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Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus
This study has been completed.
First Received: February 24, 2000   Last Updated: June 23, 2005   History of Changes
Sponsors and Collaborators: National Center for Research Resources (NCRR)
Northwestern University
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004795
  Purpose

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
Systemic Lupus Erythematosus
Drug: dehydroepiandrosterone
Phase II
Phase III

MedlinePlus related topics: Lupus
Drug Information available for: Prasterone Dehydroepiandrosterone sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control

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

Estimated Enrollment: 190
Study Start Date: August 1994
Detailed Description:

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.

  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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004795

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

No publications provided

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

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

Study placed in the following topic categories:
Autoimmune Diseases
Immunologic Factors
Lupus Erythematosus, Systemic
Lupus
Arthritis
Adjuvants, Immunologic
Rare Diseases
Connective Tissue Diseases
Dehydroepiandrosterone

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

ClinicalTrials.gov processed this record on May 07, 2009