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ANCA-associated VasculitidesPhase 3MAINRITSAN3NCT02433522

Comparison Between a Long Term and a Conventional Maintenance Treatment With Rituximab

A Phase 3 study testing rituximab in people with ANCA-associated Vasculitides, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

MAINRITSAN study compared Rituximab and azathioprine as maintenance therapy for ANCA-associated vasculitides. In this study, Rituximab (5 infusions at D1, D15, M6, M12, M18) was superior to azathioprine (2 mg/kg/day) to prevent relapses of AAV 28 months after the inclusion (Guillevin et al. NEJM 2014). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ANCA-associated Vasculitides
What is being tested?
rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
1 siteFrance
Study dates
31 Mar 2015to 16 Aug 2018
Phase
Phase 3
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

Who may be able to join

  • First, patients must have been included in MAINRITSAN 2 and in addition to meeting the criteria for inclusion and non-inclusion.
  • MAINRITSAN 2 inclusion criteria:
  • Granulomatosis with Polyangiitis Or microscopic polyangiitis complying Or kidney-limited disease With or without detectable ANCA (anti-neutrophil cytoplasmic antibodies) at the time of diagnosis or relapse, and at remission.
  • Who have achieved remission using a treatment combining corticosteroids and an immunosuppressive agent, including corticosteroids, cyclophosphamide IV or oral (the use of another immunosuppressant is allowed, according to the current French guidelines, as well as plasma exchanges and/or IV immunoglobulins, or rituximab).
  • Interval of 1 month between the end of the immunosuppressant treatment and the randomization time if cyclophosphamide or methotrexate were used, interval between 4 and 6 months if rituximab was used
  • Age > 18 years without age limit higher when the diagnosis is confirmed.
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  • Informed and having signed the consent form to take part in the study.
  • and Patients must meet all of the following criteria:
  • In complete remission (BVAS 0) at 28 months of MAINRITSAN2 study.
  • Informed patient who accepted to participate in MAINRITSAN 2 and who signed the informed consent to this extension.
  • Randomized on the day of the evaluation of the primary endpoint of MAINRITSAN 2 during the visit M28 (last visit of the protocol).

Who cannot join

  • Eosinophilic granulomatosis with polyangiitis (EGPA)
  • History of severe allergic manifestations or anaphylactic manifestations following humanized or murine monoclonal antibodies infusions
  • Pregnant or breast feeding women. Contraception is required for women who could be pregnant during treatment follow up and during the year following the last infusion.
  • Infection by HIV (positive serology), HCV (positive serology), or HBV (HBsAg positive or anti-HBc antibody positive with anti-HBs antibody negative)
  • Uncontrolled infection at time of inclusion in the extended follow-up study.
  • Other severe bacterial, viral , mycobacterial or fungal infection(s), occurring within the last 3 months before of randomization. A severe infection is defined by the hospitalization, a life or organ threatening.
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  • Severe chronic obstructive bronchopathy (FEV < 50% or dyspnea stage III).
  • Cardiac failure, stage IV according to the NYHA classification.
  • Recent history of coronary artery disease (<1 month).
  • Ongoing malignancy or hematologic disease within 5 years before inclusion.
  • Patient with severe immunodepression characterized by clinical manifestations.
  • Participation to another concomitant therapeutic study (except observational studies or studies without therapeutic intervention).
  • Psychiatric disease that may interfere with the study.
  • Non affiliation to a health insurance.
  • Uncontrolled severe cardiac disease.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital cochin

    Paris, 75014

Other trials in France

About this study

Official title: Extended Follow Up of the Mainritsan 2 Study. Comparison Between a Long Term and a Conventional Maintenance Treatment With Rituximab: a Placebo- Controlled Randomized Trial

MAINRITSAN study compared Rituximab and azathioprine as maintenance therapy for ANCA-associated vasculitides. In this study, Rituximab (5 infusions at D1, D15, M6, M12, M18) was superior to azathioprine (2 mg/kg/day) to prevent relapses of AAV 28 months after the inclusion (Guillevin et al. NEJM 2014). Nevertheless, in the follow-up study of MAINRITSAN, up to 30% of patients experienced a relapse 38 months after the last rituximab infusion (unpublished data). Right now, no randomized controlled study has been carried in order to evaluate the best duration of the maintenance treatment with rituximab.

The investigators objective is to evaluate the efficacy of a long term rituximab treatment to prevent relapses of ANCA-associated vasculitis in patients in remission after a first phase of rituximab maintenance treatment.

The investigators will conduct a randomized placebo-controlled trial of a long term rituximab maintenance treatment (46 months) against a conventional maintenance treatment (18 months).

Being tested
rituximab, Placebo
Keywords
ANCA-associated vasculitides, Maintenance treatment, Rituximab, Granulomatosis with polyangiitis, Microscopic polyangiitis
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.

  • rituximabDrug

    500 mg rituximab infusion at the randomization visit and every 6 months for 18 months. Each infusion will be preceded by an infusion of 1000 mg paracetamol, 100 mg methylprednisolone and 5 mg dexchlorpheniramine.

  • PlaceboDrug

Study groups in NCT02433522
Study groupRoleWhat they receive
RituximabExperimental500 mg rituximab infusion at the randomization visit and every 6 months for 18 months
Receives: Drug: rituximab
PlaceboPlacebo comparatorPlacebo infusion at the randomization visit and every 6 months for 18 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vasculitis score 2003 (BVAS 2003 )

    Relapse free survival rates (BVAS > 0)

    Measured: 28 months

Secondary outcomes (17)

  1. Number of adverse events,

    adverse events including infectious effects and their severity in each arm

    Measured: 28 months

  2. number of patients experiencing at least one adverse event in both arms

    Measured: 28 months

  3. correlation of ANCA level with the clinical events

    Measured: 28 months

  4. ANCA level during follow-up

    Measured: 28 months

  5. correlation B-Lymphocytes CD-19 level with the clinical events

    Measured: 28 months

  6. B-Lymphocytes CD-19 level during follow-up

    Measured: 28 months

  7. number of B memory cells during follow-up in both arms

    Measured: 28 months

  8. correlation number of B memory cells with the clinical events

    Measured: 28 months

  9. Number of patients with ANCA in each arm

    Measured: 28 months

  10. Time frame to death in both arms

    Measured: 28 months

  11. time frame of first minor relapse

    Measured: 28 months

  12. time frame of first major relapse

    "the reappearance of disease activity or worsening, with a Birmingham Vasculitis Activity Score >0, and involvement of one or more major organs, disease-related life-threatening events, or both"

    Measured: 28 months

  13. Cumulated dose of corticosteroid treatment

    Measured: 28 months

  14. Number and severity of damages

    Measured: 28 months

  15. number of of gammaglobulins

    Measured: 28 months

  16. Quality of life : SF36 (The Short Form (36) Health Survey)

    Measured: 28 months

  17. functional capacities : HAQ (Health Assessment Questionnaire )

    Measured: 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2015 (estimated)
  2. Study start31 Mar 2015
  3. Primary completion16 Aug 2018
  4. Study completion16 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02433522
Sponsor's protocol ID
P110146 extended
Other IDs
2012-001963-66
Acronym
MAINRITSAN3
Status last verified
Oct 2025
First submitted
23 Mar 2015
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No

Publications

  • Pagnoux C, Guillevin L; French Vasculitis Study Group; MAINRITSAN investigators. Rituximab or azathioprine maintenance in ANCA-associated vasculitis. N Engl J Med. 2015 Jan 22;372(4):386-7. doi: 10.1056/NEJMc1414728. No abstract available.

    PubMed 25607433

  • Charles P, Perrodeau E, Samson M, Bonnotte B, Neel A, Agard C, Huart A, Karras A, Lifermann F, Godmer P, Cohen P, Hanrotel-Saliou C, Martin-Silva N, Pugnet G, Maurier F, Sibilia J, Carron PL, Gobert P, Meaux-Ruault N, Le Gallou T, Vinzio S, Viallard JF, Hachulla E, Vinter C, Puechal X, Terrier B, Ravaud P, Mouthon L, Guillevin L; French Vasculitis Study Group. Long-Term Rituximab Use to Maintain Remission of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Trial. Ann Intern Med. 2020 Aug 4;173(3):179-187. doi: 10.7326/M19-3827. Epub 2020 Jun 2.

    PubMed 32479166

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rituximab in people with ANCA-associated Vasculitides, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 11 inclusion and 15 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Vasculitis score 2003 (BVAS 2003 ) (time frame: 28 months). 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 NCT02433522, which also lists 2 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 20 Nov 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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