VasculitisPhase 3BREVASNCT01663623

Belimumab in Remission of VASculitis

A Phase 3 study testing Belimumab 10 mg/kg and Azathioprine in people with Vasculitis, run by Human Genome Sciences Inc., a GSK Company at 89 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vasculitis
What is being tested?: Belimumab 10 mg/kg and Azathioprine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 106 participants
Where: 89 sitesin 20 countries
Study dates: 20 Mar 2013to 6 Feb 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

89 sites in 20 countries.

Country

City, postcode or hospital

89 sites in 20 countries

United States22 sites

GSK Investigational Site
Birmingham, Alabama, 35294
GSK Investigational Site
Boston, Massachusetts, 02118-2307
GSK Investigational Site
Camden, New Jersey, 08103-1438
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Columbus, Ohio, 43203
GSK Investigational Site
Covina, California, 91723
GSK Investigational Site
Detroit, Michigan, 48202
GSK Investigational Site
Great Neck, New York, 11021
GSK Investigational Site
Kansas City, Kansas, 66160
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
Mobile, Alabama, 36693
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Palo Alto, California, 94030
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
GSK Investigational Site
Pittsburgh, Pennsylvania, 15261
GSK Investigational Site
Portland, Oregon, 97239
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
San Leandro, California, 94578
GSK Investigational Site
Tucson, Arizona, 85724
GSK Investigational Site
West Springfield, Massachusetts, 1089
GSK Investigational Site
Wyomissing, Pennsylvania, 19610

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Germany8 sites

GSK Investigational Site
Berlin, 10117
GSK Investigational Site
Jena, Thuringia, 07740
GSK Investigational Site
Kirchheim unter Teck, 73230
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
München, 80336
GSK Investigational Site
Münster, North Rhine-Westphalia, 48149
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70376
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72076

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Peru7 sites

GSK Investigational Site
Callao, Callao 2
GSK Investigational Site
Lima, Lima 21
GSK Investigational Site
Lima, Lima 27
GSK Investigational Site
Lima, Lima 31
GSK Investigational Site
Lima, Lima 36
GSK Investigational Site
Lima, Lima 41
GSK Investigational Site
Lima, Lima14

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Italy6 sites

GSK Investigational Site
Bari, 70124
GSK Investigational Site
Bologna, 40138
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Milan, 20153
GSK Investigational Site
Reggio Emilia, 42100
GSK Investigational Site
Torrette Di Ancona, The Marches, 60126

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United Kingdom5 sites

GSK Investigational Site
Aberdeen, AB25 2ZD
GSK Investigational Site
Cambridge, CB2 0QQ
GSK Investigational Site
London, SE1 7EH
GSK Investigational Site
Oxford, OX3 7LD
GSK Investigational Site
Reading, Berkshire, RG1 5AN

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Australia4 sites

GSK Investigational Site
Garran, Australian Capital Territory, 2605
GSK Investigational Site
Liverpool, 2107
GSK Investigational Site
Malvern, Victoria, 3144
GSK Investigational Site
New Lambton, New South Wales, 2305

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Canada4 sites

GSK Investigational Site
Hamilton, Ontario, L8N 4A6
GSK Investigational Site
Montreal, Quebec, H1T 2M4
GSK Investigational Site
Montreal, Quebec, H3G 1A4
GSK Investigational Site
Toronto, Ontario, M5T 3L9

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France4 sites

GSK Investigational Site
Lille, 59037
GSK Investigational Site
Paris, 75014
GSK Investigational Site
Pessac, 33604
GSK Investigational Site
Rennes, 35033

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Poland4 sites

GSK Investigational Site
Gdansk, 80-952
GSK Investigational Site
Katowice, 40-635
GSK Investigational Site
Krakow, 31-066
GSK Investigational Site
Lublin, 20-954

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Belgium3 sites

GSK Investigational Site
Brussels, 1020
GSK Investigational Site
Brussels, 1090
GSK Investigational Site
Leuven, 3000

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Czechia3 sites

GSK Investigational Site
Prague, 12808
GSK Investigational Site
Prague, 12850
GSK Investigational Site
Prague, 14021

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Russia3 sites

GSK Investigational Site
Moscow, 119992
GSK Investigational Site
Saint Petersburg, 190068
GSK Investigational Site
Stavropol

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Spain3 sites

GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 8036
GSK Investigational Site
Madrid, 28034

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Switzerland3 sites

GSK Investigational Site
Bern, 3010
GSK Investigational Site
Sankt Gallen, 9007
GSK Investigational Site
Zurich, 8006

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Hungary2 sites

GSK Investigational Site
Budapest, 1023
GSK Investigational Site
Debrecen, 4032

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Ireland2 sites

GSK Investigational Site
Dublin, 4
GSK Investigational Site
Dublin, 9

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Norway2 sites

GSK Investigational Site
Kristiansand, 4604
GSK Investigational Site
Oslo, 0372

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Romania2 sites

GSK Investigational Site
Bucharest, 020125
GSK Investigational Site
Cluj-Napoca, 400006

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Mexico1 site

GSK Investigational Site
México, 7760

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Sweden1 site

GSK Investigational Site
Stockholm, 14186

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About this study

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

Conditions: Vasculitis
Being tested: Placebo, Belimumab 10 mg/kg, Azathioprine
Keywords: 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
Medical subject headings: Vasculitis, Granulomatosis with Polyangiitis, Autoimmune Diseases, Microscopic Polyangiitis, Systemic Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboBiological
Placebo
Belimumab 10 mg/kgBiological
Also called BENLYSTA™
Belimumab 10 mg/kg
AzathioprineDrug
Azathioprine

Study groups in NCT01663623
Study group	Role	What they receive
Placebo plus azathioprine	Placebo comparator	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. Receives: Biological: Placebo; Drug: Azathioprine
Belimumab 10 mg/kg plus azathioprine	Experimental	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. Receives: Biological: Belimumab 10 mg/kg; Drug: Azathioprine

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to First Relapse
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.
Measured: Approximately up to 4 years

Secondary outcomes (1)

Number of Participants With Major Relapse During the Double-blind Phase of the Study
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.
Measured: Approximately up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 20136 Feb 2017

First posted13 Aug 2012 (estimated)
Study start20 Mar 2013
Primary completion6 Feb 2017
Study completion6 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for VasculitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01663623
Sponsor's protocol ID: 115466
Acronym: BREVAS
Status last verified: Mar 2018
First submitted: 9 Aug 2012
Last updated: 17 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 30666823

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01663623
Acronym / sponsor ID: BREVAS / 115466
Conditions: Vasculitis
Keywords: Wegener's Granulomatosis, anti-MPO, WG, Belimumab, GPA, anti-proteinase 3, anti-neutrophil cytoplasmic antibody, anti-myeloperoxidase
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Human Genome Sciences Inc., a GSK CompanyIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: 20 Mar 2013 (actual)
Primary completion: 6 Feb 2017 (actual)
Study completion: 6 Feb 2017 (actual)
First posted: 13 Aug 2012 (estimated)
Results: Posted 17 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo plus azathioprine	Placebo comparator	Biological: Placebo, Drug: AzathioprinePlacebo 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.
Belimumab 10 mg/kg plus azathioprine	Experimental	Biological: Belimumab 10 mg/kg, Drug: AzathioprineBelimumab 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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 (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboPlacebo	Biological	Placebo plus azathioprine
Belimumab 10 mg/kgAlso: BENLYSTA™Belimumab 10 mg/kg	Biological	Belimumab 10 mg/kg plus azathioprine
AzathioprineAzathioprine	Drug	Belimumab 10 mg/kg plus azathioprine, Placebo plus azathioprine

Primary outcome

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.

1 secondary outcome

Number of Participants With Major Relapse During the Double-blind Phase of the Study
Time frame: Approximately up to 4 years

Results and safety

Results posted to the registry on 17 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	52	40
Belimumab 10 mg/kg	53	33

Primary outcome: Time to First Relapse

Time frame: Approximately up to 4 years. Median (Inter-Quartile Range). Unit: Days

Measure	Placebo n = 52	Belimumab 10 mg/kg n = 53
Value	NA (789.0 to NA)	NA (NA to NA)

Placebo vs Belimumab 10 mg/kg: Hazard Ratio (HR): 1.07 (95% CI 0.44 to 2.59), p = 0.884, Cox Proportional Hazards model

Population analysed: Intent-to-treat population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AE) were collected from the start of study agent administration (Day 0) through 8 weeks following administration of the last dose of study agent (approximately up to 4 years).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	16 of 52 (30.8%)	33 of 52 (63.5%)	0 of 52
Belimumab 10 mg/kg	18 of 53 (34%)	32 of 53 (60.4%)	1 of 53

Limitations and caveats (from the sponsor): The sample size was small as it was truncated from approximately 300 to 100 participants, largely owing to a change in standard of care.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30666823Jayne 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

89 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belimumab 10 mg/kg and Azathioprine in people with Vasculitis, run by Human Genome Sciences Inc., a GSK Company at 89 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Germany, Peru, Italy, United Kingdom and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Relapse (time frame: Approximately up to 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01663623, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.