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

NCT04777539 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 295

Last updated 2026-04-30

No results posted yet for this study

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 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.

Conditions

  • Multiple Sclerosis (MS)

Interventions

OTHER

At-home natalizumab treated MS patient

MS patient who are treated with natalizumab in at-home hospitalization" (HAD) setting / according at-home hospitalization program

Sponsors & Collaborators

  • Rennes University Hospital

    collaborator OTHER

  • Nantes University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2024-11-14
Completion
2025-05-14

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04777539 on ClinicalTrials.gov