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Long-term PHARMacovigilance for Adverse effects in Childhood arthritis focussing on Immune modulatory drugs

Objective

Until the age of biotechnology, treatment options for children and adolescents with severe arthritis, inflammatory bowel diseases and other serious diseases with chronic inflammation were limited. Advances in understanding the pathophysiology of the inflammatory responses have led to the development of a new class of medications that are capable of inhibiting selectively the principal mediators of inflammation and tissue damage. The introduction of these new immunomodulators, which are collectively termed biologics, has opened a new era in the treatment of inflammatory diseases. Recent reports however suggest unexpected increases in adverse - or serious events -associated with the use of these biologics. PHARMACHILD aims to detect, assess and understand long term and short term side effects of the use of biologics by studying the pharmacovigilance in a large international cohort of patients with Juvenile Idiopathic Arthritis (children and young adults) in order to support regulatory decisions on marketing authorizations for these products.

There is a clear need for a study that will enable the promotion of more effective and safer use of biologics in JIA as children and young adolescents represent an especially vulnerable patient group, JIA is the most common chronic disease of childhood treated with biologics, and data available from adults cannot be extrapolated to children. PHARMACHILD brings together leading European scientists in the field of infectious diseases, immunity, inflammation and oncology. Our network combines resources from international organizations and existing national registries. This combination will enable us to achieve the critical mass (in terms of expertise and resources) to identify the risk factors for developing adverse events, to elucidate the mechanisms involved in the adverse events (such as latent infection reactivation) and to develop methodologies for screening and predicting patients at risk.

Call for proposal

FP7-HEALTH-2010-single-stage
See other projects for this call

Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Address
Heidelberglaan 100
3584 CX Utrecht
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 501 446
Administrative Contact
Efdokia Chatzoudi (Ms.)

Participants (8)

ISTITUTO GIANNINA GASLINI
Italy
EU contribution
€ 1 241 550
Address
Via Gerolamo Gaslini 5
16147 Genova
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Nicolino Ruperto (Dr.)
ASKLEPIOS KLINIK SANKT AUGUSTIN GMBH
Germany
EU contribution
€ 41 700
Address
Arnold Janssen Strasse 29
53757 Sankt Augustin
Activity type
Other
Administrative Contact
Gerd Horneff (Prof.)
Westfälische Wilhelms-Universität Münster
Germany
EU contribution
€ 240 564
Address
Schlossplatz 2
48149 Muenster
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ingo Niendorf (Mr.)
THE UNIVERSITY OF MANCHESTER
United Kingdom
EU contribution
€ 248 948
Address
Oxford Road
M13 9PL Manchester
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Liz Fay (Ms.)
Deutsches Rheuma-Forschungszentrum Berlin
Germany
EU contribution
€ 82 602
Address
Chariteplatz 1
10117 Berlin
Activity type
Research Organisations
Administrative Contact
Petra Starke (Ms.)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Netherlands
EU contribution
€ 169 800
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Annemieke Steenbergen (Ms.)
STICHTING RADBOUD UNIVERSITEIT
Netherlands
EU contribution
€ 297 000
Address
Houtlaan 4
6525 XZ Nijmegen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maarten Van Langen (Mr.)
UCL Elizabeth Garrett Anderson Institute for Women’s Health
United Kingdom
EU contribution
€ 150 366
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Greta Borg-Carbott (Ms.)