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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04580381
Other study ID # FRA-TYS-19-11504
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date October 30, 2021

Study information

Verified date September 2020
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date October 30, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Natalizumab Injection [Tysabri]
Natalizumab infusion interval according to local practice defining the patient's group

Locations

Country Name City State
France Department of Neurology, CHU Bobigny-Avicenne Bobigny
France Department of Neurology, CHU de Caen Caen
France Department of Neurology, Percy Military Hospital Clamart
France Department of Neurology, CHU Nice Nice
France Department of Neurology, CHU Toulouse Purpan Toulouse

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Caen Biogen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety outcome Description of PML cases and variations in anti-JCV antibody status when available baseline to 12 month follow-up
Primary Annualized Relapse Ratio relapse rate per patient per year baseline to 12 month follow-up
Secondary Disability progression Increase in EDSS score during the follow-up period baseline to 12 month follow-up
Secondary NEDA-3 achievement Estimation of the proportion of patients achieving NEDA-3 criteria at the end of the follow-up period baseline to 12 month follow-up
Secondary Radiological activity Detection of increase MRI activity defined as new or enlarged T2 lesions and/or new gadolinium enhancing lesions baseline to 12 month follow-up
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