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O estudo clínico NCT04777539 (Tys at Home) para Esclerose Múltipla (EM) está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis (Tys at Home)

Ativo, não recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT04777539 (Tys at Home) é um ensaio observacional para Esclerose Múltipla (EM). Seu status atual é: ativo, não recrutando. O estudo começou em 14 de junho de 2021 e pretende incluir 279 participantes. Coordenado por Nantes University Hospital e deve ser concluído em 15 de maio de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 19 de março de 2024.
Resumo
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.

Descrição detalhada
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.

Título oficial

Assessing the Safety and Benefit of Home-hospitalization Program in the Management of Natalizumab (Tysabri®) Medication in Multiple Sclerosis

Condições
Esclerose Múltipla (EM)
Outros IDs do estudo
  • Tys at Home
  • RC20_0442
Número NCT
NCT04777539
Data de início (real)
2021-06-14
Última atualização postada
2024-03-19
Data de conclusão (estimada)
2025-05-15
Inscrição (estimada)
279
Tipo de estudo
Observacional
Status
Ativo, não recrutando
Palavras-chave
At-home hospitalization (HAD)
Natalizumab
Safety
Medico-economic data
Multiple sclerosis
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
N/A
At-home Natalizumab Treated MS Patient
MS patient who are treated with natalizumab in at-home hospitalization" (HAD) setting / according at-home hospitalization program
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Annualized Relapse Rate
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
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
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
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
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
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
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
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
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)
Critérios de elegibilidade

Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Todos
  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.

  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
Nantes University Hospital logoNantes University Hospital
Rennes University Hospital logoRennes University Hospital
Sem dados de contato.
24 Locais do estudo em 1 países

Bas-Rhin

Strasbourg University Hospital, Strasbourg, Bas-Rhin, 67000, France

Bouches-du-Rhône

Marseille University Hospital, Marseille, Bouches-du-Rhône, 13000, France

Finistère

Brest University Hospital, Brest, Finistère, 29200, France
Quimper Hospital, Quimper, Finistère, 29000, France

Gironde

Bordeaux University Hospital, Bordeaux, Gironde, 33000, France
Libourne Hospital, Libourne, Gironde, 33500, France

Haute-Garonne

Toulouse University Hospital, Toulouse, Haute-Garonne, 31000, France

Haute-Vienne

Limoges University Hospital, Limoges, Haute-Vienne, 87000, France

Hauts-de-Seine

Percy Army Training Hospital, Clamart, Hauts-de-Seine, 92140, France

Hérault

Montpellier University Hospital, Montpellier, Hérault, 34000, France

Ille-et-Vilaine

Rennes University Hospital, Rennes, Ille-et-Vilaine, 35000, France

Indre-et-Loire

Tours University Hospital, Tours, Indre-et-Loire, 37000, France

Landes

Dax Hospital, Dax, Landes, 40100, France

Loire-Atlantique

Nantes University Hospital, Nantes, Loire-Atlantique, 44000, France

Loiret

Orléans Hospital, Orléans, Loiret, 45000, France

Nord

Lille University Hospital, Lille, Nord, 59000, France

Seine-Maritime

Rouen University Hospital, Rouen, Seine-Maritime, 76000, France

Vienne

Poitiers University Hospital, Poitiers, Vienne, 86000, France
CH Ajaccio, Ajaccio, France
Les Hôpitaux de Chartres, Chartres, France
CHU Grenoble Alpes, La Tronche, 38700, France
Hôpital St Vincent de Paul, Lille, 59020, France
Adolphe de Rothschild Ophthalmological Foundation, Paris, 75000, France
AP-HP La Pitié-Salpêtrière Hospital, Paris, 75000, France