Belimumab in Remission of VASculitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01663623
• Date of registration: 09/08/2012
• Prospective Registration: Yes
• Primary sponsor: Human Genome Sciences Inc., a GSK Company
• Public title: Belimumab in Remission of VASculitis BREVAS
• Scientific 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
• Date of first enrolment: March 20, 2013
• Target sample size: 106
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01663623
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Czechia, Finland, France, Germany, Hungary, India, Ireland, Italy, Mexico, Norway, Peru, Poland, Romania, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Vasculitis

Intervention(s)

Biological: Placebo

Drug: Azathioprine

Biological: Belimumab 10 mg/kg

Primary Outcome(s)

Time to First Relapse [Time Frame: Approximately up to 4 years]

Secondary Outcome(s)

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

Secondary ID(s)

115466

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline

Results

• Results available: Yes
• Date Posted: 17/04/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01663623