RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

Launched by RENNES UNIVERSITY HOSPITAL · Mar 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two medications, rituximab and ocrelizumab, to see which one is more effective for treating patients with relapsing-remitting multiple sclerosis (RRMS). Over a period of two years, researchers will compare how many patients treated with each medication do not experience any disease activity, such as relapses or new brain lesions. Participants will have regular check-ups, complete health and quality of life questionnaires, and receive treatment infusions according to a set schedule.

To be eligible for the trial, participants must be between 18 and 55 years old, have a diagnosis of relapsing-remitting MS, and show signs of disease activity within the past year. They should also have a recent MRI scan of their brain. Women who can become pregnant need to use effective contraception during the study. If you join the trial, you’ll be closely monitored for two years, and your health and wellbeing will be prioritized throughout the process.

Gender

ALL

Eligibility 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.