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

June 23, 2005 updated by: National Center for Research Resources (NCRR)

OBJECTIVES:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

300

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Northwestern University

Investigators

  • Study Chair: Rosalind Ramsey-Goldman, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1996

Study Registration Dates

First Submitted

February 24, 2000

First Submitted That Met QC Criteria

February 24, 2000

First Posted (Estimate)

February 25, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/11918
  • NU-584

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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