Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2013-03-20
2017-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Placebo
Placebo
Azathioprine
Azathioprine
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.
Belimumab 10 mg/kg
Belimumab 10 mg/kg
Azathioprine
Azathioprine
Interventions
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Placebo
Placebo
Belimumab 10 mg/kg
Belimumab 10 mg/kg
Azathioprine
Azathioprine
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Human Genome Sciences Inc., a GSK Company
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Mobile, Alabama, United States
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Tucson, Arizona, United States
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Covina, California, United States
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Palo Alto, California, United States
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San Leandro, California, United States
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Chicago, Illinois, United States
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Kansas City, Kansas, United States
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Boston, Massachusetts, United States
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West Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Camden, New Jersey, United States
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Great Neck, New York, United States
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New York, New York, United States
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New York, New York, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Milwaukee, Wisconsin, United States
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Garran, Australian Capital Territory, Australia
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New Lambton, New South Wales, Australia
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Malvern, Victoria, Australia
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Liverpool, , Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Leuven, , Belgium
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Hamilton, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Lille, , France
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Paris, , France
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Pessac, , France
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Rennes, , France
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Stuttgart, Baden-Wurttemberg, Germany
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Tübingen, Baden-Wurttemberg, Germany
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Münster, North Rhine-Westphalia, Germany
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Leipzig, Saxony, Germany
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Jena, Thuringia, Germany
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Berlin, , Germany
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Kirchheim unter Teck, , Germany
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München, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Dublin, , Ireland
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Dublin, , Ireland
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Genoa, Liguria, Italy
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Torrette Di Ancona, The Marches, Italy
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Bari, , Italy
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Bologna, , Italy
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Milan, , Italy
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Reggio Emilia, , Italy
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México, , Mexico
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Kristiansand, , Norway
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Oslo, , Norway
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Callao, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Gdansk, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Moscow, , Russia
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Saint Petersburg, , Russia
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Stavropol, , Russia
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Stockholm, , Sweden
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Bern, , Switzerland
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Sankt Gallen, , Switzerland
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Zurich, , Switzerland
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Reading, Berkshire, United Kingdom
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Aberdeen, , United Kingdom
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Cambridge, , United Kingdom
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London, , United Kingdom
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Oxford, , United Kingdom
Countries
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References
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Jayne D, Blockmans D, Luqmani R, Moiseev S, Ji B, Green Y, Hall L, Roth D, Henderson RB, Merkel PA; BREVAS Study Collaborators. Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Controlled Study. Arthritis Rheumatol. 2019 Jun;71(6):952-963. doi: 10.1002/art.40802. Epub 2019 Apr 16.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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115466
Identifier Type: -
Identifier Source: org_study_id
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