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GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Human Genome Sciences Inc.
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01345253
First received: April 28, 2011
Last updated: April 13, 2017
Last verified: April 2017
Results First Received: June 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Systemic Lupus Erythematosus
Interventions: Drug: Belimumab
Drug: Placebo

  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
This study consisted of a screening period (up to 35 days), a 52 week blinded treatment period. An optional open-label treatment period and follow-up period for participants not receiving open-label treatment was included.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 707 participants (par.) were randomized, 705 received at least 1 dose of investigational product (Safety Population), 677 par. were included in the primary efficacy population (MITT Population) of which 663 were evaluable for the primary endpoint. The participant flow and baseline characteristics are presented for the MITT Population.

Reporting Groups
  Description
Placebo Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Belimumab 10 mg/kg Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.

Participant Flow:   Overall Study
    Placebo   Belimumab 10 mg/kg
STARTED   226   451 
COMPLETED   170   372 
NOT COMPLETED   56   79 
Adverse Event                22                27 
Lack of Efficacy                11                7 
Protocol Violation                1                5 
Met Protocol Defined Stopping Criteria                6                1 
Lost to Follow-up                3                8 
Physician Decision                4                12 
Withdrawal by Subject                9                19 



  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.
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Reporting Groups
  Description
Placebo Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Belimumab 10 mg/kg Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Total Total of all reporting groups

Baseline Measures
   Placebo   Belimumab 10 mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 226   451   677 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.7  (9.18)   32.3  (9.65)   32.1  (9.50) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      210  92.9%      419  92.9%      629  92.9% 
Male      16   7.1%      32   7.1%      48   7.1% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian - Central/South Asian Heritage   2   4   6 
Asian - East Asian Heritage   195   403   598 
Asian - Japanese Heritage   24   40   64 
Asian - South East Asian Heritage   4   3   7 
Asian - Mixed Race   1   1   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52.   [ Time Frame: Week 52 ]

2.  Secondary:   Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.   [ Time Frame: Baseline (Day 0) and Week 52 ]

3.  Secondary:   Percent of Participants With SRI7 Response at Week 52.   [ Time Frame: Baseline (Day 0) and Week 52 ]

4.  Secondary:   Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks.   [ Time Frame: Week 52 ]

5.  Secondary:   Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks.   [ Time Frame: 52 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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01345253     History of Changes
Other Study ID Numbers: 113750
Study First Received: April 28, 2011
Results First Received: June 9, 2016
Last Updated: April 13, 2017