Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study)
Not Applicable
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000015462
- Lead Sponsor
- School of Medicine, University of Occupational and Environmental Health, Japan
- Brief Summary
A total of 48 patients achieved remission at week 52. After discontinuation of tofacitinib, only 29.2% of patients remained remission, while 50.0% of patients sustained remission after MTX discontinuation. A greater proportion of bio-naive patients achieved remission at week 52 and sustained LDA with tofacitinib discontinuation at week 104. The patients who were able to discontinue tofacitinib without flares had lower rheumatoid factor and lower anti CCP antibody before discontinuation of tofacitinib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 113
Inclusion Criteria
Not provided
Exclusion Criteria
Patients judged as inadequate by the subinvestigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SDAI remission, low disease activity rate DS28 remission rate, low disease activity rate
- Secondary Outcome Measures
Name Time Method RF, MMP-3, CRP, ACPA, HAQ, Sharp score, adverse events