An Active Surveillance, Post-Authorization Study to Characterize the Safety of Tofacitinib in Patients With Moderately to Severely Active Ulcerative Colitis in the Real-World Setting Using Data From the United Registries for Clinical Assessment and Research (UR-CARE) in the European Union (EU)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 5
- 主要终点
- Malignancy excluding non-melanoma skin cancer (NMSC)
研究概览
简要总结
The purpose of this study is to estimate the incidence rates of malignancy, excluding non-melanoma skin cancer (NMSC), venous thromboembolic events VTE (deep venous thrombosis [DVT] and pulmonary embolism [PE]), NMSC, major adverse cardiac events (MACE), progressive multifocal leukoencephalopathy (PML), infections, hospitalization and specific antibiotic or antiviral treatment, lung cancer, lymphoma, herpes zoster, myocardial infarction (MI), gastrointestinal (GI) perforations, fractures, surgery for UC and death; through 4 sub-groups: adult patients with UC who initiate tofacitinib in the course of routine clinical care compared to other medications approved to treat UC.
详细描述
Rationale and background:
Tofacitinib, an inhibitor of the Janus kinase (JAK) family of kinases, was approved in the European Union (EU) in July 2018 at a dose of 5 mg twice daily or 10 mg twice daily for the treatment of adults with moderate-to-severe ulcerative colitis (UC), who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Malignancy excluding non-melanoma skin cancer (NMSC) is an important potential risk and venous thromboembolism (VTE) is an important identified risk associated with the use of tofacitinib, and follow-up of large cohorts of patients over a long period is needed to evaluate the risks of these safety events, as well as other potential safety events of interest, that may be associated with tofacitinib treatment. Pfizer will implement a post approval, active surveillance study of tofacitinib exposed and unexposed patients using actively collected prospective data included in the UR-CARE platform.
Research question:
What are the incidence rates of safety events of interest in adult patients with UC treated with tofacitinib in routine clinical care, as compared to the incidence rates in patients with UC treated with other approved systemic agents, and patients with UC naïve to biologics and immunomodulators/immunosuppressants (hereafter referred to as immunosuppressants)?
Study design:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged ≥18 years,
- •With Ulcerative colitis diagnosis per ECCO guidelines,
- •Enrolled in UR-CARE registry with 12 months of medical history available in UR-CARE prior to the index date,
- •With an informed consent signed. A minimum follow-up duration of 12 months will allow evaluation of safety events of interest.
排除标准
- •Patients not meeting the inclusion criteria
- •Patients who have any records of Crohn's Diseases (CD) or IBD unspecified in UR-CARE between the last UC diagnosis and index date [i.e. date of first prescription for tofacitinib].
结局指标
主要结局
Malignancy excluding non-melanoma skin cancer (NMSC)
时间窗: from 01 July 2018 through to 31 March 2025
Malignancy excluding non-melanoma skin cancer (NMSC). As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
venous thromboembolic events (VTE),(deep venous thrombosis [DVT] and pulmonary embolism [PE])
时间窗: from 01 July 2018 through to 31 March 2025
deep venous thrombosis \[DVT\] and pulmonary embolism \[PE\]. As this is a post-authorisation safety study requested by the EMA, the physician is simply asked to report whether such an event has occurred in the patient's life and under what treatment. The study does not aim to measure or clinically qualify this event, which is why nothing more is asked to estimate the incidence rates of the event.
次要结局
- Herpes zoster(HZ)(from 01 July 2018 through to 31 March 2025)
- Major adverse cardiac events (MACE)(from 01 July 2018 through to 31 March 2025)
- All-cause mortality(from 01 July 2018 through to 31 March 2025)
- Lymphoma(from 01 July 2018 through to 31 March 2025)
- Serious infections(from 01 July 2018 through to 31 March 2025)
- Opportunistic infections (e.g., tuberculosis)(from 01 July 2018 through to 31 March 2025)
- Fractures(from 01 July 2018 through to 31 March 2025)
- Non melanoma skin cancer (NMSC)(from 01 July 2018 through to 31 March 2025)
- Lung cancer(from 01 July 2018 through to 31 March 2025)
- Myocardial infarction (MI)(from 01 July 2018 through to 31 March 2025)
- Progressive multifocal leukoencephalopathy (PML)(from 01 July 2018 through to 31 March 2025)
- Gastrointestinal (GI) perforations(from 01 July 2018 through to 31 March 2025)
- surgery for Ulcerative colitis (UC)(from 01 July 2018 through to 31 March 2025)