Certolizumab Pegol treatment with Reducing and stoppIng MEthotrexate in patients with Rheumatoid Arthritis in stable low disease activity-state
Not Applicable
Recruiting
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-jRCTs041200048
- Lead Sponsor
- Asai Shuji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 88
Inclusion Criteria
1) Patients fulfilled the 1987 ACR classification criteria or the new ACR/EULAR diagnostic criteria for RA
2) RA patients with sustained low disease activity (CDAI <=10) for >=12 weeks while undergoing combination therapy with CZP plus MTX
3) RA patients receiving CZP, MTX, csDMARDs, and glucocorticoids at a stable dosage regimen for >=12 weeks prior to obtaining informed consent
4) RA patients aged >=20 years
5) Obtaining written informed consent
Exclusion Criteria
1) Patients with adherence problems
2) Patients judged as inadequate at the discretion of inevstigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients maintaining low disease activity without a flare* at week 36 (24 weeks after MTX discontinuation).<br>*Disease flare is defined as a CDAI score >10 or intervention with the rescue treatments for any reason.
- Secondary Outcome Measures
Name Time Method 1) Proportion of patients maintaining low disease activity evaluated with CDAI at week 12, 24, and 52<br>2) Proportion of patients maintaining clinical remission evaluated with CDAI at week 0, 12, 24, 36, and 52<br>3) Following parameters from week 0 to 52<br>- CDAI, SDAI, DAS28-CRP, J-HAQ<br>- CRP, MMP-3<br>- FSSG, EQ-5D<br>4) Changes of following parameters from week 0 to 52<br>- Total Sharp score<br>- Atlantodental interval<br>5) Proportion of patients with structural remission<br>and clinically relevant radiographic progression at week 52<br>6) Rate of regaining low disease activity in patients with CDAI>10<br>7) Predictors of maitaining low disease activity, structural remission, and clinically relevant radiographic progression<br>8) Adverse events