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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— RELEVANT  

Official title:

Real World Effectiveness of Natalizumab Extended Interval Dosing in Relapsing-Remitting Multiple Sclerosis in a French Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580381
• Other study ID #: FRA-TYS-19-11504
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

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