When and in whom to stop etanercept after successful treatment of Juvenile Idiopathic Arthritis

Phase 4

Completed

Conditions: juvenile arthritis
juvenile idiopathic arthritis
10003816

Registration Number: NL-OMON34350

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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 <18 years at start of study
- Written informed consent from parents and patients 12 years and over

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1:<br /><br>- Flare-rate (adjusted for time in remission before discontinuation and JIA<br /><br>subtype)<br /><br><br /><br>Part 2:<br /><br>- Prediction model for successful discontinuation of etanercept (variabels:<br /><br>duration of remission till withdrawal etanercept, MTX comedication at<br /><br>inclusion, optimal dosage of MTX given before start, subtype JIA, MRP8/ MRP14,<br /><br>presence of pre-existent radiological damage)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part 1:<br /><br>- Patient- and disease characteristics of the patients with a exacerbation<br /><br>- Flare-rate in the subgroups 3-9 en 9-18 months in remissie with etanercept.<br /><br>- Number of patients with protocol violence.<br /><br><br /><br>Deel 2:<br /><br>- Number of patient with persistent remmission 12 months after discontinuation<br /><br>fo therapy.<br /><br>- Course of the disease after re-introduction of etanercept in case of a<br /><br>exacerbation (using ACR pedi 30/50/70 criteria).<br /><br>- Number of patients with protocol violence.<br /><br>- Response of psoriatic skin lesions (if possible).</p><br>