Treatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREM

Phase 1

• Conditions: Patients with oligoarticular onset or rheumatoid factor negative polyarticular JIA followed in tertiary care center for paediatric rheumatology.; MedDRA version: 19.0Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2016-000312-15-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-17
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 230

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 (< 10/100 visual analogue scale), and duration of morning stiffness 15 minutes (within 7 days before the visit).
- Patient with inactive disease achieved for less than 6 months.
- Patient with stable doses of non-steroidal anti-inflammatory drugs, Methotrexate (maximum 20 mg/m2/week), and other non biologic DMARD for at least one month before inclusion.
- Patient without steroids or joint injection or live vaccines injection for at least one month.
- Signed informed consent by both parents (or legal guardian) and patient's agreement.
- Patient affiliated to the National Health Assurance system.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified