Multiple Sclerosis (MS)Tys at HomeNCT04777539
Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis
An observational study of Multiple Sclerosis (MS), run by Nantes University Hospital at 21 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- At-home natalizumab treated MS patient
- How many people
- 283 participants
- Where
- 21 sitesFrance
- Study dates
- 14 Jun 2021to 14 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with relapsing-remitting MS and treated with natalizumab at hospital will be assessed for eligibility.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
CH Ajaccio
Ajaccio
Bordeaux University Hospital
Bordeaux, Gironde, 33000
Brest University Hospital
Brest, Finistère, 29200
Les Hôpitaux de Chartres
Chartres
Percy Army Training Hospital
Clamart, Hauts-de-Seine, 92140
CHU Grenoble Alpes
La Tronche, 38700
Libourne Hospital
Libourne, Gironde, 33500
Lille University Hospital
Lille, Nord, 59000
Hôpital St Vincent de Paul
Lille, 59020
Marseille University Hospital
Marseille, Bouches-du-Rhône, 13000
Nantes University Hospital
Nantes, Loire-Atlantique, 44000
Orléans Hospital
Orléans, Loiret, 45000
Adolphe de Rothschild Ophthalmological Foundation
Paris, Paris, 75000
AP-HP La Pitié-Salpêtrière Hospital
Paris, Paris, 75000
Poitiers University Hospital
Poitiers, Vienne, 86000
Rennes University Hospital
Rennes, Ille-et-Vilaine, 35000
Rouen University Hospital
Rouen, Seine-Maritime, 76000
Saint-Nazaire Hospital Center
Saint-Nazaire, 44606
Strasbourg University Hospital
Strasbourg, Bas-Rhin, 67000
Toulouse University Hospital
Toulouse, Haute-Garonne, 31000
Tours University Hospital
Tours, Indre-et-Loire, 37000
About this study
Official title: Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple Sclerosis
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.
Read the 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 ANSM has granted temporary home use of natalizumab within the framework of a "at-home hospitalization" (HAD) program. The study purpose is to assess at-home natalizumab administration regarding safety, disease activity, quality of life, patient's perception and costs by comparing outcomes before and after "At Home" natalizumab treatment strategy.
The study consists of two periods of observation: a retrospective one corresponding to the year prior the study entry and a prospective one corresponding to patient follow-up for one year from the date of the patient inclusion. The date of the inclusion corresponds to the natalizumab-infusion conducted at hospital just before infusions hospital at-home started. Retrospective data are collected from medical record and a minimal dataset is needed to enroll the patient regarding MRI activity and safety data (i.e., nature and number of SAE and selected AE of grade 2 the year prior study entry).
The prospective period consists of 10 at-home natalizumab infusions (months 1-5 and 7-11) and 3 at-hospital natalizumab infusions (inclusion, months 6 and 12) according to standard care. In addition to clinical, MRI and safety (SAE and selected AE of grade 2) data collected as part of standard medical care from medical record over all the study period, Quality of life (EQ-5D-5L, MusiQol) and patient's preference (Musicare) questionnaires will be administered at inclusion and months 6 and 12 and clinical global impression of change will be recorded at month 6 and 12. Patients will be asked to notify any adverse events that may occur between each at-home infusion and to record each month his/her healthcare resource consumption in a diary. Patients will be contacted each month after at-home infusion to record safety and healthcare resource consumption data.
For a sub-group of 15 patients qualitative interview will be performed between month 3 and 8 as part of patient preference assessment.
Micro-costing dedicated forms and experts' statements will be used to assess resource utilization associated to natalizumab infusion during each period for medico-analyze purpose.
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- At-home natalizumab treated MS patient
- Keywords
- At-home hospitalization (HAD), Natalizumab, Safety, Medico-economic data, Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At-home natalizumab treated MS patientOther
MS patient who are treated with natalizumab in at-home hospitalization" (HAD) setting / according at-home hospitalization program
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year after enrollment
Secondary outcomes (9)
Annualized Relapse Rate
Annualized Relapse Rate
Measured: 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
Modification is based on percentage of patient with at least one new T2 lesion
Measured: 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
Modification is based percentage of patient with at least one Gd-enhancing lesion
Measured: Baseline and 12 month before and 12 month after enrollment
Multiple Sclerosis International quality of Life (MusiQoL)
MusiQoL is a self-administered disease-specific quality of life instrument that comprises 31 items encompassing 9 dimensions: activities of daily living (8), psychological well-being (4), symptoms (3), relationships with friend (4), relationships with family (3), relationship with healthcare system (3), sentimental and sexual life (2), coping (2) and rejection (2). Each item is answered using a 6-point Likert scale (Never/Not at all, Rarely/A little, Sometimes/Somewhat, Often/A lot, Always/Very much and Not applicable)
Measured: Baseline and months 6 and 12
EuroQol-5Dimension 5Level (EQ-5D-5L)
The EQ-5D-5L is a self-administered instrument consisting in 2 components that describe patient's health state:
A five dimensional questionnaire describing health in terms of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patient is asked to indicate for each one the level of functioning: no problems, slight problems, moderate problems, severe problems and extreme problems.
A visual analogue scale (VAS) that measures health state (from 0 to 100).
Measured: Baseline and months 6 and 12
Musicare
Musicare is a self-administered disease-specific instrument investigating experience of the quality of care for MS. It comprises 35 items encompassing 5 domains: Information about the disease (11), Information about the treatments/medical investigation (8), Relationships with health care teams (8) Health care access (5) Reception in care structures (3).
Measured: Baseline and months 6 and 12
Patient experience
Semi-structured interview based on " patient tracer " model will be conducted in a sub-group of 15 patients.
Measured: One point per patient between months 3 and 8
Clinical Global impressions of improvement (CGI-I)
The CGI is a generic 3-component scale used over the years in a broad range of diseases. The CGI-I (Improvement) is one of the components (one item) measuring change in health state since the entry in the study and can be rated independently.
CGI-I is rated on a 7-point scale: from 1 (very much improved) to 7 (very much worse).
Measured: Months 6 and 12
The average cost per patient
Compare the cost of the "At home" and "Hospital" management strategies in a before-after design from collective perspective
Measured: During study, it will be evaluated the average cost per patient for one year of treatment (comparison HDJ vs HAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start14 Jun 2021
- Primary completion14 Nov 2024
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rennes University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777539
- Sponsor's protocol ID
- RC20_0442
- Acronym
- Tys at Home
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2021
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04777539
- Acronym / sponsor ID
- Tys at Home / RC20_0442
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- At-home hospitalization (HAD), Natalizumab, Safety, Medico-economic data, Multiple sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Rennes University Hospital
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 ANSM has granted temporary home use of natalizumab within the framework of a "at-home hospitalization" (HAD) program. The study purpose is to assess at-home natalizumab administration regarding safety, disease activity, quality of life, patient's perception and costs by comparing outcomes before and after "At Home" natalizumab treatment strategy.
The study consists of two periods of observation: a retrospective one corresponding to the year prior the study entry and a prospective one corresponding to patient follow-up for one year from the date of the patient inclusion. The date of the inclusion corresponds to the natalizumab-infusion conducted at hospital just before infusions hospital at-home started. Retrospective data are collected from medical record and a minimal dataset is needed to enroll the patient regarding MRI activity and safety data (i.e., nature and number of SAE and selected AE of grade 2 the year prior study entry).
The prospective period consists of 10 at-home natalizumab infusions (months 1-5 and 7-11) and 3 at-hospital natalizumab infusions (inclusion, months 6 and 12) according to standard care. In addition to clinical, MRI and safety (SAE and selected AE of grade 2) data collected as part of standard medical care from medical record over all the study period, Quality of life (EQ-5D-5L, MusiQol) and patient's preference (Musicare) questionnaires will be administered at inclusion and months 6 and 12 and clinical global impression of change will be recorded at month 6 and 12. Patients will be asked to notify any adverse events that may occur between each at-home infusion and to record each month his/her healthcare resource consumption in a diary. Patients will be contacted each month after at-home infusion to record safety and healthcare resource consumption data.
For a sub-group of 15 patients qualitative interview will be performed between month 3 and 8 as part of patient preference assessment.
Micro-costing dedicated forms and experts' statements will be used to assess resource utilization associated to natalizumab infusion during each period for medico-analyze purpose.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with relapsing-remitting MS and treated with natalizumab at hospital will be assessed for eligibility.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At-home natalizumab treated MS patientMS patient who are treated with natalizumab in at-home hospitalization" (HAD) setting / according at-home hospitalization program | Other | – |
Primary outcome
Number of serious Adverse events (SAE) and selected adverse events (AEs) of grade 2
Time frame: One year after enrollment
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.
9 secondary outcomes
Annualized Relapse Rate
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 month before and 12 month after enrollment
Multiple Sclerosis International quality of Life (MusiQoL)
Time frame: Baseline and months 6 and 12
EuroQol-5Dimension 5Level (EQ-5D-5L)
Time frame: Baseline and months 6 and 12
Musicare
Time frame: Baseline and months 6 and 12
Patient experience
Time frame: One point per patient between months 3 and 8
Clinical Global impressions of improvement (CGI-I)
Time frame: Months 6 and 12
The average cost per patient
Time frame: During study, it will be evaluated the average cost per patient for one year of treatment (comparison HDJ vs HAD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis (MS), run by Nantes University Hospital at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of serious Adverse events (SAE) and selected adverse events (AEs) of grade 2 (time frame: One year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.