Tofacitinib Registry of Patients With Ulcerative Colitis in Germany - Documentation of Tofacitinib Induction and Maintenance Therapy in Conjunction With Long-term Outcome and Predictors of Response
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- partial Mayo score ≤ 1 plus a bleeding subscore of 0) in the inductionphase (week 16)
研究概览
简要总结
This registry on Tofacitinib and biologics (anti-integrin/anti-TNF) in the treatment of ulcerative colitis (UC) patients in Germany will extend the prospective documentation of safety issues and efficacy in induction and maintenance therapy of Tofacitinib (Xeljanz®) in addition to other biologics used in Germany with a particular interest in predictors of long-term responses and favorable disease outcome or to predict severe side effects caused by therapy with Januskinase(JAK)- inhibitors/biologics.
详细描述
This is an Investigator-initiated non-randomized, non-interventional observational prospective long- term research (IIR) as part of the normal treatment of UC patients for the safety and efficacy of Tofacitinib / biologic therapies. As of 01st July 2019, UC patients who have been provided Tofacitinib / biologics for UC according the respective label by the treating physician may be prospectively included in an online database by the participating study centers by 31st March 2021.
An interim analysis is planned at the end of patients ́ recruitment with respect of the induction phase (week 16) for October 2021 with a first publication of the data in a peer-reviewed journal (e.g., JCC, GUT, UEG Journal).
Up to 480 patients (including about 360 UC patients with Tofacitinib and about 120 UC patients with biologics) will be included in the online documentation. A specification to the study centers regarding the group inclusion (patients treated with Tofacitinib (group 1) or a biologics (group 2)) will not be made; this means, each study center can include patients in both groups.
The CED Service GmbH assume that approximately 20-30% of Tofacitinib patients will be biologic-naïve UC patients, many of whom will represent early disease patients (< 2 years after first diagnosis).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe Ulcerative Colitis aged 18-80 years at enrollment
- •Written informed consent is given
排除标准
- •Malignant disease in history (except for non-melanoma skin cancer)
- •Any contraindication according to the SmPC of the respective medication
结局指标
主要结局
partial Mayo score ≤ 1 plus a bleeding subscore of 0) in the inductionphase (week 16)
时间窗: 07/01/2019 - 03/31/2023
The primary endpoint is steroid-free remission (remission: partial Mayo score ≤ 1 plus a bleeding subscore of 0) in the inductionphase (week 16). For this endpoint it will be only captured if there is a current use of steroids at the time of the visit. So the patient will be asked for current steroid use at time of visit at week 16 and if he has received steroids within the last 4 weeks prior to time point of the visit.
次要结局
- occurrence of serious side effects (e.g., death, tumor, tuberculosis, severe infections, or side effects leading to hospitalization)(07/01/2019 - 03/31/2023)
- response: partial Mayo Score reduction of ≥ 3 accompanied by a decrease of at least 30% from baseline and remission: partial Mayo score ≤ 1 plus a bleeding subscore of 0 - Efficacy(07/01/2019 - 03/31/2023)
- hospitalization days via question in questionnaire(07/01/2019 - 03/31/2023)
- psychosocial impairments - EQ-5D(07/01/2019 - 03/31/2023)
- EQ-5D quality of life(07/01/2019 - 03/31/2023)
- early retirement via question in questionnaire(07/01/2019 - 03/31/2023)