Systemic Lupus Erythematosus Clinical Trial
OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone (GL701)
in women with prednisone-dependent systemic lupus erythematosus.
II. Describe the pharmacokinetics of GL701.
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by
participating institution.
Patients are randomly assigned to 1 of 2 doses of oral dehydroepiandrosterone or placebo,
administered daily for a minimum of 7 months. A prednisone taper is attempted each month in
patients with stable or improving disease. Therapy continues until a successful prednisone
taper is achieved and sustained for at least 2 months, or until a maximum of 9 months.
Patients are followed for 1 year after entry.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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