid arthritis who are naïve for TNF-alpha blocking therapy and patients who do not respond (anymore) to prior treatment with other anti-TNF-alpha medication - Not applicable | Prospective study on the effects of etanercept treatment in patients with rheumatoid arthritis who are naïve for TNF-alpha blocking therapy and patients who do not respond (anymore) to prior treatment with other anti-TNF-alpha medication - Not applicable | rheumatoid arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: etanercept Product Name: Etanercept INN or Proposed INN: METHOTREXATE Other descriptive name: methotrexate | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | |||||
| 88 | NCT01034397 (ClinicalTrials.gov) | March 2010 | 16/12/2009 | A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs | A Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDs | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: placebo;Drug: non-biological DMARDs | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 54 | Phase 4 | Portugal |
| 89 | 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 |
| 90 | EUCTR2009-012218-30-PT (EUCTR) | 06/10/2009 | 12/08/2009 | A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT | A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT | Men and women > 18 years of age with RA who are currently experiencing an inadequate clinical response to a stable dose of non-biologic DMARDs (at least 12 weeks) and with MRI documented synovitis of dominant hand. | Trade Name: RoActemra | Roche Farmacêutica Química, Lda. | NULL | Not Recruiting | Female: yes Male: yes | Portugal | ||||
| 91 | JPRN-UMIN000002169 | 2009/07/01 | 07/07/2009 | Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritis | Safety and efficacy of 3 DMARDs for 2 years of treatment in patients with early rheumatoid arthritis - TRED study | Rheumatoid Arthritis | Salazosulfapyridine Bucillamine | Higashi-Hiroshima Memorial Hospital | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 60 | Phase 4 | Japan |
| 92 | EUCTR2007-001625-10-GR (EUCTR) | 29/04/2009 | 06/03/2009 | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | RHEUMATOID ARTHRITIS | Trade Name: Etanercept INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 700 | Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria | |||
| 93 | EUCTR2007-001625-10-GB (EUCTR) | 17/02/2009 | 02/05/2008 | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Etanercept INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 700 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yes | France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom | ||
| 94 | EUCTR2007-001625-10-IE (EUCTR) | 12/12/2008 | 07/10/2008 | AN OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE RADIOGRAPHIC EFFICACY AND SAFETY OF ENBREL™ (ETANERCEPT) ADDED TO METHOTREXATE IN COMPARISON WITH USUAL TREATMENT IN SUBJECTS WITH MODERATE RHEUMATOID ARTHRITIS DISEASE ACTIVITY | AN OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE RADIOGRAPHIC EFFICACY AND SAFETY OF ENBREL™ (ETANERCEPT) ADDED TO METHOTREXATE IN COMPARISON WITH USUAL TREATMENT IN SUBJECTS WITH MODERATE RHEUMATOID ARTHRITIS DISEASE ACTIVITY | RHEUMATOID ARTHRITIS | Trade Name: Etanercept INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 700 | Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Spain;Ireland;Italy;Greece;Poland;Austria | |||
| 95 | EUCTR2007-001625-10-IT (EUCTR) | 26/11/2008 | 01/04/2009 | An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) added to Methotrexate in Comparison with Usual Treatment in Subjects with Moderate Rheumatoid Arthritis Disease Activity. - EXTRA | An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) added to Methotrexate in Comparison with Usual Treatment in Subjects with Moderate Rheumatoid Arthritis Disease Activity. - EXTRA | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: ENBREL INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 700 | France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;United Kingdom;Italy | |||
| 96 | EUCTR2006-004139-31-GR (EUCTR) | 14/10/2008 | 06/11/2009 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metotab® INN or Proposed INN: methotrexate | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 97 | EUCTR2007-001625-10-AT (EUCTR) | 09/10/2008 | 04/06/2008 | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Enbrel 50 mg Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 700 | Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria | |||
| 98 | EUCTR2007-001625-10-DE (EUCTR) | 01/10/2008 | 05/05/2008 | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Enbrel 50 mg Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 700 | Hungary;Czech Republic;United Kingdom;Germany;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria | |||
| 99 | EUCTR2006-004139-31-NO (EUCTR) | 16/09/2008 | 19/12/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Netherlands;Germany;Norway;United Kingdom;Sweden | |||
