Last updated: 11/07/2018 07:30:45
Effectiveness of belimumab treatment in a subpopulation of systemic lupus erythematosus (SLE) patients: a pooled analysis of BLISS-52 and BLISS-76
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Effectiveness of belimumab treatment in a subpopulation of systemic lupus erythematosus (SLE) patients: a pooled analysis of BLISS-52 and BLISS-76
Trial description: This pooled analysis will assess data from the Phase 3 belimumab registration studies BLISS-52 (aka BEL110752) and BLISS-76 (aka BEL110751). The analysis was pre-planned and agreed prior to the unblinding of either study. The primary objective is to evaluate the impact of belimumab treatment on a more severe subpopulation of systemic lupus erythematosus (SLE) subjects from BLISS-52 and BLISS-76 to aid physicians and payers in decision making. Subjects are from the modified Intent-to-Treat (ITT) population defined as randomized subjects who received at least 1 dose of study agent. This more severe subpopulation will have renal, neurological, haematological, or cardiovascular/respiratory organ domain involvement (as defined by a British Isles Lupus Assessment Group (BILAG) domain score of A, B or C in at least one of the domains) at baseline AND anti-double-stranded deoxyribonucleic acid (anti-dsDNA) positive (≥ 30 IU/mL) at baseline OR low C3 and/or C4 complement relative to the normal range at baseline.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Responder Rate
Timeframe: Week 52
Secondary outcomes:
SELENA SLEDAI
Timeframe: Week 52
SF-36
Timeframe: Week 24
Time to first flare by SLE Flare Index
Timeframe: Up to Week 52
Interventions:
Drug: Belimumab 1 mg/kg
Drug: Belimumab 10 mg/kg
Drug: Placebo
Enrollment:
1016
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Claude Schmitt, David A. Roth, Christi Kleoudis, Helen Birch . Efficacy of Belimumab in a Subpopulation of Systemic Lupus Erythematosus Patients With High Disease Activity in Key Organ Systems: Pooled BLISS Data. Lupus. 2013;22(1 suppl):1-96.
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Human Genome Sciences
Study date(s)
July 2009 to July 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion Criteria
- Eligible subjects for BLISS-52 and BLISS-76 included:
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria
- Eligible subjects for BLISS-52 and BLISS-76 included:
- clinical diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology (ACR) criteria
- “active” (systemic lupus erythematosus) SLE disease, defined as a safety of oestrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) disease activity score of at least 6 at screening
- an unequivocally positive antinuclear antibodies (ANA) test result, from 2 independent time points within the study screening period or 1 positive historical test result and 1 positive test result during the screening period. ANA test results obtained in the screening period were only considered positive if the ANA titer ≥ 1:80 and/or anti-dsDNA serum antibody was ≥ 30 IU/mL
- on a stable SLE treatment regimen for at least 30 days prior to Day 0, which consisted of any of the following (alone or in combination): prednisone or equivalent (from 0 to 40 mg/day when used in combination with other SLE treatment or from 7.5 to 40 mg/day alone), anti-malarials, non-steroidal anti inflammatory drugs (NSAIDs), or any immunosuppressive therapy (i.e., methotrexate, azathioprine, leflunomide, or mycophenolate calcineurin inhibitors, sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide).
- are anti-dsDNA positive (≥ 30 IU/mL) at baseline, OR
- have low C3 and/or C4 complement relative to the normal range at baseline. Exclusion Criteria:
- Key exclusion criteria for BLISS-52 and BLISS-76 included:
- severe active lupus nephritis or Central Nervous System (CNS) lupus
- pregnancy
- receipt of any B cell target therapy at any time
- receipt of an investigational agent within 60 days prior to Day 0 for non-biologics and within 1 year for biologics
- receipt of abatacept (within 1 year), intravenous (IV) cyclophosphamide (within 6 months), anti-tumor necrosis factor (anti-TNF) therapy, anakinra, IV immunoglobulin (IVIG), prednisone > 100 mg/day, or plasmapheresis within 3 months, or live vaccine within 1 month.
Additional inclusion criteria for the purpose of this analysis: subpopulation of patients from the pooled modified Intent-to-Treat population from BLISS-52 and BLISS-76 who have renal, neurological, haematological, or cardiovascular/respiratory organ domain involvement (as defined by a BILAG domain score of A, B or C in at least one of the domains) at baseline and 1 of the following:
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2010-19-07
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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