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Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis

NCT01287715 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-02-01

No results posted yet for this study

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The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached.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

Conditions

  • Juvenile Idiopathic Arthritis

Interventions

DRUG

etanercept

Discontinuation of etanercept (half of the dosis for 3 months and discontinuation thereafter)

DRUG

etanercept

Continuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter.

Sponsors & Collaborators

Principal Investigators

  • LWA van Suijlekom-Smit, MD,PhD,MSCE · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-09-30
Completion
2013-09-30

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01287715 on ClinicalTrials.gov