Belimumab in Remission of VASculitis

Vasculitis Clinical Trial

— BREVAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663623
• Other study ID #: 115466
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2012
• Last updated: November 27, 2017
• Start date: March 20, 2013
• Est. completion date: February 6, 2017

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 6, 2017
• Est. primary completion date: February 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• 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 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.

Related Conditions & MeSH terms

• Granulomatosis with Polyangiitis
• Microscopic Polyangiitis
• Vasculitis

Intervention

Biological:
• Placebo
Placebo
• Belimumab 10 mg/kg
Belimumab 10 mg/kg

Drug:
• Azathioprine
Azathioprine

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Garran	Australian Capital Territory
Australia	GSK Investigational Site	Liverpool
Australia	GSK Investigational Site	Malvern	Victoria
Australia	GSK Investigational Site	New Lambton	New South Wales
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Leuven
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Toronto	Ontario
Czechia	GSK Investigational Site	Praha 2
Czechia	GSK Investigational Site	Praha 2
Czechia	GSK Investigational Site	Praha 4
France	GSK Investigational Site	Lille cedex
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Pessac
France	GSK Investigational Site	Rennes
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Jena	Thueringen
Germany	GSK Investigational Site	Kirchheim unter Teck
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Muenchen
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Stuttgart	Baden-Wuerttemberg
Germany	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Debrecen
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Italy	GSK Investigational Site	Bari
Italy	GSK Investigational Site	Bologna
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Milano
Italy	GSK Investigational Site	Reggio Emilia
Italy	GSK Investigational Site	Torrette Di Ancona	Marche
Mexico	GSK Investigational Site	Mexico
Norway	GSK Investigational Site	Kristiansand
Norway	GSK Investigational Site	Oslo
Peru	GSK Investigational Site	Callao
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lublin
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Cluj-Napoca
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	Stavropol
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Sweden	GSK Investigational Site	Stockholm
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	St. Gallen
Switzerland	GSK Investigational Site	Zuerich
United Kingdom	GSK Investigational Site	Aberdeen
United Kingdom	GSK Investigational Site	Cambridge
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Oxford
United Kingdom	GSK Investigational Site	Reading	Berkshire
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Camden	New Jersey
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Covina	California
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Great Neck	New York
United States	GSK Investigational Site	Kansas City	Kansas
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Palo Alto	California
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Rochester	Minnesota
United States	GSK Investigational Site	San Leandro	California
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	West Springfield	Massachusetts
United States	GSK Investigational Site	Wyomissing	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  France,  Germany,  Hungary,  Ireland,  Italy,  Mexico,  Norway,  Peru,  Poland,  Romania,  Russian Federation,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first relapse	Relapse is defined as at least 1 major item on the Birmingham Vasculitis Activity Score (BVAS), or a minimum total BVAS score of 6, or receipt of a protocol prohibited medication.	Approximately 3 years
Secondary	Time to first major relapse	Major relapse is defined as having at least 1 major item on the BVAS.	Approximately 3 years
Secondary	Number of participants who experienced adverse events		Approximately 3 years