Stable weekly dose of methotrexate
( DrugBank: - / KEGG DRUG: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 4 |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
Showing 1 to 4 of 4 trials
| No. | TrialID | Date_ enrollment | 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 | JPRN-jRCT1041190125 (jRCT1041190125) | 09/03/202020200309 | 09/03/202020200309 | 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 Patient REported, Clinical, and Imaging OUtcomes oftapering methotrexatein patients with rheumatoid ... | 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. 1) MTX* Week 0 to 12 - Reduced after registration. - The dosing frequency ofMTX is decreased from weekl ... | Asai Shuji | NULL | Recruiting | >= 20age old | Not applicable | Both | 51 | N/A | Japan |
| 2 | JPRN-jRCTs041180071 (jRCTs041180071) | 13/10/201620161013 | 07/03/201920190307 | T-ReX study | Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study Tocilizumab treatment with Reducing and stopping methotreXatein patients with rheumatoid arthritis i ... | Rheumatoid arthritis | At week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were 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 or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine. At week 0, the dosing frequency ofMTX was decreased from weeklyto biweekly without a change in dose, ... | Kojima Toshihisa | NULL | Complete | >= 20age old | Not applicable | Both | 51 | N/A | Japan |
| 3 | JPRN-JapicCTI-152979 | 01/2/201520150201 | 00000000 | Dose Finding Study of Namilumab in Combination With Methotrexate in Participants With Moderate to Severe Rheumatoid Arthritis (RA) DoseFinding Study ofNamilumab in Combination With Methotrexatein Participants With Moderate to Sever ... | 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) A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 DoseFinding Study to Evaluate the Ef ... | 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. Intervention name : Namilumab Dosage And administration ofthe intervention : Namilumab 20 mg, 80 mg o ... | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | 20 | BOTH | 108 | Phase 2 | NULL | ||
| 4 | NCT00950989 (ClinicalTrials.gov) | December 200920091200 | 30/7/200920090730 | AMG 827 in Rheumatoid Arthritis Subjects With Inadequate Response to Methotrexate | A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate A Randomized, Double-blind, Placebo-controlled, Multiple-doseStudy to Evaluate the Safety, Tolerabil ... | Rheumatoid Arthritis | Drug: AMG 827 70 mg;Drug: AMG 827 140 mg;Drug: AMG 827 210 mg;Drug: Placebo;Drug: Stable weekly dose of methotrexate Drug: AMG 827 70 mg;Drug: AMG 827 140 mg;Drug: AMG 827 210 mg;Drug: Placebo;Drug: Stable weekly dose ... | Amgen | NULL | Completed | 18 Years | 70 Years | Both | 240 | Phase 2 | Bulgaria;Canada;Czech Republic;Hungary;Latvia;Mexico;Poland;United Kingdom;United States |