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Trial record 39 of 711 for:    lupus AND Lupus Erythematosus, Systemic

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

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ClinicalTrials.gov Identifier: NCT01914770
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : September 16, 2013
Sponsor:
Collaborator:
Human Genome Sciences Inc.
Information provided by (Responsible Party):
GlaxoSmithKline

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 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.

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Drug: Belimumab 1 mg/kg Drug: Belimumab 10 mg/kg Drug: Placebo

Study Type : Observational
Actual Enrollment : 1016 participants
Time Perspective: Retrospective
Official Title: Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76
Study Start Date : July 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab

Group/Cohort Intervention/treatment
Adults with systemic lupus erythematosus (SLE)
Subjects with SLE receiving ongoing stable SLE treatment
Drug: Belimumab 1 mg/kg
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).

Drug: Belimumab 10 mg/kg
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).

Drug: Placebo
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The primary population is the 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-double-stranded deoxyribonucleic acid (anti-dsDNA) positive (= 30 IU/mL) at baseline, OR
  • have low C3 and/or C4 complement relative to the normal range at baseline.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914770


Sponsors and Collaborators
GlaxoSmithKline
Human Genome Sciences Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01914770     History of Changes
Other Study ID Numbers: 114246
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013

Keywords provided by GlaxoSmithKline:
pooled analyses
quality of life
SELENA SLEDAI
SLE
steroid use
responder rate
flares
belimumab
BILAG

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
6-Mercaptopurine
Calcineurin Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors