Last updated: 11/04/2018 08:08:07
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)BLISS-52
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk 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)
Trial description: The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
SLE Responder Index (SRI) Response Rate at Week 52
Timeframe: Baseline, 52 weeks
Secondary outcomes:
Percent of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score at Wk 52.
Timeframe: Baseline, 52 weeks
Mean change in Physician's Global Assessment (PGA) at Wk 24.
Timeframe: Baseline, 24 weeks
Mean change from Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) physical component summary score (PCS) at Wk 24.
Timeframe: Baseline, 24 weeks
Percent of subjects whose average prednisone dose has been reduced by ≥ 25% from baseline to ≤ 7.5 mg/day during Weeks 40 through 52
Timeframe: Baseline, Weeks 40 through 52
Interventions:
Enrollment:
865
Primary completion date:
2009-31-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
GlaxoSmithKline, GSK
Study date(s)
May 2007 to March 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- Pregnant or nursing
- Have received treatment with any B cell targeted therapy.
Inclusion and exclusion criteria
Inclusion criteria:
- Clinical diagnosis of SLE by ACR criteria. -Active SLE disease. -Autoantibody-positive. -On stable SLE treatment regimen.
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.
Trial location(s)
Location
Hospital das Clínicas - Universidade do Paraná
Curitiba, Brazil, 80060-240
Status
Study Complete
Location
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj Napoca, Romania, 40006
Status
Study Complete
Showing 1 - 6 of 92 Results
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2009-31-05
Actual study completion date
2010-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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