GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- NCT00082511
- Lead Sponsor
- Genelabs Technologies
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 114
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
Wallace Rheumatic Study Center
🇺🇸Los Angeles, California, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Rheumatology Associates of Central Florida
🇺🇸Orlando, Florida, United States
Tampa Medical Group, P.A.
🇺🇸Tampa, Florida, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
North Shore University Hospital, Division of Rheumatology
🇺🇸Manhasset, New York, United States
Albert Einstein Medical School
🇺🇸Bronx, New York, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
St. John's Medical Research Group
🇺🇸Springfield, Missouri, United States
Center for Rheumatology, Immunology and Arthritis
🇺🇸Fort Lauderdale, Florida, United States
Seattle Rheumatology Associates
🇺🇸Seattle, Washington, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Sentara Medical Group DBA
🇺🇸Virginia Beach, Virginia, United States
Oklahoma Center for Arthritis Therapy
🇺🇸Tulsa, Oklahoma, United States
Lifestyles Health Science Center
🇺🇸Rancho Mirage, California, United States
East Bay Rheumatology Group
🇺🇸San Leandro, California, United States
Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.
🇲🇽Mexico City, Mexico
University of California San Diego
🇺🇸San Diego, California, United States