| 100 | EUCTR2007-001625-10-PL (EUCTR) | 10/09/2008 | 09/06/2008 | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Enbrel Product Name: Etanercept Product Code: 0881 INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 700 | Greece;Austria;Poland;Italy;Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain | |||
| 101 | NCT00706797 (ClinicalTrials.gov) | September 2008 | 25/6/2008 | Study Evaluating Efficacy / Safety of Etanercept + Methotrexate Compared to Usual Treatment in Moderate RA Subjects | An Open-Label, Randomized Study to Evaluate the Radiographic Efficacy and Safety of Enbrel™ (Etanercept) Added to Methotrexate in Comparison With Usual Treatment in Subjects With Moderate Rheumatoid Arthritis Disease Activity | Rheumatoid Arthritis | Drug: etanercept (EnbrelTM);Drug: methotrexate | Wyeth is now a wholly owned subsidiary of Pfizer | NULL | Terminated | 18 Years | N/A | All | 141 | Phase 4 | Czech Republic;France;Germany;Hungary;Italy;Poland;Spain;Turkey;United Kingdom;Austria;Croatia;United States |
| 102 | EUCTR2007-001625-10-DK (EUCTR) | 08/07/2008 | 18/06/2008 | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Etanercept INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 700 | Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria | |||
| 103 | JPRN-UMIN000002421 | 2008/07/01 | 04/09/2009 | Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis | Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis - Comparative study of tocilizumab therapy versus conventional therapy for the treatment of rheumatoid arthritis complicating AA amyloidosis | rheumatoid arthritis | tocilizumab Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab | AA amyloidosis clinical research conference | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 40 | Not selected | Japan |
| 104 | EUCTR2007-001625-10-CZ (EUCTR) | 19/06/2008 | 21/05/2008 | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Etanercept INN or Proposed INN: ETANERCEPT | Wyeth Research Division of Wyeth Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Hungary;Germany;United Kingdom;Czech Republic;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria | |||
| 105 | EUCTR2007-001625-10-HU (EUCTR) | 16/06/2008 | 18/03/2008 | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | RHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Etanercept INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 700 | Hungary;Czech Republic;Germany;United Kingdom;Denmark;France;Ireland;Spain;Italy;Greece;Poland;Austria | |||
| 106 | EUCTR2007-001625-10-FR (EUCTR) | 03/06/2008 | 13/05/2008 | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | RHEUMATOID ARTHRITIS | Trade Name: Etanercept INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 4 | France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom | ||
| 107 | EUCTR2007-001625-10-ES (EUCTR) | 28/05/2008 | 24/03/2008 | Estudio abierto y aleatorizado para evaluar la eficacia radiológica y la seguridad de Enbrel® (etanercept) añadido a metotrexato en comparación con el tratamiento habitual en pacientes con artritis reumatoide moderadaAn Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | Estudio abierto y aleatorizado para evaluar la eficacia radiológica y la seguridad de Enbrel® (etanercept) añadido a metotrexato en comparación con el tratamiento habitual en pacientes con artritis reumatoide moderadaAn Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity. - Extra | Artritis reumatoideRHEUMATOID ARTHRITIS MedDRA version: 9.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Enbrel INN or Proposed INN: ETANERCEPT | Wyeth Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 4 | France;Czech Republic;Hungary;Greece;Poland;Spain;Ireland;Denmark;Austria;Germany;Italy;United Kingdom | ||
| 108 | EUCTR2006-006562-42-GB (EUCTR) | 21/02/2008 | 13/01/2009 | An Observational and Exploratory Study to determine the effect of anti TNF Biologic Treatment in Rheumatoid Cachexia | An Observational and Exploratory Study to determine the effect of anti TNF Biologic Treatment in Rheumatoid Cachexia | Cachexia in patients with Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Enbrel Product Name: Etanercept 50mg | Derby Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 109 | NCT00556894 (ClinicalTrials.gov) | February 2008 | 8/11/2007 | Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CF101;Drug: Placebo | Can-Fite BioPharma | NULL | Completed | 18 Years | 75 Years | All | 253 | Phase 2 | Bulgaria;Czechia;Israel;Poland;Serbia;Ukraine;Czech Republic;Former Serbia and Montenegro |
| 110 | EUCTR2006-004139-31-NL (EUCTR) | 02/12/2007 | 26/04/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 111 | EUCTR2006-003698-29-EE (EUCTR) | 12/10/2007 | 24/08/2007 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 784 | Hungary;United Kingdom;Czech Republic;Netherlands;France;Estonia;Ireland;Italy;Latvia;Austria;Sweden | |||
| 112 | EUCTR2006-003698-29-IT (EUCTR) | 05/10/2007 | 03/04/2007 | A long term assessment of safety and physical function with AMG 108 subcutaneous monthly treatment in subjects with Rheumatoid Arthritis - AMG 108 20060119 | A long term assessment of safety and physical function with AMG 108 subcutaneous monthly treatment in subjects with Rheumatoid Arthritis - AMG 108 20060119 | Rheumatoid Arthritis AR MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: AMG 108 Product Code: AMG 108 | AMGEN S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 784 | Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden | |||
| 113 | EUCTR2006-004139-31-HU (EUCTR) | 05/09/2007 | 17/05/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | Slovakia;Greece;Spain;Austria;United Kingdom;France;Hungary;Czech Republic;Belgium;Germany;Netherlands;Norway;Sweden | ||
| 114 | EUCTR2006-003698-29-LV (EUCTR) | 03/09/2007 | 04/09/2007 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 784 | Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden | |||
| 115 | EUCTR2006-004139-31-DE (EUCTR) | 30/08/2007 | 24/04/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Czech Republic;United Kingdom;Germany;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 116 | EUCTR2006-003698-29-IE (EUCTR) | 08/08/2007 | 12/01/2007 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 784 | Estonia;France;Ireland;Italy;Latvia;Austria;Sweden;Hungary;United Kingdom;Czech Republic;Netherlands | |||
| 117 | EUCTR2006-004139-31-CZ (EUCTR) | 08/08/2007 | 15/02/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Germany;United Kingdom;Czech Republic;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 118 | EUCTR2006-003698-29-AT (EUCTR) | 18/07/2007 | 16/08/2006 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 784 | Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden | |||
| 119 | EUCTR2006-003698-29-HU (EUCTR) | 16/07/2007 | 29/05/2007 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden | |||
| 120 | EUCTR2006-004139-31-SE (EUCTR) | 02/05/2007 | 12/02/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 121 | EUCTR2006-004139-31-ES (EUCTR) | 23/04/2007 | 25/01/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis.Estudio multicéntrico, aleatorizado, doble ciego, en dos periodos, para determinar el protocolo óptimo de inicio del tratamiento combinado de metotrexato y adalimumab en pacientes con Artritis Reumatoide Temprana. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis.Estudio multicéntrico, aleatorizado, doble ciego, en dos periodos, para determinar el protocolo óptimo de inicio del tratamiento combinado de metotrexato y adalimumab en pacientes con Artritis Reumatoide Temprana. - OPTIMA | Rheumatoid Arthritis. Artritis Reumatoide MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden | |||
| 122 | EUCTR2006-004139-31-BE (EUCTR) | 03/04/2007 | 19/12/2006 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Czech Republic;Greece;Spain;Belgium;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | |||
| 123 | EUCTR2006-004139-31-FR (EUCTR) | 12/03/2007 | 12/02/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | Slovakia;Greece;Spain;Austria;United Kingdom;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Norway;Sweden | ||
| 124 | EUCTR2005-002909-23-PT (EUCTR) | 08/03/2007 | 03/01/2007 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA | Rheumatoid arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab | F Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 2420 | Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden | |||
| 125 | EUCTR2006-004139-31-GB (EUCTR) | 06/03/2007 | 02/01/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden | |||
| 126 | EUCTR2006-004139-31-SK (EUCTR) | 15/02/2007 | 19/01/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | Slovakia;Greece;Spain;Austria;United Kingdom;France;Czech Republic;Hungary;Belgium;Germany;Netherlands;Norway;Sweden | ||
| 127 | EUCTR2006-004139-31-AT (EUCTR) | 13/02/2007 | 06/02/2007 | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation with Methotrexate and Adalimumab Combination Therapy in Patients with Early Rheumatoid Arthritis. - OPTIMA | Rheumatoid Arthritis. MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Humira INN or Proposed INN: Adalimumab Trade Name: Metex® | Abbott GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Germany;Czech Republic;United Kingdom;Netherlands;France;Spain;Greece;Austria;Sweden | |||
| 128 | EUCTR2006-003698-29-BE (EUCTR) | 18/12/2006 | 13/11/2006 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 784 | France;Estonia;Hungary;Czech Republic;Belgium;Ireland;Austria;Latvia;Netherlands;Italy;United Kingdom;Sweden | |||
| 129 | EUCTR2006-003698-29-GB (EUCTR) | 14/12/2006 | 29/09/2006 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 784 | Hungary;Czech Republic;United Kingdom;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden | |||
| 130 | NCT00420927 (ClinicalTrials.gov) | December 2006 | 9/1/2007 | Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis | A Multicenter, Randomized, Double-Period, Double - Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA) | Rheumatoid Arthritis | Drug: methotrexate;Biological: placebo;Biological: adalimumab | Abbott | NULL | Completed | 18 Years | N/A | All | 1032 | Phase 4 | United States;Argentina;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Mexico;Netherlands;New Zealand;Norway;Poland;Puerto Rico;Slovakia;South Africa;Spain;Sweden;United Kingdom;Greece |
| 131 | EUCTR2006-003698-29-NL (EUCTR) | 26/10/2006 | 14/06/2007 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 784 | Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden | |||
| 132 | EUCTR2006-003698-29-CZ (EUCTR) | 20/10/2006 | 29/08/2006 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 784 | Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden | |||
| 133 | EUCTR2006-003698-29-SK (EUCTR) | 19/10/2006 | 29/09/2006 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 784 | Phase 2 | Estonia;Slovakia;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Netherlands;Latvia;Sweden | ||
| 134 | 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 | |||
| 135 | EUCTR2006-003698-29-FR (EUCTR) | 05/10/2006 | 14/09/2006 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 784 | Phase 2 | Estonia;Slovakia;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Netherlands;Latvia;Sweden | ||
| 136 | EUCTR2006-003698-29-SE (EUCTR) | 03/10/2006 | 17/08/2006 | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis | Rheumatoid arthritis (RA) MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: AMG 108 Product Code: AMG 108 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 784 | Hungary;United Kingdom;Czech Republic;Netherlands;Estonia;France;Ireland;Italy;Latvia;Austria;Sweden | |||
| 137 | NCT00369473 (ClinicalTrials.gov) | September 2006 | 24/8/2006 | Long-Term Assessment of Safety and Physical Function With AMG 108 in RA | A Long-Term Assessment of Safety and Physical Function With AMG 108 Subcutaneous Monthly Treatment in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: AMG 108 | Amgen | NULL | Completed | 18 Years | N/A | Both | 690 | Phase 2 | Australia;Belgium;Canada;Czech Republic;Estonia;France;Hungary;Ireland;Italy;Latvia;Mexico;Netherlands;Poland;Puerto Rico;Slovakia;Spain;United Kingdom;United States |
| 138 | NCT01685424 (ClinicalTrials.gov) | June 30, 2006 | 23/8/2012 | Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1) | Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis | Osteoarthritis;Rheumatoid Arthritis;Ankylosing Spondylitis;Gout;Arthritis | Drug: Etoricoxib | Organon and Co | NULL | Completed | N/A | N/A | All | 79189 | United States | |
| 139 | NCT00280917 (ClinicalTrials.gov) | June 2006 | 23/1/2006 | Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Daily CF101 Administered Orally, When Added to Weekly Methotrexate, in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: CF101 | Can-Fite BioPharma | NULL | Completed | 18 Years | 75 Years | All | 254 | Phase 2 | United States;Bulgaria;Israel;Poland;Romania;Serbia;Ukraine;Former Serbia and Montenegro |
| 140 | EUCTR2005-002909-23-IS (EUCTR) | 08/05/2006 | 25/04/2006 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Rheumatoid arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab | F Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 2420 | Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Germany;Iceland;Italy;United Kingdom;Sweden | |||
| 141 | EUCTR2005-002909-23-FI (EUCTR) | 19/04/2006 | 23/01/2006 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Rheumatoid arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab | F Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 2420 | Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden | |||
| 142 | EUCTR2005-002909-23-IT (EUCTR) | 11/04/2006 | 14/03/2006 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra INN or Proposed INN: Ro Actemra | F. Hoffmann - La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2420 | Sweden;Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;United Kingdom;Italy | |||
| 143 | EUCTR2005-002909-23-NO (EUCTR) | 30/03/2006 | 11/01/2006 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Rheumatoid arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab | F Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 2420 | Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Norway;Germany;Iceland;Sweden | |||
| 144 | EUCTR2005-002909-23-GB (EUCTR) | 27/03/2006 | 13/01/2006 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA | Rheumatoid arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab | F Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 2420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden | ||
| 145 | EUCTR2005-002909-23-SI (EUCTR) | 16/03/2006 | 20/02/2006 | A long-term 5-year study investigation whethetr tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96 | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 2420 | United States;Portugal;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Norway;Germany;Sweden | |||
| 146 | EUCTR2005-002909-23-CZ (EUCTR) | 13/03/2006 | 13/01/2006 | A long-term 5-year study investigating whether tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96 | Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F Hoffmann La-Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2420 | France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Norway;Germany;Sweden;Portugal;United States;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland | |||
| 147 | EUCTR2005-002909-23-LT (EUCTR) | 07/03/2006 | 11/01/2006 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Rheumatoid arthritis | Trade Name: RoActemra INN or Proposed INN: tocilizumab | F Hoffmann La-Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2420 | Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden | |||
| 148 | EUCTR2005-002909-23-DK (EUCTR) | 21/02/2006 | 23/01/2006 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA | Rheumatoid arthritis | Trade Name: RoActemra INN or Proposed INN: tocilizumab | F Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 2420 | Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden | |||
| 149 | EUCTR2005-003436-21-CZ (EUCTR) | 15/02/2006 | 07/11/2005 | A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 | A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: SMP-114 Product Code: SMP-114 INN or Proposed INN: rimacalib | Dainippon Sumitomo Pharma Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Hungary;Germany;United Kingdom;Czech Republic | ||
| 150 | EUCTR2005-002909-23-SE (EUCTR) | 09/02/2006 | 23/12/2005 | A long-term 5-year study investigating whether tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96 | Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F Hoffmann La-Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 2420 | Portugal;United States;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Germany;Norway;Sweden | |||
| 151 | NCT00296257 (ClinicalTrials.gov) | February 2006 | 22/2/2006 | Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114 | A Phase 2, Multi-Centre, Randomised, Double Blind, Placebo Controlled Study Evaluating the Efficacy, Safety and Pharmacokinetics of Two Doses of a Candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg Once Daily), Administered in Combination With Ongoing Methotrexate Treatment in Patients With Active Rheumatoid Arthritis. | Rheumatoid Arthritis (RA) | Drug: SMP-114 | Dainippon Sumitomo Pharma Europe LTd. | NULL | Terminated | 18 Years | N/A | Both | 312 | Phase 2 | Czech Republic;Germany;Hungary;Netherlands;Poland;United Kingdom |
| 152 | EUCTR2005-003436-21-DE (EUCTR) | 18/01/2006 | 24/10/2005 | A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 | A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: SMP-114 Product Code: SMP-114 INN or Proposed INN: rimacalib | Dainippon Sumitomo Pharma Europe Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Hungary;Czech Republic;United Kingdom;Germany | ||
| 153 | EUCTR2005-002909-23-DE (EUCTR) | 10/01/2006 | 07/10/2005 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. | Rheumatoid arthritis | Trade Name: RoActemra Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab | F Hoffmann-La Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 2420 | Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden | |||
| 154 | EUCTR2005-002423-13-HU (EUCTR) | 19/12/2005 | 05/11/2005 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - NA | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - NA | Rheumatoid arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA | F. Hoffmann La-Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 630 | Hungary;Slovakia;Germany;Bulgaria;Italy | |||
| 155 | EUCTR2005-003436-21-HU (EUCTR) | 15/12/2005 | 11/10/2005 | A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 | A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073 | Product Name: SMP-114 Product Code: SMP-114 | Sumitomo Pharmaceuticals Europe Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Hungary;Czech Republic;Germany;United Kingdom | ||
| 156 | EUCTR2005-003436-21-GB (EUCTR) | 26/10/2005 | 05/09/2005 | A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 | A phase 2, multi-centre, randomised, double blind, placebo controlled study evaluating the efficacy, safety and pharmacokinetics of two doses of a candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg once daily), administered in combination with ongoing methotrexate treatment in patients with active rheumatoid arthritis. - ASPECTS- Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment with SMP-114 | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: SMP-114 Product Code: SMP-114 INN or Proposed INN: rimacalib | Dainippon Sumitomo Pharma Europe Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Hungary;Czech Republic;Germany;United Kingdom | ||
