BeSt for kids: A randomized clinical trial to test the effectiveniss of different treatment strategies in patients with Juvenile Idiopathic Arthritis

Completed

Conditions: chronic arthritis of childhood
juvenile idiopathic arthritis
10003816
10023213

Registration Number: NL-OMON38311

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

all new patients with oligoarticular JIA (persistent and extended), RF negative polyarticular JIA and juvenile psoriatic arthritis according to ILAR classification
diagnosis between age 2-16 years
treated in one of the Dutch pediatric rheumatology centers
with a maximum of 18 months symptoms
patients with polyarthritis with active disease requiring a DMARD
patients with oligoarthritis requiring a DMARD (i.e.with active disease despite 4 months NSAIDs and/or intra-articular glucocorticoids

Exclusion Criteria

systemic JIA, RF positive JIA, JIA with enthesitis, unclassified JIA
previous treatment with DMARDs or biologicals
known contraindication for one of the study drugs
bone marrow hypoplasia
a compromised immune system
sepsis or risk of sepsis
See page 14 of the protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>I Time to inactive disease: the duration of time that it takes to achieve the<br /><br>situation of no active synovitis, no active uveitis, normal ESR/CRP, no disease<br /><br>activity according to phycisians global assessment<br /><br><br /><br>II Time to flare: the duration of time until a flare of the disease, defined as<br /><br>a minimum of 40% worsening in a minimum of 2 out of 6 components with no more<br /><br>than one component improving by >30% (see secundary study parameters).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary outcome measures<br /><br>I PRINTO-score (Pediatric Rheumatology International Trial Organisation),<br /><br>consisting of<br /><br>1) physicians global assessment of overall disease activity<br /><br>2) parents/patient*s global assessment of overall well-being<br /><br>3) functional ability<br /><br>4) the number of joints with active disease<br /><br>5) the number of joints with limitation of motion<br /><br>6) the erythrocyte sedimentation rate<br /><br><br /><br>II Quality of Life will be measured using the CHQ (Child Health Questionnaire)<br /><br><br /><br>III Safety: as measured by the number of (serious) adverse events<br /><br><br /><br>IV Joint damage will be deducted from radiographs of the involved joints<br /><br><br /><br>V Costs of medication<br /><br></p><br>