Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT04777539 En recrutement IDF

Titre

Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple Sclerosis (Tys at Home)

Type

Observational

Pathologie

Sclérose en plaques
Sclérose

Phase

Promoteur

Nantes University Hospital (Voir sur ClinicalTrials)

Date de début

juin 2021

Date de fin

mai 2025

Dernière mise à jour

24 mai 2025

Résumé

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.

Détail

Voir le détail As part of the Covid-19 pandemic, some neurologists have alerted the French authorities (ANSM: National Medicines Safety Agency) to the interruption of natalizumab treatment by some MS patients. The ANSM has granted temporary home use of natalizumab within the framework of a "at-home hospitalization" (HAD) program. The study purpose is to assess at-home natalizumab administration regarding safety, disease activity, quality of life, patient's perception and costs by comparing outcomes before and after "At Home" natalizumab treatment strategy. The study consists of two periods of observation: a retrospective one corresponding to the year prior the study entry and a prospective one corresponding to patient follow-up for one year from the date of the patient inclusion. The date of the inclusion corresponds to the natalizumab-infusion conducted at hospital just before infusions hospital at-home started. Retrospective data are collected from medical record and a minimal dataset is needed to enroll the patient regarding MRI activity and safety data (i.e., nature and number of SAE and selected AE of grade 2 the year prior study entry). The prospective period consists of 10 at-home natalizumab infusions (months 1-5 and 7-11) and 3 at-hospital natalizumab infusions (inclusion, months 6 and 12) according to standard care. In addition to clinical, MRI and safety (SAE and selected AE of grade 2) data collected as part of standard medical care from medical record over all the study period, Quality of life (EQ-5D-5L, MusiQol) and patient's preference (Musicare) questionnaires will be administered at inclusion and months 6 and 12 and clinical global impression of change will be recorded at month 6 and 12. Patients will be asked to notify any adverse events that may occur between each at-home infusion and to record each month his/her healthcare resource consumption in a diary. Patients will be contacted each month after at-home infusion to record safety and healthcare resource consumption data. For a sub-group of 15 patients qualitative interview will be performed between month 3 and 8 as part of patient preference assessment. Micro-costing dedicated forms and experts' statements will be used to assess resource utilization associated to natalizumab infusion during each period for medico-analyze purpose. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FONDATION A. DE ROTHSCHILD	Caroline BENSA	En recrutement IDF	21/06/2024 13:34:12	Contacter
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Adolphe de Rothschild Ophthalmological Foundation - 75000 - Paris - France				Contact (sur clinicalTrials)
AP-HP La Pitié-Salpêtrière Hospital - 75000 - Paris - France				Contact (sur clinicalTrials)
Bordeaux University Hospital - 33000 - Bordeaux - Gironde - France				Contact (sur clinicalTrials)
Brest University Hospital - 29200 - Brest - Finistère - France				Contact (sur clinicalTrials)
CH Ajaccio - Ajaccio - France				Contact (sur clinicalTrials)
CHU Grenoble Alpes - 38700 - La Tronche - France				Contact (sur clinicalTrials)
Dax Hospital - 40100 - Dax - Landes - France				Contact (sur clinicalTrials)
Hôpital St Vincent de Paul - 59020 - Lille - France				Contact (sur clinicalTrials)
Les Hôpitaux de Chartres - Chartres - France				Contact (sur clinicalTrials)
Libourne Hospital - 33500 - Libourne - Gironde - France				Contact (sur clinicalTrials)
Lille University Hospital - 59000 - Lille - Nord - France				Contact (sur clinicalTrials)
Limoges University Hospital - 87000 - Limoges - Haute-Vienne - France				Contact (sur clinicalTrials)
Marseille University Hospital - 13000 - Marseille - Bouches-du-Rhône - France				Contact (sur clinicalTrials)
Montpellier University Hospital - 34000 - Montpellier - Hérault - France				Contact (sur clinicalTrials)
Nantes University Hospital - 44000 - Nantes - Loire-Atlantique - France				Contact (sur clinicalTrials)
Orléans Hospital - 45000 - Orléans - Loiret - France				Contact (sur clinicalTrials)
Percy Army Training Hospital - 92140 - Clamart - Hauts-de-Seine - France				Contact (sur clinicalTrials)
Poitiers University Hospital - 86000 - Poitiers - Vienne - France				Contact (sur clinicalTrials)
Quimper Hospital - 29000 - Quimper - Finistère - France				Contact (sur clinicalTrials)
Rennes University Hospital - 35000 - Rennes - Ille-et-Vilaine - France				Contact (sur clinicalTrials)
Rouen University Hospital - 76000 - Rouen - Seine-Maritime - France				Contact (sur clinicalTrials)
Strasbourg University Hospital - 67000 - Strasbourg - Bas-Rhin - France				Contact (sur clinicalTrials)
Toulouse University Hospital - 31000 - Toulouse - Haute-Garonne - France				Contact (sur clinicalTrials)
Tours University Hospital - 37000 - Tours - Indre-et-Loire - France				Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria :

1. Male or female over 18 years old;

2. Patients with Relapsing-remitting MS followed in the neurology service

3. Treated for more than 24 months with natalizumab;

4. Anti-JCV negative status at inclusion;

5. Ability to understand the purpose of the study and provide opposition to use
protected health information in accordance with national and local subject privacy
regulations.

6. Had available medical records to meet study objectives (i.e., SAE and selected AE of
grade 2 from the past 12 infusions of natalizumab performed at the hospital before
inclusion)

7. Had a cerebral MRI within the previous 12 months (+/- 6 months) which results are
available in the medical record.

Exclusion Criteria :

1. Patient having expressed their opposition to the use of their data;

2. Women who are pregnant or breastfeeding or intending to become pregnant during the
study;

3. History of any clinically significant (as determined by the Investigator) cardiac,
endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes),
urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal,
or other major disease that would preclude participation in a clinical study, in the
opinion of the Investigator.

4. Patient under guardianship or under security measure

Critère de non inclusion

NCT04777539 - Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple Sclerosis (Tys at Home)

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