In methotrexate resistant rheumatoid arthritis, switching methotrexate to tofacitinib versus adding tofacitinib to methotrexate, open labeled, multicenter randomized non-inferiority study.
Phase 4
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000017440
- Lead Sponsor
- Graduate School of Medicine and School of Medicine, Chiba University the department of allergy and clinical immunology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 134
Inclusion Criteria
Not provided
Exclusion Criteria
(1)The patient suffering from autoimmune disease With the exception of the Sjogren's syndrome and thyroid disease. (2)Active tuberculosis, HIV, HBV or HCV infection has coexist. (3)There is a pregnancy hope. (4)There is a history of malignancy within the past 5 years. (5)There is a history of tuberculosis infection within the past one year. (6)There is a potential comorbidities requiring Intravenous glucocorticoid, Oral glucocorticoid, Immunosuppressant, biologics, Plasma exchange or IVIG during the study period. (7)Other, who is investigator or test sharing doctor was judged unsuitable to safely carry out the present study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Achievement rate of ACR20 at 12 weeks
- Secondary Outcome Measures
Name Time Method Achievement rate of ACR20 at 4 and 8 weeks Achievement rate of ACR50 and 70 at 4, 8 and 12 weeks Achievement rate of remission at 4, 8 and 12 weeks DAS28-ESR and DAS28-CRP at 4, 8 and 12 weeks HAQ score at 4, 8 and 12weeks Tender joint counts and swollen joint counts at 4, 8 and 12 weeks