Dose-to-target of etanercept treatment: a dose-tapering randomized controlled trial in patients with juvenile idiopathic arthritis in patients age 12 years and older.
- Conditions
- juvenile idiopathic arthritis10003816
- Registration Number
- NL-OMON40793
- Lead Sponsor
- Jan van Breemen Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
• 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).
Planned reasons for treatment discontinuation.
JIA, type: systemic arthritis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the proportion of patients with JIA maintaining Minimal Disease<br /><br>Activity after dose interval prolongation of etanercept. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To study the cost-effectiveness of tapering down etanercept treatment.<br /><br>To investigate whether the lowest effective etanercept dose will reduce the<br /><br>risk of adverse events.<br /><br>To study the predictive value of serum etanercept trough levels and other<br /><br>patient related factors for successful down titration.</p><br>