Towards Personalized Dosing of Natalizumab in Multiple Sclerosis

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective clinical trial with the aim of maintaining drug efficacy of natalizumab while extending dose intervals guided by drug concentrations in patients with relapsing remitting multiple sclerosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Collaborators: Erasmus Medical Center; OLVG; Rijnstate Hospital; Sanquin; Sanquin Plasma Products BV; St. Antonius Hospital
• Treatments: Natalizumab

Criteria

Inclusion Criteria:

• 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 of ≥15 μg/ml

• Written informed consent.

Exclusion Criteria:

• Any MS disease activity (radiologically or clinically) during the last 12 months of natalizumab treatment.

• Unable to undergo frequent MRI.

• The use of other immunomodulatory medication other than natalizumab.