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Completed

NCT Number: NCT03516526

Towards Personalized Dosing of Natalizumab in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OLVG, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natalizumab

Drug

Extending dose intervals of natalizumab from 4 weeks to maximum of 8 weeks based on trough natalizumab concentrations

Primary outcomes

  1. Gadolinium enhancing T1 lesions on brain MRI

    Time frame: 12 months

    Occurrence and number of gadolinium enhancing T1 lesions of brain MRI

Secondary outcomes

  1. New T2 lesions on brain MRI

    Time frame: 12 months

    Occurrence and number of new T2 lesions on brain MRI

  2. Relapses

    Time frame: 12 months

    scoring MS exacerbations

  3. EDSS

    Time frame: 12 months

    Expanded Disability Status Scale: clinical scoring of disability in MS patients

  4. MSFC

    Time frame: baseline and 12 months

    Multiple Status Functional Composite: clinical scoring of disability in MS patients

  5. patient perspective measured with the SF-36

    Time frame: baseline and 12 months

    questionnaire: Short Form-36

  6. patient perspective measured with the MSIS-29

    Time frame: baseline and 12 months

    questionnaire: Multiple Sclerosis Impact Scale-29

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Erasmus Medical Center
  • OLVG
  • Prothya Biosolutions
  • Rijnstate Hospital
  • St. Antonius Hospital

Registry information

Acronym: PDNMS

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 4, 2018
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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