Overview

Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis

Status:
Unknown status
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached. Goals: 1. to investigate in a randomized controlled trial: - which proportion of JIA patients in remission can successfully discontinue etanercept compared to JIA patients in remission who continue etanercept; - if time in remission on etanercept is an important factor in retaining remission after discontinuation of etanercept. 2. to investigate in alle JIA patients who discontinue etanercept (including the control group): - predicting factors (patient or disease characteristics, including time in remission, and MRP8/MRP14) for successfully discontinuation of etanercept; - the disease course after discontinuation of etanercept (time to flare) and the effect of restarting etanercept after flaring.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Erasmus Medical Center
Collaborator:
Dutch Arthritis Association
Treatments:
Etanercept
Criteria
Inclusion Criteria:

- Diagnosis of Juvenile Idiopathic Arthritis (all subtypes) by the International League
of Associations of Rheumatology (ILAR) criteria

- On etanercept therapy

- No MTX or low dose MTX (maximum 10 mg/m2)

- 3 or more months in remission according to the criteria of Wallace (i.e. 9 or more
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:

- Systemic corticosteroids (up to 9 months prior to inclusion)

- Intra-articular corticosteroids (up to 6 months prior to inclusion)

- Synthetic DMARDs besides low dose MTX (up to 9 months prior to inclusion)

- Biologic DMARDs besides etanercept (up to 9 months prior to inclusion)