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

Systemic Lupus Erythematosus Clinical Trial

Official title:

A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082511
• Other study ID #: GL03-01
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2004
• Last updated: January 10, 2008
• Start date: July 2003
• Est. completion date: August 2005

Study information

• Verified date: January 2008
• Source: Genelabs Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Open label safety and efficacy follow-up.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Mexico	Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.	Mexico City
United States	Johns Hopkins University	Baltimore	Maryland
United States	Albert Einstein Medical School	Bronx	New York
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Northwestern University	Chicago	Illinois
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Center for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida
United States	Wallace Rheumatic Study Center	Los Angeles	California
United States	North Shore University Hospital, Division of Rheumatology	Manhasset	New York
United States	Rheumatology Associates of Central Florida	Orlando	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
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	Seattle Rheumatology Associates	Seattle	Washington
United States	St. John's Medical Research Group	Springfield	Missouri
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Tampa Medical Group, P.A.	Tampa	Florida
United States	University of Arizona	Tucson	Arizona
United States	Oklahoma Center for Arthritis Therapy	Tulsa	Oklahoma
United States	Sentara Medical Group DBA	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Genelabs Technologies

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.		12 months	No