NCT00482170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 Auto-injector and the Etanercept Prefilled Syringe) in Patients With Psoriasis.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 421
- 试验地点
- 78
- 主要终点
- Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population
研究概览
简要总结
Primary objective of this study is to compare patient satisfaction with the prefilled syringe (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction.
详细描述
For the measures of patient's satisfaction with and perceptions of, their device, standard Likert scales are used. This allows the magnitude of individual's perceptions and satisfaction to be measured on a multipoint scale anchored at each end. In addition, the study will describe 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, injection site pain, injection anxiety, injection confidence) will be captured using a questionnaire. 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, demographics, social and educational status psychological status, willingness to self-manage, injection experience) and Psoriasis characteristics (e.g. disease severity, disease duration, co morbidities, prior treatment, quality of life). The study will also take the opportunity to measure health outcome measures as there may be important differences in cost of training and patient support between the two devices.
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
- •Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA
- •Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
- •Aged 18 years or more
- •Willing and able to self-inject etanercept.
- •Able to store test drug at 2-8oC.
- •Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week 0) for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a reliable form of contraception during the study.
- •Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed.
排除标准
- •Prior experience of biologics and anti-TNF treatment for their Psoriasis including etanercept.
- •Sepsis or risk of sepsis.
- •Current or recent infections, including chronic or localized.
- •Latex sensitivity.
- •Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study.
结局指标
主要结局
Participant Satisfaction With Injection Device Evaluated at Week 12 for Modified Intent-to-treat (mITT) Population
时间窗: Week 12
Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
Participant Satisfaction With Injection Device at Week 12 for Per-protocol (PP) Population
时间窗: Week 12
Participant satisfaction was assessed by asking the question, "How satisfied are you with your injection device?" using a 0-10 point scale, where 0= totally dissatisfied and 10= totally satisfied.
次要结局
- Percentage of Participants Satisfied With Injection Device(Baseline, Week 4 and Week 12)
- Influence of Age on Participant Satisfaction With Injection Device(Week 12)
- Influence of Gender on Participant Satisfaction With Injection Device(Week 12)
- Influence of Socio-educational Status on Participant Satisfaction With Injection Device(Week 12)
- Confidence in Injection Device Based on Response to Question Concerning Overall Confidence in Management of Injections(Baseline, Week 4 and Week 12)
- Influence of Psychological Status as Assessed by Hospital Anxiety Depression (HAD) Score on Participant Satisfaction With Injection Device(Week 12)
- Influence of Willingness to Self Manage as Assessed by Patient Activation Measure (PAM) on Participant Satisfaction With Injection Device(Week 12)
- Influence of Prior Self-injection Experience on Participant Satisfaction With Injection Device(Week 12)
- Influence of Duration of Psoriasis on Participant Satisfaction With Injection Device(Week 12)
- Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Satisfaction With Injection Device(Week 12)
- Influence of Psoriasis Area and Severity Index (PASI) on Participant Satisfaction With Injection Device(Week 12)
- Influence of Participant's Assessment of General Health on Participant Satisfaction With Injection Device(Week 12)
- Influence of Participant's Global Assessment of Psoriasis on Participant Satisfaction With Injection Device(Week 12)
- Influence of Dermatology Life Quality Index (DLQI) on Participant Satisfaction With Injection Device(Week 12)
- Influence of Co-morbidities on Participant Satisfaction With Injection Device(Week 12)
- Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Satisfaction With Injection Device(Week 12)
- Influence of Prior Injection Experience on Participant Satisfaction With Injection Device(Week 12)
- Ease of Use of Injection Device Based on Response to Question Concerning Overall Ease in Performing Injection With Device(Baseline, Week 4 and Week 12)
- Ease of Use of Injection Device Based on Response to Question Concerning Ease in Learning How to Use Device(Baseline, Week 4 and Week 12)
- Ease of Use of Injection Device Based on Response to Question Concerning Ease in Disposing Off Device(Baseline, Week 4 and Week 12)
- Ease of Use of Injection Device Based on Response to Question Concerning Ease in Knowing When Injection is Complete(Baseline, Week 4 and Week 12)
- Ease of Use of Injection Device Based on Response to Question Concerning Ease in Holding Device While Injecting(Baseline, Week 4 and Week 12)
- Ease of Use of Injection Device Based on Response to Question Concerning Hand Discomfort While Injecting(Baseline, Week 4 and Week 12)
- Side Effects Related to Administration Based on Response to Question Concerning Experience of Pain During or Immediately After Injection(Baseline, Week 4 and Week 12)
- Ease of Use of Injection Device Based on Response to Question Concerning Time Taken to Perform Injection (Includes Preparation and Disposal)(Baseline, Week 4 and Week 12)
- Convenience of Injection Device Based on Response to Question Concerning Extent of Interference of Injecting Drug With Ability to Enjoy Social or Leisure Activity(Baseline, Week 4 and Week 12)
- Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Usual Daily Activity(Baseline, Week 4 and Week 12)
- Convenience of Injection Device Based on Response to Question Concerning Interference of Injecting Drug With Traveling(Baseline, