GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

NCT ID: NCT00082511

Last Updated: 2008-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2005-08-31

Brief Summary

Open label safety and efficacy follow-up.

Detailed Description

This was a randomized, multi-center, open-label, parallel-group, trial of prasterone 200 or 100 mg/day for 12 months in women with lupus receiving glucocorticoid therapy who had completed an earlier 6-month randomized, placebo-controlled study (NCT00053560. Bone Mineral Density assessments were performed at baseline and at months 6 and 12.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Prasterone (GL701)

There were 4 arms to the study:

During a previous 6 month db RCT, patients received either prasterone 200 mg/day or placebo. Upon entry into this open-label study, they were re-assigned by randomized allocation to receive either prasterone 200 mg/day or 100 mg/day. Hence, there were 4 possible treatment arms extending over the 18 months of observation between the double-blind study and the subsequent 12 month open-label extension study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient has completed the full 6 month treatment period with study drug in the previous Genelabs' clinical study GL02-01.
• Concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day.
• Patient has read and signed an Informed Consent Form. If the patient is not fluent in English, the Informed Consent must be signed in her native language.

Exclusion Criteria

• Patient has had a serious study drug related adverse reaction at any time during the previous GL02-01 study.
• Any condition which in the Investigator's or Sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease).

MEDICATIONS PROHIBITED AT ANY TIME DURING THE STUDY

• Calcitonin
• Bisphosphonates
• Fluoride at pharmacologic dose
• Strontium at pharmacologic dose
• Estrogenic steroids (except oral contraceptives)
• Selective Estrogen Receptor Modulator (raloxifene)
• Parathyroid hormone
• Any androgens, including prescription or nutritional supplement DHEA, other than study drug
• Additional Calcium supplements other than those prescribed as part of this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genelabs Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Genelabs Technologies, Inc.

Locations

University of Arizona

Tucson, Arizona, United States

Wallace Rheumatic Study Center

Los Angeles, California, United States

Lifestyles Health Science Center

Rancho Mirage, California, United States

University of California San Diego

San Diego, California, United States

East Bay Rheumatology Group

San Leandro, California, United States

Center for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida, United States

Rheumatology Associates of Central Florida

Orlando, Florida, United States

Tampa Medical Group, P.A.

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

St. John's Medical Research Group

Springfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

SUNY Downstate Medical Center

Brooklyn, New York, United States

North Shore University Hospital, Division of Rheumatology

Manhasset, New York, United States

Albert Einstein Medical School

The Bronx, New York, United States

Oklahoma Center for Arthritis Therapy

Tulsa, Oklahoma, United States

Oregon Health & Science University

Portland, Oregon, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Sentara Medical Group DBA

Virginia Beach, Virginia, United States

Seattle Rheumatology Associates

Seattle, Washington, United States

Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.

Mexico City, , Mexico

Countries

United States; Mexico

References

Sanchez-Guerrero J, Fragoso-Loyo HE, Neuwelt CM, Wallace DJ, Ginzler EM, Sherrer YR, McIlwain HH, Freeman PG, Aranow C, Petri MA, Deodhar AA, Blanton E, Manzi S, Kavanaugh A, Lisse JR, Ramsey-Goldman R, McKay JD, Kivitz AJ, Mease PJ, Winkler AE, Kahl LE, Lee AH, Furie RA, Strand CV, Lou L, Ahmed M, Quarles B, Schwartz KE. Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy. J Rheumatol. 2008 Aug;35(8):1567-75. Epub 2008 Jul 15.

Reference Type: DERIVED

PMID: 18634158 (View on PubMed)

Other Identifiers

GL03-01

Identifier Type: -

Identifier Source: org_study_id