STOPPING OF DISEASE MODIFYING TREATMENTS AND OLIGOCLONAL BANDS IN PEOPLE WITH MULTIPLE SCLEROSIS

Recruiting

• Conditions: multiple sclerosis; MS; 10003816; 10012303

• Registration Number: NL-OMON49527
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis MS according to Poser or any version of the McDonald criteria.
• Age >=45 years of age;
• Treatment with interferon beta, glatiramer acetate, dimethyl fumarate or
teriflunomide;
• Absence of relapses within the previous 5 years;
• Absence of active MRI lesions (new T2 lesions compared to MRI <=2 years ago
OR gadolinium enhancing T2 lesions);
• Opportunity to provide written informed consent.

Exclusion Criteria

• Use of oral anticoagulants OR clopidogrel as platelet aggregation inhibitor;
• Any other contra-indication for a lumbar punction;
• Unwillingness to undergo a lumbar and/or venous puncture.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>• Presence of CSF-unique oligoclonal bands (Y/N)<br /><br>• Composite endpoint presence of inflammatory disease activity (all/one item Y<br /><br>= Y; all N=N), consisting of:<br /><br>o New T2 MRI white matter lesions at 1 year follow-up cerebral MRI scan (Y/N)<br /><br>o Gadolinium-enhancing T1 MRI white matter lesions at 1 year follow-up cerebral<br /><br>MRI scan (Y/N)<br /><br>o The presence of a clinically clear exacerbation of disease with new<br /><br>neurological symptoms lasting >24h and not suspect for a pseudo schub</p><br>