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A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-52)

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. Identifier: NCT00424476
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : May 5, 2011
Last Update Posted : December 12, 2016
Information provided by (Responsible Party):
Human Genome Sciences Inc.

Tracking Information
First Submitted Date  ICMJE January 17, 2007
First Posted Date  ICMJE January 19, 2007
Results First Submitted Date  ICMJE April 7, 2011
Results First Posted Date  ICMJE May 5, 2011
Last Update Posted Date December 12, 2016
Study Start Date  ICMJE May 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2011)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2007)
The primary efficacy endpoint is response rate at Week 52
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2011)
  • Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52. [ Time Frame: Baseline, 52 weeks ]
  • Mean Change in Physician's Global Assessment (PGA) at Wk 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.
  • Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 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.
  • 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 through 52 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2007)
The major secondary outscome measures include; SELENA SLEDAI; Physicians Global Assessment; quality of life; prednisone usage
Current Other Pre-specified Outcome Measures
 (submitted: April 7, 2011)
Adverse Events (AE) Overview [ Time Frame: Up to 56 Weeks ]
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: Placebo
    Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.
  • Drug: Belimumab 1 mg/kg
    Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
    Other Name: BENLYSTA™ (formerly LymphoStat-B™)
  • Drug: Belimumab 10 mg/kg
    Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
    Other Name: BENLYSTA™ (formerly LymphoStat-B™)
Study Arms  ICMJE
  • Placebo Comparator: 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
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2011)
Original Enrollment  ICMJE
 (submitted: January 17, 2007)
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Chile,   Colombia,   Hong Kong,   India,   Korea, Republic of,   Peru,   Philippines,   Romania,   Russian Federation,   Taiwan
Removed Location Countries Bulgaria,   China
Administrative Information
NCT Number  ICMJE NCT00424476
Other Study ID Numbers  ICMJE HGS1006-C1057
BLISS-52 ( Other Identifier: Human Genome Sciences Inc. )
110752 ( Other Identifier: GSK )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through following the timelines and process described on this site.
Responsible Party Human Genome Sciences Inc.
Study Sponsor  ICMJE Human Genome Sciences Inc.
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials Human Genome Sciences Inc.
PRS Account Human Genome Sciences Inc.
Verification Date October 2016

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