Open Label Study To Evaluate The Safety Profile And The Quality Of Life In Patients Receiving Etanercept For The Treatment Of Rheumatoid Arthritis, Ankylosing Spondylitis And Psoriatic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 880
- 试验地点
- 1
- 主要终点
- Number of Participants by Reasons for Discontinuation of Treatment
研究概览
简要总结
This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated.
详细描述
Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).
Patients have been recruited sequentially based on eligibility criteria up to the number limit assigned to each site.
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
- •18 years of age or older at time of consent
- •Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis or has a diagnosis of ankylosing spondylitis or psoriatic arthritis, as determined by the doctor
- •Provides informed consent
- •Demonstrate a negative serum or urine pregnancy test prior to administration of etanercept. Sexually active women participating in the study must use a medically acceptable form of contraception.
- •Patients already prescribed etanercept according to approved labelling
排除标准
- •Has hypersensitivity to etanercept
- •Has sepsis or risk of sepsis. Treatment with etanercept should not be initiated in patients with active infections (ie. hepatitis C, hepatitis B, active TBC)
- •Is pregnant or breast-feeding
- •Has significant concurrent medical diseases including, uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, or central nervous system (CNS) demyelinating events suggestive of multiple sclerosis
- •Has a history of confirmed blood dyscrasias
- •Received any live (attenuated) vaccines within 4 weeks of screening visit
结局指标
主要结局
Number of Participants by Reasons for Discontinuation of Treatment
时间窗: Baseline up to Month 24
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to Month 24
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants Who Discontinued Treatment
时间窗: Baseline up to Month 24
次要结局
- Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month(Baseline, Month 24)
- Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month(Baseline, Month 24)
- Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month(Baseline, Month 24)