Last updated: 07/17/2024 15:45:37
Belimumab in Remission of VASculitisBREVAS
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2017-06-02
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
GSK Investigational Site
Covina, California, United States, 91723
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
Great Neck, New York, United States, 11021
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Study Complete
Location
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG1 5AN
Status
Study Complete
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
San Leandro, California, United States, 94578
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70376
Status
Study Complete
Location
GSK Investigational Site
Torrette di Ancona, Marche, Italy, 60126
Status
Study Complete
Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Status
Study Complete
Location
GSK Investigational Site
Wyomissing, Pennsylvania, United States, 19610
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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