ANCA-associated VasculitisBRAVONCT05716334
Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator
An observational study of ANCA-associated Vasculitis and Granulomatosis With Polyangiitis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 9 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANCA-associated Vasculitis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis
- How many people
- 201 participants
- Where
- 9 sitesCanada
- Study dates
- 15 Jun 2021to 15 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 9Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
University of Calgary
Calgary, Alberta
University of Alberta
Edmonton, Alberta
St Joseph's Healthcare Hamilton (McMaster University)
Hamilton, Ontario
Lawson Research Institute (Western University)
London, Ontario
McGill University (Montreal General Hospital)
Montreal, Quebec, H3G 1A4
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
Ottawa Hospital Research Institute (Ottawa University)
Ottawa, Ontario
Sinai Health System (University of Toronto)
Toronto, Ontario
University of British Columbia (Vancouver Coastal Health Authority)
Vancouver, British Columbia
About this study
Official title: Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator (BRAVO): a CanVasc Multicentre Study
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:
Read more
- 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.
Read the detailed description
Background. Rituximab (RTX), a B-cell depleting therapy, has comparable efficacy to cyclophosphamide for induction of remission in severe granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) and superior efficacy to azathioprine for maintenance of remission (1,2). RTX is now a first-line therapy for remission induction and maintenance of remission in severe GPA and MPA (3).
Biosimilar RTX agents are molecules that are highly similar in structure to the 'originator' RTX that was initially studied and approved for the treatment of AAV. Among patients with rheumatoid arthritis, randomized controlled trials have demonstrated comparable efficacy and safety between originator and RTX biosimilars (4,5). Extension studies found that switching from originator to biosimilar does not alter disease activity, immunogenicity, or safety (6,7). Conversely, data on the outcomes of RTX biosimilars in AAV are limited. A retrospective study from Korea included 26 patients (~80% MPA) who received either Truxima (n=15) or Mabthera/Rituxan (n=11) for second-line induction after failure or intolerance to cyclosphosphamide (CYC) (8). There were no obvious deviations in relapse, mortality, end-stage kidney disease, or cardiovascular outcomes compared to other studies with similar populations. A second study was a retrospective cohort study of 77 patients with GPA in India who received RTX biosimilars not available in Canada (Reditux, Rituxipca, Mabtas) for induction, maintenance, or both (9). Outcomes were comparable to those observed in randomized controlled trials of the originator drug.
Despite this scarce amount of data, many Canadian provincial and private funders are mandating the use of biosimilar agents (e.g. Truxima, Ruxience, Riximyo) for induction and maintenance of GPA and MPA, in place of the originator drug (Rituxan). There is a need for longitudinal prospective studies to determine comparative safety and effectiveness of RTX biosimilar agents in Canadian patients with GPA or MPA.
The COVID-19 pandemic has raised concerns for patients and providers about the safety of immunosuppression with RTX. Cohort studies of patients with rheumatic disease have reported an association between RTX and the risk of severe COVID-19 and death from COVID-19 (10-12). Rituximab may also reduce the immunogenicity, and thus the effectiveness, of COVID-19 vaccination, as has been observed for other vaccines (13).
Objectives. The overarching objective of this study is to compare the real-world safety and effectiveness of originator and biosimilar RTX for the treatment of GPA/MPA.
Specific objectives:
To determine, in patients with GPA/MPA receiving biosimilar or originator RTX for remission induction and/or maintenance:
- Frequency of clinical remission at 6 and 24 months
- Frequency and time to relapse and major relapse at 6 and 24 months
- Frequency and time to serious adverse events (SAEs) at 6 and 24 months
- Frequency and time to serious infection (SI) at 6 and 24 months
- Frequency and time to discontinuation of RTX due to adverse events or relapse
- Disease damage at 6 and 24 months
- Wait time from RTX application to approval and first infusion
- Frequency of COVID-19 infections and hospitalizations
Participant recruitment:
Potential prospective participants meeting inclusion criteria will be identified by clinicians providing care to patients with GPA or MPA (i.e., the local study investigators) when patients attend their routine clinical care visits (in-person or telemedicine). The local study investigators (i.e. the clinician providing care to the patient) will then describe the study to potential participants, and if interested, will be given the informed consent form to read (in paper or electronic format, per the potential participant's wishes). The potential participant will have the opportunity to ask any questions to the clinician/investigator or research coordinator, who will be the person obtaining consent. The potential participant will also have the option of reading the consent form at a later date, and will be given the contact information of the study coordinator should he/she wish to notify the investigator and/or coordinator of his/her intent to participate at a later date.
Informed consent Informed consent will be obtained either electronically (via the secure REDCap platform) or using paper consent forms during usual care visits. Patients' participation is entirely voluntary. Prospective participants will provide informed consent to participate in the study and may discontinue their participation at any time.
This study will be conducted in accord with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2018), as well as in respect of the requirements set out in the applicable standard operation procedures of the Research Institute of the McGill University Health Centre Research Institute and of the McGill University Health Centre Research Ethics Board. The McGill University Health Centre Research Ethics Board has reviewed this study and is responsible for monitoring it at all participating institutions in the health and social services network in Québec. Each participating center outside the Réseau de la Santé et des Services Sociaux has approval from their local Research Ethics Board.
Data Collection
Participants will be followed for 24 months.
The following will be collected at enrolment/baseline:
- Age, sex, race/ethnicity, province, education, diagnosis (GPA or MPA), date of diagnosis, ANCA status at diagnosis, number of prior relapses
- Organ involvement at last relapse or at diagnosis
- Birmingham Vasculitis Activity Score (v3, BVAS) and Vasculitis Damage Index (VDI) at time of RTX treatment
- Prior RTX and cyclophosphamide doses received in the last 5 years, dates
- Type of RTX product received
- Payor (i.e., government drug plan or private insurance or participant out-of-pocket, assessed based on clinical records of drug applications and approvals located in the chart and/or participant report)
- Date of most recent RTX application and date of first infusion
- Current therapies
- Glucocorticoids with current dose
- Other immunosuppressants
- Pneumocystis/infection prophylaxis
- If switching from RTX originator to biosimilar (or vice versa), reason for switch
- COVID-19 infection and vaccination with dates if applicable
Subsequent study assessments Data collection/study visits will occur at Months 3 (+/-1) (RTX induction recipients only) , 6(+/-3), 12(+/-3), and 24(+/-6), coinciding with usual practice clinical care visits.
At these visits, the following information will be recorded, based on physician clinical assessments (participant history, physical exam), and medical chart reviews (outcome definitions are described in Outcomes):
- Interval RTX infusions: doses, dates, RTX product, payor (based on clinical records of drug applications and approvals and/or participant report)
- If RTX infusions were stopped/delayed, reason and date
- Current (ongoing) therapies
- Current GC dose
- Other immunosuppressants
- pneumocystis/infection prophylaxis
- BVAS
- VDI
- Interval disease relapses with date
- Interval serious infections (SIs) with date
- Interval Serious Adverse Events (SAEs) with date
- Symptomatic late onset neutropenia with date
- Symptomatic hypogammaglobulinemia with date
- Interval COVID-19 infection and vaccination with dates
- Date of death and cause of death if applicable
Data will be collected and entered into secure electronic data capture (REDCap) and/or through paper Case Report Forms (for centers without access to REDCap), and subsequently entered centrally in the main study REDCap database.
As this study will be conducted during the COVID-19 pandemic, virtual visits instead of in-person visits will be accepted as they represent the frequent usual care at the time of this pandemic.
Study size rational:
Planned enrollment will be 120 RTX biosimilar users and 120 RTX originator users, either prospectively or from existing registries with retrospective collection, over the course of 18 months, across 8 different participating centres. This study size would provide 80% power (at a significance level of 0.05) to show a 2-fold increase in the percentage with relapses in the biosimilar group, assuming 15% have a relapse at 24 months in the originator group.
Significance Currently very limited data exist on comparative safety or effectiveness of RTX biosimilars versus the originator drug in ANCA-associated vasculitis. This study will provide real-world data on patients receiving either RTX originator or biosimilar for induction or maintenance of GPA or MPA to permit these comparisons.
Funding The study is funded by the Canadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research (CAN-AIM). CAN-AIM has a mandate to compare safety and effectiveness of originator and biosimilar drugs across diseases and disciplines. The study is also funded by the Canadian Initiative for Outcomes in Rheumatology cAre (CIORA), which ultimately aims to improve the care of Canadians diagnosed with a rheumatic disease.
- Keywords
- Rituximab, Biosimilar, B-cell depleting therapy, Drug safety, Drug effectiveness
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From Month 0 until date of first relapse, assessed up to 24 months
Secondary outcomes (16)
Proportion of participants with a major relapse
Major relapse will be defined as any relapse with one or more of the BVAS/WG major items: gangrene, scleritis, retinal exudates/hemorrhage, sensorineural deafness, mesenteric ischemia, alveolar hemorrhage, respiratory failure, urinary red blood cell casts, rise in creatinine >30% or fall in creatinine clearance >25%, meningitis, cord lesion, stroke, cranial nerve palsy, sensory peripheral neuropathy, motor mononeuritis multiplex
The proportion of participants with a major relapse at 6 months will be compared between groups.
