Ibd CAncer and seRious Infections in France (I-CARE 2) (I-CARE 2)
This is a French prospective longitudinal observational multicentre cohort study.
Primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Number of patients : 6 000 at least Participating investigators : 250 at least
Recruitment period : 3 years 6 months
Primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.
Secondary objectives :
- To assess the presence and the extent of safety concerns in patients treated with JAKi, anti-IL23p19, and S1p modulators for each outcome of interest separately (cancer, serious infections, arterial thrombotic events, venous thrombotic events)
- To investigate prospectively the impact of JAKi, anti-IL23p19 and S1p modulators strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations
- To assess the evolution of ePROs on a trimester basis and the impact of JAKi, anti-IL23p19, and S1p modulators on ePROs in IBD
- To evaluate the benefit-risk ratio of strategies based on a wider use of JAKi, anti-IL23p19, and S1p modulators therapy for IBD
- To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Marie Coisnon
- Número de telefone: 09 72 57 61 60
- E-mail: mcoisnon@getaid.org
Estude backup de contato
- Nome: Charlotte Mailhat
- Número de telefone: 09 72 57 61 60
- E-mail: cmailhat@getaid.org
Locais de estudo
-
-
-
Amiens, França, 80000
- Recrutamento
- CHU Amiens Picardie
-
Contato:
- Mathurin FUMERY, PHD
- E-mail: Fumery.Mathurin@chu-amiens.fr
-
Investigador principal:
- Mathurin FUMERY, PHD
-
Paris, França, 75012
- Recrutamento
- APHP Hôpital Saint Antoine
-
Contato:
- Julien Kirchgesner
- E-mail: julien.kirchgesner@aphp.fr
-
Investigador principal:
- Julien Kirchgesner
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
IBD patients initiating a biologic treatment.
Descrição
Inclusion Criteria:
- Patient with an established diagnosis of Crohn's disease, ulcerative colitis or IBD unclassified based on usual radiological, endoscopic or histological criteria.
- Patient aged 18 and older accepting to sign the informed participating consent form, stating that he accepts to provide personal details (mobile and home phone number, e-mail address), to complete the e-PRO as required and to be contacted by a Study Coordinator and his gastroenterologist for the purpose of the study during the entire study period and during follow up if required.
Exclusion Criteria:
- Patient unable to sign the informed consent form
- Patient with no regular access to internet
- Patient refusing to sign the informed consent form
- Patient enrolled in a Randomized Clinical Trial (If the investigational product received was blinded, and if the treatment is unknown at time of enrolment in I-CARE 2)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Group Anti-IL23p19
Patients treated with anti-IL23p19 (risankizumab, guselkumab, mirikizumab, brazikumab) |
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures. |
|
Group Jak inhibitors
Patient treated with Jak inhibitors (tofacitinib, upadacitinib, filgotinib) |
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures. |
|
Group S1P Modulators
Patient treated with S1P modulators (ozanimod, etrasimod) |
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures. |
|
Group Anti TNF
Patient treated with anti-TNF (infliximab, adalimumab, golimumab) (with a maximal proportion of 25% as 1st first line biologic after conventional treatment (aminosalicylates, corticosteroids, thiopurines, methotrexate)) |
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures. |
|
Group Anti integrins
Patient treated with anti-integrins (vedolizumab) |
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures. |
|
Group Anti IL12/23
Patient treated with anti-IL12/23 (ustekinumab) |
This study is non-interventional, patients will be enrolled when initiating a treatment through standard of care procedures. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Prazo: 4 to 7.5 years
|
The primary objective of I-CARE 2 is to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators. The risk of cancers, serious infections and vascular events will be stratified according to IBD phenotype, disease activity (clinical, radiologic and endoscopic) and main comorbidities at baseline. |
4 to 7.5 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)
Prazo: 4 to 7.5 years
|
To assess the presence and the extent of safety concerns in patients treated with JAKi, anti-IL23p19, and S1p modulators for each outcome of interest separately
|
4 to 7.5 years
|
|
Treatment impact on IBD natural history
Prazo: 4 to 7.5 years
|
To investigate prospectively the impact of JAKi, anti-IL23p19 and S1p modulators strategies on the natural history of IBD and their potential for disease modification by collecting validated surrogate markers such as mucosal healing and disease complications such as bowel damage (strictures, fistulas, abscess), surgeries, and hospitalizations |
4 to 7.5 years
|
|
ePRO
Prazo: 4 to 7.5 years
|
To assess the evolution of ePROs on a trimester basis and the impact of JAKi, anti-IL23p19, and S1p modulators on ePROs in IBD |
4 to 7.5 years
|
|
Benefit-risk ratio
Prazo: 4 to 7.5 years
|
To evaluate the benefit-risk ratio of strategies based on a wider use of JAKi, anti-IL23p19, and S1p modulators therapy for IBD |
4 to 7.5 years
|
|
Number and duration of hospitalization, surgery, endoscopy and other imaging
Prazo: 4 to 7.5 years
|
To assess the healthcare costs and cost-efficacy of current therapeutic strategies in IBD. |
4 to 7.5 years
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Julien Kirchgesner, Hôpital Saint Antoine - APHP
- Investigador principal: Mathurin Fumery, CHU Amiens-Picardie
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GETAID-2022-02
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .