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Cheaper MS drug could match costly standard in new trial

NCT ID NCT05758831

Disease control Sponsor: Rennes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether rituximab, a less expensive drug, works as well as ocrelizumab for people with relapsing-remitting multiple sclerosis. About 386 participants will receive either drug and be followed for 2 years. The main goal is to see if rituximab can keep the disease inactive (no relapses or new brain lesions) just as effectively as ocrelizumab.

What this could mean

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

Active substance
rituximab and ocrelizumab (infused drugs)
What this could lead to
If rituximab works as well as ocrelizumab, it could offer a more affordable treatment option for relapsing-remitting MS.
What could go wrong
This is a non-inferiority trial, so rituximab might not be as effective. Both drugs have known risks like infusion reactions and increased infection risk.

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

About 386 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

May 2030

An estimate. End dates often move.

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 to 55 years

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 presenting a relapsing remitting MS according to Mac Donald 2017 criteria, with clinical or radiological criteria of activity (ie at least one relapse AND/OR one new T2 lesion in the last 12 months before inclusion); * Age between 18 and 55 years * EDSS ≤ 5 * Brain MRI within 6 months before inclusion * For women of childbearing potential\*: effective contraception (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate \<1%, for the duration of the study and until 12 months after last dose administered) \* A woman is 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 post-menopausal 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. * Having signed an informed consent form * Patients covered with social insurance Non-Inclusion Criteria: * Secondary or primary progressive MS; * Previous treatment by mitoxantrone, cladribine, alemtuzumab and anti CD20 therapies in the last two years; * Previous treatment by fingolimod or natalizumab in the last 4 weeks; * Treatment with high dose corticosteroids during the 30 days preceding the inclusion; * Occurrence of a relapse less than 30 days before inclusion; * Pregnancy or breastfeeding; * Other neurologic or systemic disease; * Concomitant participation or Participation in another therapeutic trial in the last 6 months; * Incapacity to understand or sign the consent form; * Contraindication to MRI; * Contraindication to anti-CD20 therapies: * Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization * Active malignancy. * Any ongoing infection * Severe heart failure (New York Heart Association Class IV) or severe uncontrolled cardiac disease * Positive test for HIV, hepatitis B or C, or tuberculosis * Severe immune deficiency: * Lymphopenia grade 3 (0.2 to 0.5 × 10\^9/L) or higher grades * Neutropenia grade 3 (0.5 to 1.0 × 10\^9/L) or higher grades * Known hypersensitivity or other known side effects for any of the study medications, including co-medications such as high glucocorticosteroids * AST or ALT \>=3ULN * Platelet (thrombocyte) count \< 100 x 10\^9/L * Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Multiple sclerosis Relapsing-remitting multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HM - Hôpital la Timone

    RECRUITING

    Marseille, 13385, France

  • AP-HP Höpital la Pitié-Salpétrière

    NOT_YET_RECRUITING

    Paris, 75010, France

  • CHRU de Brest - Hôpital la Cavale Blanche

    NOT_YET_RECRUITING

    Brest, 29609, France

  • CHRU de Montpellier - Hôpital Gui de Chauliac

    RECRUITING

    Montpellier, 34295, France

  • CHRU de Strasbourg - Hôpital Hautpierre

    RECRUITING

    Strasbourg, 67200, France

  • CHU de Nantes -Hôpital Nord Laennec

    RECRUITING

    Nantes, 44800, France

  • CHU de Nice - Hôpital Pasteur 2

    RECRUITING

    Nice, 06002, France

  • CHU de Nîmes - Hôpital Caremeau

    NOT_YET_RECRUITING

    Nîmes, 30029, France

  • CHU de Rouen - Hôpital Charles Nicolle

    NOT_YET_RECRUITING

    Rouen, 76038, France

  • CHU de Toulouse - Bâtiment Pierre Paul Riquet

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Centre Hospitalier Régional de Nancy

    RECRUITING

    Nancy, 54035, France

  • Centre Hospitalier Universitaire de Caen

    RECRUITING

    Caen, 14033, France

  • Centre Hospitalier Universitaire de Limoges

    NOT_YET_RECRUITING

    Limoges, 87042, France

  • Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

    RECRUITING

    Rennes, 35000, France

  • Centre Hospitalier de Cornouaille

    RECRUITING

    Quimper, 29107, France

  • Centre Hospitalier de Pontoise - GHT NOVO

    NOT_YET_RECRUITING

    Cergy-Pontoise, 95300, France

  • Centre hospitalier de Gonnesse

    NOT_YET_RECRUITING

    Gonesse, 95503, France

  • Groupe Hospitalier Universitaire Henri Mondor

    NOT_YET_RECRUITING

    Paris, 94000, France

  • Groupe Hospitalier de l'Institut Catholique de Lille

    NOT_YET_RECRUITING

    Lille, 59160, France

  • Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer

    NOT_YET_RECRUITING

    Lyon, Bron, 69677, France

  • Hôpital Foch

    NOT_YET_RECRUITING

    Suresnes, 92150, France

  • Hôpital Gabriel Montpieds

    NOT_YET_RECRUITING

    Clermont-Ferrand, 63003, France

  • Hôpital Saint-Germain

    NOT_YET_RECRUITING

    Poissy, 78303, France

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