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Towards Personalized Dosing of Natalizumab in Multiple Sclerosis (PDNMS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Natalizumab
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring natalizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • OLVG
  • VU medical center
  • Rijnstate Hospital
  • Erasmus medical center
  • St. Antonius Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All patients in this study

Arm Description

Patients treated with natalizumab with a minimum of 1 year, without signs of disease activity (relapses, new T2 lesions on MRI) for a minimum of 1 year.

Outcomes

Primary Outcome Measures

Gadolinium enhancing T1 lesions on brain MRI
Occurrence and number of gadolinium enhancing T1 lesions of brain MRI

Secondary Outcome Measures

New T2 lesions on brain MRI
Occurrence and number of new T2 lesions on brain MRI
Relapses
scoring MS exacerbations
EDSS
Expanded Disability Status Scale: clinical scoring of disability in MS patients
MSFC
Multiple Status Functional Composite: clinical scoring of disability in MS patients
patient perspective measured with the SF-36
questionnaire: Short Form-36
patient perspective measured with the MSIS-29
questionnaire: Multiple Sclerosis Impact Scale-29

Full Information

First Posted
April 12, 2018
Last Updated
July 11, 2019
Sponsor
Amsterdam UMC, location VUmc
Collaborators
Prothya Biosolutions, Erasmus Medical Center, St. Antonius Hospital, OLVG, Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03516526
Brief Title
Towards Personalized Dosing of Natalizumab in Multiple Sclerosis
Acronym
PDNMS
Official Title
Towards Personalized Dosing of Natalizumab in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 3, 2016 (Actual)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
Prothya Biosolutions, Erasmus Medical Center, St. Antonius Hospital, OLVG, Rijnstate Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
natalizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patients in this study
Arm Type
Other
Arm Description
Patients treated with natalizumab with a minimum of 1 year, without signs of disease activity (relapses, new T2 lesions on MRI) for a minimum of 1 year.
Intervention Type
Drug
Intervention Name(s)
Natalizumab
Intervention Description
Extending dose intervals of natalizumab from 4 weeks to maximum of 8 weeks based on trough natalizumab concentrations
Primary Outcome Measure Information:
Title
Gadolinium enhancing T1 lesions on brain MRI
Description
Occurrence and number of gadolinium enhancing T1 lesions of brain MRI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
New T2 lesions on brain MRI
Description
Occurrence and number of new T2 lesions on brain MRI
Time Frame
12 months
Title
Relapses
Description
scoring MS exacerbations
Time Frame
12 months
Title
EDSS
Description
Expanded Disability Status Scale: clinical scoring of disability in MS patients
Time Frame
12 months
Title
MSFC
Description
Multiple Status Functional Composite: clinical scoring of disability in MS patients
Time Frame
baseline and 12 months
Title
patient perspective measured with the SF-36
Description
questionnaire: Short Form-36
Time Frame
baseline and 12 months
Title
patient perspective measured with the MSIS-29
Description
questionnaire: Multiple Sclerosis Impact Scale-29
Time Frame
baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joep Killestein, Dr.
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
OLVG
City
Amsterdam
Country
Netherlands
Facility Name
VU medical center
City
Amsterdam
Country
Netherlands
Facility Name
Rijnstate Hospital
City
Arnhem
Country
Netherlands
Facility Name
Erasmus medical center
City
Rotterdam
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Towards Personalized Dosing of Natalizumab in Multiple Sclerosis

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