Personalized dosing of ocrelizumab in MS

Phase 1

• Conditions: Multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-004791-34-NL
• Lead Sponsor: VU medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• A current diagnosis of relapsing remitting multiple sclerosis according
to the 2017 McDonald criteria34
• Age of 18 to 60 years
• EDSS score of 0 to 6.5 inclusive
• Treatment with ocrelizumab for a minimum of 48 weeks (two 300 mg infusions and one 600 mg infusion)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 296
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Previous treatment with alemtuzumab, cladribine or stem cell transplantation
• Relapse in the past 3 months prior to inclusion
• Subsequent treatment with another DMT next to ocrelizumab in the past 6 months prior to inclusion
• Inability to undergo regular MRI scanning
• Women who are pregnant or expect to become pregnant during the study period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity compared to the standard (fixed 24 week interval) treatment.;Secondary Objective: With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of disability and brain atrophy.;Primary end point(s): The two co-primary end points are the difference of percentage of confirmed relapse-free patients between the two treatment groups after 96 weeks follow-up and the difference of percentage of patients without new/enlarging T2 MRI lesions between the two treatment groups after 96 weeks follow-up.;Timepoint(s) of evaluation of this end point: 96 weeks