EUCTR2018-002521-30-IT进行中（未招募）1 期
An extension study of subcutaneous secukinumab to evaluate the long-term efficacy, safety and tolerability up to 4 years in patients with Juvenile Idiopathic Arthritis subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis - Secukinumab long-term safety, tolerability and efficacy in JPsA and ERA up to 4 years
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
- 63
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. Patient must have participated in core study CAIN457F2304, and must have completed the entire treatment period up to and including Week 104.
- •2. Patients must be deemed by the investigator to benefit from continued secukinumab therapy.
- •Other protocol-defined inclusion criteria apply.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Plans for administration of live vaccines during the extension study period.
- •2. Any patient taking other concomitant biologic immunomodulating agent(s) except secukinumab.
- •3. Any patient who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms.
- •Other protocol-defined exclusion criteria apply.
研究者
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未知
3 期
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