46. 悪性関節リウマチ
［臨床試験数：4,183，薬物数：2,538（DrugBank：401），標的遺伝子数：183，標的パスウェイ数：219］
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollment | 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 | NCT03649061 (ClinicalTrials.gov) | June 8, 2018 | 30/7/2018 | COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA | Effectiveness of a Combination of Methotrexate and a Step Down Glucocorticoid Regimen (COBRA-Slim) for Remission Induction in Patients With Early Rheumatoid Arthritis (RA), With or Without Fast Access to 24 Weeks of Tumor Necrosis Factor (TNF) Blockade in Insufficient Responders, a Randomized, Multicenter, Pragmatic Trial | Arthritis, Rheumatoid | Drug: Etanercept 50 MG/ML;Drug: Leflunomide 10 milligram (MG) | P. Verschueren | Belgium Health Care Knowledge Centre | Active, not recruiting | 18 Years | N/A | All | 284 | Phase 4 | Belgium |
| 2 | NCT03449758 (ClinicalTrials.gov) | March 5, 2018 | 8/2/2018 | Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis | Effect of Sarilumab on Patient-reported Outcomes in Patients With Moderately to Severely Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor Inhibitors | Rheumatoid Arthritis | Drug: SARILUMAB;Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine | Sanofi | Regeneron Pharmaceuticals | Completed | 18 Years | N/A | All | 84 | Phase 4 | France |
| 3 | NCT04022525 (ClinicalTrials.gov) | February 1, 2018 | 15/7/2019 | Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches | Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches | Rheumatoid Arthritis | Drug: Leflunomide 20Mg Tab | Assiut University | NULL | Completed | 18 Years | N/A | All | 80 | Egypt | |
| 4 | EUCTR2011-004720-35-NL (EUCTR) | 22/03/2017 | 22/02/2017 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE INN or Proposed INN: METHOTREXATE INN or Proposed INN: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE INN or Proposed INN: PREDNISOLONE | The Karolinska Institute, ClinTRID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 4 | Finland;Denmark;Norway;Iceland;Netherlands;Sweden | ||
| 5 | NCT02930343 (ClinicalTrials.gov) | September 2016 | 13/9/2016 | Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy | Comparison of Sulfasalazine Versus Leflunomide Based Combination Disease Modifying Anti-rheumatic Drug Therapy (DMARD) in Patients With Rheumatoid Arthritis Failing Methotrexate Monotherapy : A Randomized Control Trial | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid;Drug: Sulfasalazine | Jawaharlal Institute of Postgraduate Medical Education & Research | NULL | Completed | 18 Years | 65 Years | All | 136 | Phase 3 | India |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | 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 |
| 7 | NCT02644499 (ClinicalTrials.gov) | December 31, 2015 | 30/12/2015 | Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis | Comparison of Combination Disease Modifying Antirheumatic Drugs (DMARDs) With Single Drug (Methotrexate) Therapy in Early Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Leflunomide;Drug: Hydroxychloroquine;Drug: Prednisolone;Drug: Folic Acid | Jawaharlal Institute of Postgraduate Medical Education & Research | NULL | Completed | 18 Years | N/A | All | 186 | Phase 4 | India |
| 8 | NCT02451748 (ClinicalTrials.gov) | August 2015 | 6/5/2015 | IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA | IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA | Rheumatoid Arthritis | Other: Lab Work;Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg);Drug: Certolizumab pegol (CDP870, tradename Cimzia);Drug: Hydroxychloroquine;Drug: Sulfasalazine;Drug: Medrol;Drug: Prednisone;Drug: Triamcinolone;Drug: Naproxen;Drug: Leflunomide;Drug: Methotrexate;Drug: humira | University of Illinois at Chicago | UCB Pharma | Completed | 18 Years | N/A | All | 32 | Phase 4 | United States |
| 9 | EUCTR2011-004720-35-NO (EUCTR) | 04/05/2015 | 26/01/2015 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Metex INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Imurel INN or Proposed INN: IMUREL Other descriptive name: AZATHIOPRINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN INN or Proposed INN: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Plaquenil Other descriptive name: HYDROXYCHLOROQUINE SULFATE | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 4 | Finland;Denmark;Norway;Sweden | ||
