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Belimumab in Remission of VASculitis (BREVAS)

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ClinicalTrials.gov Identifier: NCT01663623
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

Brief 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.

Condition or disease Intervention/treatment Phase
Vasculitis Biological: Placebo Biological: Belimumab 10 mg/kg Drug: Azathioprine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 20, 2013
Actual Primary Completion Date : February 6, 2017
Actual Study Completion Date : February 6, 2017


Arm Intervention/treatment
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.
Biological: Placebo
Placebo

Drug: Azathioprine
Azathioprine

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.
Biological: Belimumab 10 mg/kg
Belimumab 10 mg/kg
Other Name: BENLYSTA™

Drug: Azathioprine
Azathioprine




Primary Outcome Measures :
  1. Time to First Relapse [ Time Frame: Approximately up to 4 years ]
    Time to relapse is defined as the number of days from Day 0 until the participant experienced a relapse (relapse date - treatment start date +1). Only post-baseline relapses were considered in these analyses. Only relapses occurring up to and including the last visit date in the double-blind treatment period were considered in these analyses. Intent-to-treat population comprised of all randomized participants who received at least one dose of study agent (belimumab or placebo). NA indicates that the data was not available as the Number of events is too low to estimate the value. Median and Inter-quartile range were presented and were based on Kaplan Meier estimates.


Secondary Outcome Measures :
  1. Number of Participants With Major Relapse During the Double-blind Phase of the Study [ Time Frame: Approximately up to 4 years ]
    Data for number of participants with major relapse [defined as experiencing at least 1 major Birmingham Vasculitis Activity Score (BVAS) item] during the double-bind phase of the study was reported. Analysis was performed using a Cox proportional hazard model.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663623


  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
GSK Investigational Site
Mobile, Alabama, United States, 36693
United States, Arizona
GSK Investigational Site
Tucson, Arizona, United States, 85724
United States, California
GSK Investigational Site
Covina, California, United States, 91723
GSK Investigational Site
Palo Alto, California, United States, 94030
GSK Investigational Site
San Leandro, California, United States, 94578
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
United States, Kansas
GSK Investigational Site
Kansas City, Kansas, United States, 66160
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02118-2307
GSK Investigational Site
West Springfield, Massachusetts, United States, 1089
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48202
United States, Minnesota
GSK Investigational Site
Rochester, Minnesota, United States, 55905
United States, New Jersey
GSK Investigational Site
Camden, New Jersey, United States, 08103-1438
United States, New York
GSK Investigational Site
Great Neck, New York, United States, 11021
GSK Investigational Site
New York, New York, United States, 10016
GSK Investigational Site
New York, New York, United States, 10021
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43203
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15261
GSK Investigational Site
Wyomissing, Pennsylvania, United States, 19610
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Australia, Australian Capital Territory
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
GSK Investigational Site
New Lambton, New South Wales, Australia, 2305
Australia, Victoria
GSK Investigational Site
Malvern, Victoria, Australia, 3144
Australia
GSK Investigational Site
Liverpool, Australia, 2107
Belgium
GSK Investigational Site
Brussels, Belgium, 1090
GSK Investigational Site
Bruxelles, Belgium, 1020
GSK Investigational Site
Leuven, Belgium, 3000
Canada, Ontario
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 4A6
GSK Investigational Site
Toronto, Ontario, Canada, M5T 3L9
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H1T 2M4
GSK Investigational Site
Montreal, Quebec, Canada, H3G 1A4
Czechia
GSK Investigational Site
Praha 2, Czechia, 12808
GSK Investigational Site
Praha 2, Czechia, 12850
GSK Investigational Site
Praha 4, Czechia, 14021
France
GSK Investigational Site
Lille cedex, France, 59037
GSK Investigational Site
Paris, France, 75014
GSK Investigational Site
Pessac, France, 33604
GSK Investigational Site
Rennes, France, 35033
Germany
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70376
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
GSK Investigational Site
Jena, Thueringen, Germany, 07740
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Kirchheim unter Teck, Germany, 73230
GSK Investigational Site
Muenchen, Germany, 80336
Hungary
GSK Investigational Site
Budapest, Hungary, 1023
GSK Investigational Site
Debrecen, Hungary, 4032
Ireland
GSK Investigational Site
Dublin, Ireland, 4
GSK Investigational Site
Dublin, Ireland, 9
Italy
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Torrette Di Ancona, Marche, Italy, 60126
GSK Investigational Site
Bari, Italy, 70124
GSK Investigational Site
Bologna, Italy, 40138
GSK Investigational Site
Milano, Italy, 20153
GSK Investigational Site
Reggio Emilia, Italy, 42100
Mexico
GSK Investigational Site
Mexico, Mexico, 7760
Norway
GSK Investigational Site
Kristiansand, Norway, 4604
GSK Investigational Site
Oslo, Norway, 0372
Peru
GSK Investigational Site
Callao, Peru, Callao 2
GSK Investigational Site
Lima, Peru, Lima 21
GSK Investigational Site
Lima, Peru, Lima 27
GSK Investigational Site
Lima, Peru, Lima 31
GSK Investigational Site
Lima, Peru, Lima 36
GSK Investigational Site
Lima, Peru, Lima 41
GSK Investigational Site
Lima, Peru, Lima14
Poland
GSK Investigational Site
Gdansk, Poland, 80-952
GSK Investigational Site
Katowice, Poland, 40-635
GSK Investigational Site
Krakow, Poland, 31-066
GSK Investigational Site
Lublin, Poland, 20-954
Romania
GSK Investigational Site
Bucharest, Romania, 020125
GSK Investigational Site
Cluj-Napoca, Romania, 400006
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 119992
GSK Investigational Site
Saint-Petersburg, Russian Federation, 190068
GSK Investigational Site
Stavropol, Russian Federation
Spain
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 8036
GSK Investigational Site
Madrid, Spain, 28034
Sweden
GSK Investigational Site
Stockholm, Sweden, 14186
Switzerland
GSK Investigational Site
Bern, Switzerland, 3010
GSK Investigational Site
St. Gallen, Switzerland, 9007
GSK Investigational Site
Zuerich, Switzerland, 8006
United Kingdom
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG1 5AN
GSK Investigational Site
Aberdeen, United Kingdom, AB25 2ZD
GSK Investigational Site
Cambridge, United Kingdom, CB2 0QQ
GSK Investigational Site
London, United Kingdom, SE1 7EH
GSK Investigational Site
Oxford, United Kingdom, OX3 7LD
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):
Study Protocol  [PDF] February 26, 2015
Statistical Analysis Plan  [PDF] March 6, 2017


Responsible Party: Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier: NCT01663623     History of Changes
Other Study ID Numbers: 115466
First Posted: August 13, 2012    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):
Wegener's Granulomatosis
anti-MPO
WG
Belimumab
GPA
anti-proteinase 3
anti-neutrophil cytoplasmic antibody
anti-myeloperoxidase
Granulomatosis with polyangiitis
Vasculitis
Autoimmune Diseases
Microscopic Polyangiitis
anti-PR3
ANCA
MPA
Systemic Vasculitis

Additional relevant MeSH terms:
Vasculitis
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Azathioprine
Belimumab
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents