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A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00724867
First received: July 28, 2008
Last updated: March 10, 2016
Last verified: March 2016
Results First Received: November 19, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Systemic Lupus Erythematosus
Interventions: Biological: Belimumab 1 mg/kg
Biological: 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
Participants with systemic lupus erythematosus who completed the Phase 3 HGS1006-C1056 were enrolled to receive belimumab

Reporting Groups
  Description
Belimumab 10 mg/kg IV Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.

Participant Flow:   Overall Study
    Belimumab 10 mg/kg IV
STARTED   268 
COMPLETED   140 
NOT COMPLETED   128 
Adverse Event                25 
Lack of Efficacy                14 
Lost to Follow-up                12 
Non-compliance with study drug                6 
Physician Decision                17 
Protocol Violation                1 
Withdrawal by Subject                31 
Sponsor decision to end study                14 
Subject incarcerated                1 
Developed withdrawal criteria- pregnancy                4 
Subject moved out of state                1 
Elected to exit due to site closure                2 



  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 10 mg/kg IV Participants, who had received belimumab 1milligram per kilogram (mg/kg) or 10 mg/kg or placebo in study HGS1006-C1056 , received intravenous (IV) infusion of belimumab 10 mg/kg body weight over 1 hour every 28 days. The first dose of belimumab was given 4 weeks (2 to 8 weeks) after the last dose in the HGS1006-C1056 study. Treatment continued for five years from the time the last participant enrolled in the study or until there were 100 or fewer participants enrolled. All participants received standard of care (SoC) for systemic lupus erythematosus (SLE) during study participation.

Baseline Measures
   Belimumab 10 mg/kg IV 
Overall Participants Analyzed 
[Units: Participants]
 268 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.8  (11.33) 
Gender 
[Units: Participants]
 
Female   250 
Male   18 
Race/Ethnicity, Customized 
[Units: Participants]
 
Black or African American/African Heritage   57 
American Indian or Alaska Native   8 
Asian: Central Asian Heritage   0 
Asian: East Asian Heritage   2 
Asian: Japanese Heritage   3 
Asian: South Asian Heritage   1 
Asian: Southeast Asian Heritage   7 
Native Hawaiian or Other Pacific Islander   0 
White: Middle East/North African Heritage   3 
White: White/Caucasian/European Heritage   183 
Mixed Race   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs)   [ Time Frame: Up to Week 440 ]

2.  Primary:   AE Rates by System Organ Class (SOC) During the Study   [ Time Frame: Up Week 440 ]

3.  Primary:   SAE Rates by System Organ Class (SOC) During the Study   [ Time Frame: Up to Week 440 ]

4.  Primary:   Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points   [ Time Frame: Up to Week 440 ]

5.  Primary:   Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points   [ Time Frame: Up to Week 440 ]

6.  Primary:   Change From Baseline in Erythrocytes at the Indicated Time Points   [ Time Frame: Up to Week 440 ]

7.  Primary:   Change From Baseline in Hematocrit at the Indicated Time Points   [ Time Frame: Up to Week 440 ]

8.  Primary:   Change From Baseline in Hemoglobin at the Indicated Time Points   [ Time Frame: Up to Week 440 ]

9.  Primary:   Change From Baseline in Albumin and Protein at the Indicated Time Points   [ Time Frame: Up to Week 440 ]

10.  Primary:   Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points   [ Time Frame: Up to Week 440 ]

11.  Primary:   Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points   [ Time Frame: Up to Week 440 ]

12.  Primary:   Change From Baseline in Creatinine Clearance at the Indicated Time Points   [ Time Frame: Up to Week 440 ]

13.  Primary:   Change From Baseline in BUN/Creatinine at the Indicated Time Points   [ Time Frame: Up to Week 440 ]

14.  Primary:   Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points   [ Time Frame: Up to Week 432 ]

15.  Primary:   Number of Participants With the Indicated Immunogenic Response   [ Time Frame: Up to Week 440 ]

16.  Primary:   Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points.   [ Time Frame: Up to Week 432 ]

17.  Primary:   Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points.   [ Time Frame: Up to Week 440 ]

18.  Primary:   Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval.   [ Time Frame: Up to Week 440 ]

19.  Secondary:   Number of Participants With Serum Immunoglobulins Below the Lower Limit of Normal at Indicated Time Points.   [ Time Frame: Up to Week 392 ]

20.  Secondary:   Percentage of Participants Achieving SRI Response at Indicated Time Points   [ Time Frame: Up to Week 440 ]

21.  Secondary:   Observed Anti-double Stranded DNA Levels at Indicated Time Points.   [ Time Frame: Up to Week 432 ]

22.  Secondary:   Median Percent Change From Baseline in Anti-double Stranded DNA at Indicated Time Points.   [ Time Frame: Up to Week 432 ]

23.  Secondary:   Observed Complement C3 and C4 Levels at Indicated Time Points   [ Time Frame: Up to Week 440 ]

24.  Secondary:   Median Percent Change From Baseline in Complement C3 and C4 Levels at Indicated Time Points   [ Time Frame: Up to Week 432 ]

25.  Secondary:   Percent of Participants With Daily Prednisone Dose Reduction at Indicated Time Points.   [ Time Frame: Up to Week 432 ]

26.  Secondary:   Percent of Participants With >= 50% Reduction in Proteinuria at Indicated Time Points.   [ Time Frame: Up to Week 432 ]

27.  Secondary:   Observed B-cell Levels at Indicated Time Points.   [ Time Frame: Up to Week 432 ]

28.  Secondary:   Median Percent Change From Baseline in B Cell Levels at Indicated Time Points.   [ Time Frame: Up to Week 432 ]

29.  Secondary:   Percentage of Participants With Worsening in SLICC/ACR Damage Index at Indicated Time Points   [ Time Frame: Up to Week 384 ]

30.  Secondary:   Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Time Point   [ Time Frame: Up to Week 384 ]

31.  Secondary:   Change From Baseline in SF-36 Healthy Survey Overall Component Scores at Indicated Timepoints   [ Time Frame: Up to Week 384 ]

32.  Secondary:   Change From Baseline in FACIT-Fatigue Scale Total Score at Indicated Time Point   [ Time Frame: Up to Week 384 ]

33.  Secondary:   Percentage of Participants With Improvement in FACIT-Fatigue Scale Score Exceeding the MCID at Indicated Time Points   [ Time Frame: Up to Week 384 ]


  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 ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT00724867     History of Changes
Other Study ID Numbers: 112233
HGS1006-C1066 ( Other Identifier: Human Genome Sciences )
Study First Received: July 28, 2008
Results First Received: November 19, 2015
Last Updated: March 10, 2016
Health Authority: United States: Food and Drug Administration