The Caen University Hospital starts clinical trial of drug Natalizumab
University Hospital in collaboration with biotechnology company Biogen is starting a clinical trial of real world effectiveness of Natalizumab extended interval dosing in a French Cohort (RELEVANT).
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. The researchers 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.
University Hospital has initiated clinical trials in France and plans to enroll 500 participants.
The study completion date is November 30, 2020.
Study population of this clinical trial are patients receiving Natalizumab as disease-modifying monotherapy for RRMS.
The studies will be conducted in the following French cities: Bobigny (Department of Neurology, CHU Bobigny-Avicenne), Caen (Department of Neurology, CHU de Caen), Clamart (Department of Neurology, Percy Military Hospital), Nice (Department of Neurology, CHU Nice) and Toulouse (Department of Neurology, CHU Toulouse Purpan).
For more details please follow the link.
