Status:
ACTIVE_NOT_RECRUITING
Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Rennes University Hospital
Conditions:
Multiple Sclerosis (MS)
Eligibility:
All Genders
18+ years
Brief 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 com...
Detailed Description
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 A...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- 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.
- Exclusion Criteria :
- 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;
- 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.
- Patient under guardianship or under security measure
Exclusion
Key Trial Info
Start Date :
June 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 15 2025
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT04777539
Start Date
June 14 2021
End Date
May 15 2025
Last Update
March 19 2024
Active Locations (24)
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1
Strasbourg University Hospital
Strasbourg, Bas-Rhin, France, 67000
2
Marseille University Hospital
Marseille, Bouches-du-Rhône, France, 13000
3
Brest University Hospital
Brest, Finistère, France, 29200
4
Quimper Hospital
Quimper, Finistère, France, 29000