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Completed

NCT Number: NCT01914770

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Belimumab 1 mg/kg

Drug

Subjects received belimumab 1 mg/kg in addition to their ongoing stable systemic lupus erythematosus (SLE) treatment regimen. Belimumab was administered intravenously at 0, 2, 4 weeks and every 4 weeks thereafter. The ongoing SLE treatment regimen was to have been stable 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 (ie, methotrexate, azathioprine, leflunomide, or mycophenolate calcineurin inhibitors, sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide).

Belimumab 10 mg/kg

Drug

Subjects received belimumab 10 mg/kg in addition to their ongoing stable SLE treatment regimen. Belimumab was administered intravenously at 0, 2, 4 weeks and every 4 weeks thereafter. The ongoing SLE treatment regimen was to have been stable 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, NSAIDs, or any immunosuppressive therapy (ie, methotrexate, azathioprine, leflunomide, or mycophenolate calcineurin inhibitors, sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide).

Placebo

Drug

Subjects received placebo in addition to their ongoing stable SLE treatment regimen. Placebo was administered intravenously at 0, 2, 4 weeks and every 4 weeks thereafter. The ongoing SLE treatment regimen was to have been stable 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, NSAIDs, or any immunosuppressive therapy (ie, methotrexate, azathioprine, leflunomide, or mycophenolate calcineurin inhibitors, sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide).

Primary outcomes

  1. Responder Rate

    Time frame: Week 52

    Response is defined as: ≥4 point reduction from baseline in SELENA SLEDAI score, no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores.

Secondary outcomes

  1. SELENA SLEDAI

    Time frame: Week 52

    Percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score at Week 52

  2. SF-36

    Time frame: Week 24

    Mean change in SF-36 Health Survey physical component summary score (PCS) at Week 24

  3. Time to first flare by SLE Flare Index

    Time frame: Up to Week 52

    Time to 1st SLE flare after 24 weeks by modified SLE Flare Index

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Collaborators

  • Human Genome Sciences Inc.

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 2, 2013
Registry last updated
Sep 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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