PRINTO ongoing project details
Juvenile idiopathic arthritis (JIA) is the most common chronic paediatric rheumatic disease and an important cause of short and long-term disability and quality of life impairment. Methotrexate (MTX) is the second line agent of first choice for the treatment of children with polyarticular JIA who do not respond to NSAIDs.
Patients with JIA who do not respond or are intolerant to MTX are candidates for the treatment with biologic agents such as etanercept, infliximab, adalimumab, abatacept and others currently in development. However, little information exists on the long term safety of these agents that are currently being used in children with JIA.
Pharmachild is a pharmacovigilance project which aims at observing children with JIA for 3-10 years undergoing treatment with MTX or biologic agents in order to collect moderate, severe or serious adverse events occurred.
This project is conducted by the participating centres of the more than 50 countries belonging to the Paediatric Rheumatology INternational Trials Organisation (PRINTO, certified ISO 9001-2008), or the Pediatric Rheumatology European Society (PRES). More than 200 PRINTO centres worldwide have already expressed their interest in participating to the project.
Pharmachild has been funded by the European Union (EU) within the FP7 framework (contract number 260353, principal investigator Dr Nico Wulffraat, co-principal investigator Dr Nicolino Ruperto).
The Pharmachild study has obtained the ENCePP Study Seal (ENCePP). The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) is a collaborative scientific network coordinated by the European Medicines Agency and developed in collaboration with European experts in the fields of pharmacoepidemiology and pharmacovigilance. The ENCePP Study Seal means that a study upholds high standards throughout the research process based on the principles of transparency and scientific independence.
COLLABORATION WITH PHARMACEUTICAL COMPANIES
The Pharmachild protocol envisages the opportunity of a cooperation with pharmaceutical companies, which may want to use the data derived from Pharmachild for regulatory post-marketing surveillance obligations related to their product towards regulatory authorities. In this cases, PRINTO will MAINTAIN THE OWNERSHIP OVER THE DATA COLLECTED in order to continue to fulfill the ENCePP principles of transparency and scientific independence. All related possible revenues will be totally reinvested for the research needs of the project to support the prolongation of the registry over the planned 3-10 years. List of companies which have agreed to cooperate with Pharmachild: - Bristol-Myers Squibb (Abatacept in JIA)
Gabriella Giancane1*, MD, Joost F. Swart2*, MD, Elio Castagnola3, MD, Andreas H. Groll4, MD, Gerd Horneff5-6, MD, Hans-Iko Huppertz7, MD, Daniel J Lovell8, MD, MPH, Tom Wolfs2, MD, Troels Herlin9 , MD, Pavla Dolezalova10, MD, Helga Sanner11, MD, Gordana Susic12, MD, Flavio Sztajnbok13, MD, Despoina Maritsi14, MD, Tamas Constantin15, MD, Veronika Vargova16, MD, Sujata Sawhney17, MD, Marite Rygg18, MD, Sheila K. Oliveira19, MD, Marco Cattalini20, MD, Francesca Bovis1, PhD, Francesca Bagnasco1, MSc, Angela Pistorio21, MD, Alberto Martini22, MD, Nico Wulffraat2*, MD, Nicolino Ruperto1*, MD MPH, for the Paediatric Rheumatology International Trials Organisation (PRINTO)Opportunistic Infections in Immunosuppressed Patients with Juvenile Idiopathic Arthritis. Analysis by the Pharmachild Safety Adjudication Committee
Arthritis Res Ther 22:71
Swart J, Giancane G, Horneff G, Magnusson B, Hofer M, Alexeeva Е, Panaviene V, Bader-Meunier B, Anton J, Nielsen S, De Benedetti F, Kamphuis S, Staņēviča V, Tracahana M, Ailioaie LM, Tsitsami E, Klein A, Minden K, Foeldvari I, Haas JP, Klotsche J, Horne AC, Consolaro A, Bovis F, Bagnasco F, Pistorio A, Martini A, Wulffraat N, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO), BiKeR and the board of the Swedish RegistryPharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs: combined data of more than 15,000 patients from Pharmachild and national registries
Arthritis Res Ther 2018;20(1):285