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|
|- status||stopped: trial finished|
|- 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|
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.
1. Cassidy JT, Petty,R.E., Laxer,R.M. & Lindsey CB. Textbook of Pediatric Rheumatology. 2006.
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|- 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)||07-nov-2018 MT: |
Publication most important results:
PMID: 30309970 and PMID: 28166785.
|- RECORD||3-dec-2008 - 9-nov-2018|
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