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临床试验/NCT05219656
NCT05219656已完成不适用

Long-term Outcome of Patients With Acute Ulcerative Colitis Treated With Cyclosporine Rescue Therapy.

Tampere University Hospital0 个研究点目标入组 182 人开始时间: 2009年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
182
主要终点
Response

研究概览

简要总结

The efficacy and safety of Cyclosporine A as rescue therapy for acute severe ulcerative colitis in long-term follow-up.

详细描述

All UC patients treated with CyA in Tampere University Hospital between 2009 and 2018 were reviewed from patient records and analyzed. Amelioration of UC was defined as clinical response for rescue therapy with no need for colectomy or third-line rescue therapy at the same hospitalization as index flare. Relapse was defined as requiring further Cs treatment, re-hospitalization, biologicals, small molecules, or colectomy later in follow-up. Patients were followed-up from the date of index flare until colectomy, death, or the end of observation period. Adverse events related to treatment were assessed throughout the duration of treatment. Surgical complications were defined by using Clavien-Dindo classification (grade III-V classified as severe complications). The surgical complications in Cyclosporine-treated patients were compared to all patients operated for treatment refractor UC in Tampere University Hospital within the same follow-up period.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to hospital for acute flare of UC and treated with CyA rescue therapy.
  • Age 16 or over

排除标准

  • 未提供

结局指标

主要结局

Response

时间窗: From january 2009 to december 2018

Clinical response for CyA with no need for colectomy or further enhancement of treatment with infliximab at the same hospitalization ad index flare

Surgical complications

时间窗: From January 2009 to December 2018

Reported surgical complications.

Remission

时间窗: From january 2009 to december 2018

Remission was defined as no need for further corticosteroids, re-hospitalization, enhancement of treatment with biologicals or small molecules or colectomy within follow-up.

Adverse events

时间窗: From january 2009 to december 2018

Reported treatment related adverse events.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heli T Eronen

MD

Kanta-Häme Central Hospital

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