Belimumab in Remission of VASculitis - Full Text View

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: granulomatosis with polyangiitis

MedlinePlus related topics: Granulomatosis with Polyangiitis Vasculitis

Drug Information available for: Azathioprine Azathioprine Sodium Belimumab

Genetic and Rare Diseases Information Center resources: Granulomatosis With Polyangiitis Microscopic Polyangiitis ANCA-associated Vasculitis

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ):

Primary Outcome Measures:

Time to first relapse [ Time Frame: Approximately 3 years ]
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 ]
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 ]


Enrollment:	106
Actual Study Start Date:	March 20, 2013
Study Completion Date:	February 6, 2017
Primary Completion Date:	February 6, 2017 (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 (Adult, Senior)
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.

Contacts and Locations

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, see Learn About Clinical Studies.

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

Show 89 Study Locations

Sponsors and Collaborators

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information


Responsible Party:	Human Genome Sciences Inc., a GSK Company
ClinicalTrials.gov Identifier:	NCT01663623 History of Changes
Other Study ID Numbers:	115466
Study First Received:	August 9, 2012
Last Updated:	May 15, 2017


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

ClinicalTrials.gov processed this record on August 18, 2017

Belimumab in Remission of VASculitis (BREVAS)