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A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (BLISS-76)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT00410384
First received: December 8, 2006
Last updated: February 13, 2014
Last verified: February 2014

December 8, 2006
February 13, 2014
December 2006
September 2009   (final data collection date for primary outcome measure)
SLE Responder Index (SRI) Response Rate at Week 52 [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]

Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and 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 compared with baseline.

SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

The primary efficacy endpoint is response rate at Week 52.
Complete list of historical versions of study NCT00410384 on ClinicalTrials.gov Archive Site
  • SRI Response Rate at Week 76 [ Time Frame: Baseline, 76 Weeks ] [ Designated as safety issue: No ]

    Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and 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 compared with baseline.

    SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).

  • Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52. [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]
  • Mean Change in Physician's Global Assessment (PGA) at Week 24. [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
    The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
  • Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24. [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
    The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.
  • Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52 [ Time Frame: Baseline, Weeks 40-52 ] [ Designated as safety issue: No ]
  • The major secondary outcome measures include
  • SELENA SLEDAI
  • Physicians Global Assessment
  • quality of life
  • prednisone usage
Adverse Event (AE) Overview [ Time Frame: Up to 80 Weeks ] [ Designated as safety issue: Yes ]
SEE ALSO ADVERSE EVENT RESULTS SECTION
Not Provided
 
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Drug: Placebo
    Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
    Other Name: Placebo
  • Drug: Belimumab 1 mg/kg
    Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
    Other Names:
    • LymphoStat-B™
    • belimumab
  • Drug: Belimumab 10 mg/kg
    Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
    Other Names:
    • LymphoStat-B™
    • belimumab
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Belimumab 1 mg/kg
    Belimumab 1 mg/kg
    Intervention: Drug: Belimumab 1 mg/kg
  • Experimental: Belimumab 10 mg/kg
    Belimumab 10 mg/kg
    Intervention: Drug: Belimumab 10 mg/kg

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
819
March 2010
September 2009   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Clinical diagnosis of SLE by ACR criteria.
  • Active SLE disease.
  • Autoantibody-positive.
  • On stable SLE treatment regimen.

Key Exclusion Criteria:

  • Pregnant or nursing
  • Have received treatment with any B cell targeted therapy.
  • Have received treatment with a biological investigational agent in the past year.
  • Have received IV cyclophosphamide within 180 days of Day 0.
  • Have severe lupus kidney disease.
  • Have active central nervous system (CNS) lupus.
  • Have required management of acute or chronic infections within the past 60 days.
  • Have current drug or alcohol abuse or dependence.
  • Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   Costa Rica,   Czech Republic,   France,   Germany,   Israel,   Italy,   Mexico,   Netherlands,   Poland,   Puerto Rico,   Romania,   Slovakia,   Spain,   Sweden,   United Kingdom
 
NCT00410384
HGS1006-C1056, BLISS-76, 110751
Yes
Human Genome Sciences Inc.
Human Genome Sciences Inc.
GlaxoSmithKline
Study Director: GSK Clinical Trials Human Genome Sciences Inc.
Human Genome Sciences Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP