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

NCT04777539

CompletedN/A

Sponsor: Nantes University Hospital

Conditions: Multiple Sclerosis (MS)

Interventions: At-home natalizumab treated MS patient

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (21)
  • Strasbourg, Bas-Rhin, France
  • Marseille, Bouches-du-Rhône, France
  • Brest, Finistère, France
  • Bordeaux, Gironde, France
  • Libourne, Gironde, France
  • Toulouse, Haute-Garonne, France
  • Clamart, Hauts-de-Seine, France
  • Rennes, Ille-et-Vilaine, France
  • Tours, Indre-et-Loire, France
  • Nantes, Loire-Atlantique, France
  • Orléans, Loiret, France
  • Lille, Nord, France
  • Paris, Paris, France
  • Paris, Paris, France
  • Rouen, Seine-Maritime, France
  • Poitiers, Vienne, France
  • Ajaccio, France
  • Chartres, France
  • La Tronche, France
  • Lille, France
  • Saint-Nazaire, France