Systemic Lupus ErythematosusPhase 3NCT00082511
GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
A Phase 3 study testing Prasterone (GL701) in people with Systemic Lupus Erythematosus, run by Genelabs Technologies at 22 sites in 2 countries.
Trial summary
Open label safety and efficacy follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Prasterone (GL701)
- How many people
- 114 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Jul 2003to Aug 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States21 sites
Johns Hopkins University
Baltimore, Maryland, 21205
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Northwestern University
Chicago, Illinois, 60611
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33334
Wallace Rheumatic Study Center
Los Angeles, California, 90048
North Shore University Hospital, Division of Rheumatology
Manhasset, New York, 11030
Rheumatology Associates of Central Florida
Orlando, Florida, 32806-6264
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Oregon Health & Science University
Portland, Oregon, 97201
Lifestyles Health Science Center
Rancho Mirage, California, 92270
University of California San Diego
San Diego, California, 92093-0943
East Bay Rheumatology Group
San Leandro, California, 94578
Seattle Rheumatology Associates
Seattle, Washington, 98104
St. John's Medical Research Group
Springfield, Missouri, 65804
Washington University School of Medicine
St Louis, Missouri, 63110
Tampa Medical Group, P.A.
Tampa, Florida, 33614
Albert Einstein Medical School
The Bronx, New York, 10461
University of Arizona
Tucson, Arizona, 85724
Oklahoma Center for Arthritis Therapy
Tulsa, Oklahoma, 74114
Sentara Medical Group DBA
Virginia Beach, Virginia, 23462
Mexico1 site
Immunology/Rheumatology Instituto Nacional de Ciencias Medicas y Nutricion, S.Z.
Mexico City, 14000
About this 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
Open label safety and efficacy follow-up.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Prasterone (GL701)
- Keywords
- Lupus, Systemic Lupus Erythematosus, SLE, Bone Loss, DHEA
- Medical subject headings
- Lupus Erythematosus, Systemic, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prasterone (GL701)Drug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2004 (estimated)
- Study startJul 2003
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genelabs Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082511
- Sponsor's protocol ID
- GL03-01
- Status last verified
- Jan 2008
- First submitted
- 11 May 2004
- Last updated
- 14 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18634158
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00082511
- Acronym / sponsor ID
- GL03-01
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, Systemic Lupus Erythematosus, SLE, Bone Loss, DHEA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Genelabs TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 16 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prasterone (GL701)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. | Drug | – |
Primary outcome
Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2008.
- Derived from this study: PubMed 18634158Sanchez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prasterone (GL701) in people with Systemic Lupus Erythematosus, run by Genelabs Technologies at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of bone mineral density (BMD) in women with systemic lupus erythematosus receiving glucocorticoids. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00082511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2008.