Discontinuation of adalimumab without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis: An observational study
Not Applicable
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-UMIN000006669
- Lead Sponsor
- niversity of Occupational and Environmental Health, Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1) Use of glucocorticoids for 24 weeks prior to discontinuation of adalimumab, 2) use of NSAIDs for 24 weeks prior to discontinuation of adalimumab, 3) severe infection, 4) active tuberculosis, 5) demyelinating disease (multiple sclerosis), 6) congestive heart failure, 7) Patient who is lactating, pregnant, possibly pregnant or do not agree with anti-conception during the trial and 6 months after the last administration of adalimumab, 8) patients who are inadequate to enter this trial due to the other reasons as judged by investigators
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients who maintained remission status at 24 weeks after discontinuation of adalimumab
- Secondary Outcome Measures
Name Time Method Percentages of patients who maintained low disease activity (DAS28-ESR <3.2), remission (DAS28-ESR <2.6), normal function (HAQ <0.5) and no structural damage (1-year change of mTSS <0.5) at 24/52 weeks after discontinuation of adalimumab