A Phase 3 interventional study of rituximab and Placebo in ANCA-associated Vasculitides, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
Among 13 studies testing rituximab in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis — 3 open to participants now, 3 under way, 1 of them phase 3. Rituximab · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.
Among the 13 studies testing rituximab in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, this one is the 8th largest by enrollment, is the only one that started in 2015, is one of 6 in phase 3, and was the 8th registered.
157 studies on the registry are indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; 75 are open to participants now.
This study's enrollment of 97 is above the median of 34 across 116 interventional studies indexed under Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis.
Browse Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies →3 of the 13 studies testing rituximab in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis are open now, in 3 countries. Each count lists the studies.
Rituximab: first FDA approval 1997 (RITUXAN), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →
Of the 56 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies recruiting now, 21 (38%) set no upper age limit and 28 (50%) stop at 75 or younger; 9 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2015.
Median enrollment 115 across the 13 interventional studies. Of the 9 that completed or were terminated, 4 (44%) have results posted.
None of the 13 has an industry lead sponsor. The 7 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
16 studies in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis by Assistance Publique - Hôpitaux de Paris: 6 open now, 6 under way, 2 of them phase 3. Of 9 finished, 0 (0%) have results posted.
Among the 16 studies in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis by Assistance Publique - Hôpitaux de Paris, this one is the 4th largest by enrollment of the 10 interventional ones, is one of 3 that started in 2015, is one of 7 in phase 3, and was the 5th registered.
Assistance Publique - Hôpitaux de Paris’s Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis studies by the year they started, since 2001.
1 of the studies testing rituximab in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06611696Chiba UniversityAvacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis | 2027-03-31 |
Among the 13 studies testing rituximab in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Assistance Publique - Hôpitaux de Paris’s 16 in Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:
Nothing recorded among them since 2026-09-25.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
and Patients must meet all of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
500 mg rituximab infusion at the randomization visit and every 6 months for 18 months
Drug: rituximab
Placebo infusion at the randomization visit and every 6 months for 18 months
Drug: Placebo
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.
Vasculitis score 2003 (BVAS 2003 )
Relapse free survival rates (BVAS \> 0)
Time frame: 28 months
Number of adverse events,
adverse events including infectious effects and their severity in each arm
Time frame: 28 months
number of patients experiencing at least one adverse event in both arms
Time frame: 28 months
correlation of ANCA level with the clinical events
Time frame: 28 months
ANCA level during follow-up
Time frame: 28 months
correlation B-Lymphocytes CD-19 level with the clinical events
Time frame: 28 months
B-Lymphocytes CD-19 level during follow-up
Time frame: 28 months
number of B memory cells during follow-up in both arms
Time frame: 28 months
correlation number of B memory cells with the clinical events
Time frame: 28 months
Number of patients with ANCA in each arm
Time frame: 28 months
Time frame to death in both arms
Time frame: 28 months
time frame of first minor relapse
Time frame: 28 months
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"
Time frame: 28 months
Cumulated dose of corticosteroid treatment
Time frame: 28 months
Number and severity of damages
Time frame: 28 months
number of of gammaglobulins
Time frame: 28 months
Quality of life : SF36 (The Short Form (36) Health Survey)
Time frame: 28 months
functional capacities : HAQ (Health Assessment Questionnaire )
Time frame: 28 months
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rituximab
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis →
Assistance Publique - Hôpitaux de Paris →