NCT00459706已完成3 期
A 3-Month, Randomised, Open-Label, Parallel-Group, Descriptive Study To Explore And Compare Perceptions and Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 640
- 试验地点
- 113
- 主要终点
- Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population
研究概览
简要总结
The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).
详细描述
This study describes patient perceptions related to device attributes, which are of importance in describing overall patient perception. A range of potential device benefits (e.g. ease of use, convenience, confidence, presence or absence of fear, side effects related to administration) is captured using a questionnaire based on the outputs of patient interviews.
The study aims to characterize patient attributes that will indicate when one device may result in greater patient satisfaction than another. Patient attributes are composed of patient characteristics (e.g. age, sex, self efficacy, expectations of treatment, perception of their illness) and RA characteristics (e.g. disease severity, disease duration, prior treatment, functional impairment).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Modified Intent-to-treat Population
时间窗: Day 84
Participant's response to the question "How satisfied are you with your injection device?" scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism.
Participant Satisfaction on Day 84 for 2 Different Delivery Mechanisms for Etanercept, Per-Protocol Population
时间窗: Day 84
Participant's response to the question "How satisfied are you with your injection device?" scored on a 10-point ordinal scale: 0=totally dissatisfied to 10=totally satisfied. Higher score indicated greater satisfaction with the delivery mechanism.
次要结局
- Percentage of Participants on Day 28 Satisfied With Either of the Different Delivery Mechanisms for Etanercept(Day 28)
- Percentage of Participants on Day 84 Satisfied With Either of the Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by Age for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by Gender for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by Socio-Educational Level for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by the Hospital Anxiety Depression (HAD) Anxiety Subscale Score for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by the HAD Depression Subscale Score for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by Patient Activation Measure (PAM) Score for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by Prior Self-Injection Experience for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by Duration of Rheumatoid Arthritis (RA) for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by 28-joint Disease Activity Score (DAS28) for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by Participant's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by Physician's Global Assessment of RA Activity for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by Health Assessment Questionnaire - Disability Index (HAQ-DI) for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by Maximum Combination of Disease-Modifying Antirheumatic Drug (DMARD) Use for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Participant Satisfaction by Prior Injection Experience for 2 Different Delivery Mechanisms for Etanercept(Day 84)
- Short Form of the State-Trait Anxiety Inventory (SF-STAI) Global Score(Day 84)
- Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Life as a Whole?(Day 84)
- Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With His/Her Health?(Day 84)
- Device Attributes and Participant Perception Questionnaire: How Satisfied Is the Subject With All the Treatments He/She is Currently Receiving for RA?(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 1, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 2, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 3, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 4, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 5, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 6, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 7, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 8, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 9, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 10, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 11, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 12, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 13, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 14, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 15, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 16, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 17, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 18, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 19, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 20, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 21, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 22, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 23, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 24, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 25, Day 84(Day 84)
- Percentage of Participants Responding to the Device Attribute and Participant Questionnaire, Question 26, Day 84(Day 84)
- Age Associated With Participant Perception(Day 84)
- Percentage of Male Participants Associated With Participant Perception(Day 84)
- Percentage of Female Participants Associated With Participant Perception(Day 84)
- Percentage of Participants With Only Reading/Writing Capacity Associated With Participant Perception(Day 84)
- Percentage of Participants at High School/Baccalaureate Level Associated With Participant Perception(Day 84)
- Percentage of Participants at University Level Associated With Participant Perception(Day 84)
- HAD Anxiety Subscale Score Associated With Participant Perception(Day 84)
- HAD Depression Subscale Score Associated With Participant Perception(Day 84)
- PAM Score Associated With Participant Perception(Day 84)
- Percentage of Participants With Prior Injection Experience Associated With Participant Perception(Day 84)
- Percentage of Participants With Prior Self-Injection Experience Associated With Participant Perception(Day 84)
- RA Duration Associated With Participant Perception(Day 84)
- DAS28 Score Associated With Participant Perception(Day 84)
- Participant's Global Assessment of RA Activity Associated With Participant Perception(Day 84)
- Physician's Global Assessment of RA Activity Associated With Participant Perception(Day 84)
- HAQ-DI Score Associated With Participant Perception(Day 84)
- Percentage of Participants Receiving Only 1 DMARD Associated With Participant Perception(Day 84)
- Percentage of Participants Receiving Only 2 DMARDs Associated With Participant Perception(Day 84)
- Percentage of Participants Receiving Only 3 DMARDs Associated With Participant Perception(Day 84)
- Participant Satisfaction at Endpoint Associated With Participant Perception(Day 84)
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研究点 (113)
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