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Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus Erythematosus



Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus Erythematosus

For Condition: Systemic Lupus Erythematosus
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Northwestern University
Synopsis: OBJECTIVES: I. Evaluate the long-term safety and tolerance of a synthetic formulation of dehydroepiandrosterone, GL701, in patients with systemic lupus erythematosus who have completed a prior GL701 protocol.
Details: PROTOCOL OUTLINE: Patients receive daily oral dehydroepiandrosterone for 12 months. The dose is adjusted based on disease activity and tolerance of treatment. Patients are followed every 3 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Systemic lupus erythematosus by American College of Rheumatology criteria Mild to moderate disease characterized as follows: Prednisone dose (or equivalent) 10 to 30 mg/day No daily dose 1 mg/kg or greater No alternate-day regimen Failed prednisone taper in last 12 months and dose stable for at least 6 weeks prior to entry OR No attempt to taper in last 12 months and dose stable for at least 3 months prior to entry Prior completion of dehydroepiandrosterone (DHEA) study required No prior participation in double-blind DHEA study at Stanford University --Prior/Concurrent Therapy-- No concurrent immunosuppressants No concurrent participation in other clinical studies No investigational agents within the longer of 30 days or 10 half-lives of the agent At least 3 months since immunosuppressants, including: Adrenocorticotropin hormone Androgens Cyclophosphamide Azathioprine Intravenous immune globulin At least 1 month since change in dose of nonsteroidal anti-inflammatory drugs or hydroxychloroquine --Patient Characteristics-- Age: 18 and over Sex: Female only Performance status: Not specified Other: No hypersensitivity to DHEA or inactive ingredient in GL701 formulation, i.e., cornstarch, lactose, or magnesium stearate No condition that would prevent adequate compliance with study No history of breast cancer or reproductive tract malignancy Negative pregnancy test required within 2 weeks prior to entry Reliable contraception required of fertile women No estrogen-containing oral contraceptive
Total Enrollment: 20

Location and Contact Information:

Overall Study Official:
RosalindRamsey-Goldman,  Study Chair,  Northwestern University


Additional Information:
Study ID Numbers:  199/11935;  NU-552
Study Start Date: June 1995
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004665

Other Systemic Lupus Erythematosus Studies:
1. Safety of Estrogens in Lupus: Hormone Replacement Therapy

2. Role of Antibodies in Cognitive Dysfunction in Patients with Systemic Lupus Erythematosus

3. Safety of Estrogens in Lupus: Birth Control Pills

4. Humanized LL2IGG to Treat Systemic Lupus Erythematosus

5. Cyclophosphamide and Fludarabine to Treat Lupus Nephritis

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