DE-escalating ocRelizumAb In cLinical and radiological stable MS

Withdrawn

• Conditions: MS; multiple sclerosis; 10012303

• Registration Number: NL-OMON51850
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 66

Inclusion Criteria

1. Age * 18 years
2. Diagnosis of MS according to any version of the McDonald criteria
3. Being treated with anti-CD20 mAb in the context of MS
4. Having received at least 4 cycles with anti-CD20 mAb
5. No signs of clinical or radiological disease activity in the preceding 1
year

Exclusion Criteria

1. Inability to comply with yearly MRI and 6-monthly clinical monitoring
2. Inability to make an informed treatment decision because of language
barriers

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the proportion of pwMS with new and/or enhancing T2<br /><br>lesions on brain MRI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are the proportion of pwMS with symptomatic infections<br /><br>requiring hospital admission, relapses, confirmed disability progression,<br /><br>NEDA-3, timed 25-foot walk test, nine hole peg test, single digit modality<br /><br>test, serum neurofilament level evolution, SARS-CoV-2 antibodies, lymphocyte<br /><br>repopulation and immunoglobulin level evolution. We will also record the<br /><br>reasons to prioritize induction vs. continuation of maintenance therapy with<br /><br>anti-CD20.</p><br>