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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT00424476
First received: January 17, 2007
Last updated: February 13, 2014
Last verified: February 2014
Results First Received: April 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Systemic Lupus Erythematosus
Interventions: Drug: Placebo
Drug: Belimumab 1 mg/kg
Drug: Belimumab 10 mg/kg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
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 48 weeks.
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 48 weeks.

Participant Flow:   Overall Study
    Placebo     Belimumab 1 mg/kg     Belimumab 10 mg/kg  
STARTED     287     288     290  
COMPLETED     226     240     241  
NOT COMPLETED     61     48     49  
Withdrawal by Subject                 7                 6                 3  
Adverse Event                 19                 16                 15  
Lack of Efficacy                 16                 12                 12  
Lack of Compliance                 1                 1                 1  
Lost to Follow-up                 4                 6                 3  
Protocol Violation                 7                 2                 3  
Physician Decision                 3                 2                 3  
Other                 4                 3                 9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
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 48 weeks.
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 48 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Belimumab 1 mg/kg     Belimumab 10 mg/kg     Total  
Number of Participants  
[units: participants]
  287     288     290     865  
Age  
[units: years]
Mean ± Standard Deviation
  36.2  ± 11.8     35.0  ± 10.6     35.4  ± 10.8     35.5  ± 11.1  
Age, Customized  
[units: participants]
       
≤ 45 years     225     236     236     697  
Between 45 and 65 years     57     48     52     157  
≥ 65 years     5     4     2     11  
Gender  
[units: participants]
       
Female     270     271     280     821  
Male     17     17     10     44  
Region of Enrollment  
[units: participants]
       
Europe     33     34     31     98  
South America     145     143     140     428  
Southeast Asia     103     106     115     324  
Australia     6     5     4     15  



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

2.  Secondary:   Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.   [ Time Frame: Baseline, 52 weeks ]

3.  Secondary:   Mean Change in Physician's Global Assessment (PGA) at Wk 24.   [ Time Frame: Baseline, 24 weeks ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Other Pre-specified:   Adverse Events (AE) Overview   [ Time Frame: Up to 56 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by Human Genome Sciences Inc.

Publications automatically indexed to this study:


Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00424476     History of Changes
Other Study ID Numbers: HGS1006-C1057, BLISS-52, 110752
Study First Received: January 17, 2007
Results First Received: April 7, 2011
Last Updated: February 13, 2014
Health Authority: Romania: Ministry of Public Health
Brazil: National Health Surveillance Agency
United States: Food and Drug Administration
Korea: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Chile: Instituto de Salud Publica de Chile
Taiwan: Department of Health
India: Drugs Controller General of India
Philippines: Bureau of Food and Drugs
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Hong Kong: Department of Health
Russia: Ministry of Health of the Russian Federation
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Australia: Therapeutic Goods Administration