TRIO: A prospective randomized Trial of non-inferiority comparing RItuximab versus Ocrelizumab in relapsing-remitting multiple sclerosis.

Phase 1

Recruiting

• Conditions: Multiple Sclerosis, Multiple Sclerosis; MedDRA version: 21.1Level: PTClassification code: 10063399Term: Relapsing-remitting multiple sclerosis Class: 100000004852; MedDRA version: 20.0Level: SOCClassification code: 10029205Term: Nervous system disorders Class: 8; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2022-501027-25-01
• Lead Sponsor: CHU De Rennes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 430

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), - Having signed an informed consent form, - Patients covered with social insurance

Exclusion Criteria

-Secondary or primary progressive MS;, -Incapacity to understand or sign the consent form;, -Contraindication to MRI, -Previous treatment by fingolimod or natalizumab in the last 4 weeks, -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, -Previous treatment by mitoxantrone, cladribine, alemtuzumab and anti CD20 therapies in the last two years;, -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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified