etanercept, juvenile idiopathic arthritis, dose tapering, discontinuation
Conditions
Interventions
Phase 1:
Patients with low disease activity will be randomly assigned to continuation of etanercept 50 mg or 0,8 mg/kg per week or etanercept 50 mg per two weeks or treatment with etanercept of 0,8 m
Sponsors
Jan van Breemen Instituut, Reade
Eligibility
Inclusion criteria
Inclusion criteria: • Diagnosis: JIA, types: polyarthritis (RF negative and RF positive), oligo-arthritis (persistant and extended), psoriasic and enthesitis related arthritis and undifferentiated arthritis (according to the ILAR criteria). • Age 12 years or older. • Treatment with etanercept 50 mg SC weekly (or 25 mg SC twice weekly) or treatment with weekly dose etanercept of 0,8 mg/kg for at least 6 subsequent months. • Minimal Disease Activity, according to the JADAS criteria for Minimal Disease Activity at baseline and clinically low disease activity according to the rheumatologist for at least 6 months to baseline. • No uveitis for a minimum of 12 months. • No use of systemic corticosteroids or intra-articular steroids for a minimum of 6 months prior to baseline. • Written informed consent by the patient (and if applicable, the parents).
Exclusion criteria
Exclusion criteria: • Planned reasons for treatment discontinuation. • JIA, type: systemic arthritis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the proportion of patients with JIA maintaining Minimal Disease Activity after dose interval prolongation of etanercept. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study the cost-effectiveness of tapering down etanercept treatment; 2. To investigate whether the lowest effective etanercept dose will reduce the risk of adverse events; 3. To study the predictive value of serum etanercept trough levels and other patient related factors for successful down titration. | — |
Contacts
Public ContactG.J. Wolbink
Dr. Jan van Breemenstraat 2, 1065 AB Amsterdam
Outcome results
None listed