Last updated: 11/04/2018 08:06:47

A Study of Belimumab in Subjects with Systemic Lupus ErythematosusBLISS-76

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GSK study ID
HGS1006-C1056
See study documents
Clinicaltrials.gov ID
NCT00410384
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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)
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:

SRI Response Rate at Week 76

Timeframe: Baseline, 76 Weeks

Percent of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score at Week 52.

Timeframe: Baseline, 52 Weeks

Mean change in Physician's Global Assessment (PGA) at Week 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 Week 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 40-52

Interventions:
  • Drug: Placebo
  • Drug: Belimumab 1 mg/kg
  • Drug: Belimumab 10 mg/kg
    • Enrollment:
    819
    Primary completion date:
    2009-30-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    GSK
    Study date(s)
    December 2006 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
    Status
    Contact us
    Contact us
    Location
    University of Puerto Rico Medical Center
    Rio Piedras, Puerto Rico, 00935
    Status
    Study Complete
    Contact us
    Location
    Gundersen Clinic, Ltd.
    Onalaska, WI, United States, 54650
    Status
    Study Complete
    Contact us
    Location
    SUNY-Downstate Medical Center
    Brooklyn, NY, United States, 11203
    Status
    Study Complete
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    Location
    Hospital for Special Surgery
    New York, New York, United States, 10021
    Status
    Study Complete
    Contact us
    Location
    Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych
    Wroclaw, Poland, 50-556
    Status
    Study Complete
    Contact us
    Location
    University Hospital Brno
    Brno, Czech Republic, 62500
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 146 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)

    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
    2009-30-09
    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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