Last updated: 07/17/2024 15:45:37

Belimumab in Remission of VASculitisBREVAS

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GSK study ID
115466
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Clinicaltrials.gov ID
NCT01663623
See results summary
EudraCT ID
2011-004569-33
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Time to First Relapse

Timeframe: Approximately up to 4 years

Secondary outcomes:

Number of participants with major relapse during the double-blind phase of the study

Timeframe: Approximately up to 4 years

Interventions:
  • Biological/vaccine: Placebo
  • Biological/vaccine: Belimumab 10 mg/kg
  • Drug: Azathioprine
    • Enrollment:
    106
    Primary completion date:
    2017-06-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    David Jayne; Daniel Blockmans; Raashid Luqmani; Sergey Moiseev; Beulah Ji; Yulia Green; Leanne Hall; David Roth; Robert B Henderson; Peter A Merkel.Efficacy and safety of belimumab and azathioprine for maintenance of remission in ANCA-associated vasculitis: a randomized controlled study.Arthritis Rheumatol.2019;71(6):952-963 DOI: 10.1002/art.40802 PMID: 30666823
    Medical condition
    Vasculitis
    Product
    belimumab
    Collaborators
    GlaxoSmithKline, GSK
    Study date(s)
    March 2013 to February 2017
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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.
    • Pregnant or nursing.
    • Receipt of a B cell targeted therapy (other than rituximab) at anytime
    Inclusion and exclusion criteria
    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.
    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.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Aberdeen, United Kingdom, AB25 2ZD
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Barcelona, Spain, 8036
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bari, Italy, 70124
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brussels, Belgium, 1090
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Budapest, Hungary, 1023
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Callao, Peru, Callao 2
    Status
    Study Complete
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    Showing 1 - 6 of 48 Results

    Study documents

    Protocol
    Available language(s): English
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    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2017-06-02
    Actual study completion date
    2017-06-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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