GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids - Full Text View

Sponsor:	Genelabs Technologies
Information provided by:	Genelabs Technologies
ClinicalTrials.gov Identifier:	NCT00082511

Purpose

Open label safety and efficacy follow-up.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: Prasterone (GL701)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Lupus

Drug Information available for: Prasterone Dehydroepiandrosterone sulfate

U.S. FDA Resources

Further study details as provided by Genelabs Technologies:

Primary Outcome Measures:

Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	114
Study Start Date:	July 2003
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082511

Locations

United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
East Bay Rheumatology Group
San Leandro, California, United States, 94578
Lifestyles Health Science Center
Rancho Mirage, California, United States, 92270
University of California San Diego
San Diego, California, United States, 92093-0943
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
United States, Florida
Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States, 33334
Rheumatology Associates of Central Florida
Orlando, Florida, United States, 32806-6264
Tampa Medical Group, P.A.
Tampa, Florida, United States, 33614
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Missouri
St. John's Medical Research Group
Springfield, Missouri, United States, 65804
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Albert Einstein Medical School
Bronx, New York, United States, 10461
North Shore University Hospital, Division of Rheumatology
Manhasset, New York, United States, 11030
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, Oklahoma
Oklahoma Center for Arthritis Therapy
Tulsa, Oklahoma, United States, 74114
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
United States, Virginia
Sentara Medical Group DBA
Virginia Beach, Virginia, United States, 23462
United States, Washington
Seattle Rheumatology Associates
Seattle, Washington, United States, 98104
Mexico
Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.
Mexico City, Mexico, 14000

Sponsors and Collaborators

Genelabs Technologies

More Information

No publications provided by Genelabs Technologies

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Sánchez-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.

Responsible Party:	Genelabs Technologies, Inc. ( Kenneth E. Schwartz, MD )
Study ID Numbers:	GL03-01
Study First Received:	May 11, 2004
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00082511 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genelabs Technologies:

Lupus
Systemic Lupus Erythematosus
SLE
Bone Loss
DHEA

Additional relevant MeSH terms:

Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Lupus Erythematosus, Systemic
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Adjuvants, Immunologic
Connective Tissue Diseases
Dehydroepiandrosterone
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010