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BIOCYCLE

Financiado

Cerrado

BIOlogical therapy CYCLEs towards tailored needs driven safer and cost effecti...

BIOlogical therapy CYCLEs towards tailored needs driven safer and cost effective management of Crohn s disease "The BIOCYCLE Project proposes to test and critically assess the benefits and risks of an innovative regimen for improving the treatment of Crohn’s disease (CD), a chronic immune-mediated inflammatory disease affecting the gastro-... ver más

31/12/2022

CHUL

6M€

Presupuesto del proyecto: 6M€

Líder del proyecto

CENTRE HOSPITALIER UNIVERSITAIRE DE LIEGE No se ha especificado una descripción o un objeto social para esta compañía.

Fecha límite participación Sin fecha límite de participación.

Ver 17 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2022-12-31

PHC-13-2014: New therapies for chronic non-commu...

I+D

Cerrada hace 10 años

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Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

17 Participantes

CHUL

538.88K€ | Lider

CHARITE UNIVERSITAETSMEDIZI...

210.02K€ | Participante

OCEAIN

N.D. | Participante

UPCité

N.D. | Participante

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Duración del proyecto: 93 meses Fecha Inicio: 2015-03-31
Fecha Fin: 2022-12-31

Líder del proyecto

CENTRE HOSPITALIER UNIVERSITAIRE DE LIEGE No se ha especificado una descripción o un objeto social para esta compañía.

Presupuesto del proyecto 6M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto "The BIOCYCLE Project proposes to test and critically assess the benefits and risks of an innovative regimen for improving the treatment of Crohn’s disease (CD), a chronic immune-mediated inflammatory disease affecting the gastro-intestinal tract of an increasing number of patients. Currently, the combination of anti-TNFα monoclonal antibodies and immunosuppressants used without interruption is the gold standard for treating CD. However, long treatments are needed which raise safety concerns and costs. For maintaining the same level of efficacy while reducing risks and costs, the idea of BIOCYCLE is to use a regimen based on ""Treatment Cycles"" characterized by alternating periods where both drugs are administrated and periods where only either anti-TNFα or immunosuppressant is used. The central part of the Project will be a large-scale controlled multi-centric clinical study including 300 patients in EU and USA to test the feasibility of shifting from drugs combination used without interruption (control) to Treatment Cycles (experimental arms). Primary and secondary objectives of the clinical study have already been validated for generating the best qualitative and quantitative data on clinical outcomes, predictors of disease evolution and costs. In parallel, the Project will calculate costs-of-illness associated with the different regimens and will perform surveys among patients, caregivers and healthcare systems representatives to assess their readiness to include/support Treatment Cycles in the clinical practice. This will be the basis of a critical appraisal of Treatment Cycles and guidelines for helping caregivers to decide which treatment regimen best fits the specific needs of their patient. If proven, the benefits of Treatment Cycles for treating CD will be discussed with key-opinion leaders involved in the treatment of other immune-mediated inflammatory chronic diseases to support the evolution of disease-driven treatments towards needs-driven treatments."

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