| 157 | EUCTR2005-002423-13-SK (EUCTR) | 18/10/2005 | 20/09/2005 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 | Rheumatoid arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA | F. Hoffmann La-Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 630 | Hungary;Slovakia;Austria;Bulgaria;Germany;Italy | |||
| 158 | EUCTR2005-002423-13-IT (EUCTR) | 28/09/2005 | 04/11/2005 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA 17822 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA 17822 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra INN or Proposed INN: RoActemra | F.Hoffmann La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 630 | Hungary;Slovakia;Bulgaria;Germany;Italy | |||
| 159 | EUCTR2005-002909-23-ES (EUCTR) | 21/09/2005 | 08/09/2005 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Estudio de extensión, a largo plazo, de la seguridad durante el tratamiento con tocilizumab (MRA) en pacientes con artritis reumatoide que hayan terminado el tratamiento en estudios trocales con MRA | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Estudio de extensión, a largo plazo, de la seguridad durante el tratamiento con tocilizumab (MRA) en pacientes con artritis reumatoide que hayan terminado el tratamiento en estudios trocales con MRA | Rheumatoid arthritis | Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab | F Hoffmann La-Roche AG | NULL | Not Recruiting | Female: yes Male: yes | 2420 | Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden | |||
| 160 | EUCTR2005-002423-13-DE (EUCTR) | 06/09/2005 | 05/07/2005 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 | Rheumatoid arthritis | Trade Name: RoActemra Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 630 | Hungary;Slovakia;Germany;Bulgaria;Italy | |||
| 161 | NCT00720798 (ClinicalTrials.gov) | September 2005 | 22/7/2008 | An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies | Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies | Rheumatoid Arthritis | Drug: Tocilizumab;Drug: Disease-modifying anti-rheumatic drugs;Drug: Non-steroidal anti-inflammatory drugs;Drug: Oral corticosteroids | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 2067 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;China;Costa Rica;Czech Republic;Denmark;Finland;France;Germany;Hong Kong;Iceland;Israel;Italy;Lithuania;Mexico;Netherlands;Norway;Panama;Peru;Portugal;Puerto Rico;Russian Federation;Serbia;Slovenia;South Africa;Spain;Sweden;Switzerland;Thailand;United Kingdom |
| 162 | EUCTR2005-002423-13-AT (EUCTR) | 22/08/2005 | 18/07/2005 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 | Rheumatoid arthritis | Trade Name: RoActemra Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA | F. Hoffmann La-Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 630 | Hungary;Slovakia;Austria;Bulgaria;Germany;Italy | |||
| 163 | NCT00721123 (ClinicalTrials.gov) | August 2005 | 22/7/2008 | A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis | Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in WA17822 | Rheumatoid Arthritis | Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 538 | Phase 3 | Argentina;Australia;Austria;Brazil;Bulgaria;Canada;France;Germany;Hong Kong;Hungary;Israel;Italy;Mexico;Singapore;Slovakia;Switzerland;Thailand;China |
| 164 | NCT00524160 (ClinicalTrials.gov) | July 2001 | 31/8/2007 | A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, in Patients With Rheumatoid Arthritis or Osteoarthritis | Open-Label Study To Assess The Effect On Pain Control Of Durogesic (Fentanyl Transdermic Therapeutic System) Treatment In Subjects With Rheumatoid Arthritis Or Osteoarthritis Of The Knee Or Hip. | Arthritis;Osteoarthritis;Rheumatoid Arthritis | Drug: Fentanyl transdermal patch | Janssen Pharmaceutica N.V., Belgium | NULL | Completed | 18 Years | N/A | Both | 264 | Phase 4 | NULL |
| 165 | EUCTR2012-003655-11-DE (EUCTR) | 09/12/2013 | Evaluation of long-term safety, tolerability and efficacy of GLPG0634 treatment in subjects with rheumatoid arthritis regarding subject’s disability, fatigue, and quality of life | A multicenter, open-label, long-term follow-up safety and efficacy study of GLPG0634 treatment in subjects with moderately to severely active rheumatoid arthritis | Moderately to severely active rheumatoid arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 739 | Phase 2 | United States;Czechia;Spain;Guatemala;Ukraine;Austria;Chile;Israel;Russian Federation;Colombia;France;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;Moldova, Republic of | |||
| 166 | EUCTR2005-002423-13-BG (EUCTR) | 03/08/2010 | Study of safety and efficacy of long-term treatment with tocilizumab in adult patients with rheumatoid arthritis. | Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - GROWTH95 | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody | F. Hoffmann La-Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 630 | Hungary;Germany;Switzerland;Bulgaria;France;Italy;Singapore;Hong Kong;Austria;Australia;Brazil;Israel;Slovakia;Canada;Mexico;Argentina;Thailand |