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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Northwestern University |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004795 |
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.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: dehydroepiandrosterone |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Estimated Enrollment: | 190 |
Study Start Date: | August 1994 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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 No prior participation in double-blind dehydroepiandrosterone (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 the following: Adrenocorticotropin hormone Androgens Cyclophosphamide Azathioprine Intravenous immune globulin Other immunosuppressants At least 1 month since any change in dose of concurrent nonsteroidal anti- inflammatory drugs or hydroxychloroquine --Patient Characteristics-- No hypersensitivity to DHEA or inactive ingredient in DHEA, i.e.: Cornstarch Lactose 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
Study ID Numbers: | 199/11930, NU-517 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004795 History of Changes |
Health Authority: | United States: Federal Government |
arthritis & connective tissue diseases immunologic disorders and infectious disorders rare disease systemic lupus erythematosus |
Autoimmune Diseases Immunologic Factors Lupus Erythematosus, Systemic Lupus Arthritis |
Adjuvants, Immunologic Rare Diseases Connective Tissue Diseases Dehydroepiandrosterone |
Autoimmune Diseases Immunologic Factors Immune System Diseases Lupus Erythematosus, Systemic Physiological Effects of Drugs |
Adjuvants, Immunologic Connective Tissue Diseases Dehydroepiandrosterone Pharmacologic Actions |