Multiple Sclerosis (MS) Clinical Trial
— Tys at HomeOfficial title:
Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple Sclerosis
Verified date | March 2024 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 279 |
Est. completion date | May 15, 2025 |
Est. primary completion date | November 15, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CH Ajaccio | Ajaccio | |
France | Bordeaux University Hospital | Bordeaux | Gironde |
France | Brest University Hospital | Brest | Finistère |
France | Les Hôpitaux de Chartres | Chartres | |
France | Percy Army Training Hospital | Clamart | Hauts-de-Seine |
France | Dax Hospital | Dax | Landes |
France | CHU Grenoble Alpes | La Tronche | |
France | Libourne Hospital | Libourne | Gironde |
France | Hôpital St Vincent de Paul | Lille | |
France | Lille University Hospital | Lille | Nord |
France | Limoges University Hospital | Limoges | Haute-Vienne |
France | Marseille University Hospital | Marseille | Bouches-du-Rhône |
France | Montpellier University Hospital | Montpellier | Hérault |
France | Nantes University Hospital | Nantes | Loire-Atlantique |
France | Orléans Hospital | Orléans | Loiret |
France | Adolphe de Rothschild Ophthalmological Foundation | Paris | |
France | AP-HP La Pitié-Salpêtrière Hospital | Paris | |
France | Poitiers University Hospital | Poitiers | Vienne |
France | Quimper Hospital | Quimper | Finistère |
France | Rennes University Hospital | Rennes | Ille-et-Vilaine |
France | Rouen University Hospital | Rouen | Seine-Maritime |
France | Strasbourg University Hospital | Strasbourg | Bas-Rhin |
France | Toulouse University Hospital | Toulouse | Haute-Garonne |
France | Tours University Hospital | Tours | Indre-et-Loire |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital | Rennes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Annualized Relapse Rate | Annualized Relapse Rate | Two time points per patient one year prior to and one year after enrollment | |
Secondary | 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 | 12-month (+/-6 month) prior enrollment, Baseline (enrollment+/-3 months), 12 months after enrollment | |
Secondary | Change from baseline in gadolinium positive lesion as assessed by MRI | Modification is based percentage of patient with at least one Gd-enhancing lesion | Baseline and 12 month before and 12 month after enrollment | |
Secondary | 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) | Baseline and months 6 and 12 | |
Secondary | 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). |
Baseline and months 6 and 12 | |
Secondary | 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). | Baseline and months 6 and 12 | |
Secondary | Patient experience | Semi-structured interview based on " patient tracer " model will be conducted in a sub-group of 15 patients. | One point per patient between months 3 and 8 | |
Secondary | 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). |
Months 6 and 12 | |
Secondary | The average cost per patient | Compare the cost of the "At home" and "Hospital" management strategies in a before-after design from collective perspective | During study, it will be evaluated the average cost per patient for one year of treatment (comparison HDJ vs HAD) |
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