Multiple Sclerosis
Conditions
Keywords
natalizumab
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.
Detailed description
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.
Interventions
DRUGNatalizumab
Extending dose intervals of natalizumab from 4 weeks to maximum of 8 weeks based on trough natalizumab concentrations
Sponsors
Prothya Biosolutions
Erasmus Medical Center
St. Antonius Hospital
OLVG
Rijnstate Hospital
Amsterdam UMC, location VUmc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gadolinium enhancing T1 lesions on brain MRI | 12 months | Occurrence and number of gadolinium enhancing T1 lesions of brain MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapses | 12 months | scoring MS exacerbations |
| EDSS | 12 months | Expanded Disability Status Scale: clinical scoring of disability in MS patients |
| New T2 lesions on brain MRI | 12 months | Occurrence and number of new T2 lesions on brain MRI |
| patient perspective measured with the SF-36 | baseline and 12 months | questionnaire: Short Form-36 |
| patient perspective measured with the MSIS-29 | baseline and 12 months | questionnaire: Multiple Sclerosis Impact Scale-29 |
| MSFC | baseline and 12 months | Multiple Status Functional Composite: clinical scoring of disability in MS patients |
Countries
Netherlands
Outcome results
None listed