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MS patients can safely get infusions at home, new study shows

NCT ID NCT04777539

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study looked at whether it is safe for people with multiple sclerosis to receive their natalizumab (Tysabri) infusions at home instead of at a hospital. Researchers compared serious side effects, quality of life, and costs over one year in 295 patients. The goal was to see if home treatment is a good option for managing MS.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

283 people

The number who actually took part.

Started

Jun 2021

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria : 1. Male or female over 18 years old; 2. Patients with Relapsing-remitting MS followed in the neurology service 3. Treated for more than 24 months with natalizumab; 4. Anti-JCV negative status at inclusion; 5. 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. 6. 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) 7. Had a cerebral MRI within the previous 12 months (+/- 6 months) which results are available in the medical record. Exclusion Criteria : 1. Patient having expressed their opposition to the use of their data; 2. Women who are pregnant or breastfeeding or intending to become pregnant during the study; 3. 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. 4. Patient under guardianship or under security measure

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis (MS)

Contacts and locations

Locations

  • AP-HP La Pitié-Salpêtrière Hospital

    Paris, Paris, 75000, France

  • Adolphe de Rothschild Ophthalmological Foundation

    Paris, Paris, 75000, France

  • Bordeaux University Hospital

    Bordeaux, Gironde, 33000, France

  • Brest University Hospital

    Brest, Finistère, 29200, France

  • CH Ajaccio

    Ajaccio, France

  • CHU Grenoble Alpes

    La Tronche, 38700, France

  • Hôpital St Vincent de Paul

    Lille, 59020, France

  • Les Hôpitaux de Chartres

    Chartres, France

  • Libourne Hospital

    Libourne, Gironde, 33500, France

  • Lille University Hospital

    Lille, Nord, 59000, France

  • Marseille University Hospital

    Marseille, Bouches-du-Rhône, 13000, France

  • Nantes University Hospital

    Nantes, Loire-Atlantique, 44000, France

  • Orléans Hospital

    Orléans, Loiret, 45000, France

  • Percy Army Training Hospital

    Clamart, Hauts-de-Seine, 92140, France

  • Poitiers University Hospital

    Poitiers, Vienne, 86000, France

  • Rennes University Hospital

    Rennes, Ille-et-Vilaine, 35000, France

  • Rouen University Hospital

    Rouen, Seine-Maritime, 76000, France

  • Saint-Nazaire Hospital Center

    Saint-Nazaire, 44606, France

  • Strasbourg University Hospital

    Strasbourg, Bas-Rhin, 67000, France

  • Toulouse University Hospital

    Toulouse, Haute-Garonne, 31000, France

  • Tours University Hospital

    Tours, Indre-et-Loire, 37000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.