juvenile arthritis juvenile idiopathic arthritis
Conditions
Interventions
Intervention: withdrawal of etanercept therapy.
Control: continuation of therapy (etanercept).
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: - Diagnosis of Juvenile Idiopathic Arthritis (all subtypes) by the International League of Associations of Rheumatology (ILAR) criteria - On etanercept therapy - Concomitant therapy allowed are: NSAIDs, low dose MTX (maximum 10 mg/m2), and other medications not related to the treatment of JIA. - 3 to 18 months in remission according to the criteria of Wallace (i.e. 9 to 24 months of inactive disease) - Age >=4 and
Exclusion criteria
Exclusion criteria: Concomitant medications not allowed are: corticosteroids (including intra-articular corticosteroids up to 6 months prior to inclusion) and other synthetic and biologic DMARDs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: - Flare-rate (adjusted for time in remission before discontinuation and JIA subtype) Part 2: - Prediction model for successful discontinuation of etanercept (variabels: duration of remission till withdrawal etanercept, MTX comedication at inclusion, optimal dosage of MTX given before start, subtype JIA, MRP8/ MRP14, presence of pre-existent radiological damage) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: - Patient- and disease characteristics of the patients with a exacerbation - Flare-rate in the subgroups 3-9 en 9-18 months in remissie with etanercept. - Number of patients with protocol violence. Deel 2: - Number of patient with persistent remmission 12 months after discontinuation fo therapy. - Course of the disease after re-introduction of etanercept in case of a exacerbation (using ACR pedi 30/50/70 criteria). - Number of patients with protocol violence. - Response of psoriatic skin lesions (if possible). | — |
Countries
Netherlands
Outcome results
None listed