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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached.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

Condition or disease	Intervention/treatment	Phase
Juvenile Idiopathic Arthritis	Drug: etanercept	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	When and in Whom to Stop Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis
Study Start Date :	January 2011
Estimated Primary Completion Date :	September 2012
Estimated Study Completion Date :	September 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	4 Years to 17 Years (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	February 1, 2011
Last Update Posted:	February 1, 2011
Last Verified:	January 2011

Additional relevant MeSH terms:

Arthritis; Arthritis, Juvenile; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Etanercept; Anti-Inflammatory Agents, Non-Steroidal	Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Immunosuppressive Agents; Immunologic Factors