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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03516526 |
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Date of registration:
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12/04/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Towards Personalized Dosing of Natalizumab in Multiple Sclerosis
PDNMS |
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Scientific title:
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Towards Personalized Dosing of Natalizumab in Multiple Sclerosis |
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Date of first enrolment:
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November 3, 2016 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03516526 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Joep Killestein, Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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VU University Medical Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Natalizumab
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Primary Outcome(s)
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Gadolinium enhancing T1 lesions on brain MRI
[Time Frame: 12 months]
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Secondary Outcome(s)
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Relapses
[Time Frame: 12 months]
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EDSS
[Time Frame: 12 months]
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patient perspective measured with the MSIS-29
[Time Frame: baseline and 12 months]
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MSFC
[Time Frame: baseline and 12 months]
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New T2 lesions on brain MRI
[Time Frame: 12 months]
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patient perspective measured with the SF-36
[Time Frame: baseline and 12 months]
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Secondary ID(s)
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NL56584.029.16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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