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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00410384 |
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Date of registration:
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08/12/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
BLISS-76 |
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Scientific title:
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A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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819 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00410384 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Belgium
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Canada
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Costa Rica
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Czech Republic
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France
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Germany
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Israel
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Italy
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Mexico
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Netherlands
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Poland
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Puerto Rico
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Romania
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Slovakia
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Human Genome Sciences Inc. |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen.
Key Exclusion Criteria:
- Pregnant or nursing
- Have received treatment with any B cell targeted therapy.
- Have received treatment with a biological investigational agent in the past year.
- Have received IV cyclophosphamide within 180 days of Day 0.
- Have severe lupus kidney disease.
- Have active central nervous system (CNS) lupus.
- Have required management of acute or chronic infections within the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a historically positive test or test positive at screening for HIV, hepatitis B,
or hepatitis C.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Belimumab 10 mg/kg
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Drug: Belimumab 1 mg/kg
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Drug: Placebo
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Primary Outcome(s)
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SLE Responder Index (SRI) Response Rate at Week 52
[Time Frame: Baseline, 52 Weeks]
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Secondary Outcome(s)
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Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by = 25% From Baseline to = 7.5 mg/Day During Weeks 40 Through 52
[Time Frame: Baseline, Weeks 40-52]
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Mean Change in Physician's Global Assessment (PGA) at Week 24.
[Time Frame: Baseline, 24 Weeks]
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Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24.
[Time Frame: Baseline, 24 Weeks]
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Percent of Subjects With a = 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.
[Time Frame: Baseline, 52 Weeks]
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SRI Response Rate at Week 76
[Time Frame: Baseline, 76 Weeks]
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Secondary ID(s)
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HGS1006-C1056
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110751
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BLISS-76
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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