It is worth including assessment of disease activity state in juvenile arthritis clinical trials

Arthritis Care and Research

Volumn 65, Issue 8, 2013, Pages 1207-1210

  Consolaro, Alessandro ^a   Ravelli, Angelo ^a,b  

^a G GASLINI INSTITUTE   (Italy)

^b UNIVERSITY OF GENOA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; ADALIMUMAB; CANAKINUMAB; ETANERCEPT; INFLIXIMAB; METHOTREXATE; PLACEBO; TOCILIZUMAB;

CLINICAL TRIAL (TOPIC); DISEASE ACTIVITY; FOOD AND DRUG ADMINISTRATION; HUMAN; JUVENILE RHEUMATOID ARTHRITIS; PHYSICIAN; REMISSION; REVIEW; TREATMENT RESPONSE;

ARTHRITIS, JUVENILE; CHILD; CLINICAL TRIALS AS TOPIC; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); REMISSION INDUCTION; SEVERITY OF ILLNESS INDEX;

EID: 84881321711     PISSN: 2151464X     EISSN: 21514658     Source Type: Journal    
DOI: 10.1002/acr.21973     Document Type: Review

References (37)

1. 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.
2. Committee for Medicinal Product for Human Use (CHMP) European Medicines Agency. 2006. URL: http://www.ema.europa.eu/pdfs/human/ewp/042204.pdf.
3. Giannini EH, Brewer EJ, Kuzmina N, Shaikov A, Maximov A, Vorontsov I, et al, and the Pediatric Rheumatology Collaborative Study Group and Cooperative Children's Study Group. Methotrexate in resistant juvenile rheumatoid arthritis: results of the USA-USSR double-blind, placebo-controlled trial. N Engl J Med 1992; 326: 1043-9.
4. Ruperto N, Murray KJ, Gerloni V, Wulffraat N, de Oliveira SK, Falcini F, et al, for the Pediatric Rheumatology International Trials Organization. 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.
5. Lovell DJ, Giannini EH, Reiff A, Cawkwell GD, Silverman ED, Nocton JJ, et al, for the Pediatric Rheumatology Collaborative Study Group. Etanercept in children with polyarticular juvenile rheumatoid arthritis. N Engl J Med 2000; 342: 763-9.
6. Ruperto N, Lovell DJ, Cuttica R, Wilkinson N, Woo P, Espada G, et al, for the Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group. A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum 2007; 56: 3096-106.
7. Lovell DJ, Ruperto N, Goodman S, Reiff A, Jung L, Jarosova K, et al. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med 2008; 359: 810-20.
8. Ruperto N, Lovell DJ, Quartier P, Paz E, Rubio-Perez N, Silva CA, et al. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet 2008; 372: 383-91.
9. Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, et al. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet 2008; 371: 998-1006.
10. De Benedetti F, Brunner HI, Ruperto N, Kenwright A, Wright S, Calvo I, et al. Randomized trial of tocilizumab in systemic juvenile idiopathic arthritis. N Engl J Med 2012; 367: 2385-95.
11. Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat N, Horneff G, et al. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med 2012; 367: 2396-406.
12. Pincus T, Sokka T, Kavanaugh A,. Relative versus absolute goals of therapies for RA: ACR 20 or ACR 50 responses versus target values for "near remission" of DAS or single measures. Clin Exp Rheumatol 2004; Suppl 35: S50-6.
13. Dougados M,. It's good to feel better but it's better to feel good [editorial]. J Rheumatol 2005; 32: 1-2.
14. Aletaha D, Landewe R, Karonitsch T, Bathon J, Boers M, Bombardier C, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Rheum 2008; 59: 1371-7.
15. Wallace CA, Ruperto N, Giannini E,. Preliminary criteria for clinical remission for select categories of juvenile idiopathic arthritis. J Rheumatol 2004; 31: 2290-4.
16. Wallace CA, Huang B, Bandeira M, Ravelli A, Giannini EH,. Patterns of clinical remission in select categories of juvenile idiopathic arthritis. Arthritis Rheum 2005; 52: 3554-62.
17. Ravelli A, Martini A,. Remission in juvenile idiopathic arthritis. Clin Exp Rheumatol 2006; Suppl 43: S105-10.
18. Martini A, Lovell DJ,. Juvenile idiopathic arthritis: state of the art and future perspectives. Ann Rheum Dis 2010; 69: 1260-3.
19. Magnani A, Pistorio A, Magni-Manzoni S, Falcone A, Lombardini G, Bandeira M, et al. Achievement of a state of inactive disease at least once in the first 5 years predicts better outcome of patients with polyarticular juvenile idiopathic arthritis. J Rheumatol 2009; 36: 628-34.
20. Grigor C, Capell H, Stirling A, McMahon AD, Lock P, Vallance R, et al. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet 2004; 364: 263-9.
21. Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Allaart CF, van ZD, Kerstens PJ, Hazes JM, et al. Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial. Arthritis Rheum 2008; 58 Suppl: S126-35.
22. Smolen JS, Sokka T, Pincus T, Breedveld FC,. A proposed treatment algorithm for rheumatoid arthritis: aggressive therapy, methotrexate, and quantitative measures. Clin Exp Rheumatol 2003; Suppl 31: S209-10.
23. Sokka T, Pincus T,. Rheumatoid arthritis: strategy more important than agent. Lancet 2009; 374: 430-2.
24. Smolen JS, Landewe R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010; 69: 964-75.
25. Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, Burmester G, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis 2010; 69: 631-7.
26. Beresford MW, Cleary AG, Foster HE, Hutchinson E, Baildam EM, Davies K,. Comment on: developing standards of care for patients with juvenile idiopathic arthritis. Rheumatology (Oxford) 2010; 49: 2227-9.
27. Wallace CA,. Developing standards of care for patients with juvenile idiopathic arthritis [editorial]. Rheumatology (Oxford) 2010; 49: 1213-4.
28. Consolaro A, Negro G, Lanni S, Solari N, Martini A, Ravelli A,. Toward a treat-to-target approach in the management of juvenile idiopathic arthritis. Clin Exp Rheumatol 2012; Suppl 73: S157-62.
29. Wallace CA, Giannini EH, Huang B, Itert L, Ruperto N, for the Childhood Arthritis and Rheumatology Research Alliance (CARRA), the Pediatric Rheumatology Collaborative Study Group (PRCSG), and the Paediatric Rheumatology International Trials Organisation (PRINTO). American College of Rheumatology provisional criteria for defining clinical inactive disease in select categories of juvenile idiopathic arthritis. Arthritis Care Res (Hoboken) 2011; 63: 929-36.
30. Wallace CA, Giannini EH, Spalding SJ, Hashkes PJ, O'Neil KM, Zeft AS, et al, for the Childhood Arthritis and Rheumatology Research Alliance. Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis. Arthritis Rheum 2012; 64: 2012-21.
31. Magni-Manzoni S, Ruperto N, Pistorio A, Sala E, Solari N, Palmisani E, et al. Development and validation of a preliminary definition of minimal disease activity in patients with juvenile idiopathic arthritis. Arthritis Rheum 2008; 59: 1120-7.
32. Wells G, Boers M, Shea B, Anderson J, Felson D, Johnson K, et al. MCID/low disease activity state workshop: low disease activity state in rheumatoid arthritis [review]. J Rheumatol 2003; 30: 1110-1.
33. Magni-Manzoni S, Malattia C, Lanni S, Ravelli A,. Advances and challenges in imaging in juvenile idiopathic arthritis. Nat Rev Rheumatol 2012; 8: 329-36.
34. Consolaro A, Ruperto N, Bazso A, Pistorio A, Magni-Manzoni S, Filocamo G, et al, for the Paediatric Rheumatology International Trials Organisation. Development and validation of a composite disease activity score for juvenile idiopathic arthritis. Arthritis Rheum 2009; 61: 658-66.
35. Nordal EB, Zak M, Aalto K, Berntson L, Fasth A, Herlin T, et al. Validity and predictive ability of the juvenile arthritis disease activity score based on CRP versus ESR in a Nordic population-based setting. Ann Rheum Dis 2012; 71: 1122-7.
36. Consolaro A, Bracciolini G, Ruperto N, Pistorio A, Magni-Manzoni S, Malattia C, et al, for the Paediatric Rheumatology International Trials Organisation. 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: 2366-74.
37. Ruperto N, Giannini EH, Pistorio A, Brunner HI, Martini A, Lovell DJ,. Is it time to move to active comparator trials in juvenile idiopathic arthritis? A review of current study designs. Arthritis Rheum 2010; 62: 3131-9.