Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator

Summary

The goal of this multicentre observational study is to compare the safety and effectiveness of rituximab biosimilars to the originator in Canadian patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), two main forms of ANCA-associated vasculitis (AAV).

The main questions it aims to answer are:

* Is there a difference in vasculitis control between originator and biosimilar rituximab?
* Is there a difference in adverse effects between originator and biosimilar rituximab?
* In the Canadian healthcare context, are wait times to receive approval (financial coverage) for rituximab shorter for biosimilars compared to originators?

Investigators will perform study assessments (including recording disease activity, damage, and adverse events) at the time of participants' usual clinical care visits, at regular intervals for 2 years after starting rituximab (for induction or maintenance treatment) or switching from an originator to a biosimilar as part of their usual care.

Researchers will compare outcomes among participants who have received rituximab originators (from 2018 onwards) or biosimilars as part of their usual care, to see if there are differences in relapses, remission rates, damage, serious infections, serious adverse events, and treatment approval wait times.

Conditions

• ANCA-associated Vasculitis
• Granulomatosis With Polyangiitis
• Microscopic Polyangiitis

Sponsors & Collaborators

• Sinai Health System

  collaborator OTHER

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  collaborator OTHER

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

  collaborator OTHER

• St. Joseph's Healthcare Hamilton

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• University of Alberta

  collaborator OTHER

• Ottawa Hospital Research Institute

  collaborator OTHER

• CAnadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research

  collaborator UNKNOWN

• Canadian Initiative for Outcomes in Rheumatology Care

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Arielle Mendel, MD MSc · McGill University

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-15

Primary Completion

2025-09-15

Completion

2025-09-15

Countries

• Canada

Study Locations