EUCTR2006-000089-35-IT进行中（未招募）不适用
Phase II, open label, international, multicentre clinical trial to investigate safety and efficacy of oral ITF 2357 in patients with active systemic onset juvenile idiopathic arthritis SOJIA - ND
ITALFARMACO0 个研究点目标入组 16 人开始时间: 2006年8月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
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
- •- established diagnosis of Systemic Onset Juvenile Idiopathic Arthritis SOJIA according to ILAR criteria for at least six months before the study entry, with inadequate response or intolerance to standard therapy with oral steroids and/or methotrexate, with or without previously used biologic agents. - active disease for at least one month prior to enrolment - age at enrolment between 2 and 25 years - age at first SOJIA diagnosis 16 years - reviously introduced standard treatment of disease with steroids without satisfactory effect and concomitant treatment with oral steroids at a dose equivalent to 0,2 mg/kg/day of prednisolone, unmodified for at least four weeks before patient s enrolment - previously introduced methotrexate treatment for at least three months, without satisfactory results on disease activity or with drug intolerability; and concomitant methotrexate, if any, on a stable dose 61619; 10 mg/m2 weekly for at least four weeks before patient s enrolment - concomitant nonsteroidal anti-inflammatory drugs, if any, on a stable dose for at least four weeks before patient s enrolment
- •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
- •- any active infection irrespective of its severity - history of macrophage activation syndrome - clinically significant illness - psychiatric illness - congenital heart and/or central nervous system disorders - inherited metabolic diseases - HIV infection or active hepatitis B and/or C
研究者
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