RecruitingPhase 3Relapsing and progressiveNCT057588312022-501027-25-01

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Perfusion of treatment Rituximab
  • Rituximab

    B-lymphocyte antigen CD20 binding agent

Compared with

  • Perfusion of treatment Ocrelizumab
  • Ocrelizumab

    B-lymphocyte antigen CD20 binding agent

What it measured

Main measures

  • 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.

    at 2 years

    RelapsesMRI lesions
  • % 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

    RelapsesMRI lesions

Other measures (21)

  • To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Annualized relapse rate

    at 2 years

    Relapses
  • To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Time of onset of the first relapse

    at 2 years

    Relapses
  • To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without relapse

    at 2 years

    Relapses
  • To compare the two groups (ocrelizumab vs rituximab) for Clinical Criteria : o Percentage of patients without disability progression

    at 2 years

    Disability progression
  • MRI parameters : gadolinium (Gd) enhancing lesions

    at 6 month

    MRI lesions
  • MRI parameters : Mean Number of new T2 lesions

    From Month 6 to Month 24

    MRI lesions
  • MRI parameters : Percentage of patients with one or more new T2 lesions

    From Month 6 to Month 24

    MRI lesions
  • Patients quality of life : EQ-5D-5L

    From baseline (Day 0) to every six month of follow up until Month 24

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)
  • Patients quality of life : MusiQOL (Multiple Sclerosis International Quality of Life questionnaire)

    From baseline (Day 0) to Month 12

    Bladder, bowel and sexual functionQuality of life (reported by participants)
  • Patients quality of life : MusiQOL

    From baseline (Day 0) to Month 24

    Bladder, bowel and sexual functionQuality of life (reported by participants)

Who could take part

Relapsing and progressive · 18 to 55

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Jun 2023

      2. Main results due

        Mar 2030

      3. Finished

        May 2030

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