Last updated: 11/07/2018 04:45:25

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)BLISS-SC

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GSK study ID
112341
See study documents
Clinicaltrials.gov ID
NCT01484496
See results summary
EudraCT ID
2011-003814-18
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, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE)
Trial description: The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Percentage of par. achieving a SLE Responder Index (SRI) response rate at Week 52

Timeframe: Week 52

Secondary outcomes:

Time to first severe flare (as measured by the modified SLE Flare Index)

Timeframe: Baseline (Day 0, prior to dosing) to Week 52

Percentage of par. whose average prednisone dose had been reduced by >=25% from Baseline to <=7.5 mg/day during weeks 40 through 52 in par. receiving greater than 7.5 mg/day at Baseline

Timeframe: Baseline (Day 0, prior to dosing), Weeks 40 through Week 52

Interventions:
  • Biological/vaccine: Placebo
  • Biological/vaccine: Belimumab 200 mg SC
  • Drug: Standard therapy
    • Enrollment:
    839
    Primary completion date:
    2015-13-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Stohl W, Schwarting A, Okada M, Scheinberg MA, Doria A, Hammer A, Kleoudis C, Groark J,Bass D, Fox NL, Roth D, Gordon D. Efficacy and safety of subcutaneous belimumab in systemic lupus erythematosus: A randomized, double-blind, placebo-controlled, 52-week study. Arthritis Rheum. 2017;69(5):1016-1027.
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    GlaxoSmithKline, GSK
    Study date(s)
    November 2011 to October 2015
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 1. At least 18 years of age.
    • 2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
    • 1. Pregnant or nursing.
    • 2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 1. At least 18 years of age. 2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria. 3. Active SLE disease. 4. Autoantibody-positive. 5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)
    Exclusion criteria:
    • 1. Pregnant or nursing. 2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab). 3. Have received treatment an investigational biological agent in the past year. 4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0. 5. Have severe active lupus kidney disease. 6. Have severe active central nervous system (CNS) lupus. 7. Have required management of acute or chronic infections within the past 60 days. 8. Have current drug or alcohol abuse or dependence. 9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. 10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02115
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bucuresti, Romania, 020475
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Barcelona, Spain, 8035
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ft. Lauderdale, Florida, United States, 33334
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75231
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hokkaido, Japan, 060-8648
    Status
    Study Complete
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    Showing 1 - 6 of 201 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    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
    2015-13-02
    Actual study completion date
    2015-01-10

    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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