BeSt for kids: comparing treatment strategies in juvenile idiopathic arthritis.

Completed

Conditions: juvenile idiopathic arthritisjeugdreumatreatment strategybehandelings strategie

Registration Number: NL-OMON26585

Lead Sponsor: MC

Brief Summary: Publications: Treat to target (drug-free) inactive disease in DMARD-naive juvenile idiopathic arthritis: 24-month clinical outcomes of a three-armed randomised trial. Hissink Muller P, Brinkman DMC, Schonenberg-Meinema D, van den Bosch WB, Koopman-Keemink Y, Brederije ICJ, Bekkering PW, Kuijpers TW, Van Rossum M, van Suijlekom-Smit LW, van den Berg JM, Boehringer S, Allaart CF, Ten Cate R. Ann Rheum Dis. 2018 Oct 11. pii: annrheumdis-2018-213902. doi: 10.1136/annrheumdis-2018-213902. A comparison of three treatment strategies in recent onset non-systemic Juvenile Idiopathic Arthritis: initial 3-months results of the BeSt for Kids-study. Hissink Muller PC, Brinkman DM, Schonenberg D, Koopman-Keemink Y, Brederije IC, Bekkering WP, Kuijpers TW, van Rossum MA, van Suijlekom-Smit LW, van den Berg JM, Allaart CF, Ten Cate R. Pediatr Rheumatol Online J. 2017 Feb 6;15(1):11. doi: 10.1186/s12969-017-0138-4. Reference List: 1. Cassidy JT, Petty,R.E., Laxer,R.M. & Lindsey CB. Textbook of Pediatric Rheumatology. 2006. Ref Type: Generic 2. Wallace,C.A. Current management of juvenile idiopathic arthritis. Best. Pract. Res. Clin. Rheumatol. 20, 279-300 (2006). 3. Ravelli,A. Toward an understanding of the long-term outcome of juvenile idiopathic arthritis. Clin. Exp. Rheumatol. 22, 271-275 (2004). 4. Fantini,F. et al. Remission in juvenile chronic arthritis: a cohort study of 683 consecutive cases with a mean 10 year followup. J. Rheumatol. 30, 579-584 (2003). 5. Wallace,C.A., Huang,B., Bandeira,M., Ravelli,A. & Giannini,E.H. Patterns of clinical remission in select categories of juvenile idiopathic arthritis. Arthritis Rheum. 52, 3554-3562 (2005). 6. Guillaume,S., Prieur,A.M., Coste,J. & Job-Deslandre,C. Long-term outcome and prognosis in oligoarticular-onset juvenile idiopathic arthritis. Arthritis Rheum. 43, 1858-1865 (2000). 7. Giannini,E.H. et al. Preliminary definition of improvement in juvenile arthritis. Arthritis Rheum. 40, 1202-1209 (1997). 8. Felson,D.T., Anderson,J.J., Lange,M.L., Wells,G. & LaValley,M.P. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent? Arthritis Rheum. 41, 1564-1570 (1998). 9. Ringold,S. & Wallace,C.A. Measuring clinical response and remission in juvenile idiopathic arthritis. Curr. Opin. Rheumatol. 19, 471-476 (2007). 10. Goekoop-Ruiterman,Y.P. 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. 58, S126-S135 (2008). 11. Allaart,C.F., Breedveld,F.C. & Dijkmans,B.A. Treatment of recent-onset rheumatoid arthritis: lessons from the BeSt study. J. Rheumatol. Suppl 80, 25-33 (2007). 12. Albers HM et al. Time to Treatment is an Important Factor for the Response to Methotrexate in Juvenile Idiopathic Arthritis. Arthritis & Rheumatism (Arthritis Care & Research) 61, 00 (2009). 13. Plosker,G.L. & Croom,K.F. Sulfasalazine: a review of its use in the management of rheumatoid arthritis. Drugs 65, 1825-1849 (2005). 14. van Rossum,M.A. et al. Sulfasalazine in the treatment of juvenile chronic arthritis: a randomized, double-blind, placebo-controlled, multicenter study. Dutch Juvenile Chronic Arthritis Study Group. Arthritis Rheum. 41, 808-816 (1998). 15. van Rossum,M.A. et al. Long-term outcome of juvenile idiopathic arthritis following a placebo-controlled trial: sustained benefits of early sulfasalazine treatment. Ann. Rheum. Dis. 66, 1518-1524 (2007). 16. Giannini,E.H. et al. Methotrexate in resistant juvenile rheumatoid arthritis. Results of the U.S.A.-U.S.S.R. double-blind, placebo-controlled trial. The Pediatric Rheumatology Collaborative Study Group and The Cooperative Children's Study Group. N. Engl. J. Med. 326, 1043-1049 (1992). 17. Ruperto,N. 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. 50, 2191-2201 (2004). 18. Lovell,D.J. et al. Long-term efficacy and safety of etanercept in children with polyarticular-course juvenile rheumatoid arthritis: interim results from an ongoing multicenter, open-label, extended-treatment trial. Arthritis Rheum. 48, 218-226 (2003). 19. Lovell,D.J. et al. Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis. Arthritis Rheum. 58, 1496-1504 (2008). 20. Prince,F.H. et al. Long-term follow-up on effectiveness and safety of etanercept in JIA: the Dutch national register. Ann. Rheum. Dis. (2008). 21. Horneff,G. et al. Safety and efficacy of combination of Etanercept and Methotrexate compared to treatment with Etanercept only in patients with juvenile idiopathic arthritis (JIA). Preliminary data from the German JIA Registry. Ann. Rheum. Dis. (2008). 22. Nielsen,S. et al. Preliminary evidence that etanercept may reduce radiographic progression in juvenile idiopathic arthritis. Clin. Exp. Rheumatol. 26, 688-692 (2008). 23. Kuemmerle-Deschner,J.B. & Horneff,G. Safety and efficacy of once-weekly application of Etanercept in children with juvenile idiopathic arthritis. Rheumatol. Int. 28, 153-156 (2007). 24. Prince,F.H., Twilt,M., Jansen-Wijngaarden,N.C. & Suijlekom-Smit,L.W. Effectiveness of a once weekly double dose of etanercept in patients with juvenile idiopathic arthritis: a clinical study. Ann. Rheum. Dis. 66, 704-705 (2007). 25. Wallace,C.A., Ruperto,N. & Giannini,E. Preliminary criteria for clinical remission for select categories of juvenile idiopathic arthritis. J. Rheumatol. 31, 2290-2294 (2004). 26. Singh,G., Athreya,B.H., Fries,J.F. & Goldsmith,D.P. Measurement of health status in children with juvenile rheumatoid arthritis. Arthritis Rheum. 37, 1761-1769 (1994). 27. Wulffraat,N. et al. The Dutch version of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ). Clin. Exp. Rheumatol. 19, S111-S115 (2001). 28. Fuchs,H.A. & Pincus,T. Reduced joint counts in controlled clinical trials in rheumatoid arthritis. Arthritis Rheum. 37, 470-475 (1994). 29. Len,C. et al. Pediatric Escola Paulista de Medicina Range of Motion Scale: a reduced joint count scale for general use in juvenile rheumatoid arthritis. J. Rheumatol. 26, 909-913 (1999). 30. Duffy,C.M. Measurement of health status, functional status, and quality of life in children with juvenile idiopathic arthritis: clinical science for the pediatrician. Pediatr. Clin. North Am. 52, 359-72, v (2005).

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

1. All new patients with JIA with the oligo- and polyarticular subtype, treated in one of the Dutch pediatric rheumatology centers with a maximum of 18 months symptoms with active disease despite 4 months NSAIDs and/or intra-articular steroids.

Exclusion Criteria

1. Systemic JIA

2. Pretreatment with methotrexate, prednisone and/or etanercept (for > 3 months)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Time to remission.<br /><br>2. Time to flare.<br />

Secondary Outcome Measures

Name	Time	Method
1. PRINTO-score. <br /><br>2. Quality of Life. <br /><br>3. Safety. <br /><br>4. Joint damage.<br /> <br>5. Costs of medication.<br /><br><br /> <br>Nature and extent of the burden and risks associated.