Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity
Phase 4
Suspended
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-jRCTs071190001
- Lead Sponsor
- Miyazaki Yusuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
1) Patients aged over 16 years (at the time of informed consent)
2) Patients diagnosed with rheumatoid arthritis (RA) under the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) criteria
3) Patients who have been receiving combination therapy with MTX ( over 6 mg/week) and CZP for 24 weeks before enrollment of the study
4) Patients who showed SDAI less than 11 at any visit for over 3 months before enrollment without taking any steroids
5) Patients who provided written informed consent
Exclusion Criteria
Patients judged by the investigator to be unsuitable for participants in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with SDAI less than 11 at 12, 24, and 52 weeks after starting the study
- Secondary Outcome Measures
Name Time Method SDAI remission rate at 52 weeks after starting the study<br>DAS28-ESR remission rate at 52 weeks after starting the study<br>Duration of protocol therapy<br>Change from baseline in the mTSS at 52 weeks after starting the study