Not Signed In -
Systemic Lupus Erythematosus |
Sle |
Clinical Trial: GL701 (Prestara™) in Women with Systemic Lupus Erythematosus Receiving Treatment with Glucocorticoids
This study is currently recruiting patients.
|
Purpose
Open label safety and efficacy follow-up.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Systemic Lupus Erythematosus | Drug: Prasterone (GL701) | Phase III |
MedlinePlus related topics: Lupus
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, 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
Further Study Details:
Expected Total Enrollment: 155
Study start: July 2003
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Female
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
Location and Contact Information
Betty Quarles, B.Sc. 650-562-1425 bquarles@genelabs.com
Kenneth Schwartz, MD 650-562-1510 kschwartz@genelabs.com
Kenneth Schwartz, MD 650-562-1510 kschwartz@genelabs.com
Arizona
University of Arizona, Tucson, Arizona, 85724, United States; Recruiting
Jeffrey R. Lisse, MD, Principal Investigator
California
East Bay Rheumatology Group, San Leandro, California, 94578, United States; Recruiting
Michael Neuwelt, MD, Principal Investigator
Lifestyles Health Science Center, Rancho Mirage, California, 92270, United States; Recruiting
Ellen Blanton, MD, Principal Investigator
University of California San Diego, San Diego, California, 92093-0943, United States; Recruiting
Arthur Kavanaugh, MD, Principal Investigator
Wallace Rheumatic Study Center, Los Angeles, California, 90048, United States; Recruiting
Daniel Wallace, MD, Principal Investigator
Florida
Center for Rheumatology, Immunology and Arthritis, Fort Lauderdale, Florida, 33334, United States; Recruiting
Yvonne S. Sherrer, MD, Principal Investigator
Rheumatology Associates of Central Florida, Orlando, Florida, 32806-6264, United States; Recruiting
Pamela G. Freeman, MD, Principal Investigator
Tampa Medical Group, P.A., Tampa, Florida, 33614, United States; Recruiting
Harris McIlwain, MD, CMD, Principal Investigator
Illinois
Northwestern University, Chicago, Illinois, 60611, United States; No longer recruiting
Maryland
Johns Hopkins University, Baltimore, Maryland, 21205, United States; Recruiting
Michelle Petri, MD, Principal Investigator
Missouri
St. John's Medical Research Group, Springfield, Missouri, 65804, United States; No longer recruiting
Washington University School of Medicine, St. Louis, Missouri, 63110, United States; No longer recruiting
New York
Albert Einstein Medical School, Bronx, New York, 10461, United States; Recruiting
Cynthia Aranow, MD, Principal Investigator
North Shore University Hospital, Division of Rheumatology, Manhasset, New York, 11030, United States; No longer recruiting
SUNY Downstate Medical Center, Brooklyn, New York, 11203, United States; No longer recruiting
Oklahoma
Oklahoma Center for Arthritis Therapy, Tulsa, Oklahoma, 74114, United States; Recruiting
James D. McKay, MD, Principal Investigator
Oregon
Oregon Health & Science University, Portland, Oregon, 97201, United States; Recruiting
Atul Deodhar, MD, Principal Investigator
Pennsylvania
Altoona Center for Clinical Research, Duncansville, Pennsylvania, 16635, United States; No longer recruiting
University of Pittsburgh, Pittsburgh, Pennsylvania, 15261, United States; No longer recruiting
Virginia
Sentara Medical Group DBA, Virginia Beach, Virginia, 23462, United States; No longer recruiting
Washington
Seattle Rheumatology Associates, Seattle, Washington, 98104, United States; No longer recruiting
Mexico
Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z., Mexico City, 14000, Mexico; Recruiting
F. Jorge Sanchez-Guerrero, MD, Principal Investigator
More Information
Study ID Numbers: GL03-01
Record last reviewed: November 2004
Last Updated: November 10, 2004
Record first received: May 11, 2004
ClinicalTrials.gov Identifier: NCT00082511
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: November 2004
Last Updated: November 10, 2004
Record first received: May 11, 2004
ClinicalTrials.gov Identifier: NCT00082511
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Autoimmune Diseases (Cleveland Clinic)
- Lupus (Cleveland Clinic)
email this page
print this page
bookmark this page
feedback on this page
