Status:
COMPLETED
Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Human Genome Sciences Inc.
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Brief Summary
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 unblin...
Eligibility Criteria
Inclusion
- 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).
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
1016 Patients enrolled
Trial Details
Trial ID
NCT01914770
Start Date
July 1 2009
End Date
November 1 2010
Last Update
September 16 2013
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