PHARMACHILD

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

Coordinatore	UNIVERSITAIR MEDISCH CENTRUM UTRECHT    more  Organization address address: HEIDELBERGLAAN 100 city: UTRECHT postcode: 3584 CX contact info Titolo: Ms. Nome: Efdokia Cognome: Chatzoudi Email: send email Telefono: +31 88 755 4579 Fax: +31 88 755 5351
Nazionalità Coordinatore	Netherlands [NL]
Totale costo	3˙924˙102 €
EC contributo	2˙973˙976 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2010-single-stage
Funding Scheme	CP-FP
Anno di inizio	2011
Periodo (anno-mese-giorno)	2011-04-01   -   2014-09-30

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	UNIVERSITAIR MEDISCH CENTRUM UTRECHT  Organization address address: HEIDELBERGLAAN 100 city: UTRECHT postcode: 3584 CX contact info Titolo: Ms. Nome: Efdokia Cognome: Chatzoudi Email: send email Telefono: +31 88 755 4579 Fax: +31 88 755 5351	NL (UTRECHT)	coordinator	501˙446.00
2	ISTITUTO GIANNINA GASLINI  Organization address address: VIA GEROLAMO GASLINI 5 city: GENOVA postcode: 16147 contact info Titolo: Dr. Nome: Nicolino Cognome: Ruperto Email: send email Telefono: +39 010 382854 Fax: +39 010 4211018	IT (GENOVA)	participant	1˙241˙550.00
3	STICHTING KATHOLIEKE UNIVERSITEIT  Organization address address: GEERT GROOTEPLEIN NOORD 9 city: NIJMEGEN postcode: 6525 EZ contact info Titolo: Mr. Nome: Maarten Cognome: Van Langen Email: send email Telefono: +31 24 3618937 Fax: +31 24 3540529	NL (NIJMEGEN)	participant	297˙000.00
4	THE UNIVERSITY OF MANCHESTER  Organization address address: OXFORD ROAD city: MANCHESTER postcode: M13 9PL contact info Titolo: Ms. Nome: Liz Cognome: Fay Email: send email Telefono: 441613000000 Fax: 441613000000	UK (MANCHESTER)	participant	248˙948.00
5	WESTFAELISCHE WILHELMS-UNIVERSITAET MUENSTER  Organization address address: SCHLOSSPLATZ 2 city: MUENSTER postcode: 48149 contact info Titolo: Mr. Nome: Ingo Cognome: Niendorf Email: send email Telefono: 492518000000 Fax: 492518000000	DE (MUENSTER)	participant	240˙564.00
6	ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM  Organization address address: 's Gravendijkwal 230 city: ROTTERDAM postcode: 3015CE contact info Titolo: Ms. Nome: Annemieke Cognome: Steenbergen Email: send email Telefono: +31 10 7036945 Fax: +31 10 4636801	NL (ROTTERDAM)	participant	169˙800.00
7	UNIVERSITY COLLEGE LONDON  Organization address address: GOWER STREET city: LONDON postcode: WC1E 6BT contact info Titolo: Ms. Nome: Greta Cognome: Borg-Carbott Email: send email Telefono: 442031000000 Fax: 442078000000	UK (LONDON)	participant	150˙366.00
8	Deutsches Rheuma-Forschungszentrum Berlin  Organization address address: Chariteplatz 1 city: Berlin postcode: 10117 contact info Titolo: Ms. Nome: Petra Cognome: Starke Email: send email Telefono: +49 30 28460616 Fax: +49 30 28460612	DE (Berlin)	participant	82˙602.00
9	ASKLEPIOS KLINIK SANKT AUGUSTIN GMBH  Organization address address: ARNOLD JANSSEN STRASSE 29 city: SANKT AUGUSTIN postcode: 53757 contact info Titolo: Prof. Nome: Gerd Cognome: Horneff Email: send email Telefono: +49 2241 249 200 Fax: +49 2241 249 203	DE (SANKT AUGUSTIN)	participant	41˙700.00

Mappa

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 Obiettivo del progetto (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.'

Introduzione (Teaser)

To address rising concerns regarding a new class of anti-inflammatory medications used for children, an international study investigated their side-effects over time.