Measured: 6 months
Proportion in clinical remission 6 months post-induction
Assessed in subgroup receiving RTX induction. Clinical remission will be defined as absence of disease activity in any organ system (BVAS v3=0)
Measured: 6 months
Proportion with a Serious Adverse Event (SAE)
SAE will be defined as any medical event, not necessarily causally related to the treatment, that requires inpatient hospitalization, prolongation of hospitalization, causes a congenital malformation, results in significant disability or incapacity, that is life threatening or that results in death. Sensitivity analysis will exclude hospitalizations due to disease relapse as SAEs.
The proportion of participants with >=1 SAE will be compared between groups at 6 months.
Measured: 6 months
Proportion with a Serious Infection (SI)
SI will be defined as any infection requiring intravenous (IV) antibiotics, or resulting in hospitalization, prolonging hospitalization, or death
The proportion of participants with >=1 SI will be compared between groups at 6 months. Survival analyses will compare time to SI between biosimilar and originator groups, adjusting potential confounders and stratifying by RTX exposure type (induction only vs induction + maintenance).
Measured: 6 months
Wait time (days) from RTX application to approval and first infusion
Among participants newly starting RTX for induction or maintenance, mean wait time from RTX application to approval and infusion will be compared between originator and biosimilar groups using multiple linear regression, adjusting for potential confounders.
Secondary analyses will stratify outcomes according RTX exposure category (RTX induction only, RTX induction followed by RTX maintenance, RTX maintenance without RTX induction).
Measured: 6 months
Change in Vasculitis Damage Index (VDI)
Vasculitis damage will be measured with the Vasculitis Damage Index (VDI).
Change in VDI over time will be compared between groups using linear mixed effects models for repeated measures, overall and according RTX exposure category (RTX induction only, RTX induction followed by RTX maintenance, RTX maintenance without RTX induction).
Measured: From Baseline (Month 0) to 6 months
Proportion 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 >=1 relapse at 24 months will be compared between originator and biosimilar recipients.
Measured: 24 months
Proportion with Major relapse
Major relapse will be defined as any relapse with one or more of the BVAS/WG major items: gangrene, scleritis, retinal exudates/hemorrhage, sensorineural deafness, mesenteric ischemia, alveolar hemorrhage, respiratory failure, urinary red blood cell casts, rise in creatinine >30% or fall in creatinine clearance >25%, meningitis, cord lesion, stroke, cranial nerve palsy, sensory peripheral neuropathy, motor mononeuritis multiplex
The proportion of participants with >=1 major relapse at 24 months will be compared between originator and biosimilar groups.
Measured: 24 months
Proportion with a Serious Adverse Event (SAE)
SAE will be defined as any medical event, not necessarily causally related to the treatment, that requires inpatient hospitalization, prolongation of hospitalization, causes a congenital malformation, results in significant disability or incapacity, that is life threatening or that results in death. Sensitivity analysis will exclude hospitalizations due to disease relapse as SAEs.
The proportion of participants with >=1 SAE will be compared between groups at 24 months.
Measured: 24 months
Proportion with a Serious Infection (SI)
SI will be defined as any infection requiring intravenous (IV) antibiotics, or resulting in hospitalization, prolonging hospitalization, or death
The proportion of participants with >=1 SI will be compared between groups at 24 months.
Measured: 24 months
Proportion needing to discontinue RTX due to treatment failure
Treatment failure is defined as rituximab cessation due to an adverse event or relapse. The proportion discontinuing RTX due to treatment failure (due to adverse events or relapse) will be compared between groups.
Measured: 24 months
Change in Vasculitis Damage Index (VDI)
Vasculitis damage will be measured with the Vasculitis Damage Index (VDI).
Change in VDI over time will be compared between groups using linear mixed effects models for repeated measures, overall and according RTX exposure category (RTX induction only, RTX induction followed by RTX maintenance, RTX maintenance without RTX induction).
Measured: From Baseline (Month 0) to 24 months
Time to major relapse
Major relapse will be defined as any relapse with one or more of the BVAS/WG major items: gangrene, scleritis, retinal exudates/hemorrhage, sensorineural deafness, mesenteric ischemia, alveolar hemorrhage, respiratory failure, urinary red blood cell casts, rise in creatinine >30% or fall in creatinine clearance >25%, meningitis, cord lesion, stroke, cranial nerve palsy, sensory peripheral neuropathy, motor mononeuritis multiplex
Survival analyses will compare time to major relapse between originator and biosimilar recipients.
Measured: From Month 0 until date of first major relapse, assessed up to 24 months
Time to Serious Adverse Event (SAE)
SAE will be defined as any medical event, not necessarily causally related to the treatment, that requires inpatient hospitalization, prolongation of hospitalization, causes a congenital malformation, results in significant disability or incapacity, that is life threatening or that results in death. Sensitivity analysis will exclude hospitalizations due to disease relapse as SAEs.
Survival analyses will compare time to SAE between exposure groups, adjusting for potential confounders
Measured: From baseline (Month 0) until date of first SAE, assessed up to 24 months
Time to Serious Infection (SI)
SI will be defined as any infection requiring intravenous (IV) antibiotics, or resulting in hospitalization, prolonging hospitalization, or death
Survival analyses will compare time to SI between biosimilar and originator groups, adjusting potential confounders and stratifying by RTX exposure type (induction only vs induction + maintenance).
Measured: From baseline (Month 0) until date of first SI, assessed up to 24 months
Time to RTX discontinuation due to treatment failure
Treatment failure is defined as rituximab cessation due to an adverse event or relapse.
Survival analyses will compare time to RTX discontinuation due to adverse event or relapse between originator and biosimilar groups.
Measured: From Month 0 until date of first relapse, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start15 Jun 2021
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ANCA-associated VasculitisStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sinai Health System, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, St. Joseph's Healthcare Hamilton, University of Calgary, University of British Columbia, University of Alberta, Ottawa Hospital Research Institute, CAnadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research, Canadian Initiative for Outcomes in Rheumatology Care
- Responsible party
- Principal investigator, Arielle Mendel, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Arielle Mendel, MD MSc, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716334
- Sponsor's protocol ID
- MP-37-2021-7545
- Acronym
- BRAVO
- Status last verified
- Oct 2025
- First submitted
- 30 Nov 2022
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U; RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. doi: 10.1056/NEJMoa0909905.
PubMed 20647199Guillevin L, Pagnoux C, Karras A, Khouatra C, Aumaitre O, Cohen P, Maurier F, Decaux O, Ninet J, Gobert P, Quemeneur T, Blanchard-Delaunay C, Godmer P, Puechal X, Carron PL, Hatron PY, Limal N, Hamidou M, Ducret M, Daugas E, Papo T, Bonnotte B, Mahr A, Ravaud P, Mouthon L; French Vasculitis Study Group. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014 Nov 6;371(19):1771-80. doi: 10.1056/NEJMoa1404231.
PubMed 25372085Mendel A, Ennis D, Go E, Bakowsky V, Baldwin C, Benseler SM, Cabral DA, Carette S, Clements-Baker M, Clifford AH, Cohen Tervaert JW, Cox G, Dehghan N, Dipchand C, Dhindsa N, Famorca L, Fifi-Mah A, Garner S, Girard LP, Lessard C, Liang P, Noone D, Makhzoum JP, Milman N, Pineau CA, Reich HN, Rheaume M, Robinson DB, Rumsey DG, Towheed TE, Trudeau J, Twilt M, Yacyshyn E, Yeung RSM, Barra LB, Khalidi N, Pagnoux C. CanVasc Consensus Recommendations for the Management of Antineutrophil Cytoplasm Antibody-associated Vasculitis: 2020 Update. J Rheumatol. 2021 Apr;48(4):555-566. doi: 10.3899/jrheum.200721. Epub 2020 Sep 15.
PubMed 32934123Smolen JS, Cohen SB, Tony HP, Scheinberg M, Kivitz A, Balanescu A, Gomez-Reino J, Cen L, Zhu P, Shisha T. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017 Sep;76(9):1598-1602. doi: 10.1136/annrheumdis-2017-211281. Epub 2017 Jun 21.
PubMed 28637670Park W, Bozic-Majstorovic L, Milakovic D, Berrocal Kasay A, El-Khouri EC, Irazoque-Palazuelos F, Molina FFC, Shesternya P, Miranda P, Medina-Rodriguez FG, Wiland P, Jeka S, Chavez-Corrales J, Garmish O, Linde T, Rekalov D, Hrycaj P, Krause A, Fomina N, Piura O, Abello-Banfi M, Suh CH, Shim SC, Lee SJ, Lee SY, Kim SH, Yoo DH. Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial. MAbs. 2018 Aug/Sep;10(6):934-943. doi: 10.1080/19420862.2018.1487912. Epub 2018 Jul 16.
PubMed 30010481Cohen SB, Burgos-Vargas R, Emery P, Jin B, Cronenberger C, Vazquez-Abad MD. Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1598-1606. doi: 10.1002/acr.23586.
PubMed 29692005Park W, Suh CH, Shim SC, Molina FFC, Jeka S, Medina-Rodriguez FG, Hrycaj P, Wiland P, Lee EY, Shesternya P, Kovalenko V, Myasoutova L, Stanislav M, Radominski S, Lim MJ, Choe JY, Lee SJ, Lee SY, Kim SH, Yoo DH. Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis. BioDrugs. 2017 Aug;31(4):369-377. doi: 10.1007/s40259-017-0233-6.
PubMed 28600696Kwon HC, Kim MK, Song JJ, Park YB, Lee SW. Rituximab Biosimilar Prevents Poor Outcomes of Microscopic Polyangiitis and Granulomatosis with Polyangiitis as Effectively as Rituximab Originator. Yonsei Med J. 2020 Aug;61(8):712-719. doi: 10.3349/ymj.2020.61.8.712.
PubMed 32734735Mittal S, Naidu GSRSNK, Jha S, Rathi M, Nada R, Minz RW, Sharma K, Dhir V, Jain S, Sharma A. Experience with similar biologic rituximab in 77 patients of granulomatosis with polyangiitis-a real-life experience. Clin Rheumatol. 2021 Feb;40(2):645-651. doi: 10.1007/s10067-020-05261-7. Epub 2020 Jul 12.
PubMed 32656662Loarce-Martos J, Garcia-Fernandez A, Lopez-Gutierrez F, Garcia-Garcia V, Calvo-Sanz L, Del Bosque-Granero I, Teran-Tinedo MA, Boteanu A, Bachiller-Corral J, Vazquez-Diaz M. High rates of severe disease and death due to SARS-CoV-2 infection in rheumatic disease patients treated with rituximab: a descriptive study. Rheumatol Int. 2020 Dec;40(12):2015-2021. doi: 10.1007/s00296-020-04699-x. Epub 2020 Sep 18.
PubMed 32945944FAI2R /SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors. Severity of COVID-19 and survival in patients with rheumatic and inflammatory diseases: data from the French RMD COVID-19 cohort of 694 patients. Ann Rheum Dis. 2021 Apr;80(4):527-538. doi: 10.1136/annrheumdis-2020-218310. Epub 2020 Dec 2.
PubMed 33268442Strangfeld A, Schafer M, Gianfrancesco MA, Lawson-Tovey S, Liew JW, Ljung L, Mateus EF, Richez C, Santos MJ, Schmajuk G, Scire CA, Sirotich E, Sparks JA, Sufka P, Thomas T, Trupin L, Wallace ZS, Al-Adely S, Bachiller-Corral J, Bhana S, Cacoub P, Carmona L, Costello R, Costello W, Gossec L, Grainger R, Hachulla E, Hasseli R, Hausmann JS, Hyrich KL, Izadi Z, Jacobsohn L, Katz P, Kearsley-Fleet L, Robinson PC, Yazdany J, Machado PM; COVID-19 Global Rheumatology Alliance. Factors associated with COVID-19-related death in people with rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance physician-reported registry. Ann Rheum Dis. 2021 Jul;80(7):930-942. doi: 10.1136/annrheumdis-2020-219498. Epub 2021 Jan 27.
PubMed 33504483Rondaan C, Furer V, Heijstek MW, Agmon-Levin N, Bijl M, Breedveld FC, D'Amelio R, Dougados M, Kapetanovic MC, van Laar JM, Ladefoged de Thurah A, Landewe R, Molto A, Muller-Ladner U, Schreiber K, Smolar L, Walker J, Warnatz K, Wulffraat NM, van Assen S, Elkayam O. Efficacy, immunogenicity and safety of vaccination in adult patients with autoimmune inflammatory rheumatic diseases: a systematic literature review for the 2019 update of EULAR recommendations. RMD Open. 2019 Sep 9;5(2):e001035. doi: 10.1136/rmdopen-2019-001035. eCollection 2019.
PubMed 31565247
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator (BRAVO): a CanVasc Multicentre Study
- ClinicalTrials.gov ID
- NCT05716334
- Acronym / sponsor ID
- BRAVO / MP-37-2021-7545
- Keywords
- Rituximab, Biosimilar, B-cell depleting therapy, Drug safety, Drug effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Sinai Health System, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, St. Joseph's Healthcare Hamilton, University of Calgary, University of British Columbia, University of Alberta, Ottawa Hospital Research Institute, CAnadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research, Canadian Initiative for Outcomes in Rheumatology Care
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background. Rituximab (RTX), a B-cell depleting therapy, has comparable efficacy to cyclophosphamide for induction of remission in severe granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) and superior efficacy to azathioprine for maintenance of remission (1,2). RTX is now a first-line therapy for remission induction and maintenance of remission in severe GPA and MPA (3).
Biosimilar RTX agents are molecules that are highly similar in structure to the 'originator' RTX that was initially studied and approved for the treatment of AAV. Among patients with rheumatoid arthritis, randomized controlled trials have demonstrated comparable efficacy and safety between originator and RTX biosimilars (4,5). Extension studies found that switching from originator to biosimilar does not alter disease activity, immunogenicity, or safety (6,7). Conversely, data on the outcomes of RTX biosimilars in AAV are limited. A retrospective study from Korea included 26 patients (~80% MPA) who received either Truxima (n=15) or Mabthera/Rituxan (n=11) for second-line induction after failure or intolerance to cyclosphosphamide (CYC) (8). There were no obvious deviations in relapse, mortality, end-stage kidney disease, or cardiovascular outcomes compared to other studies with similar populations. A second study was a retrospective cohort study of 77 patients with GPA in India who received RTX biosimilars not available in Canada (Reditux, Rituxipca, Mabtas) for induction, maintenance, or both (9). Outcomes were comparable to those observed in randomized controlled trials of the originator drug.
