Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus - Full Text View

Purpose

OBJECTIVES:

I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with active systemic lupus erythematosus.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: dehydroepiandrosterone	Phase III

MedlinePlus related topics:

Lupus

ChemIDplus related topics:

Dehydroepiandrosterone sulfate Prasterone

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:	300
Study Start Date:	March 1996

Detailed Description:

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.

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 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:

DHEA
Adrenocorticotropin hormone
Androgens
Cyclophosphamide
Cyclosporine
Immune globulin

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:

No hypersensitivity to DHEA or inactive ingredients in GL701 formulation, i.e., cornstarch, lactose, or magnesium stearate
No history of breast cancer or reproductive tract malignancy
Cervical carcinoma eligible if surgically cured, i.e., no evidence of disease for 5 years
No condition that would prevent compliance or follow-up, e.g.: Alcoholism Drug addiction Acute withdrawal from chemical dependency
Psychiatric disease
No pregnant or nursing women
Negative pregnancy test required of fertile women
Reliable contraception required of fertile women
No estrogen-containing oral contraceptives on study
At least 3 weeks since estrogen-containing oral contraceptives

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004662

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Northwestern University

Investigators


Study Chair:	Rosalind Ramsey-Goldman	Northwestern University

More Information

Study ID Numbers:	199/11918, NU-584
First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004662
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

Lupus Erythematosus, Systemic

Arthritis

Rare Diseases

Connective Tissue Diseases

Dehydroepiandrosterone

Additional relevant MeSH terms:

Immunologic Factors

Immune System Diseases

Physiological Effects of Drugs

Adjuvants, Immunologic

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Northwestern University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004662