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Clinical Trials/NL-OMON34350
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

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