PRECIOUS-B study
Not Applicable
Recruiting
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-jRCT1041190125
- Lead Sponsor
- Asai Shuji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 51
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 BAR plus MTX
3) RA patients receiving BAR, 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 low disease activity evaluated with SDAI, DAS28-CRP, and DAS28-ESR at week 0, 12, 24, 36, and 52<br>3) Proportion of patients maintaining remission evaluated with CDAI, SDAI, DAS28-CRP, and DAS28-ESR at week 0, 12, 24, 36, and 52<br>4) Following parameters from week 0 to 52<br> - CDAI, SDAI, DAS28-CRP, DAS28-ESR, J-HAQ <br> - CRP, ESR, MMP-3<br> - FSSG, EQ-5D, SF-36, FACIT fatigue<br>5) Change from week 0 to 52 in total Sharp score<br>6) Proportion of patients with structural remission and clinically relevant radiographic progression at week 52<br>7) Rate of regaining low disease activity in patients with CDAI>10<br>8) Predictors of maitaining low disease activity, structural remission, and clinically relevant radiographic progression<br>9) Adverse events