Reduce the number of natalizumab infusions in patients with multiple sclerosis

Towards personalized dosing of natalizumab in multiple sclerosis - Personalised Dosing of Natalizumab in Multiple Sclerosis (The PDNMS trial)

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000345-31-NL

Enrollment

Registered

2016-04-11

Start date

2016-09-30

Completion date

Unknown

Last updated

2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple sclerosis MedDRA version: 18.1 Level: LLT Classification code 10070425 Term: Multiple sclerosis exacerbation System Organ Class: 100000004852

Interventions

Trade Name: tysabri Product Name: natalizumab Pharmaceutical Form: Solution for infusion INN or Proposed INN: NATALIZUMAB CAS Number: 189261-10-7 Concentration unit: mg/ml milligram(s)/millilitre Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18 years or older. - Relapsing-remitting multiple sclerosis (RRMS) according to the McDonald criteria, revised by Polman 2010. - Natalizumab treatment for 6 months or longer at inclusion. - An expanded disability status scale (EDSS) score of 0.0-6.0 at baseline. - Natalizumab level of >10 µg/ml at least 24 weeks after the initiation of natalizumab or later (4 weeks after last dose, 2 consecutive months). - Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: - Any MS disease activity (radiologically or clinically) during natalizumab treatment, with exclusion of the first three months of treatment. - Unable to undergo frequent MRI. - The use of other immunomodulatory medication other than natalizumab.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcome measures are the cumulative number of new/and or enlarging T2-weighted lesions on the brain MRI, clinical disease activity (number of relapses and 12-weeks sustained EDSS progression) and SF-36.;Timepoint(s) of evaluation of this end point: 12 months after inclusion	—

Primary

Measure	Time frame
Main Objective: The primary objective of this research is to demonstrate that personalized extending of natalizumab infusions in MS patients will not result in an increase of Gd+ T1-weighted lesions on brain MRI.;Secondary Objective: 1) Clinical disease activity, measured by the number of relapses and expanded disability status scale (EDSS) progression. We hypothesize that extending dose interval will not aggravate clinical disease activity. 2) We will measure quality of life (QoL) and hypothesize that the QoL with improve with extending infusions of natalizumab. 3) Cumulative number of new/and or enlarging T2-weighted lesions on brain MRI, we hypothesize that extending dose interval will not result in increased T2 lesion load. 4) We will investigate the correlation between patients weight and natalizumab serum concentration and a4ß1 integrin receptor saturation. ;Primary end point(s): Our primary endpoint is the number of patients with the formation of new Gd+ enhancing lesions on brain MRI ;Timepoint(s) of evaluation of this end point: 12 months after inclusion	—

Measure

Time frame

Main Objective: The primary objective of this research is to demonstrate that personalized extending of natalizumab infusions in MS patients will not result in an increase of Gd+ T1-weighted lesions on brain MRI.;Secondary Objective: 1) Clinical disease activity, measured by the number of relapses and expanded disability status scale (EDSS) progression. We hypothesize that extending dose interval will not aggravate clinical disease activity. 2) We will measure quality of life (QoL) and hypothesize that the QoL with improve with extending infusions of natalizumab. 3) Cumulative number of new/and or enlarging T2-weighted lesions on brain MRI, we hypothesize that extending dose interval will not result in increased T2 lesion load. 4) We will investigate the correlation between patients weight and natalizumab serum concentration and a4ß1 integrin receptor saturation. ;Primary end point(s): Our primary endpoint is the number of patients with the formation of new Gd+ enhancing lesions on brain MRI ;Timepoint(s) of evaluation of this end point: 12 months after inclusion

—

Countries

Netherlands

Contacts

Public ContactMS center

VU medical center

z.vankempen@vumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026