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 | NCT03938701 (ClinicalTrials.gov) | March 2021 | 25/2/2019 | Fluorescence Imaging of Disease Activity in IBD and Rheumatoid Arthritis Using OTL38 | Fluorescence Imaging for the Evaluation of Disease Activity in IBD and Rheumatoid Arthritis Using the Fluorescent Tracer OTL38 Targeting the Folate ß Receptor: a Single-center Pilot Study | IBD;Rheumatoid Arthritis | Drug: OTL38;Device: Fluorescence Imaging | University Medical Center Groningen | GlaxoSmithKline;On Target Laboratories, LLC;VU University Medical Center | Not yet recruiting | 18 Years | N/A | All | 30 | Phase 1 | Netherlands |
| 2 | JPRN-jRCT1041190125 | 09/03/2020 | 09/03/2020 | PRECIOUS-B study | Patient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study | Rheumatoid arthritis | 1) MTX* Week 0 to 12 - Reduced after registration. - The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose. - The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used. Week 12 to 52 - Discontinued if low disease activity was maintained. - Folic acid is discontinued if concomitantly used. *The allowable range of adherence is -20% to +20%. 2) BAR - Continued at a stable dose and interval throughout the course of the study. 3) csDMARDs other than MTX - Continued at a stable dose and interval throughout the course of the study. 4) Glucocorticoids - Continued at a stable dose up to week 36, and allowed to taper after week 36. 5) Rescue treatments One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request - Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX. - Increasing doses of or adding csDMARDs other than MTX. - Increasing doses of or adding glucocorticoids. - Drainage of synovial fluid. - Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. | Takahashi Nobunori | NULL | Pending | >= 20age old | Not applicable | Both | 51 | N/A | Japan |
| 3 | EUCTR2018-004429-94-NL (EUCTR) | 21/01/2020 | 17/06/2019 | Monitoring of respons to therapy in rheumatoid arthritis with the help of a PET scan. | [18F]PEG-folate PET-CT imaging for monitoring of therapy response in rheumatoid arthritis patients | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: [18F]PEG-Folate | VU Medical Center, department of Rheumatology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Phase 4 | Netherlands | ||
| 4 | NCT04066803 (ClinicalTrials.gov) | August 1, 2018 | 11/12/2018 | Optimal MTX Dose With Folic Acid Randomized Case-control Trial | Safety and Efficacy of Optimal Methotrexate With Folic Acid in Patients With Rheumatoid Arthritis in Meizhou, Guangdong: a Randomized Case-control Study | Rheumatoid Arthritis | Drug: MTX;Drug: Folic Acid;Drug: DMARDs | Sun Yat-sen University | Shanghai Pharmaceuticals Holding Co., Ltd | Recruiting | 18 Years | 70 Years | All | 160 | Phase 4 | China |
| 5 | JPRN-jRCT1031180088 | 18/04/2018 | 18/01/2019 | MIRACLE Study | MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study | Rheumatoid Arthritis Rheumatoid Arthritis | Subjects meeting all of the inclusion criteria and not applicable to any of the exclusion criteria will start receiving MTX 6 to 8 mg/week after the assessment at Week 0. Also, 10 mg of folic acid will be orally administered once a week 48 hours after the first MTX dosing day of the week to prevent ADRs related to MTX (A daily dosage of 1 mg folic acid is acceptable in South Korea on a condition that the dosage cannot be changed during the study period). To achieve remission, the dosage of MTX will be promptly escalated to the maximum tolerable dose (MTD) <=25 mg/week (the maximum dose should be set according to the package insert of each country) 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 ADR. Weekly dose of MTX will be administered orally at once or twice a day in principle. If the dosage of MTX is maintained >=10 mg/week and SDAI remission is achieved at Week 24, the MTX therapy will be continued until Week 48 (ARM-1). If SDAI remission is not achieved despite the maintenance of >=10 mg/week MTX dose at Week 24, ADA 40 mg will be administered subcutaneously every other week until Week 48. Subjects then will be stratified by countries (Japan, South Korea, and Taiwan) as a stratification factor, and for each stratum, subjects will be randomized at a 1:1 ratio to either 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). The MTX dosage shall be either 6 mg/week or 7.5 mg/week in subjects in ARM-3 whose maintenance dose of MTX at Week 24 is 10 mg/week. Subjects in whom MTX at a dosage >= | Kaneko Yuko | Eisai Co., Ltd. | Not Recruiting | >= 18age old | Not applicable | Both | 300 | Phase 4 | South Korea;Taiwan;Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT02795299 (ClinicalTrials.gov) | January 2018 | 2/5/2016 | Study Evaluating Gerilimzumab´s Safety/Efficacy for Patients MTX or TNFa Antagonist Failed in Rheumatoid Arthritis | Phase 2, Rand, Placebo-Controlled, Double-Blind, Dose Ranging Study to Evaluating Safety/Efficacy of Gerilimzumab in Patients With Moderately to Severely Active Rheumatoid Arthritis Inadequately Treated With Methotrexate or TNFa Antagonist | Rheumatoid Arthritis | Drug: Gerilimzumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Placebo | Bird Rock Bio, Inc. | Techtrials Pesquisa e Tecnologia Ltda;Pharmagenix | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 2 | NULL |