| 10 | NCT02373202 (ClinicalTrials.gov) | February 2015 | 12/2/2015 | A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) | A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: Mizoribine | Sanofi | Regeneron Pharmaceuticals | Completed | 20 Years | N/A | All | 91 | Phase 3 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2014-002374-36-SE (EUCTR) | 19/11/2014 | 27/08/2014 | A study with dose de-escalation of coventional or biologic treatments in early rheeumatoid arthritis in patients with low disease activity. | A multicenter, randomized, open-label, blinded-assessor, follow-up, phase 4 study in patients with rheumatoid arthritis who have completed the initial treatment part (active conventional therapy versus three biologic treatments) in the NORD-STAR study and have reached stable low disease activity - CO-STAR | Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra Trade Name: Methotrexate Trade Name: Metoject Trade Name: Azathioprine Trade Name: Leflunomide | The Karolinska Institutet, ClinTRID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 4 | Sweden | ||
| 12 | EUCTR2011-004720-35-FI (EUCTR) | 10/09/2014 | 09/09/2014 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: METHOTREXATE DISODIUM Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Oxiklorin Product Code: 118-42-3 Other descriptive name: HYDROXYCHLOROQUINE SULFATE | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Finland;Denmark;Sweden | |||
| 13 | EUCTR2011-004720-35-DK (EUCTR) | 28/05/2014 | 24/02/2014 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 4 | Finland;Denmark;Netherlands;Norway;Iceland;Sweden | ||
| 14 | NCT02057250 (ClinicalTrials.gov) | March 2014 | 31/1/2014 | To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis | A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy | RA | Drug: Sarilumab;Device: Auto-Injector Device (AID);Device: Pre-filled Syringe (PFS);Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Hydroxychloroquine | Sanofi | Regeneron Pharmaceuticals | Completed | 18 Years | N/A | All | 217 | Phase 3 | United States;Chile;Mexico;Poland;Russian Federation;South Africa;France |
| 15 | NCT01941095 (ClinicalTrials.gov) | November 20, 2013 | 30/8/2013 | A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis | Multicenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Tocilizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 100 | Phase 3 | Greece |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT02275299 (ClinicalTrials.gov) | September 2013 | 23/10/2014 | Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis | A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Iguratimod;Drug: Leflunomide;Drug: Methotrexate | Jiangsu Simcere Pharmaceutical Co., Ltd. | NULL | Recruiting | 18 Years | 70 Years | Both | 240 | Phase 4 | China |
| 17 | NCT01774877 (ClinicalTrials.gov) | July 2013 | 22/1/2013 | A Clinical Study of Xin'an Medicine in the Treatment of Bi Syndrome | Efficacy and Safety of Xinfeng Capsule in the Treatment of Rheumatoid Arthritis (RA):A Randomized, Double-blind, Double-dummy, Multi-center Trial | Rheumatoid Arthritis | Drug: Xinfeng capsule;Drug: leflunomide | The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | Ministry of Science and Technology of the People´s Republic of China | Completed | 18 Years | 65 Years | Both | 304 | N/A | China |
| 18 | NCT01768572 (ClinicalTrials.gov) | March 2013 | 11/1/2013 | To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN) | A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placebo | Sanofi | Regeneron Pharmaceuticals | Completed | 18 Years | N/A | All | 202 | Phase 3 | United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic |
