PRINTO past project details
The methotrexate trial in intermediate versus higher dose in juvenile idiopathic arthritis
Thanks to a first grant from the European Union (Contract no. BMH4 983531 CA 1998/2001) PRINTO set up a randomized trial to compare intermediate versus higher doses of MTX in children with JIA. The trial was built on the current "standard of care" in such a way that the cost of insurance coverage, the medication, clinic visits, and laboratory monitoring, were paid by the usual method of cost reimbursement for clinical care in each participating country. The trial enrolled 633 patients from 20 different countries and showed that the plateau of efficacy of MTX in JIA is reached with the parenteral administration of 15 mg/m2/week and that further increase in dosage is not associated with any additional therapeutic benefit. MTX should be administered for up to 9-12 months to appreciate full therapeutic effect.
Ruperto N, Murray KJ, Gerloni V, Wulffraat N, Oliveira S, Falcini F, Dolezalova P, Alessio M, Burgos-Vargas R, Corona F, Vesely R, Foster H, Davidson J, Zulian F, Asplin L, Baildam E, Garcia Consuegra J, Ozdogan H, Saurenmann R, Joos R, Pistorio A, Woo P, Alberto Martini A, for the Pediatric Rheumatology INternational Trials Organization (PRINTO).A randomized trial of parenteral methotrexate comparing an intermediate with a higher dose in children with juvenile idiopathic arthritis who failed to respond to standard doses of methotrexate.
Arthritis Rheum 2004; 50(7);2191-2201.
Céspedes-Cruz A, Gutiérrez-Suárez R, Pistorio A, Ravelli A, Loy A, Murray KJ, Gerloni V, Wulffraat NM, Oliveira S, Walsh J, Calvo Penades I, Alpigiani MG, Lahdenne P, Saad-Magalhães C, Cortis E, Lepore L, Kimura Y, Wouters C, Martini A, Ruperto N. for the Pediatric Rheumatology International Trials Organization (PRINTO) and the Pediatric Rheumatology Stud Group of the Italian Society of PediatricsMethotrexate improves the health-related quality of life of children with juvenile idiopathic arthritis.
Ann Rheum Dis 2008;67:309-314
Consolaro A, Bracciolini G, Ruperto N, Pistorio A, Magni-Manzoni S, Malattia C, Pederzoli S, Davì S, Martini A, Ravelli A for the Paediatric Rheumatology International Trials Organisation (PRINTO).Remission, Minimal Disease Activity, and Acceptable Symptom State in Juvenile Idiopathic Arthritis. Defining Criteria Based on the Juvenile Arthritis Disease Activity Score
Arthritis Rheum 2012;64(7):2366-2374