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NCT04777539

Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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

Interventions

OTHER

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