A Phase 2 Trial of Hydroxychloroquine in Individuals at Risk for Rheumatoid Arthritis
Primary result · Clinical RAResult — go to the resultDifference −0.058 95% CI −0.336 to 0.220Authors' conclusion
In this trial involving individuals with anti-CCP3 levels ≥2 times the ULN, 12 months of HCQ did not prevent the development of clinical RA at 36 months.
Study context
- Population
- Individuals at risk for rheumatoid arthritis (RA) with anti-CCP3 ≥2 times the upper limit of normal (ULN)randomized
- Participants
- 144 individuals
- Comparison
- Hydroxychloroquine (HCQ) for 12 months vs placebo
- HCQn = 71
- Placebon = 73reference
- Primary endpoint
- Development of clinical RA, as defined in the protocol
- Follow-up
- 36 months
Methodological detailsphase 2, placebo-controlled
- Phase 2
- Placebo-controlled
Primary result
Clinical RA
Difference
−0.058
95% CI −0.336 to 0.220
P = 0.52
Events by treatment group
HCQvs Placebo
difference −0.058 (95% CI −0.336 to 0.220); P = 0.52
As reported in the abstract
Secondary outcomes
Inflammatory arthritis (IA)
- Results for IA were similar
Participant-reported joint symptoms
- Occurrence and severity of joint symptoms not observed to differ between groups
Safety
- Adverse event incidence was similar between groups
Original publication
A Phase 2 Trial of Hydroxychloroquine in Individuals at Risk for Rheumatoid Arthritis. Arthritis Rheumatol. Published 16 March 2026. doi:10.
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