A Phase 4 interventional study of Natalizumab in Multiple Sclerosis, sponsored by Amsterdam UMC, location VUmc. Completed at 5 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-12.
Sponsored by Amsterdam UMC, location VUmc · Phase 4, Interventional, and Treatment
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 61 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Natalizumab
Extending dose intervals of natalizumab from 4 weeks to maximum of 8 weeks based on trough natalizumab concentrations
Gadolinium enhancing T1 lesions on brain MRI
Occurrence and number of gadolinium enhancing T1 lesions of brain MRI
Time frame: 12 months
New T2 lesions on brain MRI
Occurrence and number of new T2 lesions on brain MRI
Time frame: 12 months
Relapses
scoring MS exacerbations
Time frame: 12 months
EDSS
Expanded Disability Status Scale: clinical scoring of disability in MS patients
Time frame: 12 months
MSFC
Multiple Status Functional Composite: clinical scoring of disability in MS patients
Time frame: baseline and 12 months
patient perspective measured with the SF-36
questionnaire: Short Form-36
Time frame: baseline and 12 months
patient perspective measured with the MSIS-29
questionnaire: Multiple Sclerosis Impact Scale-29
Time frame: baseline and 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Amsterdam UMC, location VUmc