| 19 | ChiCTR-TRC-13003948 | 2013-01-01 | 2013-12-05 | The evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney pattern | The evaluation of clinical curative effect of 'supplying of shen and nourishing sui' law of electroacupuncture combined with ZeLing joint swelling mixture in the treatment of rheumatoid arthritis with yin-deficiency of liver and kidney pattern | rheumatoid arthritis | Control:Methotrexate 10mg qw PO + Leflunomide 10mg qd PO ;EA combined with medicine group:M+L+SEA+ZJSM ; | Institute of Acupuncture-Moxibustion and Meridian, Shanghai University of Traditional Chinese Medicine | NULL | Completed | 18 | 70 | Both | Control:60;EA combined with medicine group:60; | China | |
| 20 | NCT01749787 (ClinicalTrials.gov) | November 2012 | 6/12/2012 | Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid Arthritis | A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: PRTX-100 at 1.5 mcg/kg;Drug: PRTX-100 at 3.0 mcg/kg;Drug: PRTX-100 at 6.0 mcg/kg;Drug: PRTX-100 at 12.0 mcg/kg;Drug: PRTX-100 at 240 mcg;Drug: Placebo;Drug: PRTX-100 at 420 mcg | Protalex, Inc. | NULL | Completed | 18 Years | N/A | Both | 61 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT01709578 (ClinicalTrials.gov) | October 2012 | 15/10/2012 | To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET) | A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing the Efficacy and Safety of Sarilumab Added to Non-biologic DMARD Therapy in Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF-a Antagonists | Rheumatoid Arthritis | Drug: Sarilumab;Drug: placebo;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide | Sanofi | Regeneron Pharmaceuticals | Completed | 18 Years | N/A | All | 546 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;Czechia;Ecuador;Germany;Greece;Guatemala;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Slovakia;Spain;Taiwan;Turkey;Ukraine;Czech Republic;Hong Kong |
| 22 | NCT01619176 (ClinicalTrials.gov) | October 2012 | 5/6/2012 | Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood | Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: methotrexate;Drug: non-steroidal anti-inflammatory drug (NSAID);Drug: leflunomide;Procedure: Acupuncture | Chinese Academy of Sciences | Shanghai GuangHua Hospital of integrated traditional and western medicine | Completed | 18 Years | 65 Years | Female | 15 | N/A | China |
| 23 | NCT01659242 (ClinicalTrials.gov) | July 2012 | 3/8/2012 | Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis:an Ultrasound/Magnetic Resonance Imaging Study | Leflunomide Versus Sulfasalazine/Methotrexate in Rheumatoid Arthritis Patients With Active Disease Despite Methotrexate: an Ultrasound and Magnetic Resonance Imaging Study | Rheumatoid Arthritis | Drug: Methotrexate plus sulfasalazine;Drug: Leflunomide | Singapore General Hospital | NULL | Terminated | 21 Years | 65 Years | Both | 1 | Phase 4 | Singapore |
| 24 | EUCTR2011-004720-35-SE (EUCTR) | 28/05/2012 | 22/12/2011 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE | The Karolinska Institute, ClinTRID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Sweden | |||
| 25 | NCT01617590 (ClinicalTrials.gov) | May 2012 | 28/5/2012 | Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research | A 48-week, Multi-center, Randomized, Open-lable, Controlled Study to Assess the Response (ACR20) Using Different Disease-Modifying Antirheumatic Drugs Cycle Combination Regimen in Adult Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: leflunomide;Drug: methotrexate | Shanxi Medical University | NULL | Recruiting | 18 Years | 75 Years | Both | 500 | N/A | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | ChiCTR-TRC-12001859 | 2012-01-01 | 2012-01-04 | Treatment of coronary heart disease in rheumatoid arthritis with leflunomide combined with ligustrazine in clinical research | Treatment of coronary heart disease in rheumatoid arthritis with leflunomide combined with ligustrazine in clinical research | coronary heart disease in rheumatoid arthritis | 1:leflunomide combined with ligustrazine;2:leflunomide combined with placebo; | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences | NULL | Completed | 18 | 65 | Both | 1:30;2:30; | China | |
