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Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

This study has been terminated.
(Sponsor terminated study for business reasons.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732940
First Posted: August 12, 2008
Last Update Posted: August 7, 2013
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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Human Genome Sciences Inc.
Results First Submitted: April 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Systemic Lupus Erythematosus
Intervention: Drug: Belimumab 100 mg SC

  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
Belimumab SC Q2WKS 100 mg of belimumab (1 subcutaneous injection) on days 0, 7, and 14, then every other week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
Belimumab SC 3X/WK 200 mg of belimumab (2 subcutaneous injections of 100 mg each) on days 0, 2, and 4 then 100 mg three times a week until Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.

Participant Flow:   Overall Study
    Belimumab SC Q2WKS   Belimumab SC 3X/WK
STARTED   28   28 
COMPLETED   26   25 
NOT COMPLETED   2   3 
Withdrawal by Subject                1                2 
Adverse Event                0                1 
Lost to Follow-up                1                0 



  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
Belimumab SC Q2WKS No text entered.
Belimumab SC 3X/WK No text entered.
Total Total of all reporting groups

Baseline Measures
   Belimumab SC Q2WKS   Belimumab SC 3X/WK   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   28   56 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.2  (11.5)   40.9  (13.1)   40.1  (12.2) 
Gender 
[Units: Participants]
     
Female   26   27   53 
Male   2   1   3 
Region of Enrollment 
[Units: Participants]
     
United States   24   25   49 
Mexico   4   3   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.   [ Time Frame: Up to 24 weeks ]

2.  Primary:   Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24   [ Time Frame: Baseline, 24 weeks ]

3.  Primary:   Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.   [ Time Frame: Baseline, 24 Weeks ]

4.  Primary:   Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24   [ Time Frame: Baseline, 24 weeks ]

5.  Primary:   Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24   [ Time Frame: Baseline, 24 weeks ]

6.  Primary:   Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24   [ Time Frame: Baseline, 24 Weeks ]

7.  Primary:   Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24   [ Time Frame: Baseline, 24 Weeks ]

8.  Primary:   Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24   [ Time Frame: Baseline, 24 Weeks ]

9.  Primary:   Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24   [ Time Frame: Baseline, 24 Weeks ]

10.  Secondary:   Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.   [ Time Frame: Baseline, 24 weeks ]

11.  Secondary:   Absolute Change From Baseline in IgA at Week 24   [ Time Frame: Baseline, 24 Weeks ]

12.  Secondary:   Median Percent Change From Baseline in IgA at Week 24   [ Time Frame: Baseline, 24 weeks ]

13.  Secondary:   Absolute Change From Baseline in IgG at Week 24   [ Time Frame: Baseline, 24 Weeks ]

14.  Secondary:   Median Percent Change From Baseline in IgG at Week 24   [ Time Frame: Baseline, 24 Weeks ]

15.  Secondary:   Absolute Change From Baseline in IgM at Week 24   [ Time Frame: Baseline, 24 Weeks ]

16.  Secondary:   Median Percent Change From Baseline in IgM at Week 24   [ Time Frame: Baseline, 24 weeks ]

17.  Secondary:   Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24   [ Time Frame: Baseline, 24 Weeks ]

18.  Secondary:   Mean Percent Change From Baseline in PGA Score at Week 24.   [ Time Frame: Baseline, 24 weeks ]

19.  Secondary:   Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24   [ Time Frame: Baseline, 24 Weeks ]

20.  Secondary:   Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24   [ Time Frame: Baseline, 24 weeks ]

21.  Secondary:   Absolute Change From Baseline in Complement C3 at Week 24   [ Time Frame: Baseline, 24 Weeks ]

22.  Secondary:   Median Percent Change From Baseline in Compliment C3 at Week 24   [ Time Frame: Baseline, 24 Weeks ]

23.  Secondary:   Absolute Change From Baseline in Complement C4 at Week 24   [ Time Frame: Baseline, 24 weeks ]

24.  Secondary:   Median Percent Change From Baseline in Complement C4 at Week 24   [ Time Frame: Baseline, 24 Weeks ]

25.  Secondary:   Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24   [ Time Frame: Baseline, 24 Weeks ]

26.  Secondary:   Median Percent Change From Baseline in Anti-dsDNA at Week 24   [ Time Frame: Baseline, 24 weeks ]

27.  Secondary:   Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24   [ Time Frame: Baseline, 24 Weeks ]

28.  Secondary:   Median Percent Change From Baseline in HDL at Week 24   [ Time Frame: Baseline, 24 week ]

29.  Secondary:   Absolute Change From Baseline in Total Cholesterol at Week 24   [ Time Frame: Baseline, 24 Weeks ]

30.  Secondary:   Median Percent Change From Baseline in Total Cholesterol at Week 24   [ Time Frame: Baseline, 24 Weeks ]

31.  Secondary:   Median Percent Change From Baseline in Triglycerides at Week 24   [ Time Frame: Baseline, 24 weeks ]

32.  Secondary:   Absolute Change From Baseline in Triglycerides at Week 24   [ Time Frame: Baseline, 24 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: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00732940     History of Changes
Other Study ID Numbers: HGS1006-1070
112232 ( Other Identifier: GlaxoSmithKline )
First Submitted: August 8, 2008
First Posted: August 12, 2008
Results First Submitted: April 7, 2011
Results First Posted: May 5, 2011
Last Update Posted: August 7, 2013