chronic arthritis of childhood juvenile idiopathic arthritis
Conditions
Interventions
randomisation according to the study design (see above)
Sponsors
Academisch Medisch Centrum
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I Time to inactive disease: the duration of time that it takes to achieve the situation of no active synovitis, no active uveitis, normal ESR/CRP, no disease activity according to phycisians global assessment II Time to flare: the duration of time until a flare of the disease, defined as a minimum of 40% worsening in a minimum of 2 out of 6 components with no more than one component improving by >30% (see secundary study parameters). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcome measures I PRINTO-score (Pediatric Rheumatology International Trial Organisation), consisting of 1) physician*s global assessment of overall disease activity 2) parent*s/patient*s global assessment of overall well-being 3) functional ability 4) the number of joints with active disease 5) the number of joints with limitation of motion 6) the erythrocyte sedimentation rate II Quality of Life will be measured using the CHQ (Child Health Questionnaire) III Safety: as measured by the number of (serious) adverse events IV Joint damage will be deducted from radiographs of the involved joints V Costs of medication | — |
Countries
Netherlands
Outcome results
None listed