A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis - CAIN457F2304

ovartis0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•- Confirmed diagnosis of Enthesitis-related arthritis (ERA) or Juvenile psoriatic arthritis (JPsA) according to the international League of Associations for Rheumatology (ILAR) classification criteria of at least 6 months duration.
•- Active disease (ERA or JPsA) defined as having both:
•at least 3 active joints
•at least 1 site of active enthesitis at baseline or documented by history.
•- Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drugs (NSAID)
•- Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying antirheumatic drugs (DMARD)
•- No concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs.

•- Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.
•- Patients who have ever received biologic immunomodulating agents.
•- Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA patients only).
•- Patients with active uncontrolled inflammatory bowel disease or active uncontrolled uveitis.

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