RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
TRIO
A Prospective Randomized Trial of Non-inferiority Comparing RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis
1 other identifier
interventional
386
1 country
23
Brief Summary
The goal of this randomized clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years. During the 2 years, the study includes 6 follow-up visits and the completion of various health and quality of life questionnaires. The protocol visits follow the usual schedule of treatment infusions for the disease (at initiation of treatment, 15 days after, and then every 6 months). Two comparison groups: Researchers will compare rituximab treated patients versus ocrelizumab treated patients to see the % of patients without disease activity at 2 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-sclerosis
Started Jun 2023
Longer than P75 for phase_3 multiple-sclerosis
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2023
CompletedFirst Posted
Study publicly available on registry
March 7, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
February 2, 2026
January 1, 2026
6.8 years
February 17, 2023
January 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the percentage of patients without disease activity at 2 years.
Percentage of patients without disease activity at 2 years (Disease activity is defined as: * At least one relapse between baseline and M24 * OR MRI activity defined as Gd enhancing lesions at M6 or as the appearance of at least one new T2 lesion between M6 and M24)
at 2 years
Secondary Outcomes (16)
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Annualized relapse rate
at 2 years
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Time of onset of the first relapse
at 2 years
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without relapse
at 2 years
To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without disability progression
at 2 years
MRI parameters : gadolinium (Gd) enhancing lesions
at 6 month
- +11 more secondary outcomes
Study Arms (2)
Ocrelizumab
ACTIVE COMPARATORDay 0 (300mg), Day 15(300mg), and then 300 mg every 6 months (M6, M12, M18 and M24)
Rituximab
EXPERIMENTALDay 0 (1000mg), Day 15 (1000 mg), and then 500 mg every 6 months (M6, M12, M18 and M24)
Interventions
Perfusion of treatment (Mabthera®, Truxima®, Rixathon®, Ruxience®)
Eligibility Criteria
You may qualify if:
- Age between 18 and 55 years
- EDSS ≤ 5
- 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
- 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;
- 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:
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer
Lyon, Bron, 69677, France
CHRU de Brest - Hôpital la Cavale Blanche
Brest, 29609, France
Centre Hospitalier Universitaire de Caen
Caen, 14033, France
Centre Hospitalier de Pontoise - GHT NOVO
Cergy-Pontoise, 95300, France
Hôpital Gabriel Montpieds
Clermont-Ferrand, 63003, France
Centre hospitalier de Gonnesse
Gonesse, 95503, France
Groupe Hospitalier de l'Institut Catholique de Lille
Lille, 59160, France
Centre Hospitalier Universitaire de Limoges
Limoges, 87042, France
AP-HM - Hôpital la Timone
Marseille, 13385, France
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295, France
Centre Hospitalier Régional de Nancy
Nancy, 54035, France
CHU de Nantes -Hôpital Nord Laennec
Nantes, 44800, France
CHU de Nice - Hôpital Pasteur 2
Nice, 06002, France
CHU de Nîmes - Hôpital Caremeau
Nîmes, 30029, France
AP-HP Höpital la Pitié-Salpétrière
Paris, 75010, France
Groupe Hospitalier Universitaire Henri Mondor
Paris, 94000, France
Hôpital Saint-Germain
Poissy, 78303, France
Centre Hospitalier de Cornouaille
Quimper, 29107, France
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
Rennes, 35000, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76038, France
CHRU de Strasbourg - Hôpital Hautpierre
Strasbourg, 67200, France
Hôpital Foch
Suresnes, 92150, France
CHU de Toulouse - Bâtiment Pierre Paul Riquet
Toulouse, 31059, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomisation code transmitted to the pharmacy preparing the treatment. Blind labelling of treatments
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2023
First Posted
March 7, 2023
Study Start
June 1, 2023
Primary Completion (Estimated)
March 31, 2030
Study Completion (Estimated)
May 1, 2030
Last Updated
February 2, 2026
Record last verified: 2026-01