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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
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 72 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 72 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 72 weeks.

Participant Flow:   Overall Study
    Placebo     Belimumab 1 mg/kg     Belimumab 10 mg/kg  
STARTED     275     271     273  
COMPLETED     186     199     191  
NOT COMPLETED     89     72     82  
Withdrawal by Subject                 28                 17                 20  
Adverse Event                 23                 18                 23  
Lack of Efficacy                 20                 12                 17  
Lack of Compliance                 2                 2                 2  
Lost to Follow-up                 4                 6                 6  
Protocol Violation                 6                 6                 6  
Physician Decision                 3                 3                 4  
Other                 3                 8                 4  



  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 72 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 72 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 72 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Belimumab 1 mg/kg     Belimumab 10 mg/kg     Total  
Number of Participants  
[units: participants]
  275     271     273     819  
Age  
[units: years]
Mean ± Standard Deviation
  40.0  ± 11.9     40.0  ± 11.4     40.5  ± 11.1     40.2  ± 11.5  
Age, Customized  
[units: participants]
       
≤ 45 years     189     184     178     551  
Between 45 and 65 years     77     83     92     252  
≥ 65 years     9     4     3     16  
Gender  
[units: participants]
       
Female     252     253     259     764  
Male     23     18     14     55  
Region of Enrollment  
[units: participants]
       
North America     145     155     136     436  
Europe     100     90     105     295  
Central America     30     26     32     88  



  Outcome Measures
  Show All Outcome Measures

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

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

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

4.  Secondary:   Mean Change in Physician's Global Assessment (PGA) at Week 24.   [ Time Frame: Baseline, 24 Weeks ]

5.  Secondary:   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 ]

6.  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 40-52 ]

7.  Other Pre-specified:   Adverse Event (AE) Overview   [ Time Frame: Up to 80 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


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: NCT00410384     History of Changes
Other Study ID Numbers: HGS1006-C1056, BLISS-76, 110751
Study First Received: December 8, 2006
Results First Received: April 7, 2011
Last Updated: February 13, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
Romania: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
France: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: Ministry of Health
Poland: Ministry of Health
Canada: Health Canada
Mexico: Ministry of Health
Israel: Ministry of Health
Sweden: Medical Products Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Czech Republic: State Institute for Drug Control