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BIOlogical therapy CYCLEs towards tailored, needs-driven, safer and cost-effective management of Crohn’s disease

Objective

"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."

Field of science

  • /medical and health sciences/health sciences/inflammatory diseases

Call for proposal

H2020-PHC-2014-two-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

CENTRE HOSPITALIER UNIVERSITAIRE DE LIEGE
Address
Sart Tilman B35
4000 Liege
Belgium
Activity type
Research Organisations
EU contribution
€ 538 881,25

Participants (13)

GROUPE D'ETUDES THERAPEUTIQUES DES AFFECTIONS INFLAMMATOIRES DIGESTIVES ASSOCIATION
France
EU contribution
€ 2 667 600
Address
2 Rue Ambroise Pare
75010 Paris
Activity type
Research Organisations
THE UNIVERSITY OF EDINBURGH
United Kingdom
EU contribution
€ 524 000
Address
Old College, South Bridge
EH8 9YL Edinburgh
Activity type
Higher or Secondary Education Establishments
SKANE LANS LANDSTING
Sweden
EU contribution
€ 293 133,13
Address
.
291 89 Kristianstad
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
EU contribution
€ 210 017,50
Address
Chariteplatz 1
10117 Berlin
Activity type
Higher or Secondary Education Establishments
MEDICAL RESEARCH INFRASTRUCTURE DEVELOPMENT AND HEALTH SERVICES FUND BY THE SHEBA MEDICAL CENTER
Israel
EU contribution
€ 165 963
Address
Tel Hashomer Sheba Medical Center
52621 Ramat Gan
Activity type
Research Organisations
IBDIM - IBD IN MOTION GMBH
Austria
EU contribution
€ 239 416,25
Address
Ungargasse 6/13
1030 Wien
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CROHN'S & COLITIS FOUNDATION OF AMERICA, INC.
United States
EU contribution
€ 114 311
Address
733 Third Road Suite 501
10017 New York
Activity type
Other
ASSOCIATION FRANCOIS AUPETIT
France
EU contribution
€ 73 625
Address
32 Rue De Cambrai
75019 Paris
Activity type
Research Organisations
GOETEBORGS UNIVERSITET
Sweden
EU contribution
€ 121 875
Address
Vasaparken
405 30 Goeteborg
Activity type
Higher or Secondary Education Establishments
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 314 271
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
UNIVERSITE CATHOLIQUE DE LOUVAIN
Belgium
EU contribution
€ 122 475
Address
Place De L Universite 1
1348 Louvain La Neuve
Activity type
Higher or Secondary Education Establishments
BRIDGE2HEALTH
Belgium
EU contribution
€ 186 500
Address
Domaine Universitaire Du Bat B 35
4000 Liege
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 390 028,75
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments