Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis
Summary
The purpose of this study is to determine if hydroxychloroquine (HCQ) is safe and effective for the prevention of future onset of rheumatoid arthritis (RA) in individuals who have elevations of an autoantibody, anti-cyclic citrullinated peptide (anti-CCP3). The following recruitment strategies will be employed towards identifying healthy subjects with elevated anti-cyclic citrullinated peptide (anti-CCP3) levels: -Pre-screening: * first degree relatives of patients with rheumatoid arthritis (RA); * subjects at health-fairs; and * identification of subjects with elevated anti-CCP3 levels in the absence of inflammatory arthritis in rheumatology clinics.
Timeline
- Start
- 2016-04-27
- Primary completion
- 2022-11-01
- Completion
- 2022-11-01
Outcome
Missed primary endpoint
Stopped (Enrollment): “Enrollment was closed before reaching the target. In the 1st interim analysis after enrollment closure, the follow up \& treatment of active participants were stopped early due to evidence of futility.”
registry analysis (superiority test); Hydroxychloroquine vs Placebo; p = 0.522; Risk Difference (RD) -0.058 (95% CI -0.336 to 0.220); NCT02603146 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxychloroquine | Small molecule | 200 mg | — |
| Subject | Hydroxychloroquine | Small molecule | 400 mg | — |