Despite this scarce amount of data, many Canadian provincial and private funders are mandating the use of biosimilar agents (e.g. Truxima, Ruxience, Riximyo) for induction and maintenance of GPA and MPA, in place of the originator drug (Rituxan). There is a need for longitudinal prospective studies to determine comparative safety and effectiveness of RTX biosimilar agents in Canadian patients with GPA or MPA.
The COVID-19 pandemic has raised concerns for patients and providers about the safety of immunosuppression with RTX. Cohort studies of patients with rheumatic disease have reported an association between RTX and the risk of severe COVID-19 and death from COVID-19 (10-12). Rituximab may also reduce the immunogenicity, and thus the effectiveness, of COVID-19 vaccination, as has been observed for other vaccines (13).
Objectives. The overarching objective of this study is to compare the real-world safety and effectiveness of originator and biosimilar RTX for the treatment of GPA/MPA.
Specific objectives:
To determine, in patients with GPA/MPA receiving biosimilar or originator RTX for remission induction and/or maintenance:
- Frequency of clinical remission at 6 and 24 months
- Frequency and time to relapse and major relapse at 6 and 24 months
- Frequency and time to serious adverse events (SAEs) at 6 and 24 months
- Frequency and time to serious infection (SI) at 6 and 24 months
- Frequency and time to discontinuation of RTX due to adverse events or relapse
- Disease damage at 6 and 24 months
- Wait time from RTX application to approval and first infusion
- Frequency of COVID-19 infections and hospitalizations
Participant recruitment:
Potential prospective participants meeting inclusion criteria will be identified by clinicians providing care to patients with GPA or MPA (i.e., the local study investigators) when patients attend their routine clinical care visits (in-person or telemedicine). The local study investigators (i.e. the clinician providing care to the patient) will then describe the study to potential participants, and if interested, will be given the informed consent form to read (in paper or electronic format, per the potential participant's wishes). The potential participant will have the opportunity to ask any questions to the clinician/investigator or research coordinator, who will be the person obtaining consent. The potential participant will also have the option of reading the consent form at a later date, and will be given the contact information of the study coordinator should he/she wish to notify the investigator and/or coordinator of his/her intent to participate at a later date.
Informed consent Informed consent will be obtained either electronically (via the secure REDCap platform) or using paper consent forms during usual care visits. Patients' participation is entirely voluntary. Prospective participants will provide informed consent to participate in the study and may discontinue their participation at any time.
This study will be conducted in accord with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2018), as well as in respect of the requirements set out in the applicable standard operation procedures of the Research Institute of the McGill University Health Centre Research Institute and of the McGill University Health Centre Research Ethics Board. The McGill University Health Centre Research Ethics Board has reviewed this study and is responsible for monitoring it at all participating institutions in the health and social services network in Québec. Each participating center outside the Réseau de la Santé et des Services Sociaux has approval from their local Research Ethics Board.
Data Collection
Participants will be followed for 24 months.
The following will be collected at enrolment/baseline:
- Age, sex, race/ethnicity, province, education, diagnosis (GPA or MPA), date of diagnosis, ANCA status at diagnosis, number of prior relapses
- Organ involvement at last relapse or at diagnosis
- Birmingham Vasculitis Activity Score (v3, BVAS) and Vasculitis Damage Index (VDI) at time of RTX treatment
- Prior RTX and cyclophosphamide doses received in the last 5 years, dates
- Type of RTX product received
- Payor (i.e., government drug plan or private insurance or participant out-of-pocket, assessed based on clinical records of drug applications and approvals located in the chart and/or participant report)
- Date of most recent RTX application and date of first infusion
- Current therapies
- Glucocorticoids with current dose
- Other immunosuppressants
- Pneumocystis/infection prophylaxis
- If switching from RTX originator to biosimilar (or vice versa), reason for switch
- COVID-19 infection and vaccination with dates if applicable
Subsequent study assessments Data collection/study visits will occur at Months 3 (+/-1) (RTX induction recipients only) , 6(+/-3), 12(+/-3), and 24(+/-6), coinciding with usual practice clinical care visits.
At these visits, the following information will be recorded, based on physician clinical assessments (participant history, physical exam), and medical chart reviews (outcome definitions are described in Outcomes):
- Interval RTX infusions: doses, dates, RTX product, payor (based on clinical records of drug applications and approvals and/or participant report)
- If RTX infusions were stopped/delayed, reason and date
- Current (ongoing) therapies
- Current GC dose
- Other immunosuppressants
- pneumocystis/infection prophylaxis
- BVAS
- VDI
- Interval disease relapses with date
- Interval serious infections (SIs) with date
- Interval Serious Adverse Events (SAEs) with date
- Symptomatic late onset neutropenia with date
- Symptomatic hypogammaglobulinemia with date
- Interval COVID-19 infection and vaccination with dates
- Date of death and cause of death if applicable
Data will be collected and entered into secure electronic data capture (REDCap) and/or through paper Case Report Forms (for centers without access to REDCap), and subsequently entered centrally in the main study REDCap database.
As this study will be conducted during the COVID-19 pandemic, virtual visits instead of in-person visits will be accepted as they represent the frequent usual care at the time of this pandemic.
Study size rational:
Planned enrollment will be 120 RTX biosimilar users and 120 RTX originator users, either prospectively or from existing registries with retrospective collection, over the course of 18 months, across 8 different participating centres. This study size would provide 80% power (at a significance level of 0.05) to show a 2-fold increase in the percentage with relapses in the biosimilar group, assuming 15% have a relapse at 24 months in the originator group.
Significance Currently very limited data exist on comparative safety or effectiveness of RTX biosimilars versus the originator drug in ANCA-associated vasculitis. This study will provide real-world data on patients receiving either RTX originator or biosimilar for induction or maintenance of GPA or MPA to permit these comparisons.
Funding The study is funded by the Canadian Network for Advanced Interdisciplinary Methods for comparative effectiveness research (CAN-AIM). CAN-AIM has a mandate to compare safety and effectiveness of originator and biosimilar drugs across diseases and disciplines. The study is also funded by the Canadian Initiative for Outcomes in Rheumatology cAre (CIORA), which ultimately aims to improve the care of Canadians diagnosed with a rheumatic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants with a relapse
Time frame: 6 months
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.
Time to relapse
Time frame: From Month 0 until date of first relapse, assessed up to 24 months
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
16 secondary outcomes
Proportion of participants with a major relapse
Time frame: 6 months
Proportion in clinical remission 6 months post-induction
Time frame: 6 months
Proportion with a Serious Adverse Event (SAE)
Time frame: 6 months
Proportion with a Serious Infection (SI)
Time frame: 6 months
Wait time (days) from RTX application to approval and first infusion
Time frame: 6 months
Change in Vasculitis Damage Index (VDI)
Time frame: From Baseline (Month 0) to 6 months
Proportion with a Relapse
Time frame: 24 months
Proportion with Major relapse
Time frame: 24 months
Proportion with a Serious Adverse Event (SAE)
Time frame: 24 months
Proportion with a Serious Infection (SI)
Time frame: 24 months
Proportion needing to discontinue RTX due to treatment failure
Time frame: 24 months
Change in Vasculitis Damage Index (VDI)
Time frame: From Baseline (Month 0) to 24 months
Time to major relapse
Time frame: From Month 0 until date of first major relapse, assessed up to 24 months
Time to Serious Adverse Event (SAE)
Time frame: From baseline (Month 0) until date of first SAE, assessed up to 24 months
Time to Serious Infection (SI)
Time frame: From baseline (Month 0) until date of first SI, assessed up to 24 months
Time to RTX discontinuation due to treatment failure
Time frame: From Month 0 until date of first relapse, assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 20647199Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U; RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. doi: 10.1056/NEJMoa0909905.
- Background: PubMed 25372085Guillevin L, Pagnoux C, Karras A, Khouatra C, Aumaitre O, Cohen P, Maurier F, Decaux O, Ninet J, Gobert P, Quemeneur T, Blanchard-Delaunay C, Godmer P, Puechal X, Carron PL, Hatron PY, Limal N, Hamidou M, Ducret M, Daugas E, Papo T, Bonnotte B, Mahr A, Ravaud P, Mouthon L; French Vasculitis Study Group. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014 Nov 6;371(19):1771-80. doi: 10.1056/NEJMoa1404231.
- Background: PubMed 32934123Mendel A, Ennis D, Go E, Bakowsky V, Baldwin C, Benseler SM, Cabral DA, Carette S, Clements-Baker M, Clifford AH, Cohen Tervaert JW, Cox G, Dehghan N, Dipchand C, Dhindsa N, Famorca L, Fifi-Mah A, Garner S, Girard LP, Lessard C, Liang P, Noone D, Makhzoum JP, Milman N, Pineau CA, Reich HN, Rheaume M, Robinson DB, Rumsey DG, Towheed TE, Trudeau J, Twilt M, Yacyshyn E, Yeung RSM, Barra LB, Khalidi N, Pagnoux C. CanVasc Consensus Recommendations for the Management of Antineutrophil Cytoplasm Antibody-associated Vasculitis: 2020 Update. J Rheumatol. 2021 Apr;48(4):555-566. doi: 10.3899/jrheum.200721. Epub 2020 Sep 15.
