RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.
NCT ID: NCT05758831
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
386 participants
INTERVENTIONAL
2023-06-01
2030-05-01
Brief Summary
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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.
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Detailed Description
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Clinical trials with B cell depleting therapies have shown efficacy in relapsing-remitting MS (RRMS) and are increasingly perceived as an important addition to the existing panel of Disease-modifying treatments (DMTs). Rituximab, a mouse chimeric anti CD20, is approved for non-Hodgkin's lymphoma, chronic lymphocytic leukemia, certain forms of vasculitis and Rheumatoid Arthritis with first marketing approval in 1998. Rituximab has undergone clinical testing in RRMS in 2008 in a phase II placebo-controlled trial, demonstrating the clinico-radiological efficacy in 104 patients. Despite these promising results and the absence of adverse events, its clinical development was interrupted by the manufacturer (Roche). However, for several years, rituximab has been increasingly prescribed (off-label) in Europe and USA in patients refractory to first-line therapies, with a very good safety and efficacy. Thus, rituximab is prescribed for 40% of RRMS patients treated in Sweden. Roche has then developed a humanized anti-CD20 monoclonal antibody (Ocrelizumab). Two phase III clinical trials (OPERA I and II) have demonstrated its efficacy in active RRMS. Ocrelizumab has just been authorized in France in this indication: RRMS patients with active disease (clinical or radiological). So, it can be prescribed as a first line or second line therapy in active RRMS patients.
According to literature, there are no biological arguments to think that ocrelizumab could be more effective in active RRMS compared to rituximab. Moreover, regarding safety, rituximab has been used for other indications for almost two decades and no serious concern has arisen.
The high cost of this new antibody (x6 to 10) compared to rituximab) makes it wonder about its place inside the anti-CD20 therapeutic strategy compared to rituximab for treating relapsing MS patients.
Hypothesis: Researchers hypothesize that rituximab and ocrelizumab have the same efficacy in active RRMS patients. Indeed, if the non-inferiority of rituximab on the % of patients without disease activity is confirmed by the trial, the potential medico-economic benefit from a societal perspective will be a strong argument to ask for authorization of rituximab in active RRMS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ocrelizumab
Day 0 (300mg), Day 15(300mg), and then 300 mg every 6 months (M6, M12, M18 and M24)
Perfusion of treatment Ocrelizumab
Perfusion of treatment (Ocrevus®)
Rituximab
Day 0 (1000mg), Day 15 (1000 mg), and then 500 mg every 6 months (M6, M12, M18 and M24)
Perfusion of treatment Rituximab
Perfusion of treatment (Mabthera®, Truxima®, Rixathon®, Ruxience®)
Interventions
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Perfusion of treatment Rituximab
Perfusion of treatment (Mabthera®, Truxima®, Rixathon®, Ruxience®)
Perfusion of treatment Ocrelizumab
Perfusion of treatment (Ocrevus®)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Locations
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Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer
Lyon, Bron, France
CHRU de Brest - Hôpital la Cavale Blanche
Brest, , France
Centre Hospitalier Universitaire de Caen
Caen, , France
Centre Hospitalier de Pontoise - GHT NOVO
Cergy-Pontoise, , France
Hôpital Gabriel Montpieds
Clermont-Ferrand, , France
Centre hospitalier de Gonnesse
Gonesse, , France
Groupe Hospitalier de l'Institut Catholique de Lille
Lille, , France
Centre Hospitalier Universitaire de Limoges
Limoges, , France
AP-HM - Hôpital la Timone
Marseille, , France
CHRU de Montpellier - Hôpital Gui de Chauliac
Montpellier, , France
Centre Hospitalier Régional de Nancy
Nancy, , France
CHU de Nantes -Hôpital Nord Laennec
Nantes, , France
CHU de Nice - Hôpital Pasteur 2
Nice, , France
CHU de Nîmes - Hôpital Caremeau
Nîmes, , France
AP-HP Höpital la Pitié-Salpétrière
Paris, , France
Groupe Hospitalier Universitaire Henri Mondor
Paris, , France
Hôpital Saint-Germain
Poissy, , France
Centre Hospitalier de Cornouaille
Quimper, , France
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
Rennes, , France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, , France
CHRU de Strasbourg - Hôpital Hautpierre
Strasbourg, , France
Hôpital Foch
Suresnes, , France
CHU de Toulouse - Bâtiment Pierre Paul Riquet
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Laure MICHEL, MD
Role: primary
Other Identifiers
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35RC20_9812_TRIO
Identifier Type: -
Identifier Source: org_study_id
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