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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: | NCT00004662 |
OBJECTIVES:
I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with active systemic lupus erythematosus.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: dehydroepiandrosterone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Estimated Enrollment: | 300 |
Study Start Date: | March 1996 |
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.
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 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:
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:
Study ID Numbers: | 199/11918, NU-584 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004662 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 |