Belimumab in Remission of VASculitis (BREVAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: June 5, 2014
Last verified: March 2014

August 9, 2012
June 5, 2014
March 2013
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01663623 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Belimumab in Remission of VASculitis
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Vasculitis
  • Biological: Placebo
    Placebo
  • Biological: Belimumab 10 mg/kg
    Belimumab 10 mg/kg
    Other Name: BENLYSTA™
  • Drug: Azathioprine
    Azathioprine
  • 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.
    Interventions:
    • Biological: Placebo
    • Drug: 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.
    Interventions:
    • Biological: Belimumab 10 mg/kg
    • Drug: Azathioprine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
August 2016
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
United States,   Australia,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Ireland,   Italy,   Mexico,   Norway,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT01663623
115466, 2011-004569-33, HGS1006-C1100
Yes
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
Human Genome Sciences Inc., a GSK Company
GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP