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Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis
Sponsor: Nantes University Hospital
Summary
At-home use of Natalizumab in multiple sclerosis (MS) patients has been temporarily granted by French security agency of medicines and Health products (ANSM). The main objective of the study is to compare the safety of natalizumab administration at home vs at hospital based on retrospective and prospective data collection. Quality of life, patient perception of at-home natalizumab administration are also evaluated as secondary objectives as well as medico-economic assessment of the method. Data will be collected for a 12-month retrospective period and a 12-month prospective period.
Official title: Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
295
Start Date
2021-06-14
Completion Date
2025-05-14
Last Updated
2026-04-30
Healthy Volunteers
No
Conditions
Interventions
At-home natalizumab treated MS patient
MS patient who are treated with natalizumab in at-home hospitalization" (HAD) setting / according at-home hospitalization program
Locations (21)
Strasbourg University Hospital
Strasbourg, Bas-Rhin, France
Marseille University Hospital
Marseille, Bouches-du-Rhône, France
Brest University Hospital
Brest, Finistère, France
Bordeaux University Hospital
Bordeaux, Gironde, France
Libourne Hospital
Libourne, Gironde, France
Toulouse University Hospital
Toulouse, Haute-Garonne, France
Percy Army Training Hospital
Clamart, Hauts-de-Seine, France
Rennes University Hospital
Rennes, Ille-et-Vilaine, France
Tours University Hospital
Tours, Indre-et-Loire, France
Nantes University Hospital
Nantes, Loire-Atlantique, France
Orléans Hospital
Orléans, Loiret, France
Lille University Hospital
Lille, Nord, France
Adolphe de Rothschild Ophthalmological Foundation
Paris, Paris, France
AP-HP La Pitié-Salpêtrière Hospital
Paris, Paris, France
Rouen University Hospital
Rouen, Seine-Maritime, France
Poitiers University Hospital
Poitiers, Vienne, France
CH Ajaccio
Ajaccio, France
Les Hôpitaux de Chartres
Chartres, France
CHU Grenoble Alpes
La Tronche, France
Hôpital St Vincent de Paul
Lille, France
Saint-Nazaire Hospital Center
Saint-Nazaire, France