Belimumab in Remission of VASculitis (BREVAS)
|ClinicalTrials.gov Identifier: NCT01663623|
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : November 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Vasculitis||Biological: Placebo Biological: Belimumab 10 mg/kg Drug: Azathioprine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination With Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis|
|Actual Study Start Date :||March 20, 2013|
|Actual Primary Completion Date :||February 6, 2017|
|Actual Study Completion Date :||February 6, 2017|
Placebo Comparator: Placebo plus azathioprine
Placebo IV plus oral azathioprine 2 mg/kg/day; placebo administered on Days 0, 14, 28, and then every 28 days until the end of the study. If the results in the double-blind period show that belimumab is safe and effective, then participants have the option to receive treatment with belimumab in a 6-month open-label extension phase. Placebo patients who opt to participate in the extension will receive belimumab 10 mg/kg IV every 28 days plus oral azathioprine 2 mg/kg/day for an additional 6 months.
Experimental: Belimumab 10 mg/kg plus azathioprine
Belimumab 10 mg/kg IV plus oral azathioprine 2 mg/kg/day; belimumab administered on Days 0, 14, 28, and then every 28 days until the end of the study. If the results in the double-blind period show that belimumab is safe and effective, then participants have the option to continue treatment with belimumab in a 6-month open-label extension phase. Patients who opt to participate in the extension will continue to receive belimumab 10 mg/kg IV every 28 plus oral azathioprine 2 mg/kg/day days for an additional 6 months.
Biological: Belimumab 10 mg/kg
Belimumab 10 mg/kg
Other Name: BENLYSTA™Drug: Azathioprine
- Time to First Relapse [ Time Frame: Approximately up to 4 years ]Time to relapse is defined as the number of days from Day 0 until the participant experienced a relapse (relapse date - treatment start date +1). Only post-baseline relapses were considered in these analyses. Only relapses occurring up to and including the last visit date in the double-blind treatment period were considered in these analyses. Intent-to-treat population comprised of all randomized participants who received at least one dose of study agent (belimumab or placebo). NA indicates that the data was not available as the Number of events is too low to estimate the value. Median and Inter-quartile range were presented and were based on Kaplan Meier estimates.
- Number of Participants With Major Relapse During the Double-blind Phase of the Study [ Time Frame: Approximately up to 4 years ]Data for number of participants with major relapse [defined as experiencing at least 1 major Birmingham Vasculitis Activity Score (BVAS) item] during the double-bind phase of the study was reported. Analysis was performed using a Cox proportional hazard model.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663623
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|