Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis (ABC-STOP)

January 31, 2011 updated by: Erasmus Medical Center

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

The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached.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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Not yet recruiting
        • Academic Medical Centre Emma Children's Hospital
        • Contact:
        • Principal Investigator:
          • MAJ van Rossum, MD, PhD
      • Amsterdam, Netherlands
        • Not yet recruiting
        • Reade Institute Amsterdam
        • Contact:
        • Principal Investigator:
          • MAJ van Rossum, MD, PhD
      • Amsterdam, Netherlands
        • Active, not recruiting
        • Sint-Lucas Andreas Hospital
      • Groningen, Netherlands
        • Not yet recruiting
        • University medical centre Groningen
        • Contact:
        • Principal Investigator:
          • W Armbrust, MD, PhD
      • Leiden, Netherlands
        • Not yet recruiting
        • Leiden University Medical Center
        • Contact:
        • Principal Investigator:
          • R ten Cate, MD, PhD
      • Maastricht, Netherlands
        • Not yet recruiting
        • Maastricht University Medical Centre
        • Contact:
        • Principal Investigator:
          • SL Gorter, MD, PhD
      • Nijmegen, Netherlands
        • Not yet recruiting
        • St Maartenskliniek
        • Contact:
        • Principal Investigator:
          • EPAH Hoppenreijs, MD, PhD
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus MC Sophia Children's Hospital
        • Contact:
        • Principal Investigator:
          • LWA van Suijlekom-Smit, MD,PhD,MSCE
      • The Hague, Netherlands
        • Not yet recruiting
        • Haga Hospital, Juliana Children's Hospital
        • Contact:
        • Principal Investigator:
          • Y Koopman, MD
      • Utrecht, Netherlands
        • Not yet recruiting
        • Utrecht Medical Centre Wilhelmina Children's Hospital
        • Contact:
        • Principal Investigator:
          • A van Royen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: STOP-arm
Discontinuation of etanercept
Drug: etanercept
Discontinuation of etanercept (half of the dosis for 3 months and discontinuation thereafter)
Other Names:
  • enbrel
Drug: etanercept
Continuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter.
Other Names:
  • enbrel
NO_INTERVENTION: CONTROL-arm
Continuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter.
Drug: etanercept
Discontinuation of etanercept (half of the dosis for 3 months and discontinuation thereafter)
Other Names:
  • enbrel
Drug: etanercept
Continuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter.
Other Names:
  • enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flare-rate
Time Frame: 9 months
To evaluate if the flare-rate is different between the 2 arms (continuation and discontinuation of etanercept).
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of remission before withdrawal of etanercept
Time Frame: 9 months
To evaluate between the 2 arms (continuation and discontinuation of etanercept) if time in remission on etanercept is an important factor in retaining remission after discontinuation of etanercept.
9 months
Predictors for successful discontinuation of etanercept
Time Frame: 12 months after discontinuation of etanercept
Evaluation of predictors (patient or disease characteristics, including time in remission, and MRP8/MRP14) for successful discontinuation of etanercept in all JIA patient who discontinue etanercept.
12 months after discontinuation of etanercept
Disease course after flaring
Time Frame: 6 months after flare
After a flare (exacerbation) occurs: evaluation of time to flare and the effect of restarting etanercept after flaring.
6 months after flare

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

Dutch Arthritis Association

Investigators

  • Principal Investigator: LWA van Suijlekom-Smit, MD,PhD,MSCE, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ANTICIPATED)

September 1, 2012

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

January 31, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (ESTIMATE)

February 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2011

Last Update Submitted That Met QC Criteria

January 31, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR 10-1-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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