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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
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

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
CH Ajaccio
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AjaccioFranceUnknown status
Bordeaux University Hospital
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BordeauxFranceUnknown status
Brest University Hospital
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BrestFranceUnknown status
Les Hôpitaux de Chartres
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ChartresFranceUnknown status
Percy Army Training Hospital
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ClamartFranceUnknown status
Chu Grenoble Alpes
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La TroncheFranceUnknown status
Libourne Hospital
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LibourneFranceUnknown status
Lille University Hospital
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LilleFranceUnknown status
Hôpital St Vincent de Paul
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LilleFranceUnknown status
Marseille University Hospital
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MarseilleFranceUnknown status
Nantes University Hospital
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NantesFranceUnknown status
Orléans Hospital
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OrléansFranceUnknown status
AP-HP La Pitié-Salpêtrière Hospital
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ParisFranceUnknown status
Adolphe de Rothschild Ophthalmological Foundation
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ParisFranceUnknown status
Poitiers University Hospital
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PoitiersFranceUnknown status
Rennes University Hospital
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RennesFranceUnknown status
Rouen University Hospital
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RouenFranceUnknown status
Saint-Nazaire Hospital Center
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Saint-NazaireFranceUnknown status
Strasbourg University Hospital
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StrasbourgFranceUnknown status
Toulouse University Hospital
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ToulouseFranceUnknown status
Tours University Hospital
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ToursFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.