| 7 | NCT03028467 (ClinicalTrials.gov) | January 24, 2017 | 10/1/2017 | Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis | A Phase 1/2, Double-Blind, Placebo-Controlled Study of the Pharmacokinetics, Safety and Tolerability of GSK3196165 in Combination With Methotrexate Therapy, in Japanese Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Methotrexate | Arthritis, Rheumatoid | Drug: GSK3196165 Dose 1;Drug: GSK3196165 Dose 2;Drug: GSK3196165 Dose 3;Drug: Methotrexate;Drug: Placebo;Drug: Folic acid | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 15 | Phase 1;Phase 2 | Japan |
| 8 | NCT02833350 (ClinicalTrials.gov) | September 9, 2016 | 12/7/2016 | Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) | A Two-Cohort Randomized Phase II, Double-Blind, Parallel Group Study in Patients With Active Rheumatoid Arthritis Evaluating the Efficacy and Safety of GDC-0853 Compared With Placebo and Adalimumab in Patients With an Inadequate Response to Previous Methotrexate Therapy (Cohort 1) and Compared With Placebo in Patients With an Inadequate Response or Intolerance to Previous TNF Therapy (Cohort 2) | Rheumatoid Arthritis | Drug: GDC-0853;Drug: Adalimumab;Drug: Folic Acid;Drug: MTX;Drug: Placebo | Genentech, Inc. | NULL | Completed | 18 Years | 75 Years | All | 578 | Phase 2 | United States;Argentina;Brazil;Bulgaria;Colombia;Korea, Republic of;Mexico;Poland;Russian Federation;Serbia;Ukraine;Chile |
| 9 | 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 |
| 10 | NCT02762838 (ClinicalTrials.gov) | January 2016 | 4/4/2016 | Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | International Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC BIOCAD, Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: BCD-055;Biological: Remicade®;Drug: Methotrexate;Drug: Folic acid | Biocad | NULL | Completed | 18 Years | 75 Years | All | 426 | Phase 3 | Belarus;India;Russian Federation |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | 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 |
| 12 | NCT03172325 (ClinicalTrials.gov) | November 18, 2015 | 24/5/2017 | Study to Demonstrate Non-Inferiority Efficacy and Safety of CinnoRA® Produced by CinnaGen Company Versus Humira® for Treatment of Active Rheumatoid Arthritis | A Phase III, Randomized, Two-armed, Double-blind (Patient and Assessor Blinded), Parallel Active Controlled Non-Inferiority Clinical Trial to Determine the Non-inferior Therapeutic Efficacy and Safety of Two Disease-modifying Anti Rheumatic Drugs CinnoRA® (Produced by CinnaGen Company) Versus Humira® for Treatment of Active Rheumatoid Arthritis | Active Rheumatoid Arthritis | Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid;Drug: Prednisolone | Cinnagen | NULL | Completed | 18 Years | 75 Years | All | 136 | Phase 3 | NULL |
| 13 | NCT02504671 (ClinicalTrials.gov) | July 23, 2015 | 20/7/2015 | Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis | A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination With Methotrexate Therapy, in Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Methotrexate | Arthritis, Rheumatoid | Drug: GSK3196165;Drug: MTX;Drug: Folic acid;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 222 | Phase 2 | Bulgaria;Canada;Czechia;Estonia;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic |
| 14 | NCT02467504 (ClinicalTrials.gov) | July 1, 2015 | 4/6/2015 | Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Methotrexate (MTX)-Naive Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: hrIL-2 active;Drug: hrIL-2 placebo;Drug: MTX;Drug: Folic Acid;Drug: Loxoprofen | Peking University People's Hospital | Monash University;Beijing ShuangLu Pharmaceutical Co., Ltd. | Completed | 18 Years | 70 Years | All | 47 | Phase 2 | China |
