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Study of Antimalarials in Incomplete Lupus Erythematosus (SMILE)
This is a study to test whether a widely-used drug, hydroxychloroquine, might slow the progression of lupus like features in individuals who are at high risk for developing systemic lupus erythematosus. This will be measured by the accumulation of clinical and laboratory features of lupus. The study will randomize subjects to the active drug, hydroxychloroquine, or placebo, with an equal chance of receiving either treatment. The study treatment lasts approximately 2 years with visits approximately every 3 months.
Visits occur every 3 months for 2 years, Vitals signs and blood draws will occur at every visit.
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-4921
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NCT03030118
STUDY00003506
Inclusion Criteria:
Positive for ANA (antinuclear antibodies)Age 18 to 49 years, inclusive
Have never taken hydroxychloroquine
Exclusion Criteria:
Previous use of immunosuppressive drugsDiagnosis of systemic lupus erythematosus
Arthritis & Rheumatic Diseases