Hydroxychloroquine for Japanese patients with rheumatoid arthritis
Phase 2
- Conditions
- Rheumatoid arthritisD001172
- Registration Number
- JPRN-jRCTs031180050
- Lead Sponsor
- Kaneko Yuko
- Brief Summary
We investigated the efficacy and safety of hydroxychloroquine (HCQ) in patients with rheumatoid arthritis (RA). HCQ was administered to active RA despite conventional synthetic disease-modifying antirheumatic drugs for 24 weeks, in addition to prior treatment. The primary endpoint, the proportion of ACR20 achievements at week 24, was significantly higher in HCQ group compared to that of a propensity score matched control group. Neither hydroxychloroquine retinopathy nor any new safety signal was observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Rheumatoid arthritis patients with active disease (DAS28 greater than or equal to 2.6) over 18 years old
Exclusion Criteria
Contraindication to HCQ, e.g. history of retinopathy and hypersensitivity to 4-aminoquinoline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method