Belimumab in Remission of VASculitis (BREVAS)

March 15, 2018 updated by: Human Genome Sciences Inc., a GSK Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Azathioprine
Azathioprine
Biological: Belimumab 10 mg/kg
Belimumab 10 mg/kg
Other Names:
  • BENLYSTA™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Approximately up to 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Approximately up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Human Genome Sciences Inc., a GSK Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 115466

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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