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Wegener GranulomatosisPhase 3MAINRITSANNCT00748644

Efficacy Study of Two Treatments in the Remission of Vasculitis

A Phase 3 study testing Rituximab and Azathioprine in people with Wegener Granulomatosis and Microscopic Polyangiitis, 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

Study of the efficacy of rituximab for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of rituximab versus azathioprine Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Rituximab and Azathioprine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
1 siteFrance
Study dates
Oct 2008to Jun 2013
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Wegener's granulomatosis 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 according to current French guideline, 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).
  • Interval of 1 month between the end of the immunosuppressant treatment and the randomization time
  • Age > 18 years and < 75 years when the diagnosis is confirmed.
  • Informed and having signed the consent form to take part in the study.

Who cannot join

  • Other systemic vasculitis
  • Secondary vasculitis (following neoplastic disease or an infection in particular)·
  • Induction treatment with a regimen not corresponding to that recommended in France.
  • Patient who has not achieved remission.·
  • Patient who has already received a treatment by biological agents (monoclonal antibody - antiCD20 or antiTNFα).
  • Incapacity or refusal to understand or sign the informed consent form.
Show all 28Show fewer
  • Incapacity or refusal to adhere to treatment or perform the follow-up examinations required by the study. Non-compliance·
  • Allergy, documented hypersensitivity or contraindication to the study medication (cyclophosphamide, corticosteroids, azathioprine, rituximab),
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
  • Patients receiving allopurinol cannot be included if the allopurinol must absolutely be maintained.
  • Pregnancy, breastfeeding. Women of childbearing age must use a reliable method of contraception throughout the duration of immunosuppressive treatment up to 1 year after the last infusion of rituximab
  • Infection by HIV, HCV or HBV
  • Progressive, uncontrolled infection requiring a prolonged treatment (tuberculosis, HIV infection, etc.).
  • Severe infection declared during the 3 months before randomization (CMV, HBV, HHV8, HCV, HIV, tuberculosis).
  • Progressive cancer or malignant blood disease diagnosed during the 5 years before the diagnosis of vasculitis. Patients suffering from non-metastatic prostate cancer or those cured of a cancer or a malignant blood disorder for more than 5 years and not taking any antineoplastic agents for more than 5 years may be included.
  • patients presenting a systemic disease receiving protocolized treatments (azathioprine, rituximab) which could have unexpected and inappropriate side effects.
  • Participation in another clinical research protocol during the 4 weeks before inclusion.
  • Any medical or psychiatric disorder which, in the investigator's opinion, may prevent the administration of treatment and patient follow-up according to the protocol, and/or which may expose the patient to a too greater risk of an adverse effect.
  • No social security
  • Churg and Strauss syndrome
  • viral, bacterial or fungic or mycobacterial infection uncontrolled in the 4 weeks before the inclusion
  • history of deep tissue infection (fasciitis, osteomyelitis, septic arthritis)in the first year before the inclusion
  • History of chronic and severe or recurrent infection or history of preexisting disease predisposing to severe infection
  • Severe immunodepression
  • Administration of live vaccine in the four weeks before inclusion
  • severe chronic obstructive pulmonary diseases (VEMS < 50 % or dyspnea grade III)
  • chronic heart failure stade III and IV (NYHA)
  • History of recent acute coronary syndrome

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital Cochin

    Paris, 75014

Other trials in France

About this study

Official title: MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis

Study of the efficacy of rituximab for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of rituximab versus azathioprine

Read the detailed description

Randomized, controlled, national, multicenter, prospective study to compare between azathioprine (conventional therapy) and rituximab in patients with systemic ANCA-associated vasculitis, in remission (achieved with an induction treatment combining corticosteroids and an immunosuppressant, mainly intravenous pulses of cyclophosphamide, and plasma exchanges and/or polyvalent immunoglobulins when indicated) after the first flare of the disease (new diagnosis) or after a relapse. It is planned to stratify patients by first flare (66% of the patients) or relapse (33% of the patients). Patients complying with the inclusion criteria may be included when they are in remission from their vasculitis. Patients who have already received biologics (antiCD20, antiTNFα) will not be included. Patients will be included at the time of remission and then randomized. They will receive maintenance treatment by azathioprine for 18 months or a rituximab infusion every 6 months until month 18 (i.e. a total of 4 infusions), at the dose of 375 mg/m2 (maximum dosage, 500 mg). ANCA status and CD19+ lymphocyte count will be monitored but will not be used to adjust therapy. After the 18 month length of maintenance phase, i.e. after stopping immunosuppressive maintenance therapy, patients will be followed for an additional 10 month period. Patients with Wegener's granulomatosis will be prescribed cotrimoxazole 160/800 tid (for 2 additional years).

Being tested
Rituximab, Azathioprine
Keywords
Wegener's granulomatosis,, microscopic polyangiitis,, ANCA-associated vasculitis,, rituximab,, azathioprine
Medical subject headings
Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    rituximab infusion will be performed at J1, J15, M6, M12 and M18(i.e. a total of 5 infusions), at the dose of 500 mg at a fixed dosage.

    All patients received corticosteroids, starting from induction with prednisone (or equivalent) at a dose of 1 mg/kg/day with gradual tapering according to a regimen adjusted to body weight over a mean of 18 months since diagnosis.

  • AzathioprineDrug

    azathioprine (2 mg/kg/d) for 12 months, then progressively tapered until its discontinuation at month 22.

    All patients received corticosteroids, starting from induction with prednisone (or equivalent) at a dose of 1 mg/kg/day with gradual tapering according to a regimen adjusted to body weight over a mean of 18 months since diagnosis.

Study groups in NCT00748644
Study groupRoleWhat they receive
1ExperimentalExperimental drug = rituximab for maintenance
Receives: Drug: Rituximab
2Active comparatorComparator drug = azathioprine for maintenance
Receives: Drug: Azathioprine

What is being measured

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

  1. Number of major relapse (BVAS>10) in each group at the end of the maintenance treatment (18 months treatment + 10 months follow-up)

    Measured: 28 months

Secondary outcomes (6)

  1. To assess the number of adverse events and their severity in each group

    Measured: 28 months

  2. Number of patients with ANCA in each group

    Measured: 28 months

  3. mortality rate in each group

    Measured: 28 months

  4. number of minor relapse in each group

    Measured: 28 months

  5. Cumulated dose and the length of corticosteroid treatment in each group at 28 months

    Measured: 28 months

  6. same criteria with an analysis at 6 months after the end of maintenance treatment

    Measured: 24 months

Timeline

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

  1. First posted8 Sep 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionMar 2013
  4. Study completionJun 2013

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
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00748644
Sponsor's protocol ID
P 070703
Acronym
MAINRITSAN
Status last verified
Oct 2025
First submitted
5 Sep 2008
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Pugnet G, Pagnoux C, Terrier B, Perrodeau E, Puechal X, Karras A, Khouatra C, Aumaitre O, Cohen P, Maurier F, Decaux O, Ninet J, Gobert P, Quemeneur T, Blanchard-Delaunay C, Godmer P, Carron PL, Hatron PY, Limal N, Hamidou M, Ducret M, Daugas E, Papo T, Bonnotte B, Mahr A, Ravaud P, Mouthon L, Guillevin L; French Vasculitis Study Group. Rituximab versus azathioprine for ANCA-associated vasculitis maintenance therapy: impact on global disability and health-related quality of life. Clin Exp Rheumatol. 2016 May-Jun;34(3 Suppl 97):S54-9. Epub 2016 Mar 25.

    PubMed 27049404

  • Guillevin 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 25372085

  • Romand X, Paclet MH, Chuong MV, Gaudin P, Pagnoux C, Guillevin L, Terrier B, Baillet A. Serum calprotectin and renal function decline in ANCA-associated vasculitides: a post hoc analysis of MAINRITSAN trial. RMD Open. 2023 Oct;9(4):e003477. doi: 10.1136/rmdopen-2023-003477.

    PubMed 37903568

  • Terrier B, Pagnoux C, Perrodeau E, Karras A, Khouatra C, Aumaitre O, Cohen P, Decaux O, Desmurs-Clavel H, Maurier F, Gobert P, Quemeneur T, Blanchard-Delaunay C, Bonnotte B, Carron PL, Daugas E, Ducret M, Godmer P, Hamidou M, Lidove O, Limal N, Puechal X, Mouthon L, Ravaud P, Guillevin L; French Vasculitis Study Group. Long-term efficacy of remission-maintenance regimens for ANCA-associated vasculitides. Ann Rheum Dis. 2018 Aug;77(8):1150-1156. doi: 10.1136/annrheumdis-2017-212768. Epub 2018 May 3.

    PubMed 29724729

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab and Azathioprine in people with Wegener Granulomatosis and Microscopic Polyangiitis, 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 5 inclusion and 28 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. 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?

Number of major relapse (BVAS>10) in each group at the end of the maintenance treatment (18 months treatment + 10 months follow-up) (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 NCT00748644, which also lists 4 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.

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