46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details


臨床試験数 : 4,325 薬物数 : 2,681 - (DrugBank : 417) / 標的遺伝子数 : 185 - 標的パスウェイ数 : 223

  
7 trials found
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1JPRN-JapicCTI-194928
26/8/201922/08/2019-An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101An assessor-blinded, subject-blinded, double-dummy, active-controlled, randomised trial to compare the safety and efficacy of subcutaneous methotrexate (MJK101) with oral methotrexate in methotrexate-naive subjects with active rheumatoid arthritis followed by an open-label, single-arm extension to assess the long-term safety of MJK101 Rheumatoid ArthritisIntervention name : methotrexate
INN of the intervention : methotrexate
Dosage And administration of the intervention : Part 1: 7.5 mg MJK101 (SC) or dummy MJK101 (SC) will be administered once a week over a period of 12 weeks. Part 2: All subjects will receive once-weekly MJK101 (SC) for 12 months. At Trial Week 12, the once-weekly dose of MJK101 (SC) will be determined according to the disease activity status of the subject and an assessment of safety. If the subject has not met a low disease activity status at the visits every 4 weeks and has been well tolerated, then the once-weekly MJK101 (SC) dose will be increased by 2.5 mg to a maximum dose of 15 mg.
Control intervention name : methotrexate
INN of the control intervention : methotrexate
Dosage And administration of the control intervention : Part 1: 8 mg MTX (oral) or placebo MTX (oral) will be administered once a week over a period of 12 weeks. The oral administration of MTX or placebo MTX will be divided into 2 doses to be administered approximately within a 12-hour interval.
medac GmbHNULLcomplete2075BOTH100Phase 3Japan
2NCT04179513
(ClinicalTrials.gov)
August 15, 201925/11/2019A Study to Evaluate the Safety and Tolerability of Multiple Doses of Gerilimzumab in Rheumatoid Arthritis PatientsPhase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Gerilimzumab for Injection in Combination With Oral Methotrexate in Rheumatoid Arthritis Patients in Two Dose GroupsRheumatoid ArthritisBiological: GB224 10mg;Biological: GB224 20mgGenor Biopharma Co., Ltd.NULLRecruiting18 Years45 YearsAll24Phase 1China
3NCT02373813
(ClinicalTrials.gov)
February 20, 201512/1/2015Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis RemissionA Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid ArthritisRheumatoid ArthritisDrug: etanercept pre-filled syringe sq injection;Drug: Oral methotrexate;Drug: Placebo for etanercept sq injection;Drug: Placebo for methotrexateAmgenNULLCompleted18 YearsN/AAll371Phase 3United States;Argentina;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;South Africa;Spain;Czech Republic
4NCT01618968
(ClinicalTrials.gov)
May 20124/6/2012Comparison of Methotrexate (MTX) and the VIBEX™ MTX DeviceExposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid ArthritisRheumatoid Arthritis (RA)Drug: MTXAntares Pharma Inc.NULLCompleted18 YearsN/AAll49Phase 2United States
5NCT00620685
(ClinicalTrials.gov)
March 200810/1/2008A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking MethotrexateA 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Safety And Pharmacokinetic Profile Of 1 And 5 Mg Ph-797804 Administered Once Daily In Subjects With Rheumatoid Arthritis Who Are Taking Oral MethotrexateArthritis, RheumatoidDrug: Placebo;Drug: PH-797804PfizerNULLCompleted18 YearsN/AAll27Phase 2United States
6NCT00487825
(ClinicalTrials.gov)
March 200718/6/2007Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid ArthritisA 26-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR50) and to Determine a Biomarker Profile in Responders to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) Plus MTX as Compared to MTX Alone in Early Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: Canakinumab (investigational);Drug: Placebo;Drug: Methotrexate (MTX)NovartisNULLCompleted18 Years75 YearsAll78Phase 2United States;Belgium;Germany;Italy;Netherlands;Spain
7NCT01745055
(ClinicalTrials.gov)
April 20054/12/2012Co-Administration Of Methotrexate And CP-690,550A Phase 1, Open Label Study Of The Pharmacokinetics Of Multiple Doses Of Oral CP-690,550 And Single Doses Of Oral Methotrexate In Rheumatoid Arthritis SubjectsRheumatoid ArthritisDrug: CP-690,550 (tofacitinib);Drug: Methotrexate (MTX)PfizerNULLCompleted18 Years70 YearsAll12Phase 1United States