NCT01287715

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The purpose of this study is to determine whether etanercept can be withdrawn successfully (i.e. no occurrence of flares) in juvenile idiopathic arthritis (JIA) patients in whom disease remission is reached.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

  • 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.
  • 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

Enrollment Period

1.7 years

First QC Date

January 31, 2011

Last Update Submit

January 31, 2011

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Flare-rate

    To evaluate if the flare-rate is different between the 2 arms (continuation and discontinuation of etanercept).

    9 months

Secondary Outcomes (3)

  • Duration of remission before withdrawal of etanercept

    9 months

  • Predictors for successful discontinuation of etanercept

    12 months after discontinuation of etanercept

  • Disease course after flaring

    6 months after flare

Study Arms (2)

STOP-arm

EXPERIMENTAL

Discontinuation of etanercept

Drug: etanercept

CONTROL-arm

NO INTERVENTION

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

Drug: etanercept

Interventions

etanerceptDRUG

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

Also known as: enbrel
STOP-arm

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Academic Medical Centre Emma Children's Hospital

Amsterdam, Netherlands

NOT YET RECRUITING

Reade Institute Amsterdam

Amsterdam, Netherlands

NOT YET RECRUITING

Sint-Lucas Andreas Hospital

Amsterdam, Netherlands

ACTIVE NOT RECRUITING

University Medical Centre Groningen

Groningen, Netherlands

NOT YET RECRUITING

Leiden University Medical Center

Leiden, Netherlands

NOT YET RECRUITING

Maastricht University Medical Centre

Maastricht, Netherlands

NOT YET RECRUITING

St Maartenskliniek

Nijmegen, Netherlands

NOT YET RECRUITING

Erasmus MC Sophia Children's Hospital

Rotterdam, Netherlands

RECRUITING

Haga Hospital, Juliana Children's Hospital

The Hague, Netherlands

NOT YET RECRUITING

Utrecht Medical Centre Wilhelmina Children's Hospital

Utrecht, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Etanercept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • LWA van Suijlekom-Smit, MD,PhD,MSCE

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LWA van Suijlekom-Smit, MD,PhD,MSCE

CONTACT

+31-10-7036146l.vansuijlekom@erasmusmc.nl

MH Otten, MD

CONTACT

+31-10-7036778m.otten@erasmusmc.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 1, 2011

Study Start

January 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

February 1, 2011

Record last verified: 2011-01

Locations

NL(10)