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Belimumab in Remission of VASculitis (BREVAS)

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ClinicalTrials.gov Identifier: NCT01663623
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : April 17, 2018
Last Update Posted : April 17, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Vasculitis
Interventions: Biological: Placebo
Biological: Belimumab 10 mg/kg
Drug: Azathioprine

  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 with diagnosis of Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) were randomized in this study. The study was conducted at 37 centers in 15 countries in North America, Central America, South America, Western Europe, Eastern Europe, and Australia during 20 March 2013 - 06 February 2017.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 164 participants were screened and 106 were enrolled and randomized in a 1:1 ratio to receive placebo or belimumab 10 milligram per kilogram (mg/kg). Of which, 105 received at least 1 dose of study agent and one participant was randomized in error.

Reporting Groups
  Description
Placebo Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered matching placebo intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 milligram per kilogram per day (mg/kg/day). In Belgium-only open-label extension, all participants received belimumab 10mg/day every 28 days until Week 24, with a final evaluation at Week 28.
Belimumab 10 mg/kg Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered belimumab 10 mg/kg intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 mg/kg/day. In Belgium-only open-label extension, all participants received belimumab 10 mg/kg every 28 days until Week 24, with a final evaluation at Week 28.

Participant Flow:   Overall Study
    Placebo   Belimumab 10 mg/kg
STARTED   52   53 
COMPLETED   40   33 
NOT COMPLETED   12   20 
Adverse Event                3                7 
Lack of Efficacy                5                6 
Protocol Violation                0                1 
Other-Study closed/terminated                1                1 
Physician Decision                1                4 
Withdrawal by Subject                2                1 



  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 Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered matching placebo intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 milligram per kilogram per day (mg/kg/day). In Belgium-only open-label extension, all participants received belimumab 10mg/day every 28 days until Week 24, with a final evaluation at Week 28.
Belimumab 10 mg/kg Participants were administered induction therapy (corticosteroids and either cyclophosphamide or rituximab) in the 6 months leading up to randomization. After randomization, participants were administered belimumab 10 mg/kg intravenously over 1 hour, at Day 0, 14, 28 and every 28 days thereafter until 12 months after the last subject was randomized. All participants received oral azathioprine at a target dose of 2 mg/kg/day. In Belgium-only open-label extension, all participants received belimumab 10 mg/kg every 28 days until Week 24, with a final evaluation at Week 28.
Total Total of all reporting groups

Baseline Measures
   Placebo   Belimumab 10 mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   53   105 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.5  (13.56)   56.2  (13.59)   54.8  (13.58) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      25  48.1%      26  49.1%      51  48.6% 
Male      27  51.9%      27  50.9%      54  51.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
African American/African Heritage   1   1   2 
American Indian or Alaskan Native   5   6   11 
Central/South Asian Heritage   2   0   2 
White   44   46   90 


  Outcome Measures

1.  Primary:   Time to First Relapse   [ Time Frame: Approximately up to 4 years ]

2.  Secondary:   Number of Participants With Major Relapse During the Double-blind Phase of the Study   [ Time Frame: Approximately up to 4 years ]


  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
The sample size was small as it was truncated from approximately 300 to 100 participants, largely owing to a change in standard of care.


  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
e-mail: GSKClinicalSupportHD@gsk.com



Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT01663623     History of Changes
Other Study ID Numbers: 115466
First Submitted: August 9, 2012
First Posted: August 13, 2012
Results First Submitted: January 30, 2018
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018