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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
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: dehydroepiandrosterone
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 20
Study Start Date: June 1995
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004665

Sponsors and Collaborators
Northwestern University
Investigators
Study Chair: Rosalind Ramsey-Goldman Northwestern University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004665     History of Changes
Other Study ID Numbers: 199/11935, NU-552
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
arthritis & connective tissue diseases
immunologic disorders and infectious disorders
rare disease
systemic lupus erythematosus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014