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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Treatment: Other - Placebo
Treatment: Other - 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.


Treatment: Other: Placebo
Placebo

Treatment: Other: Belimumab 10 mg/kg
Belimumab 10 mg/kg

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

Outcomes
Primary outcome [1] 0 0
Time to First Relapse
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
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
Sex
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
20/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/02/2017
Sample size
Target
Accrual to date
Final
106
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
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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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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Pessac
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Rennes
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Germany
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Baden-Wuerttemberg
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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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Krakow
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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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Bern
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Zuerich
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Berkshire
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Aberdeen
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Cambridge
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01663623