Belimumab in Remission of VASculitis (BREVAS)

This study is not yet open for participant recruitment.

Verified January 2013 by GlaxoSmithKline

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )

ClinicalTrials.gov Identifier:

NCT01663623

First received: August 9, 2012

Last updated: February 7, 2013

Last verified: January 2013

History of Changes

Purpose

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	Intervention	Phase
Vasculitis	Biological: Placebo Biological: Belimumab 10 mg/kg Drug: Azathioprine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Autoimmune Diseases Vasculitis Wegener's Granulomatosis

Drug Information available for: Azathioprine Azathioprine Sodium Belimumab

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Time to first relapse [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
Relapse is defined as at least 1 major item on the Birmingham Vasculitis Activity Score (BVAS), or a minimum total BVAS score of 6, or receipt of a protocol prohibited medication.

Secondary Outcome Measures:

Time to first major relapse [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
Major relapse is defined as having at least 1 major item on the BVAS.
Number of participants who experienced adverse events [ Time Frame: Approximately 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	January 2013
Estimated Study Completion Date:	August 2016
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663623

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Show 78 Study Locations

Sponsors and Collaborators

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:	NCT01663623 History of Changes
Other Study ID Numbers:	115466, 2011-004569-33, HGS1006-C1100
Study First Received:	August 9, 2012
Last Updated:	February 7, 2013
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by GlaxoSmithKline:

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
Wegener Granulomatosis
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

Azathioprine
Antibodies, Antineutrophil Cytoplasmic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013

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