At a glance
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Study of Anti-Malarials in Incomplete Lupus Erythematosus
In Brief
A Phase 2 clinical trial evaluating Hydroxychloroquine and Placebo Oral Capsule for Systemic Lupus Erythematosus. Completed, enrolled 187 participants across 7 sites.
Detailed Summary
This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial that is designed to test whether treating patients who are at risk for development of lupus with hydroxychloroquine can slow accumulation of disease features. Effects on clinical progression of symptoms, patient-reported outcomes and changes in the immune markers of response will be measured and toxicity of the treatment will be assessed. This trial is a first step in testing a prevention strategy for lupus.
Study Details
Timeline
Interventions
Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.