GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
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
1 other identifier
interventional
114
2 countries
22
Brief Summary
Open label safety and efficacy follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2003
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 11, 2004
CompletedFirst Posted
Study publicly available on registry
July 16, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedJanuary 14, 2008
January 1, 2008
2.1 years
May 11, 2004
January 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.
12 months
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
University of Arizona
Tucson, Arizona, 85724, United States
Wallace Rheumatic Study Center
Los Angeles, California, 90048, United States
Lifestyles Health Science Center
Rancho Mirage, California, 92270, United States
University of California San Diego
San Diego, California, 92093-0943, United States
East Bay Rheumatology Group
San Leandro, California, 94578, United States
Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33334, United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806-6264, United States
Tampa Medical Group, P.A.
Tampa, Florida, 33614, United States
Northwestern University
Chicago, Illinois, 60611, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
St. John's Medical Research Group
Springfield, Missouri, 65804, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
North Shore University Hospital, Division of Rheumatology
Manhasset, New York, 11030, United States
Albert Einstein Medical School
The Bronx, New York, 10461, United States
Oklahoma Center for Arthritis Therapy
Tulsa, Oklahoma, 74114, United States
Oregon Health & Science University
Portland, Oregon, 97201, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Sentara Medical Group DBA
Virginia Beach, Virginia, 23462, United States
Seattle Rheumatology Associates
Seattle, Washington, 98104, United States
Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.
Mexico City, 14000, Mexico
Related Publications (1)
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.
PMID: 18634158DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 11, 2004
First Posted
July 16, 2004
Study Start
July 1, 2003
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
January 14, 2008
Record last verified: 2008-01