Clinical trial NCT04580381: Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort
Official title: Real World Effectiveness of Natalizumab Extended Interval Dosing in Relapsing-Remitting Multiple Sclerosis in a French Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Natalizumab
Extended Interval Dosing
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2020-10-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving Natalizumab as disease-modifying monotherapy for RRMS

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Annualized Relapse Ratio
timeFrame: baseline to 12 month follow-up
Secondary outcomes:
measure: Disability progression
timeFrame: baseline to 12 month follow-up
measure: NEDA-3 achievement
timeFrame: baseline to 12 month follow-up
measure: Radiological activity
timeFrame: baseline to 12 month follow-up
Other outcomes:
measure: Safety outcome
timeFrame: baseline to 12 month follow-up
Locations:
city: Bobigny
country: France
facility: Department of Neurology, CHU Bobigny-Avicenne
city: Caen
country: France
facility: Department of Neurology, CHU de Caen
city: Clamart
country: France
facility: Department of Neurology, Percy Military Hospital
city: Nice
country: France
facility: Department of Neurology, CHU Nice
city: Toulouse
country: France
facility: Department of Neurology, CHU Toulouse Purpan
Study officials:
References: