Rituximab vs. azathioprine: which drug better prevents EGPA flares?

NCT ID NCT03164473

What the study statuses mean

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Recruitment status, easiest to join first

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 Results may not be published yet.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

Expanded access (not trials)

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

When the status isn't known

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This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tested whether rituximab (given as an infusion every 6 months) is better than azathioprine (daily pills) at keeping eosinophilic granulomatosis with polyangiitis (EGPA) in remission. 98 adults with newly diagnosed or relapsing EGPA who had already achieved remission took part. The goal was to see which drug helped them stay flare-free longer while reducing steroid use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rituximab (a biologic drug) and azathioprine (an immunosuppressant)
What this could lead to
If rituximab works better, it could offer a more effective way to keep EGPA in remission, reducing flares and the need for steroids.
What could go wrong
This is a completed Phase 3 trial with 98 participants, so results are limited in size. Rituximab may not prove superior, and both drugs carry risks like infections.

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

Study facts

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

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

98 people

The number who actually took part.

Started

Mar 2018

Finished

Sep 2024

Lead sponsor

Other sponsor

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

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

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

Show the full entry requirements

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

Inclusion Criteria: * patients with a diagnosis of EGPA according to Lanham and/or ACR 1990 criteria and/or Revised Chapel Hill Nomenclature and/or MIRRA study inclusion criteria * 18 years of age or more * with newly-diagnosed EGPA or after a vasculitis flare and remission achieved within the past year * independently of ANCA status * within 30-360 days following achievement of vasculitis remission (corresponding to a Birmingham Vasculitis Activity Score (BVAS)=0) achieved with an induction regimen including the one used in the REOVAS trial: either CS alone or in association with CYC (total dose ranging from 4.5-10 g for patients \<65 years old and from 3-10g for patients ≥65 years old) or RTX (2 x 1g (D1, D15) or 4 weekly 375 mg/m2). * with a stable prednisone dose for 30 days or no more prednisone * after oral immunosuppressive drug cessation if started at remission. * Patients included in the REOVAS trial and achieving remission can be included at month 12 visit if they fulfil the other criteria * Patients able to give written informed consent prior to participation in the study. * Affiliation with a mode of social security (profit or being entitled). Exclusion Criteria: * patients with GPA, MPA or other vasculitides * patients with vasculitis not in remission defined as a BVAS \>0 * acute or chronic active infections (including HIV, HBV or HCV) * active or recent cancer ( \<5 years), except basocellular carcinoma and low activity prostatic cancer controlled by hormonal treatment * severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease * pregnant women and lactation * patients with childbearing potential will have reliable contraception for all the duration of the study and another 12 months after. Women are considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient * men who refuse to use effective method of contraception (condom) from the date of consent through the end of the study * patients who had already been treated with rituximab before the last relapse/flare * patients who have been treated with rituximab with a different induction regimen than 2 x 1g (D1, D14) or 4 weekly 375 mg/m2 infusions * hypersensitivity to a monoclonal antibody or biologics * contraindication to rituximab or azathioprine * other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation * patients included in other investigational therapeutic study within the previous 3 months except in the REOVAS trial, after which patients achieving remission can be included if they fulfil the other criteria * patients suspected not to be observant to the proposed treatments * white blood cell count ≤4,000/mm3 * platelet count ≤100,000/mm3 * ALT or AST level \>3 times the upper limit of normal * patients not able to stop allopurinol and febuxostat which may enhance azathioprine toxicity * patients unable to give written informed consent prior to participation in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hôpital Cochin

    Paris, Paris, 75014, France

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