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

Completed · Phase 3 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

Open label safety and efficacy follow-up.

Key facts

Study ID

NCT00082511

Run by

Genelabs Technologies

People needed

114

Starts

2003-07-01

Expected to finish

2005-08-01

Last updated by the study team

2008-01-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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