EUCTR2016-000312-15-FR进行中（未招募）1 期
Treatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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