NCT04777539Completed
Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis
Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 283 (actual)
- First submitted
- 23 Feb 2021
- Start date
- 14 Jun 2021
- Primary completion date
- 14 Nov 2024
- Lead sponsor
- Nantes University Hospital
- Diseases
- Multiple sclerosis
- NCT number
- NCT04777539
What you commit to
- Study type: Observational
- Participants enrolled: 283
- From 14 Jun 2021 to the primary completion date, 14 Nov 2024
- 21 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Patient having expressed their opposition to the use of their data;
- Women who are pregnant or breastfeeding or intending to become pregnant during the study;
- Patient under guardianship or under security measure
Who the study is looking for
- Male or female over 18 years old;
- Patients with Relapsing-remitting MS followed in the neurology service
- Treated for more than 24 months with natalizumab;
- Anti-JCV negative status at inclusion;
- 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.
- 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)
- Had a cerebral MRI within the previous 12 months (+/- 6 months) which results are available in the medical record.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CH Ajaccio Coordinator of this site? Confirm its status | Ajaccio | France | Unknown status |
| Bordeaux University Hospital Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Brest University Hospital Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Les Hôpitaux de Chartres Coordinator of this site? Confirm its status | Chartres | France | Unknown status |
| Percy Army Training Hospital Coordinator of this site? Confirm its status | Clamart | France | Unknown status |
| Chu Grenoble Alpes Coordinator of this site? Confirm its status | La Tronche | France | Unknown status |
| Libourne Hospital Coordinator of this site? Confirm its status | Libourne | France | Unknown status |
| Lille University Hospital Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital St Vincent de Paul Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Marseille University Hospital Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Nantes University Hospital Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Orléans Hospital Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
| AP-HP La Pitié-Salpêtrière Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Adolphe de Rothschild Ophthalmological Foundation Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Poitiers University Hospital Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Rennes University Hospital Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Rouen University Hospital Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Saint-Nazaire Hospital Center Coordinator of this site? Confirm its status | Saint-Nazaire | France | Unknown status |
| Strasbourg University Hospital Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Toulouse University Hospital Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Tours University Hospital Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.