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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01663623
Registration number
NCT01663623
Ethics application status
Date submitted
9/08/2012
Date registered
13/08/2012
Date last updated
17/04/2018
Titles & IDs
Public title
Belimumab in Remission of VASculitis
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Scientific 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
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Secondary ID [1]
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115466
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Universal Trial Number (UTN)
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Trial acronym
BREVAS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vasculitis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Inflammatory and Immune System
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Autoimmune diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Placebo
Other interventions - Belimumab 10 mg/kg
Treatment: Drugs - Azathioprine
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.
Other interventions: Placebo
Placebo
Other interventions: Belimumab 10 mg/kg
Belimumab 10 mg/kg
Treatment: Drugs: Azathioprine
Azathioprine
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to First Relapse
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Assessment method [1]
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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.
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Timepoint [1]
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Approximately up to 4 years
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Secondary outcome [1]
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Number of Participants With Major Relapse During the Double-blind Phase of the Study
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Assessment method [1]
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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.
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Timepoint [1]
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Approximately up to 4 years
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Eligibility
Key inclusion criteria
Key
- Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill
criteria.
- Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids
and 1 of the following medications: rituximab, oral cyclophosphamide OR IV
cyclophosphamide.
- Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO)
antibodies at any time prior to enrollment.
- Achieve remission no more than 26 weeks after first dose of induction treatment.
Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and
receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive
visits 21 to 35 days apart.
- Maintenance therapy on this study must start no more than 2 weeks after confirmation
of remission.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Pregnant or nursing.
- Receipt of a B cell targeted therapy (other than rituximab) at anytime
- Receipt of an investigational biological agent within the past 60 days.
- Required management of acute or chronic infections within the past 60 days.
- Current drug or alcohol abuse or dependence.
- Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or
hepatitis C.
- History of severe allergic reaction to contrast agents or biological medicines.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/03/2013
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
6/02/2017
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Sample size
Target
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Accrual to date
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Final
106
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
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Recruitment hospital [1]
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GSK Investigational Site - Garran
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GSK Investigational Site - New Lambton
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GSK Investigational Site - Malvern
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GSK Investigational Site - Liverpool
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2605 - Garran
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2305 - New Lambton
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Recruitment postcode(s) [3]
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3144 - Malvern
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Recruitment postcode(s) [4]
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2107 - Liverpool
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Recruitment outside Australia
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Human Genome Sciences Inc., a GSK Company
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Address
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Commercial sector/Industry
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Name [1]
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GlaxoSmithKline
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination
with azathioprine, for the maintenance of remission following a standard induction regimen in
patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in
this study is "1 to 1" which means that participants have an equal chance of receiving
belimumab or placebo.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01663623
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Trial related presentations / publications
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01663623
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