- Background: PubMed 28637670Smolen JS, Cohen SB, Tony HP, Scheinberg M, Kivitz A, Balanescu A, Gomez-Reino J, Cen L, Zhu P, Shisha T. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017 Sep;76(9):1598-1602. doi: 10.1136/annrheumdis-2017-211281. Epub 2017 Jun 21.
- Background: PubMed 30010481Park W, Bozic-Majstorovic L, Milakovic D, Berrocal Kasay A, El-Khouri EC, Irazoque-Palazuelos F, Molina FFC, Shesternya P, Miranda P, Medina-Rodriguez FG, Wiland P, Jeka S, Chavez-Corrales J, Garmish O, Linde T, Rekalov D, Hrycaj P, Krause A, Fomina N, Piura O, Abello-Banfi M, Suh CH, Shim SC, Lee SJ, Lee SY, Kim SH, Yoo DH. Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial. MAbs. 2018 Aug/Sep;10(6):934-943. doi: 10.1080/19420862.2018.1487912. Epub 2018 Jul 16.
- Background: PubMed 29692005Cohen SB, Burgos-Vargas R, Emery P, Jin B, Cronenberger C, Vazquez-Abad MD. Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1598-1606. doi: 10.1002/acr.23586.
- Background: PubMed 28600696Park W, Suh CH, Shim SC, Molina FFC, Jeka S, Medina-Rodriguez FG, Hrycaj P, Wiland P, Lee EY, Shesternya P, Kovalenko V, Myasoutova L, Stanislav M, Radominski S, Lim MJ, Choe JY, Lee SJ, Lee SY, Kim SH, Yoo DH. Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis. BioDrugs. 2017 Aug;31(4):369-377. doi: 10.1007/s40259-017-0233-6.
- Background: PubMed 32734735Kwon HC, Kim MK, Song JJ, Park YB, Lee SW. Rituximab Biosimilar Prevents Poor Outcomes of Microscopic Polyangiitis and Granulomatosis with Polyangiitis as Effectively as Rituximab Originator. Yonsei Med J. 2020 Aug;61(8):712-719. doi: 10.3349/ymj.2020.61.8.712.
- Background: PubMed 32656662Mittal S, Naidu GSRSNK, Jha S, Rathi M, Nada R, Minz RW, Sharma K, Dhir V, Jain S, Sharma A. Experience with similar biologic rituximab in 77 patients of granulomatosis with polyangiitis-a real-life experience. Clin Rheumatol. 2021 Feb;40(2):645-651. doi: 10.1007/s10067-020-05261-7. Epub 2020 Jul 12.
- Background: PubMed 32945944Loarce-Martos J, Garcia-Fernandez A, Lopez-Gutierrez F, Garcia-Garcia V, Calvo-Sanz L, Del Bosque-Granero I, Teran-Tinedo MA, Boteanu A, Bachiller-Corral J, Vazquez-Diaz M. High rates of severe disease and death due to SARS-CoV-2 infection in rheumatic disease patients treated with rituximab: a descriptive study. Rheumatol Int. 2020 Dec;40(12):2015-2021. doi: 10.1007/s00296-020-04699-x. Epub 2020 Sep 18.
- Background: PubMed 33268442FAI2R /SFR/SNFMI/SOFREMIP/CRI/IMIDIATE consortium and contributors. Severity of COVID-19 and survival in patients with rheumatic and inflammatory diseases: data from the French RMD COVID-19 cohort of 694 patients. Ann Rheum Dis. 2021 Apr;80(4):527-538. doi: 10.1136/annrheumdis-2020-218310. Epub 2020 Dec 2.
- Background: PubMed 33504483Strangfeld A, Schafer M, Gianfrancesco MA, Lawson-Tovey S, Liew JW, Ljung L, Mateus EF, Richez C, Santos MJ, Schmajuk G, Scire CA, Sirotich E, Sparks JA, Sufka P, Thomas T, Trupin L, Wallace ZS, Al-Adely S, Bachiller-Corral J, Bhana S, Cacoub P, Carmona L, Costello R, Costello W, Gossec L, Grainger R, Hachulla E, Hasseli R, Hausmann JS, Hyrich KL, Izadi Z, Jacobsohn L, Katz P, Kearsley-Fleet L, Robinson PC, Yazdany J, Machado PM; COVID-19 Global Rheumatology Alliance. Factors associated with COVID-19-related death in people with rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance physician-reported registry. Ann Rheum Dis. 2021 Jul;80(7):930-942. doi: 10.1136/annrheumdis-2020-219498. Epub 2021 Jan 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arielle Mendel, MD MSc principal investigator
McGill University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ANCA-associated Vasculitis and Granulomatosis With Polyangiitis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a relapse (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05716334, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.