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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."

Call for proposal

H2020-PHC-2014-2015

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Sub call

H2020-PHC-2014-two-stage

Coordinator

CENTRE HOSPITALIER UNIVERSITAIRE DE LIEGE
Net EU contribution
€ 432 475,00
Address
Avenue De L Hopital 1
4000 Liege
Belgium

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Region
Région wallonne Prov. Liège Arr. Liège
Activity type
Research Organisations
Other funding
€ 432 475,00

Participants (16)

Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

UNIVERSITE DE LIEGE
Belgium
Net EU contribution
€ 106 406,25
Address
Place Du 20 Aout 7
4000 Liege

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Region
Région wallonne Prov. Liège Arr. Liège
Activity type
Higher or Secondary Education Establishments
Other funding
€ 106 406,25
GROUPE D'ETUDES THERAPEUTIQUES DES AFFECTIONS INFLAMMATOIRES DIGESTIVES ASSOCIATION
France
Net EU contribution
€ 2 667 600,00
Address
2 Rue Ambroise Pare
75010 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 2 667 600,00
THE UNIVERSITY OF EDINBURGH
United Kingdom
Net EU contribution
€ 524 000,00
Address
Old College, South Bridge
EH8 9YL Edinburgh

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Region
Eastern Scotland Edinburgh
Activity type
Higher or Secondary Education Establishments
Other funding
€ 524 000,00
REGION SKANE
Sweden
Net EU contribution
€ 293 133,13
Address
Region Skane
291 89 Kristianstad

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Region
Södra Sverige Sydsverige Skåne län
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Other funding
€ 293 133,13
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
Net EU contribution
€ 210 017,50
Address
Chariteplatz 1
10117 Berlin

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Region
Berlin Berlin Berlin
Activity type
Higher or Secondary Education Establishments
Other funding
€ 210 017,50
MEDICAL RESEARCH INFRASTRUCTURE DEVELOPMENT AND HEALTH SERVICES FUND BY THE SHEBA MEDICAL CENTER
Israel
Net EU contribution
€ 165 963,00
Other funding
€ 165 963,00
IBDIM - IBD IN MOTION GMBH
Austria
Net EU contribution
€ 168 687,50
Address
Ungargasse 6/13
1030 Wien

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Wien Wien
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 168 687,50
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

OCEAIN - ORGANISATION, CONGRESS, EMOTION, ASSOCIATION, INNOVATION GMBH
Austria
Net EU contribution
€ 70 728,75
Address
Ungargasse 6/13
1030 Wien

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Region
Wien Wien
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 70 728,75
CROHN'S & COLITIS FOUNDATION OF AMERICA, INC.
United States
Net EU contribution
€ 114 311,00
Other funding
€ 114 311,00
ASSOCIATION FRANCOIS AUPETIT
France
Net EU contribution
€ 73 625,00
Address
32 Rue De Cambrai
75019 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 73 625,00
GOETEBORGS UNIVERSITET
Sweden
Net EU contribution
€ 121 875,00
Address
Vasaparken
405 30 Goeteborg

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Region
Södra Sverige Västsverige Västra Götalands län
Activity type
Higher or Secondary Education Establishments
Other funding
€ 121 875,00
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
Net EU contribution
€ 314 271,00
Address
Rue De Tolbiac 101
75654 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Other funding
€ 314 271,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

UNIVERSITE PARIS CITE
France
Net EU contribution
€ 0,00
Address
85 Bd Saint Germain
75006 Paris

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Region
Ile-de-France Ile-de-France Paris
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,00
UNIVERSITE CATHOLIQUE DE LOUVAIN
Belgium
Net EU contribution
€ 122 475,00
Address
Place De L Universite 1
1348 Louvain La Neuve

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Region
Région wallonne Prov. Brabant Wallon Arr. Nivelles
Activity type
Higher or Secondary Education Establishments
Other funding
€ 122 475,00
BRIDGE2HEALTH
Belgium
Net EU contribution
€ 186 500,00
Address
Domaine Universitaire Du Bat B 35
4000 Liege

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Region
Région wallonne Prov. Liège Arr. Liège
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 186 500,00
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
Net EU contribution
€ 390 028,75
Address
Wellington Square University Offices
OX1 2JD Oxford

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Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Higher or Secondary Education Establishments
Other funding
€ 390 028,75