Personalized Extended Interval Dosing of Natalizumab in Relapsing Remitting Multiple Sclerosis

  • STATUS
    Recruiting
  • End date
    Jan 2, 2024
  • participants needed
    300
  • sponsor
    VU University Medical Center
Updated on 24 January 2021
natalizumab
disease or disorder
relapsing multiple sclerosis
progressive multifocal leukoencephalopathy

Summary

Rationale: Natalizumab is an effective drug in the treatment for relapsing remitting multiple sclerosis (RRMS) and is approved in the treatment regimen of 4-weekly 300mg natalizumab infusions. Natalizumab trough concentrations after a 4-weekly interval are high in the large majority of patients which implies a relative overdose in most patients. The investigators have demonstrated that efficacy of natalizumab is maintained when the infusion interval is extended based on natalizumab trough concentrations (personalized extended interval dosing). This leads to fewer hospital visits, a decrease of healthcare costs and decrease of risk of complications of natalizumab treatment.

Objective: The objective is to test feasibility and validate safety of personalized extended interval dosing of natalizumab in a large real-life cohort across the Netherlands.

Study design: Prospective national phase IV natalizumab cohort study.

Study population: All patients, aged 18 years or older, who are currently treated with natalizumab in the Netherlands for RRMS, with a minimum of 6 consecutive infusions.

Intervention: Patients will receive a personalized extended interval dosing (4-8 weeks) based on two natalizumab trough concentrations in the standard 4 week interval.

Main study parameters/endpoints: The main study endpoint is the safety (defined by radiological disease activity) of personalized natalizumab dosing in a large real-life cohort across the Netherlands. Data will be collected regarding disease activity and disability progression. A cost analysis will be performed to show the extent of cost reduction. Patients will be annually followed to assess the influence of personalized dosing on John Cunningham virus (JCV) conversion, JCV index, incidence of progressive multifocal leukoencephalopathy and treatment satisfaction and quality of life. The influence of personalized dosing on pharmacokinetics will be monitored. Furthermore, personalized extended interval dosing will be studied in a subgroup with the aim to explore lower than previously studied trough values of natalizumab.

Details
Condition Multiple Sclerosis, relapsing-remitting multiple sclerosis, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave
Treatment Personalized extended interval dosing of natalizumab, Standard interval dosing
Clinical Study IdentifierNCT04225312
SponsorVU University Medical Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Radiologically Isolated Syndrome or Multiple Sclerosis or Dermatite Atopique modérée ou grave or relapsing-remitting multiple sclerosis?
Do you have any of these conditions: Dermatite Atopique modérée ou grave or relapsing-remitting multiple sclerosis or Multiple Sclerosis or Radiologically Isolated Syndrome?
Diagnosis of relapsing remitting multiple sclerosis according to the 2017 criteria21
or more consecutive natalizumab infusions
years or older
Agreed to participate (written informed consent)
Disease stability (radiological and clinical) 12 months (only in low personalized extended interval dosing group)

Exclusion Criteria

High titer natalizumab (>100 arbitrary units (AU)/ml) antibodies
Contraindication for frequent magnetic resonance imaging (MRI) (ie, pacemaker or other contraindicated implanted metal devices, or have claustrophobia that cannot be medically managed)
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