Towards Personalized Dosing of Natalizumab in Multiple Sclerosis
PDNMS
1 other identifier
interventional
61
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 multiple-sclerosis
Started Nov 2016
Typical duration for phase_4 multiple-sclerosis
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2016
CompletedFirst Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
May 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJuly 12, 2019
July 1, 2019
2.6 years
April 12, 2018
July 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gadolinium enhancing T1 lesions on brain MRI
Occurrence and number of gadolinium enhancing T1 lesions of brain MRI
12 months
Secondary Outcomes (6)
New T2 lesions on brain MRI
12 months
Relapses
12 months
EDSS
12 months
MSFC
baseline and 12 months
patient perspective measured with the SF-36
baseline and 12 months
- +1 more secondary outcomes
Study Arms (1)
All patients in this study
OTHERPatients 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.
Interventions
Extending dose intervals of natalizumab from 4 weeks to maximum of 8 weeks based on trough natalizumab concentrations
Eligibility Criteria
You may qualify if:
- Relapsing-remitting multiple sclerosis (RRMS) according to the McDonald criteria, revised by Polman 2010
- An expanded disability status scale (EDSS) score of 0.0-6.0 at baseline.
- Natalizumab level of ≥15 μg/ml
- Written informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amsterdam UMC, location VUmclead
- Prothya Biosolutionscollaborator
- Erasmus Medical Centercollaborator
- St. Antonius Hospitalcollaborator
- OLVGcollaborator
- Rijnstate Hospitalcollaborator
Study Sites (5)
OLVG
Amsterdam, Netherlands
VU medical center
Amsterdam, Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Erasmus medical center
Rotterdam, Netherlands
St. Antonius Hospital
Utrecht, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joep Killestein, Dr.
Amsterdam UMC, location VUmc
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Coordinating investigator
Study Record Dates
First Submitted
April 12, 2018
First Posted
May 4, 2018
Study Start
November 3, 2016
Primary Completion
June 21, 2019
Study Completion
July 1, 2019
Last Updated
July 12, 2019
Record last verified: 2019-07