Back to resultsGL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Prasterone (GL701)
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Lupus, Systemic Lupus Erythematosus, SLE, Bone Loss, DHEA
Eligibility 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
Sites / Locations
- University of Arizona
- Wallace Rheumatic Study Center
- Lifestyles Health Science Center
- University of California San Diego
- East Bay Rheumatology Group
- Center for Rheumatology, Immunology and Arthritis
- Rheumatology Associates of Central Florida
- Tampa Medical Group, P.A.
- Northwestern University
- Johns Hopkins University
- St. John's Medical Research Group
- Washington University School of Medicine
- Albert Einstein Medical School
- SUNY Downstate Medical Center
- North Shore University Hospital, Division of Rheumatology
- Oklahoma Center for Arthritis Therapy
- Oregon Health & Science University
- Altoona Center for Clinical Research
- University of Pittsburgh
- Sentara Medical Group DBA
- Seattle Rheumatology Associates
- Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.
Outcomes
Primary Outcome Measures
Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00082511
Brief Title
GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Genelabs Technologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Lupus, Systemic Lupus Erythematosus, SLE, Bone Loss, DHEA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Prasterone (GL701)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Wallace Rheumatic Study Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Lifestyles Health Science Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093-0943
Country
United States
Facility Name
East Bay Rheumatology Group
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Center for Rheumatology, Immunology and Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Rheumatology Associates of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-6264
Country
United States
Facility Name
Tampa Medical Group, P.A.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
St. John's Medical Research Group
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Albert Einstein Medical School
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
North Shore University Hospital, Division of Rheumatology
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Oklahoma Center for Arthritis Therapy
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Sentara Medical Group DBA
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Seattle Rheumatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
18634158
Citation
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.
Results Reference
derived
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GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
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