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

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHRU de Brest - Hôpital la Cavale Blanche
NOT_YET_RECRUITING
Brest
Centre Hospitalier Universitaire de Caen
RECRUITING
Caen
Centre Hospitalier de Pontoise - GHT NOVO
NOT_YET_RECRUITING
Cergy-pontoise
Hôpital Gabriel Montpieds
NOT_YET_RECRUITING
Clermont-ferrand
Centre hospitalier de Gonnesse
NOT_YET_RECRUITING
Gonesse
Groupe Hospitalier de l'Institut Catholique de Lille
NOT_YET_RECRUITING
Lille
Centre Hospitalier Universitaire de Limoges
NOT_YET_RECRUITING
Limoges
Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer
NOT_YET_RECRUITING
Lyon
AP-HM - Hôpital la Timone
RECRUITING
Marseille
CHRU de Montpellier - Hôpital Gui de Chauliac
RECRUITING
Montpellier
Centre Hospitalier Régional de Nancy
RECRUITING
Nancy
CHU de Nantes -Hôpital Nord Laennec
RECRUITING
Nantes
CHU de Nice - Hôpital Pasteur 2
RECRUITING
Nice
CHU de Nîmes - Hôpital Caremeau
NOT_YET_RECRUITING
Nîmes
AP-HP Höpital la Pitié-Salpétrière
NOT_YET_RECRUITING
Paris
Groupe Hospitalier Universitaire Henri Mondor
NOT_YET_RECRUITING
Paris
Hôpital Saint-Germain
NOT_YET_RECRUITING
Poissy
Centre Hospitalier de Cornouaille
RECRUITING
Quimper
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
RECRUITING
Rennes
CHU de Rouen - Hôpital Charles Nicolle
NOT_YET_RECRUITING
Rouen
CHRU de Strasbourg - Hôpital Hautpierre
RECRUITING
Strasbourg
Hôpital Foch
NOT_YET_RECRUITING
Suresnes
CHU de Toulouse - Bâtiment Pierre Paul Riquet
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Laure MICHEL, MD
laure.michel@chu-rennes.fr
0299286774
Backup
Agnès Gazzola
agnes.gazzola@chu-rennes.fr
0299289194
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2030-05-01
Participants
Target number of participants: 386
Treatments
Active_comparator: Ocrelizumab
Day 0 (300mg), Day 15(300mg), and then 300 mg every 6 months (M6, M12, M18 and M24)
Experimental: Rituximab
Day 0 (1000mg), Day 15 (1000 mg), and then 500 mg every 6 months (M6, M12, M18 and M24)
Related Therapeutic Areas
Sponsors
Leads: Rennes University Hospital

This content was sourced from clinicaltrials.gov