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

NCT04777539 | Completed

• 1 other identifier: RC20_0442
• Study Type: observational
• Target: 295
• Locations: 1 country
• Sites: 21

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 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)

Keywords

At-home hospitalization (HAD); Natalizumab; Safety; Medico-economic data; Multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• Number of serious Adverse events (SAE) and selected adverse events (AEs) of grade 2

  Grades are based on CTCAE V5. Selected AEs of grade 2: myocarditis, pericarditis, diarrhea, enterocolitis, esophagitis, mucositis, fever/hypothermia folicullitis, papular and/or pustular rash, herpes zoster.

  One year after enrollment

Secondary Outcomes (9)

• Annualized Relapse Rate

  Two time points per patient one year prior to and one year after enrollment

• Change from baseline in T2 lesion load as assessed by MRI

  12-month (+/-6 month) prior enrollment, Baseline (enrollment+/-3 months), 12 months after enrollment

• Change from baseline in gadolinium positive lesion as assessed by MRI

  Baseline and 12 month before and 12 month after enrollment

• Multiple Sclerosis International quality of Life (MusiQoL)

  Baseline and months 6 and 12

• EuroQol-5Dimension 5Level (EQ-5D-5L)

  Baseline and months 6 and 12

Interventions

At-home natalizumab treated MS patient OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with relapsing-remitting MS and treated with natalizumab at hospital will be assessed for eligibility.

You may qualify if:

• 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;
• 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 a cerebral MRI within the previous 12 months (+/- 6 months) which results are available in the medical record.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: collaborator
• Nantes University Hospital: lead

Study Sites (21)

Strasbourg University Hospital

Strasbourg, Bas-Rhin, 67000, France

Location

Marseille University Hospital

Marseille, Bouches-du-Rhône, 13000, France

Location

Brest University Hospital

Brest, Finistère, 29200, France

Location

Bordeaux University Hospital

Bordeaux, Gironde, 33000, France

Location

Libourne Hospital

Libourne, Gironde, 33500, France

Location

Toulouse University Hospital

Toulouse, Haute-Garonne, 31000, France

Location

Percy Army Training Hospital

Clamart, Hauts-de-Seine, 92140, France

Location

Rennes University Hospital

Rennes, Ille-et-Vilaine, 35000, France

Location

Tours University Hospital

Tours, Indre-et-Loire, 37000, France

Location

Nantes University Hospital

Nantes, Loire-Atlantique, 44000, France

Location

Orléans Hospital

Orléans, Loiret, 45000, France

Location

Lille University Hospital

Lille, Nord, 59000, France

Location

Adolphe de Rothschild Ophthalmological Foundation

Paris, Paris, 75000, France

Location

AP-HP La Pitié-Salpêtrière Hospital

Paris, Paris, 75000, France

Location

Rouen University Hospital

Rouen, Seine-Maritime, 76000, France

Location

Poitiers University Hospital

Poitiers, Vienne, 86000, France

Location

CH Ajaccio

Ajaccio, France

Location

Les Hôpitaux de Chartres

Chartres, France

Location

CHU Grenoble Alpes

La Tronche, 38700, France

Location

Hôpital St Vincent de Paul

Lille, 59020, France

Location

Saint-Nazaire Hospital Center

Saint-Nazaire, 44606, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 2, 2021
• Study Start: June 14, 2021
• Primary Completion: November 14, 2024
• Study Completion: May 14, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (21)