PDNMS
What it found
We found no results in the registry or in papers.
This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
Gadolinium enhancing T1 lesions on brain MRI
12 months
MRI lesionsOur primary endpoint is the number of patients with the formation of new Gd+ enhancing lesions on brain MRI
MRI lesions
Other measures (7)
New T2 lesions on brain MRI
12 months
MRI lesionsRelapses
12 months
RelapsesEDSS
12 months
Disability progressionMSFC
baseline and 12 months
Disability progressionpatient perspective measured with the SF-36
baseline and 12 months
Quality of life (reported by participants)patient perspective measured with the MSIS-29
baseline and 12 months
Quality of life (reported by participants)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.
Disability progressionRelapsesMRI lesionsQuality of life (reported by participants)
Who could take part
Relapsing MS · 18 and over
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Nov 2016
Main results due
Jun 2019
Finished
Jul 2019
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