Last updated: 11/04/2018 00:18:46

Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients with High Disease Activity (anti-dsDNA positive and low complement and SELENA-SLEDAI score >=10): A Pooled Analysis of the HGS1006-C1056 (BLISS-76) and HGS1006-C1057 (BLISS-52) Studies

GSK study ID
207878
See study documents
Clinicaltrials.gov ID
Not applicable
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: Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients with High Disease Activity (anti-dsDNA positive and low complement and SELENA-SLEDAI score >=10): A Pooled Analysis of the HGS1006-C1056 (BLISS-76) and HGS1006-C1057 (BLISS-52) Studies
Trial description: This pooled analysis will assess data from the Phase III belimumab clinical studies HGS1006-C1056 (BLISS-76) and HGS1006-C1057 (BLISS-52). The objective of this study is to evaluate the impact of belimumab treatment on a subgroup of SLE subjects with high disease activity, to provide physicians with the information regarding belimumab treatment for appropriate subjects and to aid payers in making decisions regarding reimbursement and market access.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Assessment of response rate by SLE response index (SRI) at Week 52

Timeframe: Week 52

Secondary outcomes:

SRI Response Rate at Week 76

Timeframe: Week 76

Number of subjects with reduction of prednisone dose by >=25% from Baseline to <= 7.5 milligram per day (mg/day) during Weeks 40 through 52

Timeframe: Up to Week 52

Time to first flare by SLE Flare Index

Timeframe: Up to Week 52

Time to first severe SLE flare

Timeframe: Up to Week 52

Change from baseline in Short Form Health Survey (SF-36) physical component summary (PCS)

Timeframe: Up to Week 24

Interventions:
  • Drug: Belimumab
  • Drug: Placebo
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    June 2010 to December 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    None
    • Clinical diagnosis of SLE by ACR criteria.
    • Active SLE disease (SELENA_SLEDAI>=10).
    • 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 (SELENA_SLEDAI>=10).
    • 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)

    This study does not involve prospective enrollment of participants.

    Study documents

    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-01-12

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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