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临床试验/NCT05964946
NCT05964946已完成不适用

Real-life Study of the Characteristics of Patients Treated With Ilaris® (Canakinumab) for Gouty Arthritis in France

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
1
主要终点
Number of patients treated with canakinumab in France for the treatment of gouty arthritis

研究概览

简要总结

This was a non-interventional, retrospective, cross-sectional, descriptive study, conducted on the National Health Data System (Système National des Données de Santé, SNDS).

The study did not modify the doctor-patient relationship, nor the management or follow-up of patients. Patients with dispensation of canakinumab for gouty arthritis were selected over the period from 08 April 2018 to 07 April 2020; index date was defined as date of the first dispensation of canakinumab in community pharmacy during study period.

Patients were described at index date. Medical history and comorbidities, and previous treatments for gouty arthritis were assessed during 3 years prior to index date. Co-treatments of interest for which standard treatments for gouty arthritis were contraindicated or required precautions for use were assessed during 6 months prior to index date.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Received at least one reimbursement of Ilaris® from 08 April 2018 to 07 April
  • Benefited from at least one of the following healthcare consumptions during 3 years prior to index date:
  • o At least one hospitalization with a main diagnosis or a related diagnosis in a Medical Unit Summary or a significant associated diagnosis in a Standardized Discharge Summary corresponding to the International Classification of Diseases, 10th Revision (ICD-10) code:
  • M10.0 "Idiopathic gout"
  • M10.1 "Saturnine gout"
  • M10.2 "Medicated gout"
  • M10.3 "Gout due to impaired renal function"
  • M10.4 "Other secondary gout"
  • M10.9 "Gout, unspecified"
  • And/or an active long-term disease (Affection Longue Durée, ALD) with an ICD-10 code: "M10 Gout"
  • And/or at least one dispensation of colchicine and urate-lowering therapy (allopurinol and/or febuxostat and/or benzbromarone and/or probenecid) at any time.

排除标准

  • 未提供

结局指标

主要结局

Number of patients treated with canakinumab in France for the treatment of gouty arthritis

时间窗: 2 years

次要结局

  • Geographic location of patients(3 years)
  • Number of patients with previous treatments for gouty arthritis(3 years)
  • Mean age of patients(3 years)
  • Number of male patients(3 years)
  • Medical history of patients(3 years)
  • Number of patients with comorbidities(3 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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