Towards personalized dosing of natalizumab in multiple sclerosis

Phase 4

Completed

• Conditions: MS; multiple sclerosis; 10012303

• Registration Number: NL-OMON43550
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- 18 years or older.
- Relapsing-remitting multiple sclerosis (RRMS) according to the McDonald criteria, revised by Polman 2010.
- Natalizumab treatment for 12 months or longer at inclusion.
- An expanded disability status scale (EDSS) score of 0.0-6.0 at baseline.
- Natalizumab level more than 15 µg/ml just prior natalizumab infusions for 2 consecutive months.
- Written informed consent.

Exclusion Criteria

- Any MS disease activity (radiologically or clinically) during natalizumab treatment, with exclusion of the first three months of treatment.
- Unable to undergo frequent MRI.
- The use of other immunomodulatory medication other than natalizumab.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the number of patients developing gadolinium (Gd+)<br /><br>enhancing lesions on brain MRI. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are new or enlarging T2 lesions on brain MRI,<br /><br>progression on the expanded disability status scale (EDSS) and clinical<br /><br>relapses and measurements of the quality of life by the SF-36.</p><br>