| 27 | ChiCTR-TRC-11001789 | 2011-11-14 | 2011-12-12 | Effect of TGP combined with MTX and LEF on liver function in RA patients: Clinical study protocol | Effect of TGP combined with MTX and LEF on liver function in RA patients: Clinical study protocol | Rheumatoid Arthritis | Treatment:TGP capsules (TGP) + methotrexate (MTX) + leflunom;Control:methotrexate(MTX) + leflunomide (LEF); | Anhui Provincial Hospital Department of Rheumatism | NULL | Completed | 18 | 65 | Both | Treatment:140;Control:140; | China | |
| 28 | NCT01225393 (ClinicalTrials.gov) | November 2010 | 18/10/2010 | A Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patients With Active Rheumatoid Arthritis | A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: MLTA3698A;Drug: adalimumab;Drug: leflunomide;Drug: methotrexate;Drug: placebo | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | Both | 211 | Phase 2 | Romania;Spain;Bulgaria;Chile;Germany;Hungary;Mexico;Peru;Poland;United States |
| 29 | ChiCTR-TRC-10001014 | 2010-09-01 | 2010-08-30 | Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Method of Activating Blood Circulation by Removing Blood Stasis | Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Method of Activating Blood Circulation by Removing Blood Stasis | Rheumatoid Arthritis;M06.991 | Group A:observation group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po. Ligustrazine Powder-Needle, 0.12g, solubling in 5% GS/NS 100ml, qd, iv, in 30 to 60 minutes. ;Group B:control group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po. ; | Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences | NULL | Completed | 18 | 65 | Both | Group A:60;Group B:60; | I (Phase 1 study) | China |
| 30 | NCT01244958 (ClinicalTrials.gov) | August 2010 | 28/9/2010 | Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis | Addition of Rituximab to Leflunomide in Patients With Active Rheumatoid Arthritis - a Multicenter Randomised Double-blind Clinical Trial | Rheumatoid Arthritis | Biological: Rituximab;Drug: Placebo | Frank Behrens | NULL | Completed | 18 Years | 75 Years | Both | 156 | Phase 3 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2009-015740-42-DE (EUCTR) | 12/05/2010 | 12/01/2010 | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | A PHASE 3, MULTICENTER, RANDOMIZED, OPEN, PROSPECTIVE, CONTROLLED, PARALLEL-GROUP STUDY OF REDUCTION OF THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ONGOING REMISSIONRETRO – REduction of Therapy in RA patients in Ongoing remission,Reduzierung der Therapie bei RA-Patienten in Remission - RETRO | Rheumatoid arthritis MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: Prednisolon Product Code: Prednisolon INN or Proposed INN: PREDNISOLONE Trade Name: Humira INN or Proposed INN: ADALIMUMAB Product Name: Azathioprin Other descriptive name: AZATHIOPRINE Trade Name: Immunosporin Product Name: Immunosporin INN or Proposed INN: CICLOSPORIN Trade Name: Cimzia Product Name: Cimzia INN or Proposed INN: GOLIMUMAB Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT Product Name: Quensyl Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: REMICADE Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Lantarel Product Name: Lantarel INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Lantarel Trade Name: Arava Product Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Metex 2,5mg INN or Proposed INN: METHOTREXATE SODIUM Other descriptive name: Metex 2,5mg | Universitätsklinkum Erlangen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Germany | |||
| 32 | 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 | ||||
| 33 | ChiCTR-TRC-09000472 | 2009-07-20 | 2009-07-15 | Weekly dose of leflunomide for the treatment of early rheumatoid arthritis | Weekly dose of leflunomide for the treatment of early rheumatoid arthritis: a multicentre, open, randomized clincal trial | Rheumatoid arthritis | Group A:leflunomide 10mg,orally taken once daily for 24 weeks;Group B:leflunomide 50mg, orally taken weekly for 24 weeks; | People's Hospital, Peking University | NULL | Completed | 18 | 65 | Both | Group A:160;Group B:160; | China | |
| 34 | ChiCTR-TRC-12003871 | 2009-05-01 | 2012-01-01 | Phase II of Tong Luo Hua Shi Capsules in Rheumatoid Arthritis | A Multi-center, Randomized, Double-blind, Phase II Study Evaluating the Safety and Efficacy of Tong Luo Hua Shi Capsules in Participants with Rheumatoid Arthritis | Rheumatoid arthritis | A:2 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;B:3 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;C:4 pieces of Tong Luo Hua Shi Capsules. Votalin and Leflunomide Tablets when necessary;D:4 pieces placebo; | The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | NULL | Completed | 18 | 68 | Both | A:60;B:60;C:60;D:60; | I+2 (Phase 1;Phase 2) | China |
| 35 | NCT01172639 (ClinicalTrials.gov) | February 2009 | 28/7/2010 | Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. | A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Prednisone | P. Verschueren | Agentschap voor Innovatie door Wetenschap en Technologie | Completed | 18 Years | N/A | All | 400 | Phase 4 | Belgium |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2008-007225-39-BE (EUCTR) | 06/01/2009 | 12/02/2009 | A 2 year follow up to assess the effectiveness in daily practice of different treatment strategies for early Rheumatoid Arthritis patients. | A 2 year prospective multicentre randomised controlled trial comparing effectiveness in daily practice of different treatment strategies for early RA - CareRA | early active Rheumatoid Arthritis, previously untreated with DMARDS MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Ledertrexate INN or Proposed INN: methotrexate Other descriptive name: METHOTREXATE DISODIUM Trade Name: Salazopyrine INN or Proposed INN: SULFASALAZINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE | University Hospitals Leuven | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 4 | Belgium | ||
| 37 | EUCTR2007-000886-40-IT (EUCTR) | 04/06/2008 | 21/03/2008 | Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER | Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER | Patients with a diagnosis of early active rhematoid arthritis in the previous 6 months, naive of previous treatment by DMARD and who need to be treated by DMARD. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: ARAVA INN or Proposed INN: Leflunomide Trade Name: ARAVA INN or Proposed INN: Leflunomide Trade Name: ARAVA INN or Proposed INN: Leflunomide | sanofi-aventis Groupe | NULL | Not Recruiting | Female: yes Male: yes | 200 | Portugal;Italy | |||
| 38 | NCT00596206 (ClinicalTrials.gov) | December 2007 | 4/1/2008 | Leflunomide EfficAcy Response Related to Dosing Regimen in Early Rheumatoid Arthritis | Assessment of the Early Efficacy Response Rate of Leflunomide According to the Initial Dosing Regimen in the Treatment of Naive-DMARD (Disease Modifying Anti-Rheumatic Drug) Early RA (Rheumatoid Arthritis)-Patients | Arthritis, Rheumatoid | Drug: leflunomide | Sanofi | NULL | Completed | 18 Years | N/A | Both | 124 | Phase 3 | Czech Republic;Italy;Korea, Republic of;Portugal;Romania |
| 39 | EUCTR2007-000886-40-PT (EUCTR) | 09/11/2007 | 07/08/2007 | Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER | Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER | patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE | sanofi-aventis groupe | NULL | Not Recruiting | Female: yes Male: yes | 200 | Portugal;Italy | |||
| 40 | EUCTR2007-000886-40-CZ (EUCTR) | 17/07/2007 | 30/05/2007 | Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER | Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADER | patients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARD MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE Trade Name: ARAVA® INN or Proposed INN: LEFLUNOMIDE | sanofi-aventis groupe | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Czech Republic;Italy | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT00521924 (ClinicalTrials.gov) | June 2007 | 27/8/2007 | Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab Therapy (Study P04644AM1) (TERMINATED) | Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab-therapy | Rheumatoid Arthritis | Biological: infliximab;Drug: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89. | Merck Sharp & Dohme Corp. | AESCA Pharma GmbH | Terminated | 19 Years | 65 Years | All | 8 | Phase 3 | Austria |
