Trial NCT02603146

View at ClinicalTrials.gov 
Org. Study IDs: DAIT ARA08
Secondary IDs: NIAID CRMS ID#: 20681

Last trial update was posted on 2023-12-20

MeSH Interventions

Hydroxychloroquine

MeSH Conditions

Arthritis Arthritis, Rheumatoid

Other Conditions

Healthy Participants Rheumatoid Arthritis (RA) Prevention

Stopping Reasons

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.

Limitations And Caveats

Enrollment closed at 144 randomized participants before reaching the target of 200 due to slow participant accrual. The decision was supported by a revised power analysis suggesting sufficient power for the study with reduced numbers assuming a clinically-relevant difference in RA rates between arms (50% risk for placebo & 25% risk for HCQ). In the 1st interim analysis after enrollment closure, the follow up & treatment of the active participants were stopped early due to evidence of futility.

Result Publications

N/A

Annotations

Category Annotations
No annotators decided on categories yet

Intervention Annotations
# Outdated Intervention Condition
Name Route DrugBank ID