Systemic Lupus Erythematosus
Conditions
Keywords
arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
Brief summary
OBJECTIVES: I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with active systemic lupus erythematosus.
Detailed description
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomly assigned to daily oral dehydroepiandrosterone or placebo for 52 weeks. Patients are evaluated every 13 weeks on study and return for a follow-up 6 weeks after completion of therapy. Concurrent therapy with estrogen replacement and stable doses of prednisone, azathioprine, methotrexate (with folate supplementation), hydroxychloroquine, and nonsteroidal anti-inflammatory drugs is allowed. Other investigational medications and immunosuppressants are prohibited.
Interventions
DRUGdehydroepiandrosterone
Sponsors
Northwestern University
National Center for Research Resources (NCRR)
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Systemic lupus erythematosus by 1982 American College of Rheumatology criteria Diagnosed for at least 6 months Systemic Lupus Activity Measure score at least 7 Points for erythrocyte sedimentation rate excluded SLEDAI score of greater than 2 at both screening and qualifying visits --Prior/Concurrent Therapy-- No prior participation in any dehydroepiandrosterone (DHEA) study No investigational agent within the longer of 30 days or 10 half-lives of the agent Prednisone (or equivalent) dose 0 to 10 mg/day Unchanged for at least 6 weeks prior to entry At least 3 months since immunosuppressants other than azathioprine and methotrexate, including: * DHEA * Adrenocorticotropin hormone * Androgens * Cyclophosphamide * Cyclosporine * Immune globulin At least 6 weeks since change in azathioprine, methotrexate, or hydroxychloroquine --Patient Characteristics-- Renal: No requirement for hemodialysis Cardiovascular: No serious abnormality on electrocardiogram Other: * No hypersensitivity to DHEA or inactive ingredients in GL701 formulation, i.e., cornstarch, lactose, or magnesium stearate * No history of breast cancer or reproductive tract malignancy * Cervical carcinoma eligible if surgically cured, i.e., no evidence of disease for 5 years * No condition that would prevent compliance or follow-up, e.g.: Alcoholism Drug addiction Acute withdrawal from chemical dependency * Psychiatric disease * No pregnant or nursing women * Negative pregnancy test required of fertile women * Reliable contraception required of fertile women * No estrogen-containing oral contraceptives on study * At least 3 weeks since estrogen-containing oral contraceptives
Outcome results
None listed