| 42 | NCT00476996 (ClinicalTrials.gov) | May 15, 2007 | 18/5/2007 | A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-a Therapy (SCRIPT) | A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-a Therapy | Rheumatoid Arthritis | Drug: Leflunomide;Drug: Methotrexate;Drug: Ocrelizumab;Drug: Placebo | Genentech, Inc. | Roche Pharma AG | Terminated | 18 Years | N/A | All | 836 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Japan;Mexico;Netherlands;New Zealand;Panama;Peru;Poland;Slovakia;Slovenia;Spain;Sweden;Switzerland;Taiwan |
| 43 | EUCTR2007-001190-28-GB (EUCTR) | 09/05/2007 | 17/04/2007 | Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT | Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis - TACIT | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Methotrexate Product Code: Methotrexate INN or Proposed INN: METHOTREXATE Product Name: Sulfasalazine Product Code: Sulfasalazine INN or Proposed INN: SULFASALAZINE Product Name: Hydroxychloroquine Product Code: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine Product Name: Ciclosporin Product Code: Ciclosporin INN or Proposed INN: Ciclosporin Product Name: Leflunomide Product Code: Leflunomide INN or Proposed INN: Leflunomide Product Name: Sodium aurothiomalate (intramuscular gold) Product Code: Sodium aurothiomalate (intramuscular gold) INN or Proposed INN: Sodium aurothiomalate Product Name: methylprednisolone Product Code: methylprednisolone INN or Proposed INN: Methylprednisolone Product Name: Prednisolone Product Code: Predniso | King's College London | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 4 | United Kingdom | ||
| 44 | EUCTR2005-004582-41-GB (EUCTR) | 24/03/2006 | 27/01/2006 | Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA | Safety and efficacy of combination treatment with rituximab and leflunomide in patients with active rheumatoid arthritis - Rituximab and Leflunomide in RA | Active Rheumatoid Arthritis | University of Leeds | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | United Kingdom | |||
| 45 | NCT00280644 (ClinicalTrials.gov) | April 2004 | 19/1/2006 | Leflunomide in Rheumatoid Arthritis | Efficacy of Leflunomide on Joint Inflammation and Destruction of Joint Integrity in Active Rheumatoid Arthritis (RA) Patients | Arthritis, Rheumatoid | Drug: Leflunomide | Sanofi | NULL | Completed | 18 Years | 75 Years | Both | 60 | Phase 4 | Turkey |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT00563849 (ClinicalTrials.gov) | May 2003 | 21/11/2007 | Leflunomide + Methotrexate in Rheumatoid Arthritis | An Open-Label, Multi-Center Study to Evaluation of Leflunomide Plus Methotexate for the Treatment of Rheumatoid Arthritis in DMARDs:(Disease-Modifying Antirheumatic Drug) na¿ve or Restart (Skip DMARDs More Than 4 Weeks) Subjects. | Rheumatoid Arthritis | Drug: Leflunomide | Sanofi | NULL | Completed | 18 Years | 75 Years | Both | 74 | Phase 4 | Korea, Republic of |
| 47 | NCT00946686 (ClinicalTrials.gov) | September 2002 | 24/7/2009 | To Demonstrate the Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions | A Relative Bioavailability, Parallel Study Of Leflunomide 20 mg Tablets Under Fasting Conditions | Rheumatoid Arthritis;Psoriatic Arthritis | Drug: Leflunomide 20 mg Tablets (Geneva Pharmaceutical);Drug: Arava 20 mg Tablets (Aventis Pharmaceutical, Inc.) | Sandoz | NULL | Completed | 18 Years | N/A | All | 52 | Phase 1 | NULL |
| 48 | NCT00451971 (ClinicalTrials.gov) | March 2002 | 23/3/2007 | Objective Study in Rheumatoid Arthritis | Objective Study in Rheumatoid Arthritis | Arthritis, Rheumatoid | Drug: LEFLUNOMIDE | Sanofi | NULL | Completed | 18 Years | 75 Years | Both | 249 | Phase 4 | Australia |
| 49 | NCT00579878 (ClinicalTrials.gov) | December 1999 | 17/12/2007 | Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis | Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations (Leflunomide-Hydroxychloroquine-Sulfasalazine or Methotrexate-Hydroxychloroquine-Sulfasalazine) in the Treatment of Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Leflunomide;Drug: Methotrexate-Sulfasalazine-Hydroxychloroquine;Drug: Leflunomide-Sulfasalazine-Hydroxychloroquine | University of Nebraska | NULL | Completed | 19 Years | 80 Years | All | 69 | Phase 3 | United States |