Withdrawal of Etanercept After Successful Treatment of Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

— ABC-STOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01287715
• Other study ID #: NR 10-1-203
• Status: Recruiting
• Phase: Phase 4
• First received: January 31, 2011
• Last updated: January 31, 2011
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: January 2011
• Source: Erasmus Medical Center
• Contact: LWA van Suijlekom-Smit, MD,PhD,MSCE
• Phone: +31-10-7036146
• Email: l.vansuijlekom[@]erasmusmc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

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The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached.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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• etanercept
Discontinuation of etanercept (half of the dosis for 3 months and discontinuation thereafter)
• etanercept
Continuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter.

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre Emma Children's Hospital	Amsterdam
Netherlands	Reade Institute Amsterdam	Amsterdam
Netherlands	Sint-Lucas Andreas Hospital	Amsterdam
Netherlands	University Medical Centre Groningen	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Maastricht University Medical Centre	Maastricht
Netherlands	St Maartenskliniek	Nijmegen
Netherlands	Erasmus MC Sophia Children's Hospital	Rotterdam
Netherlands	Haga Hospital, Juliana Children's Hospital	The Hague
Netherlands	Utrecht Medical Centre Wilhelmina Children's Hospital	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Dutch Arthritis Association

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flare-rate	To evaluate if the flare-rate is different between the 2 arms (continuation and discontinuation of etanercept).	9 months	Yes
Secondary	Duration of remission before withdrawal of etanercept	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	No
Secondary	Predictors for successful 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	No
Secondary	Disease course after flaring	After a flare (exacerbation) occurs: evaluation of time to flare and the effect of restarting etanercept after flaring.	6 months after flare	No