Patients with oligoarticular onset or rheumatoid factor negative polyarticular JIA followed in tertiary care center for paediatric rheumatology. MedDRA version: 19.0 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: ENBREL
Product Name: ENBREL
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Etanercept
Other descriptive name: Etanercept
Concentration unit: mg/ml milligram(s)/millilitre
Con
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria - Patient aged 2 to 17 years and treated with etanercept or tocilizumab or adalimumab or patient aged 6 to 17 years and treated with abatacept. - Patient with oligoarticular or polyarticular rheumatoid factor negative JIA - Patient treated with biologic treatment for persistent arthritis according to the marketing authorization. - Patient who achieved inactive disease within one year of treatment with the last biologic agent administered, according to Wallace criteria : no joints with active arthritis, no active uveitis (the Standardization of Uveitis Nomenclature (SUN) Working Group defines inactive anterior uveitis as "grade zero cells," indicating_1 cell in field sizes of 1 mm by a 1-mm slit beam), ESR or CRP level within normal limits in the laboratory where tested (or, if elevated, not attributable to JIA), physician's global assessment of disease activity score (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria - Patient with systemic form, rheumatoid factor positive, psoriatic or associated enthesitis related JIA. - Patient undergoing biologic therapy due to JIA-associated uveitis or with active uveitis at time of randomization. - Patient with any contraindication to continue ongoing biologic treatment, notably ongoing uncontrolled infection, suspicion or evidence of demyelinating disease of the central nervous system, ... - Pregnancy or absence of effective contraception (including abstinence) in a pubertal patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary assessment criteria The primary outcome is the persistence of inactive disease 24 weeks after randomization. Inactive disease is defined by the criterion of Wallace 1 28: - no joints with active arthritis, - no active uveitis as defined by the SUN Working Group 2, (The Standardization of Uveitis Nomenclature (SUN) Working Group defines inactive anterior uveitis as "grade zero cells," indicating_1 cell in field sizes of 1 mm by a 1-mm slit beam), - erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) level within normal limits in the laboratory where tested or, if elevated, not attributable to JIA, - physician's global assessment of disease activity score (< 10/100 visual analogue scale), - and duration of morning stiffness 15 minutes (within 7 days before the visit). For all the visits, joint counts and physician global assessment of disease activity will be performed by an investigator blinded to patient study group. Secondary assessment criteria - Persistent inactive disease at W72 as defined by Wallace criteria. - Adverse and serious adverse events and special interest at each time point. - The JADAS at each time point (Juvenile Arthritis Disease Activity Score), which includes the child or parental assessment of disease activity. - Biological agent and anti-drug antibodies concentrations at each time point during treatment and 12 weeks after the end of treatment. - Pharmacogenomic analysis. - Concentration of S100 proteins (MRP8/14) every 24 weeks. - The scores of quality of life every 24 weeks with: - The Paediatric Quality of Life Inventory 4.0 Generic Core Scale 29, - The Childhood Health Assessment Questionnaire (CHAQ) 30 , - Life Quality Questionnaire related to the health (EQ-5D Y) 31. -The cost of both strategies and economic evaluation of early withdrawal. ;Main Objective: Primary objective Demonstrate the non inferiority of a strategy of early tapering of biological agent, compared to the maintenance of sta | — |
Countries
France
Contacts
Public ContactDRCD Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed