跳至主要内容
临床试验/EUCTR2018-002521-30-ES
EUCTR2018-002521-30-ES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

ovartis Farmacéutica, S.A.0 个研究点目标入组 63 人开始时间: 2019年3月27日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
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

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: 44
  • 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

发起方
ovartis Farmacéutica, S.A.

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