Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-10-30

Brief Summary

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Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Thus, several studies have tried to assess how to minimize this risk.

One suggested approach is to move from the standard interval dose (SID) of 4 weeks to an extended interval dose (EID) of 5 weeks or longer. Extending the dosing interval of NTZ has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (PML) while maintaining efficacy. We propose to retrospectively analyze data from clinical records coming from RRMS patients treated in France at 5 different centers; Caen, Nice, Bobigny and Toulouse hospitals as well as Percy Military Hospital, to evaluate the effectiveness of natalizumab EID in subjects who have previously been treated with natalizumab SID for 12 months, in relation to continued SID treatment. In the clinical practice of these centers, patients are shifted after minimum 12 months under SID to an EID of 6 weeks regardless antibody JC serum status. Clinical, magnetic resonance imaging (MRI) and serum anti-JCV antibody status data are collected when available.

The objective of this study is to assess the efficacy in term of ARR and safety.

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Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Standard Interval Dosing (SID)

Patients continuing Natalizumab treatment with standard interval dosing defined as \> 11 infusions per year

Natalizumab Injection [Tysabri]

Intervention Type DRUG

Natalizumab infusion interval according to local practice defining the patient's group

Extended Interval Dosing (EID)

Patients switching to extended interval dosing defined as ≤ 10 infusions per year

Natalizumab Injection [Tysabri]

Intervention Type DRUG

Natalizumab infusion interval according to local practice defining the patient's group

Interventions

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Natalizumab Injection [Tysabri]

Natalizumab infusion interval according to local practice defining the patient's group

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients receiving at least 11 infusions of natalizumab as disease-modifying monotherapy for RRMS that is consistent with the approved dosing

Exclusion Criteria

* Patients for whom the NTZ infusion history and/or MRI and clinical history is not available.
* Patients with dosing gap defined as \>=12 weeks between any two doses.
* Patients with over dose defined as \<3 weeks between any two doses.
* Pregnancy during the follow-up period

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No