施尼茨勒综合症的临床试验-临床试验注册中心-ICH GCP

研究概览

地位

招聘中

条件

施尼茨勒综合症

研究类型

观察性的

注册 (估计的)

10

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Novartis Pharmaceuticals
电话号码：+41613241111
邮箱：novartis.email@novartis.com

研究联系人备份

姓名：Novartis Pharmaceuticals

学习地点

日本
- - Osaka、日本、5458586
    - 招聘中
    - Novartis Investigative Site
- Hyōgo
  - Kobe、Hyōgo、日本、6500047
    - 招聘中
    - Novartis Investigative Site
- Ibaraki
  - Ushiku、Ibaraki、日本、300-1231
    - 招聘中
    - Novartis Investigative Site
- Kagoshima-ken
  - Kanoya、Kagoshima-ken、日本、8930024
    - 招聘中
    - Novartis Investigative Site
- Kanagawa
  - Yokohama、Kanagawa、日本、2360004
    - 招聘中
    - Novartis Investigative Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Schnitzler's syndrome patients receiving canakinumab for the first time for the indication of Schnitzler's syndrome as described in the package insert.

描述

Inclusion criteria

1. Patients diagnosed with Schnitzler's syndrome using canakinumab for the first time for the indication of Schnitzler's syndrome as described in the package insert.

Patients starting treatment with canakinumab before conclusion of the contract for this study will also be included in the study so that all patients diagnosed with Schnitzler's syndrome who received canakinumab will be registered in this study.

Exclusion criteria

Patients previously treated with canakinumab in Study IACT21071.
All patients treated with canakinumab for the following indications:
Indications: Cryopyrin-associated periodic syndromes (familial cold autoinflammatory syndrome, Muckle-Wells syndrome, neonatal onset multisystem inflammatory disease), hyper immunoglobulin D (IgD) syndrome (mevalonate kinase deficiency), tumor necrosis factor (TNF) receptor-associated periodic syndrome, familial mediterranean fever, systemic juvenile idiopathic arthritis, adult-onset Still's disease.
Patients receiving canakinumab for off-label use under the Clinical Trials Act or GCP (e.g., patient-proposed healthcare services, investigator-initiated clinical trial).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

1

队列和干预

团体/队列
Canakinumab Cohort Patients diagnosed with Schnitzler's syndrome using canakinumab for the first time.

研究衡量的是什么？

主要结果指标

次要结果测量

结果测量	大体时间
Number and Percentage of Patients With Adverse Reactions 大体时间：From Baseline to Week 48	From Baseline to Week 48
Number and Percentage of Patients With Serious Adverse Events 大体时间：From Baseline to Week 48	From Baseline to Week 48

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

调查人员

研究主任：Novartis Pharmaceuticals、Novartis Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月13日

初级完成 (估计的)

2032年11月25日

研究完成 (估计的)

2032年11月25日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年9月3日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年9月1日

结果测量	措施说明	大体时间
Proportion of Patients Achieving Complete Clinical Response in the Period From 7 Days to 8 Weeks After the First Dose 大体时间：Day 8 to Week 8	Complete clinical response is defined as a Physician's Global Assessment (PGA) score of ≤ 5, with none of 5 items (urticaria, fatigue, fever and chills, myalgia, and arthralgia and bone pain) rated as > 1. The PGA is a tool designed to evaluate each of 5 items (urticaria, fatigue, fever/chills, myalgia, and arthralgia/bone pain), which are clinical symptoms observed in patients with Schnitzler's syndrome, on a 5-point scale of 0 (no), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) based on the physician's clinical examination to calculate the total score.	Day 8 to Week 8
Proportion of Patients Achieving Partial or Complete Clinical Response at all Time Points From 7 Days After the First Dose to 48 Weeks After the First Dose 大体时间：Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48	Complete clinical response is defined as a PGA score of ≤ 5, with none of 5 items (urticaria, fatigue, fever and chills, myalgia, and arthralgia and bone pain) rated as > 1. Partial clinical response is defined as a PGA score of ≥ 6, with a decrease in PGA of ≥ 30% from baseline, or PGA score of ≤ 5, with any of 5 items (urticaria, fatigue, fever and chills, myalgia, and arthralgia and bone pain) rated as > 1. The PGA is a tool designed to evaluate each of 5 items (urticaria, fatigue, fever/chills, myalgia, and arthralgia/bone pain), which are clinical symptoms observed in patients with Schnitzler's syndrome, on a 5-point scale of 0 (no), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) based on the physician's clinical examination to calculate the total score.	Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Rate of Each Clinical Response 大体时间：Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48	The proportion of patients who achieve a clinical response: Complete clinical response: PGA score of ≤ 5, with none of 5 items (urticaria, fatigue, fever and chills, myalgia, and arthralgia and bone pain) rated as > 1 Partial clinical response: PGA score of ≥ 6, with a decrease in PGA of ≥ 30% from baseline, or PGA score of ≤ 5, with any of 5 items (urticaria, fatigue, fever and chills, myalgia, and arthralgia and bone pain) rated as > 1 No clinical response: PGA score that increases, is stable, or decreases by < 30% as compared to baseline Relapse or worsening of clinical symptoms: Increase in PGA score of ≥ 50% from baseline The PGA is a tool designed to evaluate each of 5 items, which are clinical symptoms observed in patients with Schnitzler's syndrome, on a 5-point scale of 0 (no), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) based on the physician's clinical examination to calculate the total score.	Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Mean PGA Score 大体时间：Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48	The PGA is a tool designed to evaluate each of 5 items (urticaria, fatigue, fever/chills, myalgia, and arthralgia/bone pain), which are clinical symptoms observed in patients with Schnitzler's syndrome, on a 5-point scale of 0 (no), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) based on the physician's clinical examination to calculate the total score.	Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Change From Baseline in PGA Score 大体时间：Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48	The PGA is a tool designed to evaluate each of 5 items (urticaria, fatigue, fever/chills, myalgia, and arthralgia/bone pain), which are clinical symptoms observed in patients with Schnitzler's syndrome, on a 5-point scale of 0 (no), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) based on the physician's clinical examination to calculate the total score.	Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Mean White Blood Cell Count 大体时间：Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48		Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Change From Baseline in White Blood Cell Count 大体时间：Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48		Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Mean Neutrophil Count 大体时间：Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48		Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Change From Baseline in Neutrophil Count 大体时间：Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48		Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Mean C-reactive Protein (CRP) Level 大体时间：Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48		Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Change From Baseline in CRP Level 大体时间：Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48		Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Mean Alkaline phosphatase (ALP) Level 大体时间：Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48		Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Change From Baseline in ALP Level 大体时间：Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48		Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Mean Serum Immunoglobulin (Ig) G and IgM Levels 大体时间：Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48		Baseline, Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Change From Baseline in Serum IgG and IgM Levels 大体时间：Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48		Baseline to Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48
Rate of Physicians Global Assessment of Impression of Improvement 大体时间：Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48	The proportion of patients summarized by improvement status as assessed by the physician. Improvement assessment categories: markedly responded, responded, not responded, worsen, or indeterminate.	Day 8, Weeks 8, 16, 24, 32, 40, and at treatment discontinuation, up to and including Week 48

A Study to Assess the Effectiveness and Safety of Canakinumab in Clinical Use in Patients With Schnitzler's Syndrome

Specified Use-Results Study of ILARIS Solution for S.C. Injection (Schnitzler's Syndrome)