Comparing Rituximab and Ocrelizumab for Relapsing-Remitting Multiple Sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier Universitaire de Caen
  Caen, France Recruiting
• AP-HM - Hôpital la Timone
  Marseille, France Recruiting
• CHRU de Montpellier - Hôpital Gui de Chauliac
  Montpellier, France Recruiting
• Centre Hospitalier Régional de Nancy
  Nancy, France Recruiting
• CHU de Nantes -Hôpital Nord Laennec
  Nantes, France Recruiting
• CHU de Nice - Hôpital Pasteur 2
  Nice, France Recruiting

Study contacts

• Study coordinator: Laure MICHEL, MD
• Email: laure.michel@chu-rennes.fr
• Phone: 0299286774

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ocrelizumab given under the skin after switching from another anti-CD20 therapy

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• HiHat: Rituximab Followed by Cladribine in Relapsing-Remitting MS

  This trial tests whether giving rituximab and then cladribine in sequence is safe and doable for people with relapsing-remitting MS.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.