Belimumab in Remission of VASculitis (BREVAS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01663623 |
Recruitment Status :
Completed
First Posted : August 13, 2012
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Documents provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):
Responsible Party: | Human Genome Sciences Inc., a GSK Company |
ClinicalTrials.gov Identifier: | NCT01663623 |
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 |
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 |
Microscopic Polyangiitis Vasculitis Vascular Diseases Cardiovascular Diseases Systemic Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated 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 |