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Clinical Trials/JPRN-jRCTs031180050
JPRN-jRCTs031180050
Completed
Phase 2

Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis

Kaneko Yuko0 sites60 target enrollmentStarted: December 7, 2018Last updated:
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ConditionsRheumatoid arthritisD001172

Overview

Phase
Phase 2
Status
Completed
Sponsor
Kaneko Yuko
Enrollment
60
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 18age old to ot applicable (—)
Sex
All

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

Investigators

Sponsor
Kaneko Yuko

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