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Trial record 57 of 703 for:    lupus AND Lupus Erythematosus, Systemic

A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)

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ClinicalTrials.gov Identifier: NCT01484496
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : July 25, 2017
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Systemic Lupus Erythematosus
Interventions: Biological: Placebo
Biological: Belimumab 200 mg SC
Drug: Standard therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants (Par.) with active systemic lupus erythematosus (SLE) and who were on appropriate stable standard SLE therapy for a period of at least 30 days prior to Day 0 before entering the study were eligible for participation in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1427 par. were screened, out of these 588 par. were screen failures and 839 par. were randomized, of which 836 par. received at least one dose of study treatment. Par. who successfully completed the initial 52-week Double-blind Phase had a choice to enter into a 6-month Open-label Extension Phase of this study.

Reporting Groups
  Description
Placebo SC Par. received placebo administered subcutaneously (SC) once weekly through 51 weeks of thetreatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Belimumab 200 mg SC Par. received belimumab 200 milligrams (mg) administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Open-Label - Placebo SC to Belimumab 200 mg SC Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly.
Open-Label - Belimumab 200 SC to Belimumab 200 mg SC Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly

Participant Flow for 2 periods

Period 1:   Period 1
    Placebo SC   Belimumab 200 mg SC   Open-Label - Placebo SC to Belimumab 200 mg SC   Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
STARTED   280   556   0   0 
COMPLETED   214   463   0   0 
NOT COMPLETED   66   93   0   0 
Protocol Violation                3                4                0                0 
Physician Decision                5                1                0                0 
Lack of Efficacy                10                15                0                0 
Adverse Event                25                40                0                0 
Withdrawal by Subject                15                12                0                0 
Lost to Follow-up                2                6                0                0 
Positive Pregnancy                1                6                0                0 
Treatment Failure                3                6                0                0 
Lack of Compliance                2                1                0                0 
Unable to Visit Site                0                2                0                0 

Period 2:   Period 2
    Placebo SC   Belimumab 200 mg SC   Open-Label - Placebo SC to Belimumab 200 mg SC   Open-Label - Belimumab 200 SC to Belimumab 200 mg SC
STARTED   0   0   206   456 
COMPLETED   0   0   191   434 
NOT COMPLETED   0   0   15   22 
Lack of Efficacy                0                0                1                3 
Adverse Event                0                0                5                13 
Other                0                0                9                6 



  Baseline Characteristics

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 SC Par. received placebo administered SC, once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Belimumab 200 mg SC Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period.
Total Total of all reporting groups

Baseline Measures
   Placebo SC   Belimumab 200 mg SC   Total 
Overall Participants Analyzed 
[Units: Participants]
 280   556   836 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.6  (12.61)   38.1  (12.10)   38.6  (12.29) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      268  95.7%      521  93.7%      789  94.4% 
Male      12   4.3%      35   6.3%      47   5.6% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White/Caucasian/European Heritage   160   326   486 
Middle East/North African Heritage   6   10   16 
Central Asian Heritage   0   2   2 
East Asian Heritage   15   29   44 
Japanese Heritage   16   13   29 
South Asian Heritage   0   2   2 
Southeast Asian Heritage   32   73   105 
African American/African Heritage   30   56   86 
American Indian or Alaska Native   21   43   64 
Native Hawaiian or Other Pacific Islander   0   2   2 


  Outcome Measures

1.  Primary:   Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52   [ Time Frame: Week 52 ]

2.  Secondary:   Time to First Severe Flare (as Measured by the Modified SLE Flare Index)   [ Time Frame: Baseline (Day 0, prior to dosing) to Week 52 ]

3.  Secondary:   Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline   [ Time Frame: Baseline (Day 0, prior to dosing), Weeks 40 through Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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


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

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT01484496     History of Changes
Other Study ID Numbers: 112341
2011-003814-18
HGS1006-C1115
First Submitted: November 28, 2011
First Posted: December 2, 2011
Results First Submitted: January 30, 2017
Results First Posted: July 25, 2017
Last Update Posted: June 5, 2018