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

NCT05716334 | Completed

• 1 other identifier: MP-37-2021-7545
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Rituximab; Biosimilar; B-cell depleting therapy; Drug safety; Drug effectiveness

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with a relapse

  Relapse will be defined as active disease in any organ system (BVAS v3\>0) after remission had previously been achieved AND need to escalate glucocorticoids (GC) to ≥20 mg/day OR change immunosuppression, including receiving RTX infusion earlier than planned/higher dose than planned The proportion of participants with relapses at 6 months will be compared between groups.

  6 months

• Time to relapse

  Relapse will be defined as active disease in any organ system (BVAS v3\>0) after remission had previously been achieved AND need to escalate glucocorticoids (GC) to ≥20 mg/day OR change immunosuppression, including receiving RTX infusion earlier than planned/higher dose than planned. Survival analyses will compare time to disease relapse between originator and biosimilar recipients, adjusting for potential confounders

  From Month 0 until date of first relapse, assessed up to 24 months

Secondary Outcomes (16)

• Proportion of participants with a major relapse

  6 months

• Proportion in clinical remission 6 months post-induction

  6 months

• Proportion with a Serious Adverse Event (SAE)

  6 months

• Proportion with a Serious Infection (SI)

  6 months

• Wait time (days) from RTX application to approval and first infusion

  6 months

Other Outcomes (6)

• COVID-19 infections

  6 months

• COVID-19 hospitalizations

  6 months

• COVID-19 infections

  24 months

Study Arms (2)

Rituximab originator recipients

Patients aged ≥18 with a diagnosis of GPA or MPA treated with rituximab (RTX) originator for induction and/or maintenance.

Rituximab biosimilar recipients

Patients aged ≥18 with a diagnosis of GPA or MPA treated with RTX biosimilars (e.g. Ruxience, Truxima, Riximyo, etc) for induction and/or maintenance.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged ≥18 with a diagnosis of GPA or MPA who initiated rituximab (RTX) originator or biosimilar within the last 6 months at the time of enrolment, OR who belong to prospective longitudinal registries and initiated RTX originator or biosimilar after 2018 and \> 6 months before enrolment. The limit of January 2018 was chosen to keep the historical cohort as contemporary as possible and limit measurement bias regarding study outcomes.

You may qualify if:

• Prospective cohort:
• Initiated within the last 6 months:
• RTX biosimilar or originator for induction OR
• RTX biosimilar or originator for maintenance (with or without prior RTX induction) OR
• Switched from RTX originator maintenance to biosimilar maintenance (4-12 months between infusions)
• Historical cohort:
• Followed in a prospective longitudinal cohort study/registry within the CanVasc network, and initiated the following after January 1, 2018 but \>6 months prior to study enrollment
• RTX biosimilar or originator for induction OR
• RTX biosimilar or originator for maintenance (with or without RTX induction)

You may not qualify if:

• patients without a diagnosis of GPA or MPA
• patients who did not/are not receiving RTX induction or maintenance therapy
• patients who initiated most recent RTX treatment course prior to Jan 1, 2018
• patients receiving RTX for reasons other than GPA or MPA induction or maintenance (e.g. other concurrent disease)
• unable to provide informed consent

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Sinai Health System: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator
• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: collaborator
• St. Joseph's Healthcare Hamilton: collaborator
• University of Calgary: collaborator
• University of British Columbia: collaborator
• University of Alberta: collaborator
• Ottawa Hospital Research Institute: collaborator
• CAnadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research: collaborator
• Canadian Initiative for Outcomes in Rheumatology Care: collaborator

Study Sites (9)

University of Calgary

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

University of British Columbia (Vancouver Coastal Health Authority)

Vancouver, British Columbia, Canada

Location

St Joseph's Healthcare Hamilton (McMaster University)

Hamilton, Ontario, Canada

Location

Lawson Research Institute (Western University)

London, Ontario, Canada

Location

Ottawa Hospital Research Institute (Ottawa University)

Ottawa, Ontario, Canada

Location

Sinai Health System (University of Toronto)

Toronto, Ontario, Canada

Location

McGill University (Montreal General Hospital)

Montreal, Quebec, H3G 1A4, Canada

Location

Centre Intégré Universitaire de Santé et de Services Sociaux du Nord-de-l'île-de-Montréal (CIUSSS NÎM) / Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Location

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MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granulomatosis with Polyangiitis; Microscopic Polyangiitis

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Arielle Mendel, MD MSc

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Rheumatology; Clinician Investigator

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: February 8, 2023
• Study Start: June 15, 2021
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-10

Locations

CA (9)