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Trial record 2 of 9 for:    belimumab BLISS | Lupus Erythematosus
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A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (BLISS-76)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00410384
Recruitment Status : Completed
First Posted : December 12, 2006
Results First Posted : May 5, 2011
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Human Genome Sciences Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Placebo Drug: Belimumab 1 mg/kg Drug: Belimumab 10 mg/kg Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 819 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : December 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Belimumab

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Experimental: Belimumab 1 mg/kg
Belimumab 1 mg/kg
 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
Experimental: Belimumab 10 mg/kg
Belimumab 10 mg/kg
 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


Outcome Measures
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Primary Outcome Measures :
  1. SLE Responder Index (SRI) Response Rate at Week 52 [ Time Frame: Baseline, 52 Weeks ]

    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).



Secondary Outcome Measures :
  1. SRI Response Rate at Week 76 [ Time Frame: Baseline, 76 Weeks ]

    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).


  2. Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52. [ Time Frame: Baseline, 52 Weeks ]
  3. Mean Change in Physician's Global Assessment (PGA) at Week 24. [ Time Frame: Baseline, 24 Weeks ]
    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.

  4. 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 ]
    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.

  5. 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 ]

Other Outcome Measures:
  1. Adverse Event (AE) Overview [ Time Frame: Up to 80 Weeks ]
    SEE ALSO ADVERSE EVENT RESULTS SECTION


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT00410384


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

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: HGS1006-C1056
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: HGS1006-C1056
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: HGS1006-C1056
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: HGS1006-C1056
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: HGS1006-C1056
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: HGS1006-C1056
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: HGS1006-C1056
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00410384    
Other Study ID Numbers: HGS1006-C1056
BLISS-76
110751 ( Other Identifier: GSK )
First Posted: December 12, 2006    Key Record Dates
Results First Posted: May 5, 2011
Last Update Posted: February 1, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by Human Genome Sciences Inc.:
Antibodies
Autoimmune Diseases
Systemic Lupus Erythematosus
 SLE
Belimumab
Lupus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs