EUCTR2009-017938-46-DE进行中（未招募）不适用
A Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects with Enthesitis Related Arthritis
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
- •1. Age 6 through 17 years
- •2. Diagnosis of ERA as defined by ILAR
- •3. Disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location
- •4. Inadequate response or intolerance to at least one nonsteroidal anti-nflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate.
- •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
- •1. Any ILAR JIA subtype other than ERA
- •2. Psoriasis or a history of psoriasis in the patient or first-degree relative
- •3. Presence of IgM rheumatoid factor
- •4. Presence of systemic JIA, history of inflammatory bowel disease, previous biologic therpay including anti-TNF therapy with a potential impact on pediatric ERA
- •5. Infection(s) requiring treatment with IV anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline
研究者
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