A Post-Marketing Surveillance For Safety And Adherence To Treatment Of Enbrel In Adults With Psoriatic Arthritis In Belgium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1
研究概览
简要总结
The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Active erosive psoriatic arthritis of poly-articular type or active erosive or with joint space narrowing psoriatic arthritis of oligo-articular type
- •At least 18 years old
- •Have fulfilled reimbursement criteria for Enbrel in psoriatic arthritis of poly-articular type or oligo-articular type
- •Physician decides to prescribe Enbrel or patient is already on Enbrel
- •Give written informed consent at time of inclusion to study
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1
时间窗: Baseline up to Year 1
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2
时间窗: Year 1 up to Year 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3
时间窗: Year 2 up to Year 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4
时间窗: Year 3 up to Year 4
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5
时间窗: Year 4 up to Year 5
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6
时间窗: Year 5 up to Year 6
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
次要结局
- Incidence of Adverse Events and Serious Adverse Events Per Participant-Year(Baseline up to Month 6, 12, 18, 30, 42, 54, 66)
- Percentage of Participants With at Least 1 Adverse Event (AE) Per Year(Baseline up to Year 6)
- Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment(Baseline up to Month 78)
- Number of Joints With Active Arthritis(Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78)
- Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation(Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78)
- Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Physician Evaluation(Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78)
- Quality of Life Assessed by Health Assessment Questionnaire (HAQ) For Poly-Articular Type Psoriatic Arthritis (PsA)(Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78)