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Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis

Information source: Erasmus Medical Center
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Juvenile Idiopathic Arthritis

Intervention: etanercept (Drug); etanercept (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Erasmus Medical Center

Official(s) and/or principal investigator(s):
LWA van Suijlekom-Smit, MD,PhD,MSCE, Principal Investigator, Affiliation: Erasmus Medical Center

Overall contact:
LWA van Suijlekom-Smit, MD,PhD,MSCE, Phone: +31-10-7036146, Email: l.vansuijlekom@erasmusmc.nl

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The purpose of this study is to determine whether etanercept can be withdrawn successfully (i. e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached.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.

Clinical Details

Official title: When and in Whom to Stop Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Flare-rate

Secondary outcome:

Duration of remission before withdrawal of etanercept

Predictors for successful discontinuation of etanercept

Disease course after flaring

Detailed description: Juvenile Idiopathic Arthritis (JIA) is the most common cause of chronic arthritis in children. Etanercept has proven to be an effective treatment for JIA. Considering the risk of occurrence of long-term side-effects and to prevent the burden of the weekly injections and costs, it is a logical step to discontinue etanercept after reaching remission (no disease activity for at least six months). Especially since there are concerns about the long-term effect of suppressing the immune system with etanercept. However, little is known about if successful discontinuation is possible or when to stop. Risk is that the disease might flare (reactivate) again. For this study, JIA patients in remission will be selected from the ABC-register (an observational study including all Dutch JIA patients who use etanercept). Eligible patients will be randomized to stop etanercept or continue it for another 9 months. Patients are followed with standard visits evaluating disease activity until 12 months after discontinuation of etanercept. In case of a disease flare etanercept therapy will be reintroduced immediately and the patient will be treated according to the insight of their treating physician. Expected is that JIA patients who were in remission for more than 12 months before discontinuation have a better chance to retain remission.

Eligibility

Minimum age: 4 Years. Maximum age: 17 Years. Gender(s): Both.

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)

Locations and Contacts

LWA van Suijlekom-Smit, MD,PhD,MSCE, Phone: +31-10-7036146, Email: l.vansuijlekom@erasmusmc.nl

Academic Medical Centre Emma Children's Hospital, Amsterdam, Netherlands; Not yet recruiting
MAJ van Rossum, MD, PhD, Email: m.a.vanrossum@amc.uva.nl
MAJ van Rossum, MD, PhD, Principal Investigator

Reade Institute Amsterdam, Amsterdam, Netherlands; Not yet recruiting
MAJ van Rossum, MD, PhD, Email: m.a.vanrossum@amc.uva.nl
MAJ van Rossum, MD, PhD, Principal Investigator

Sint-Lucas Andreas Hospital, Amsterdam, Netherlands; Active, not recruiting

University Medical Centre Groningen, Groningen, Netherlands; Not yet recruiting
W Armbrust, MD, PhD, Email: w.armbrust@bkk.umcg.nl
W Armbrust, MD, PhD, Principal Investigator

Leiden University Medical Center, Leiden, Netherlands; Not yet recruiting
R ten Cate, MD, PhD, Email: r.tencate@lumc.nl
R ten Cate, MD, PhD, Principal Investigator

Maastricht University Medical Centre, Maastricht, Netherlands; Not yet recruiting
SL Gorter, MD, PhD, Email: sgo@sint.azm.nl
SL Gorter, MD, PhD, Principal Investigator

St Maartenskliniek, Nijmegen, Netherlands; Not yet recruiting
EPAH Hoppenreijs, MD, PhD, Email: e.hoppenreijs@cukz.umcn.nl
EPAH Hoppenreijs, MD, PhD, Principal Investigator

Erasmus MC Sophia Children's Hospital, Rotterdam, Netherlands; Recruiting
LWA van Suijlekom-Smit, MD,PhD,MSCE, Email: l.vansuijlekom@erasmusmc.nl
LWA van Suijlekom-Smit, MD,PhD,MSCE, Principal Investigator

Haga Hospital, Juliana Children's Hospital, The Hague, Netherlands; Not yet recruiting
Y Koopman, MD, Email: y.koopman@hagaziekenhuis.nl
Y Koopman, MD, Principal Investigator

Utrecht Medical Centre Wilhelmina Children's Hospital, Utrecht, Netherlands; Not yet recruiting
R van Royen, MD, PhD, Email: a.vanroyen@umcutrecht.nl
A van Royen, MD, PhD, Principal Investigator

Additional Information

Link to ABC-register (observational study including all JIA patients who use biological agents in The Netherlands)

Starting date: January 2011
Last updated: January 31, 2011

Page last updated: November 27, 2014

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