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

This study has been completed.
Sponsor:
Collaborator:
Northwestern University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004665
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001

February 24, 2000
June 23, 2005
June 1995
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Complete list of historical versions of study NCT00004665 on ClinicalTrials.gov Archive Site
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Phase II Study of Long-Term Dehydroepiandrosterone for Systemic Lupus Erythematosus
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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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Systemic Lupus Erythematosus
Drug: dehydroepiandrosterone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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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

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004665
199/11935, NU-552
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National Center for Research Resources (NCRR)
Northwestern University
Study Chair: Rosalind Ramsey-Goldman Northwestern University
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP