BeSt for kids: comparing treatment strategies in juvenile idiopathic arthritis.|
|- candidate number||4663|
|- NTR Number||NTR1574|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-dec-2008|
|- Secondary IDs||Bestforkids MEC LUMC|
|- Public Title||BeSt for kids: comparing treatment strategies in juvenile idiopathic arthritis.|
|- Scientific Title||BeSt for kids: A randomized clinical trial to test the effectiveniss of different treatment strategies in patients with Juvenile Idiopathic Arthritis. |
|- ACRONYM||BeSt for kids|
|- hypothesis||treatment strategy will induce a swift remission which will ameliorate the outcome.|
|- Healt Condition(s) or Problem(s) studied||Trauma , Juvenile idiopathic arthritis (JIA), Treatment, Etanercept, Treatment strategies , Sulfasalazine, Methotrexate , Prednison|
|- 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)
3. Bone marrow hypoplasia
4. Sepsis or risk of sepsis
5. Current or recent infections (last three months), including chronic or localized:
evidence of active CMV or EBV, infectious hepatitis, active pneumocystis carinii, drug resistant atypical mycobacterium or other bacterial infections. Documented HIV infection
6. Positive signs or symptoms, by physical examination or PPD and/or X-thorax, of latent or active tuberculosis in patients who cannot/will not be treated with the appropriate antibiotic treatment, as recommended by the local specialist
7. History of lymphoproliferative disease including lymphoma or signs suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or splenomegaly
8. Other comorbidity that prevents treatment with oral corticosteroids and/or sulfasalazine and/or methotrexate and/or etanercept, or other comorbidity that, in the opinion of the pediatrician, prevents participation in the trial
9. Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study
10. Previous clinical trial involvement in last 3 months
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2009|
|- planned closingdate||1-jun-2013|
|- Target number of participants||180|
|- Interventions||After informed consent, patients will be randomised to one of 3 treatment strategies: |
1. Initial sulfasalazine 50 mg/kg/dag, next methotrexate 10 mg/m2/week (followed by MTX dose increase 15 mg/m2/week), next etanercept 0,8 mg/kg/week + MTX10 mg/m2/week.
2. Initial MTX 10 mg/m2/week and prednisone bridging (followed by MTX dose increase 15 mg/m2/week), next etancercept 0,8 mg/kg/week + MTX 10 mg/m2/week.
3. Initial etanercept 0,8 mg/kg/week with MTX 10 mg/m2/week.
ACR 50, next target: remission according to definition of Wallace.
Tapering of drugs after three months clinical remission according to Wallace for oligoarticular JIA and six months for polyarticular JIA.
There is no controlgroup.
|- Primary outcome||1. Time to remission.|
2. Time to flare.
|- Secondary outcome||1. PRINTO-score. |
2. Quality of Life.
4. Joint damage.
5. Costs of medication.
Nature and extent of the burden and risks associated.
|- Timepoints||three-monthly visits|
two year follow-up
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. R. Cate, ten|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R. Cate, ten|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Wyeth Pharmaceuticals BV|
|- Publications||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).
|- Brief summary||Disease outcome for children with all subsets of juvenile Idiopathic Arthritis is disappointing. As longstanding disease activity leads to damage of joints and possible incapacity early introduction ie within the window of opportunity of "powerfull" medication is compared with the classic treatment. This early intervention may induce rapid remission enabling the treating phycisian to taper and stop this medication. |
|- Main changes (audit trail)|
|- RECORD||3-dec-2008 - 15-dec-2008|
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