Health TrialsbyHealthPanel

RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.

ConditionsMultiple SclerosisRelapsing-remitting Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorRennes University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Perfusion of treatment Rituximab

    Drug

    Perfusion of treatment (Mabthera®, Truxima®, Rixathon®, Ruxience®)

  • Perfusion of treatment Ocrelizumab

    Drug

    Perfusion of treatment (Ocrevus®)

Treatment groups

386 Participants
are divided into 2 treatment groups
Group A: OcrelizumabActive comparator 1 intervention
Group B: RituximabExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
at 2 years

Secondary outcomes

1

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

Relapses: annualized relapse rate

Time frame
at 2 years
2

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

mean time of onset of the first relapse

Time frame
at 2 years
3

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

Percentage of patients without relapse

Time frame
at 2 years
4

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

Percentage of patients without disability progression (Expanded Disability Status Scale-EDSS) (Disability progression will be defined as an increase of 1.5 pt if baseline EDSS=0, 1pt EDSS (if baseline 1 ≤ EDSS\<6), or an increase of 0.5pt if baseline EDSS is ≥ 6; confirmed at 6 months.) EDSS : Minimum Score 1, Maximum score 10, higher scores mean a worse outcome.

Time frame
at 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rennes University Hospital

Lead sponsor

Source ClinicalTrials.gov
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