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Comparing Rituximab and Ocrelizumab for Relapsing-Remitting Multiple Sclerosis

A Prospective Randomized Trial of Non-inferiority Comparing RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis

Phase 3 Interventional Rennes University Hospital · NCT05758831

This study is testing whether rituximab can work just as well as ocrelizumab in helping people with relapsing-remitting multiple sclerosis manage their symptoms over two years.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment386 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorRennes University Hospital Academic / other
Drugs / interventionsalemtuzumab, natalizumab, ocrelizumab, rituximab
Locations23 sites (Lyon, Bron and 22 other locations)
Trial IDNCT05758831 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of rituximab versus ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS) over a two-year period. Participants will be randomly assigned to receive either treatment and will be monitored for disease activity through follow-up visits and health questionnaires. The primary goal is to demonstrate that rituximab is not inferior to ocrelizumab in preventing disease activity in RRMS patients. The study will include six follow-up visits aligned with the standard treatment infusion schedule.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 with active relapsing-remitting multiple sclerosis and an EDSS score of 5 or less.

Not a fit: Patients with non-active relapsing-remitting multiple sclerosis or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective alternative treatment option for patients with relapsing-remitting multiple sclerosis.

How similar studies have performed: Previous studies have shown success with similar B cell depleting therapies in treating relapsing-remitting multiple sclerosis, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Lyon, Bron and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple SclerosisRelapsing-remitting Multiple SclerosisRelapsing-remitting
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.