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Cheaper rituximab versions just as safe and effective for rare vasculitis?

NCT ID NCT05716334

Disease control Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 201 Canadian patients with ANCA-associated vasculitis to see if cheaper biosimilar versions of rituximab work as well as the original drug. Researchers compared disease control, side effects, and how long it took to get insurance approval for treatment. The goal was to find out if biosimilars are a safe and effective alternative that could improve access to care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

201 people

The number who actually took part.

Started

Jun 2021

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Prospective cohort: Initiated within the last 6 months: 1. RTX biosimilar or originator for induction OR 2. RTX biosimilar or originator for maintenance (with or without prior RTX induction) OR 3. 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 1. RTX biosimilar or originator for induction OR 2. RTX biosimilar or originator for maintenance (with or without RTX induction) Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis granulomatosis with polyangiitis microscopic polyangiitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ANCA associated vasculitis Granulomatosis with polyangiitis Microscopic polyangiitis

Contacts and locations

Locations

  • 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

  • Lawson Research Institute (Western University)

    London, Ontario, Canada

  • McGill University (Montreal General Hospital)

    Montreal, Quebec, H3G 1A4, Canada

  • Ottawa Hospital Research Institute (Ottawa University)

    Ottawa, Ontario, Canada

  • Sinai Health System (University of Toronto)

    Toronto, Ontario, Canada

  • St Joseph's Healthcare Hamilton (McMaster University)

    Hamilton, Ontario, Canada

  • University of Alberta

    Edmonton, Alberta, Canada

  • University of British Columbia (Vancouver Coastal Health Authority)

    Vancouver, British Columbia, Canada

  • University of Calgary

    Calgary, Alberta, Canada

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