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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Erasmus Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Dutch Arthritis Association
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01287715
First received: January 31, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached.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

Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: etanercept
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: When and in Whom to Stop Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • Flare-rate [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    To evaluate if the flare-rate is different between the 2 arms (continuation and discontinuation of etanercept).


Secondary Outcome Measures:
  • Duration of remission before withdrawal of etanercept [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.

  • Predictors for successful discontinuation of etanercept [ Time Frame: 12 months after discontinuation of etanercept ] [ Designated as safety issue: No ]
    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.

  • Disease course after flaring [ Time Frame: 6 months after flare ] [ Designated as safety issue: No ]
    After a flare (exacerbation) occurs: evaluation of time to flare and the effect of restarting etanercept after flaring.


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STOP-arm
Discontinuation of etanercept
Drug: etanercept
Discontinuation of etanercept (half of the dosis for 3 months and discontinuation thereafter)
Other Name: 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
Continuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter.
Other Name: enbrel

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

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287715

Contacts
Contact: LWA van Suijlekom-Smit, MD,PhD,MSCE +31-10-7036146 l.vansuijlekom@erasmusmc.nl
Contact: MH Otten, MD +31-10-7036778 m.otten@erasmusmc.nl

Locations
Netherlands
Academic Medical Centre Emma Children's Hospital Not yet recruiting
Amsterdam, Netherlands
Contact: MAJ van Rossum, MD, PhD       m.a.vanrossum@amc.uva.nl   
Principal Investigator: MAJ van Rossum, MD, PhD         
Reade Institute Amsterdam Not yet recruiting
Amsterdam, Netherlands
Contact: MAJ van Rossum, MD, PhD       m.a.vanrossum@amc.uva.nl   
Principal Investigator: MAJ van Rossum, MD, PhD         
Sint-Lucas Andreas Hospital Active, not recruiting
Amsterdam, Netherlands
University Medical Centre Groningen Not yet recruiting
Groningen, Netherlands
Contact: W Armbrust, MD, PhD       w.armbrust@bkk.umcg.nl   
Principal Investigator: W Armbrust, MD, PhD         
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands
Contact: R ten Cate, MD, PhD       r.tencate@lumc.nl   
Principal Investigator: R ten Cate, MD, PhD         
Maastricht University Medical Centre Not yet recruiting
Maastricht, Netherlands
Contact: SL Gorter, MD, PhD       sgo@sint.azm.nl   
Principal Investigator: SL Gorter, MD, PhD         
St Maartenskliniek Not yet recruiting
Nijmegen, Netherlands
Contact: EPAH Hoppenreijs, MD, PhD       e.hoppenreijs@cukz.umcn.nl   
Principal Investigator: EPAH Hoppenreijs, MD, PhD         
Erasmus MC Sophia Children's Hospital Recruiting
Rotterdam, Netherlands
Contact: LWA van Suijlekom-Smit, MD,PhD,MSCE       l.vansuijlekom@erasmusmc.nl   
Principal Investigator: LWA van Suijlekom-Smit, MD,PhD,MSCE         
Haga Hospital, Juliana Children's Hospital Not yet recruiting
The Hague, Netherlands
Contact: Y Koopman, MD       y.koopman@hagaziekenhuis.nl   
Principal Investigator: Y Koopman, MD         
Utrecht Medical Centre Wilhelmina Children's Hospital Not yet recruiting
Utrecht, Netherlands
Contact: R van Royen, MD, PhD       a.vanroyen@umcutrecht.nl   
Principal Investigator: A van Royen, MD, PhD         
Sponsors and Collaborators
Erasmus Medical Center
Dutch Arthritis Association
Investigators
Principal Investigator: LWA van Suijlekom-Smit, MD,PhD,MSCE Erasmus Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: L.W.A. van Suijlekom-Smit, MD, PhD, MSCE, Erasmus Medical Center Sophia Children's Hospital
ClinicalTrials.gov Identifier: NCT01287715     History of Changes
Other Study ID Numbers: NR 10-1-203
Study First Received: January 31, 2011
Last Updated: January 31, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014