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Towards Personalized Dosing of Natalizumab in Multiple Sclerosis — PDNMS  

Multiple Sclerosis Clinical Trial

Official title:
Towards Personalized Dosing of Natalizumab in Multiple Sclerosis

Clinical Trial 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.

Clinical Trial Description

Our main objective is to prove that extending dose intervals guided by natalizumab serum concentrations, will not result in radiological or clinical disease activity in completely stable RRMS patients treated with natalizumab. Adult patients with RRMS with no evident disease activity during the last 12 months of natalizumab infusions with a minimum treatment of 12 months wil be included. Before subsequent natalizumab infusions, serum concentrations will be evaluated. If the concentration exceeds 15μg/ml the dose interval will be extended with a week to a maximum of eight weeks. Patients will get regular brain MRI scans and clinical follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03516526
Study type Interventional
Source VU University Medical Center
Contact
Status Completed
Phase Phase 4
Start date November 3, 2016
Completion date July 1, 2019
View Details
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