Performing trials in children with rheumatic diseases: Comment on the editorial by Lehman

Arthritis and Rheumatism

Volumn 58, Issue 4, 2008, Pages 1201-1202

  Ruperto, Nicolino ^a   Martini, Alberto ^b   Lovell, Daniel J ^c   Giannini, Edward H ^c  

^a G GASLINI INSTITUTE   (Italy)

^b UNIVERSITY OF GENOA   (Italy)

^c CINCINNATI CHILDREN'S HOSPITAL MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AURANOFIN; HYDROXYCHLOROQUINE; INFLIXIMAB; METHOTREXATE; PENICILLAMINE; PLACEBO;

CLINICAL TRIAL; COMPARATIVE STUDY; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; HUMAN; JUVENILE RHEUMATOID ARTHRITIS; LETTER; PEDIATRICS; PRIORITY JOURNAL; RHEUMATIC DISEASE; RHEUMATOID ARTHRITIS; RHEUMATOLOGY; STATISTICAL SIGNIFICANCE;

AGE FACTORS; ANTIRHEUMATIC AGENTS; ARTHRITIS, JUVENILE RHEUMATOID; CHILD; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; EUROPEAN UNION; HUMANS; REPRODUCIBILITY OF RESULTS; UNITED STATES;

EID: 42449091845     PISSN: 00043591     EISSN: None     Source Type: Journal    
DOI: 10.1002/art.23413     Document Type: Letter

References (16)

1. Lehman TJ. The future of pediatric rheumatology: many questions remain [editorial]. Arthritis Rheum 2007;56:2815-6.
2. Ruperto N, Lovell DJ, Cuttica R, Wilkinson N, Woo P, Espada G, et al, for the Paediatric Rheumatology International Trials Organisation. A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum 2007;56:3096-106.
3. Giannini EH, Ruperto N, Ravelli A, Lovell DJ, Felson DT, Martini A. Preliminary definition of improvement in juvenile arthritis. Arthritis Rheum 1997;40:1202-9.
4. Ruperto N, Martini A. International research networks in pediatric rheumatology: the PRINTO perspective. Curr Opin Rheumatol 2004;16:566-70.
5. Giannini EH, Brewer EJ, Kuzmina N, Shaikov A, Maximov A, Vorontsov I, et al, and The Pediatric Rheumatology Collaborative Study Group and The Cooperative Children's Study Group. Methotrexate in resistant juvenile rheumatoid arthritis. Results of the U.S.A.-U.S.S.R. double-blind, placebo-controlled trial. N Engl J Med 1992;326:1043-9.
6. Lovell DJ, Giannini EH, Reiff A, Cawkwell GD, Silverman ED, Nocton JJ, et al, and Pediatric Rheumatology Collaborative Study Group. Etanercept in children with polyarticular juvenile rheumatoid arthritis. N Engl J Med 2000;342:763-9.
7. Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet 2007; 369:767-78.
8. Brewer EJ, Giannini EH, Kuzmina N, Alekseev L. Penicillamine and hydroxychloroquine in the treatment of severe juvenile rheumatoid arthritis: Results of the U.S.A.-U.S.S.R double-blind, placebo controlled trial. N Engl J Med 1986;314:1269-76.
9. Giannini EH, Brewer EJ, Person DA. Auranofin in the treatment of juvenile rheumatoid arthritis. J Pediatr 1983;102:138-41.
10. Giannini EH, Brewer EJ Jr, Kuzmina N, Shaikov A, Wallin B, for the USA Pediatric Rheumatology Collaborative Study Group and the USSR Cooperative Children's Study Group. Auranofin in the treatment of juvenile rheumatoid arthritis: results of the USA-USSR double-blind, placebo controlled trial. Arthritis Rheum 1990;33:466-76.
11. Food and Drug Administration (FDA). Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biologic products in pediatrics patients (21 CFR Parts 201, 312, 314, and 601). Federal Register 1998;63(231).
12. Regulation (EC) no 1901/2006 of the European parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union 2006;L378: 1-19.
13. Ruperto N, Lovell DJ, Prieur AM, Paz E, Rubio Perez NE, Silva CA, et al. Efficacy and safety of abatacept in children and adolescents with active juvenile idiopathic arthritis (JIA) [abstract]. Ann Rheum Dis 2006;65 Suppl 11:248.
14. Ruperto N, Lovell DJ, Goodman S, Reiff A, Jung L, Nemcova D, et al. 48-week data from the study of adalimumab in children with juvenile rheumatoid arthritis (JRA) [abstract]. Ann Rheum Dis 2006;65 Suppl 11:56.
15. Woo P, Southwood TR, Prieur AM, Dore CJ, Grainger J, David J, et al. Randomized, placebo-controlled, crossover trial of low-dose oral methotrexate in children with extended oligoarticular or systemic arthritis. Arthritis Rheum 2000;43:1849-57.
16. Ruperto N, Murray KJ, Gerloni V, Wulffraat N, de Oliveira SK, Falcini F, et al. A randomized trial of parenteral methotrexate comparing an intermediate dose with a higher dose in children with juvenile idiopathic arthritis who failed to respond to standard doses of methotrexate. Arthritis Rheum 2004;50:2191-201.