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 - Secukinumab safety and efficacy in JPsA and ERA

OVARTIS PHARMA AG0 个研究点目标入组 86 人开始时间: 2020年11月10日最近更新: 2021年8月17日

试验速览

暂无简介。

•1. 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.
•2. 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.
•3. Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drugs (NSAID)
•4. Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying antirheumatic drugs (DMARD)
•5. No concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs.
•Other protocol-defined inclusion/exclusion criteria apply.
•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

•1. Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.
•2. Patients who have ever received biologic immunomodulating agents.
•3. Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA patients only).
•4. Patients with active uncontrolled inflammatory bowel disease or active uncontrolled uveitis.
•Other protocol-defined inclusion/exclusion criteria apply.

发起方