| 15 | NCT02393378 (ClinicalTrials.gov) | April 8, 2015 | 15/3/2015 | Namilumab vs Adalimumab in Participants With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate | A 24-week Randomized, Open-Label, Parallel-Group, Active-Controlled, Exploratory, Proof-of-Mechanism Imaging Study Investigating the Efficacy of 150 mg of Namilumab Administered Subcutaneously vs Adalimumab in Patients With Moderate to Severe Early Rheumatoid Arthritis Inadequately Responding to Methotrexate | Rheumatoid Arthritis | Drug: Namilumab;Drug: Adalimumab;Drug: Methotrexate;Drug: Folic Acid | Takeda | NULL | Terminated | 18 Years | N/A | All | 7 | Phase 2 | Czechia;Estonia;Russian Federation;Spain;United Kingdom;Czech Republic |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | JPRN-JapicCTI-152979 | 01/2/2015 | Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) | A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) | Rheumatoid Arthritis | Intervention name : Namilumab Dosage And administration of the intervention : Namilumab 20 mg, 80 mg or 150 mg subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study. Control intervention name : Placebo Dosage And administration of the control intervention : Namilumab placebo-matching SC injection, once on Days 1, 15, 43, 71 and every 4 weeks up to Week 24 and a stable dose of methotrexate (15-25 mg weekly, 6-16 mg weekly in Japan), and folic acid (at least 5 mg/week), orally, throughout the duration of the study. | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | 20 | BOTH | 108 | Phase 2 | NULL | |||
| 17 | NCT02293902 (ClinicalTrials.gov) | November 2014 | 13/11/2014 | A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI) | A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy | Rheumatoid Arthritis | Drug: Sarilumab SAR153191 (REGN88);Other: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic acid | Sanofi | Regeneron Pharmaceuticals | Completed | 20 Years | 75 Years | All | 243 | Phase 3 | Japan |
| 18 | NCT01873443 (ClinicalTrials.gov) | May 2013 | 22/5/2013 | Long-Term Efficacy and Safety of CT-P10 in Patients With RA | An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1 | Rheumatoid Arthritis | Drug: Rituximab, MTX, folic acid | Celltrion | NULL | Completed | 18 Years | 75 Years | Both | 87 | Phase 1 | Korea, Republic of |
| 19 | NCT01850680 (ClinicalTrials.gov) | April 2013 | 1/5/2013 | Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis | A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered Sarilumab in Japanese Patients With Rheumatoid Arthritis Receiving Concomitant Methotrexate | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Drug: placebo;Drug: methotrexate;Drug: folic acid | Sanofi | Regeneron Pharmaceuticals | Completed | 20 Years | 65 Years | Both | 61 | Phase 1 | Japan |
| 20 | NCT01711359 (ClinicalTrials.gov) | November 2012 | 18/10/2012 | A Study in Participants With Moderate to Severe Rheumatoid Arthritis | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs | Rheumatoid Arthritis | Drug: Baricitinib;Drug: Methotrexate;Drug: Baricitinib Placebo;Drug: MTX Placebo;Drug: Folic Acid | Eli Lilly and Company | NULL | Completed | 18 Years | N/A | All | 588 | Phase 3 | United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Greece;India;Italy;Japan;Korea, Republic of;Mexico;Portugal;Puerto Rico;Russian Federation;South Africa;Sweden;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT01583959 (ClinicalTrials.gov) | April 2012 | 15/3/2012 | Study of Different Doses of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis | Randomized Trial of 10 mg Versus 30 mg Per Week of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Folic Acid;Drug: Placebo | Postgraduate Institute of Medical Education and Research | NULL | Completed | 18 Years | 75 Years | Both | 100 | Phase 4 | India |
| 22 | NCT01283971 (ClinicalTrials.gov) | May 2011 | 25/1/2011 | A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor | A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor | Rheumatoid Arthritis | Drug: tocilizumab [RoActemra/Actemra];Drug: adalimumab;Drug: placebo to tocilizumab;Drug: placebo to adalimumab;Drug: methotrexate;Drug: folate | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 96 | Phase 4 | United States;Denmark;Finland;France;Germany;Greece;Italy;Netherlands;Puerto Rico;Russian Federation;Spain;Sweden;United Kingdom |
| 23 | EUCTR2010-019134-27-BG (EUCTR) | 23/12/2010 | 18/10/2010 | A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY | A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY | Rhuematoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Trade Name: Methotrexate 10 mg tablets Product Name: Methotrextate INN or Proposed INN: Methotrexate Trade Name: Folimet Product Name: Folic Acid INN or Proposed INN: Folic Acid | Chelsea Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | United States;Czech Republic;Mexico;Argentina;Poland;Bulgaria | ||
| 24 | EUCTR2010-019134-27-CZ (EUCTR) | 19/10/2010 | 28/06/2010 | A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY | A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY | Rhuematoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Product Name: CH-4051 Product Code: CH-4051 INN or Proposed INN: Dipotassium Salt Trade Name: Methotrexate Product Name: Methotrextate INN or Proposed INN: Methotrexate Trade Name: Folic Acid Product Name: Folic Acid INN or Proposed INN: Folic Acid | Chelsea Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Bulgaria | ||
| 25 | NCT01116141 (ClinicalTrials.gov) | September 2010 | 3/5/2010 | A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA) | A Phase II, Multi-center, Randomized, Parallel Group, Double-blind, MTX Controlled Study to Assess the Clinical Efficacy, Safety and Tolerability of CH-4051 in Patients With Active RA Who Have Shown an Inadequate Response to MTX Monotherapy | Rheumatoid Arthritis | Drug: CH-4051;Drug: Methotrexate (MTX);Drug: Folic Acid | Chelsea Therapeutics | NULL | Completed | 18 Years | 80 Years | Both | 250 | Phase 2 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT01061736 (ClinicalTrials.gov) | March 2010 | 2/2/2010 | Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients | A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy | Rheumatoid Arthritis | Drug: Sarilumab;Drug: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic Acid | Sanofi | Regeneron Pharmaceuticals | Completed | 18 Years | 75 Years | All | 1675 | Phase 2;Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Brazil;Canada;Chile;Colombia;Czechia;Egypt;Estonia;Finland;Germany;Greece;Hungary;India;Korea, Republic of;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Norway;Philippines;Poland;Portugal;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Turkey;Ukraine;Czech Republic |
| 27 | NCT01010581 (ClinicalTrials.gov) | November 2009 | 9/11/2009 | SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis | A Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: SC12267 (4SC-101);Drug: Placebo;Drug: Methotrexate;Drug: Folic Acid | 4SC AG | NULL | Completed | 18 Years | N/A | Both | 266 | Phase 2 | Bulgaria;Czech Republic;Poland;Romania |
| 28 | NCT00965653 (ClinicalTrials.gov) | August 2009 | 18/8/2009 | A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis | Open-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: folic acid;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra] | Hoffmann-La Roche | NULL | Completed | 18 Years | 75 Years | Both | 29 | Phase 1 | Canada;New Zealand;Spain;United Kingdom |
| 29 | NCT00578305 (ClinicalTrials.gov) | November 2007 | 19/12/2007 | A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate | A Randomized, Placebo Controlled, Multicenter Clinical Study Investigating Efficacy of Rituximab in the Inhibition of Joint Structural Damage Assessed by Magnetic Resonance Imaging in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate | Rheumatoid Arthritis | Biological: Rituximab;Drug: Placebo;Drug: Methylprednisolone;Drug: Methotrexate;Drug: Folic acid or folate | Hoffmann-La Roche | NULL | Completed | 18 Years | 80 Years | All | 185 | Phase 3 | Argentina;Brazil;Canada;Czech Republic;Denmark;Estonia;France;Germany;Greece;Latvia;Lithuania;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Switzerland;Turkey;Former Serbia and Montenegro;United Kingdom |
| 30 | NCT00462345 (ClinicalTrials.gov) | June 2007 | 18/4/2007 | A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies. | An Open-label Study to Evaluate the Effect of MabThera in Combination With Methotrexate on Treatment Response in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies | Rheumatoid Arthritis | Drug: rituximab;Drug: Methotrexate;Drug: Corticosteroid or NSAID;Dietary Supplement: Folate | Hoffmann-La Roche | NULL | Completed | 18 Years | 80 Years | All | 40 | Phase 4 | Korea, Republic of |
| No. | TrialID | Date_ enrollment | 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 | NCT01308255 (ClinicalTrials.gov) | September 2006 | 3/3/2011 | Infliximab as Induction Therapy in Early Rheumatoid Arthritis (IDEA) | A Multi-centre Randomised Double Blind Placebo Controlled Study Comparing Two Regimens of Combination Therapy in Early DMARD Naive Rheumatoid Arthritis. | Rheumatoid Arthritis | Drug: Infliximab;Drug: Methylprednisolone;Drug: Methotrexate;Dietary Supplement: Folic acid | University of Leeds | NULL | Completed | 18 Years | 80 Years | All | 112 | Phase 4 | United Kingdom |
| 32 | NCT00588393 (ClinicalTrials.gov) | September 2006 | 22/12/2007 | FolateScan in Autoimmune Disease | Study of the Efficacy and Safety of FolateScan (Technetium TC99m EC20) in Patients With Rheumatoid Arthritis and Other Inflammatory Diseases | Rheumatoid Arthritis;Osteoarthritis;Multiple Sclerosis;Crohn's Disease;Systemic Lupus Erythematosus | Drug: FolateScan (Technetium Tc 99mEC20) | Mayo Clinic | Endocyte | Completed | 18 Years | N/A | Both | 75 | Phase 2 | United States |
| 33 | NCT00298272 (ClinicalTrials.gov) | May 2006 | 1/3/2006 | Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis | A Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Tolerability and Safety of Rituximab When Given in Combination With Methotrexate and Etanercept (Enbrel) or Methotrexate and Adalimumab (Humira) in Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: IDEC-C2B8 (rituximab);Drug: Placebo;Drug: Methotrexate;Drug: Etanercept;Drug: Adalimumab;Drug: Methylprednisolone;Dietary Supplement: Folate | Biogen | Hoffmann-La Roche;Genentech, Inc. | Terminated | 18 Years | 65 Years | All | 54 | Phase 2 | United States |
| 34 | NCT00266227 (ClinicalTrials.gov) | January 2006 | 14/12/2005 | A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Retreatment With Rituximab in Subjects With Rheumatoid Arthritis Receiving Background Methotrexate | Rheumatoid Arthritis | Drug: placebo;Drug: rituximab;Drug: methotrexate;Drug: folate | Genentech, Inc. | NULL | Completed | 18 Years | 80 Years | All | 559 | Phase 3 | United States |
| 35 | NCT00299104 (ClinicalTrials.gov) | January 2006 | 2/3/2006 | A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis | A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: placebo;Drug: rituximab | Genentech, Inc. | Hoffmann-La Roche | Completed | 18 Years | 80 Years | All | 755 | Phase 3 | United States |
| No. | TrialID | Date_ enrollment | 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 | NCT00299130 (ClinicalTrials.gov) | October 2005 | 3/3/2006 | A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis | A Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Folate;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Placebo;Drug: Rituximab | Genentech, Inc. | Hoffmann-La Roche | Completed | 18 Years | 80 Years | All | 511 | Phase 3 | United States |
| 37 | EUCTR2005-000551-15-GB (EUCTR) | 05/09/2005 | 05/08/2005 | Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate | Effect of folic acid supplementation and allopurinol on endothelial function in patients with rheumatoid arthritis treated with methotrexate - Endothelial function in rheumatoid arthritis patients on methotrexate | Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory polyarthritis associated with excess cardiovascular (CV) mortality. Hyperhomocysteinaemia is recognized as an independent CV risk factor and homocysteine levels are frequently elevated in RA patients.Endothelial dysfunction is considered a marker of early atherosclerotic disease and seems to correlate well with future increase CV risk. RA patients are known to have endothelial dysfunction. | Product Name: Allopurinol Product Code: Allopurinol INN or Proposed INN: Allopurinol Product Name: Folic acid Product Code: Folic acid INN or Proposed INN: Folic acid | University of Dundee | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | United Kingdom | |||
| 38 | NCT00243412 (ClinicalTrials.gov) | August 2005 | 21/10/2005 | A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate | A Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of Methotrexate | Rheumatoid Arthritis | Drug: folate;Drug: methotrexate;Drug: methylprednisolone;Drug: Placebo;Drug: Rituximab | Genentech, Inc. | NULL | Completed | 18 Years | 65 Years | All | 42 | Phase 2 | United States |
| 39 | NCT02093026 (ClinicalTrials.gov) | August 2002 | 19/3/2014 | Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA) | An Open-label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera®/Rituxan®) in Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Rituximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Folic Acid | Hoffmann-La Roche | Genentech, Inc. | Completed | 21 Years | N/A | All | 465 | Phase 2 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;Finland;Germany;Israel;Italy;Mexico;New Zealand;Poland;Spain;Sweden;United Kingdom |
| 40 | NCT00000395 (ClinicalTrials.gov) | September 1996 | 3/11/1999 | Antifolate Effectiveness in Arthritis | Mechanisms of Antifolate Efficacy in Arthritis | Rheumatoid Arthritis;Adjuvant Arthritis | Drug: Methotrexate;Dietary Supplement: Folinic acid;Dietary Supplement: Folic acid | University of Alabama at Birmingham | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Office of Dietary Supplements (ODS) | Completed | 18 Years | 85 Years | Both | 40 | Phase 2 | United States |