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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01663623




Registration number
NCT01663623
Ethics application status
Date submitted
9/08/2012
Date registered
13/08/2012
Date last updated
18/04/2018

Titles & IDs
Public title
Belimumab in Remission of VASculitis
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
Secondary ID [1] 0 0
115466
Universal Trial Number (UTN)
Trial acronym
BREVAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vasculitis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Relapse - 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.
Timepoint [1] 0 0
Approximately up to 4 years
Secondary outcome [1] 0 0
Number of Participants With Major Relapse During the Double-blind Phase of the Study - 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.
Timepoint [1] 0 0
Approximately up to 4 years

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.

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Garran
Recruitment hospital [2] 0 0
GSK Investigational Site - New Lambton
Recruitment hospital [3] 0 0
GSK Investigational Site - Malvern
Recruitment hospital [4] 0 0
GSK Investigational Site - Liverpool
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
2107 - Liverpool
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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California
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Illinois
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Kansas
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Massachusetts
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Michigan
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Minnesota
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New Jersey
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New York
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Ohio
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Oregon
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Pennsylvania
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Wisconsin
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Leuven
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Praha 2
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Czechia
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Praha 4
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France
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Lille cedex
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France
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Paris
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France
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Pessac
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France
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Rennes
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Germany
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Thueringen
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Germany
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Berlin
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Germany
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Kirchheim unter Teck
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Germany
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Muenchen
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Hungary
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Budapest
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Hungary
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Debrecen
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Ireland
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Dublin
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Italy
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Liguria
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Italy
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Marche
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Italy
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Bari
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Italy
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Bologna
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Italy
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Milano
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Italy
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Reggio Emilia
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Mexico
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Mexico
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Norway
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Kristiansand
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Norway
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Oslo
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Peru
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Callao
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Peru
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Lima
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Poland
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Gdansk
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Lublin
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Stavropol
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Spain
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Barcelona
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Madrid
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Stockholm
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Bern
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Switzerland
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St. Gallen
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Switzerland
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Zuerich
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United Kingdom
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Berkshire
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United Kingdom
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Aberdeen
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United Kingdom
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Cambridge
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United Kingdom
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London
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United Kingdom
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Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Human Genome Sciences Inc., a GSK Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01663623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications