NL-OMON34350CompletedPhase 4
When and in whom to stop etanercept after successful treatment of Juvenile Idiopathic Arthritis - Withdrawal of etanercept after successful treatment
Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites50 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 to 17 (—)
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.
Investigators
Similar Trials
Unknown
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