Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01914770
• Date of registration: 03/04/2012
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76
• Scientific title: Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76
• Date of first enrolment: July 2009
• Target sample size: 1016
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01914770
• Study type: Observational
• Study design: Time Perspective: Retrospective
• Phase: N/A

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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).

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Belimumab 10 mg/kg

Drug: Placebo

Drug: Belimumab 1 mg/kg

Primary Outcome(s)

Responder Rate [Time Frame: Week 52]

Secondary Outcome(s)

Time to first flare by SLE Flare Index [Time Frame: Up to Week 52]

SELENA SLEDAI [Time Frame: Week 52]

SF-36 [Time Frame: Week 24]

Secondary ID(s)

114246

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Human Genome Sciences Inc.