Towards Personalized Dosing of Natalizumab in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— PDNMS  

Official title:

Towards Personalized Dosing of Natalizumab in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516526
• Other study ID #: NL56584.029.16
• Status: Completed
• Phase: Phase 4
• Start date: November 3, 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 1, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Natalizumab
Extending dose intervals of natalizumab from 4 weeks to maximum of 8 weeks based on trough natalizumab concentrations

Locations

Country	Name	City	State
Netherlands	OLVG	Amsterdam
Netherlands	VU medical center	Amsterdam
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Erasmus medical center	Rotterdam
Netherlands	St. Antonius Hospital	Utrecht

Sponsors (6)

Lead Sponsor	Collaborator
VU University Medical Center	Erasmus Medical Center, OLVG, Rijnstate Hospital, Sanquin Plasma Products BV, St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gadolinium enhancing T1 lesions on brain MRI	Occurrence and number of gadolinium enhancing T1 lesions of brain MRI	12 months
Secondary	New T2 lesions on brain MRI	Occurrence and number of new T2 lesions on brain MRI	12 months
Secondary	Relapses	scoring MS exacerbations	12 months
Secondary	EDSS	Expanded Disability Status Scale: clinical scoring of disability in MS patients	12 months
Secondary	MSFC	Multiple Status Functional Composite: clinical scoring of disability in MS patients	baseline and 12 months
Secondary	patient perspective measured with the SF-36	questionnaire: Short Form-36	baseline and 12 months
Secondary	patient perspective measured with the MSIS-29	questionnaire: Multiple Sclerosis Impact Scale-29	baseline and 12 months