rheumatoid arthritis
Conditions
Interventions
Treatment with hydroxyxhloroquine for 24 weeks.
Sponsors
Division of Rheumatology, Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who fulfill the following four criteria in Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine 1) Age 18- years 2) RA satisfying either the 1987 ACR criteria or 2010 ACR/ EULAR criteria 3) active disease (DAS28 2.6-) with poor prognostic factors with methotrexate treatment for over 3 months (stable dose for at least 4 weeks) or active disease with two or more oral conventional synthetic DMARDs for over 3 months (stable dose for at least 4 weeks) 4) One or more swollen joints and one or more tender joints 5) Written informed consent provided 6) Prior use of biological agent is permitted
Exclusion criteria
Exclusion criteria: 1) Pregnancy or hope to bear a child 2) Contraindication to HCQ, e.g. history of retinopathy and hypersensitivity to 4-aminoquinoline 3) Uncontrollable diabetes mellitus 4) Porphyria 5) Psoriasis 6) G6PD deficiency 7) Ineligible for the study judged by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement rate of ACR20 at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement rate of improving DAS28 category at weeks 4, 8, 12 and 24 Achievement rate of low disease activity in DAS 28 at weeks 4, 8, 12 and 24 Achievement rate of clinical remission in DAS 28 at weeks 4, 8, 12 and 24 Achievement rate of functional remission in HAQ at weeks 4, 8, 12 and 24 Achievement rate of structural remission in modified total Sharp score at week 24 Achievement rate of ACR 20 at at weeks 4, 8, and 12 Achievement rate of ACR 50/70 at weeks 4, 8, 12 and 24 Adverse effects during whole study | — |
Countries
Japan
Contacts
Public ContactYuko Kaneko
Keio University School of Medicine Division of Rheumatology
Outcome results
None listed