A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 160
- 试验地点
- 15
- 主要终点
- Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks
研究概览
简要总结
This is an open-label, multicenter and observational study in China, which is designed to record the data of RA & AS patients within 52 weeks after rheumatologists decided to prescribe etanercept, and evaluate the safety and efficacy of the treatment. All eligible subjects agreed to be recruited in the study and can withdraw anytime if they choose so.
Patients with RA or AS are typically managed by rheumatologists. As this study seeks to record the data of RA & AS patient in etanercept and evaluate the safety and efficacy of the treatment, patients will be recruited from Rheumatic department. Rheumatologist will be asked to build up the database for RA & AS patient surveillance prospectively in outpatient dept, which benefits for the patient treatment outcomes evaluation and clinical management.
详细描述
The primary objective of this non-interventional study is to evaluate the safety of etanercept in Chinese RA and AS subjects. Total of 600 subjects (300 RA subjects and 300 AS subjects) will be enrolled in the study. If the true rate of an adverse event is no less than 0.5%, with sample size of 600 subjects, this study will have 95% probability to detect at least one occurrence of the adverse event. The study prematurely discontinued on January 15, 2013 due to slow enrollment and low adherence of etanercept. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Subject has a confirmed diagnosis of rheumatoid arthritis or ankylosing spondylitis.
- •Subject has accepted physician's prescription of etanercept in rheumatology department.
- •Subject agreed to be enrolled in the observational study and sign the ICD.
- •Subject is≥18 years of age at the time of consent.
- •Subject is willing and able to understand and complete questionnaires
排除标准
- •Presence of active or suspected latent infection including HIV, or any underlying disease, including open cutaneous ulcers that could predispose the subject to infections.
- •Immunodeficiency syndromes including Felty syndrome or large granular lymphocyte syndrome.
- •Active tuberculosis (TB) or a history of TB, or findings consistent with previous exposure to TB on a chest x-ray (CXR). Investigators must follow China's guidelines for appropriate screening and treatment of TB.
- •History of hypersensitivity to any of the ingredients in either preparation.
研究组 & 干预措施
RA, AS
Rheumatoid arthritis patients Ankylosing spondylitis patients
干预措施: Enbrel (Drug)
结局指标
主要结局
Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks
时间窗: First day of receiving etanercept through 24 weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Number of Participants Who Had Any AEs During 52 Weeks
时间窗: First day of receiving etanercept through 52 weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks
时间窗: Informed consent or signed data privacy statement through 24 weeks
An SAE was defined as 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.
Number of Participants Who Had Any SAEs During 52 Weeks
时间窗: Informed consent or signed data privacy statement through 52 weeks
An SAE was defined as 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.
Number of Participants With AEs Per System Organ Class During 24 Weeks
时间窗: First day of receiving etanercept through 24 weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.
Number of Participants With AEs Per System Organ Class During 52 Weeks
时间窗: First day of receiving etanercept through 52 weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.
次要结局
- Evaluate the Association Between Participant's Age and Treatment Adherence Rate(First day of receiving etanercept up to Week 52)
- Number of Participants With Any Abnormal Laboratory Test Results(Baseline (Week 0) up to Week 52)
- Tender Joint Count (TJC) for RA Participants(Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52)
- Swollen Joint Count (SJC) for RA Participants(Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52)
- Physician's Global Assessment of Disease Activity(Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52)
- Participant's Global Assessment (PtGA) of Disease Activity(Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52)
- VAS Score for Pain(Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52)
- Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%(First day of receiving etanercept up to Week 52)
- Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])(Baseline (Week 0), Week 2, Week 4, Week 12, Week 52)
- Number of RA Participants Had DAS28-4 (ESR) Improvement(Week 2, Week 4, Week 8, Week 12, Week 36, Week 52)
- Number of RA Participants Had Remission of Disease(Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52)