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

Systemic Lupus Erythematosus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004665
• Other study ID #: 199/11935
• Secondary ID: NU-552
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: June 1995

Study information

• Verified date: December 2001
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• dehydroepiandrosterone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Northwestern University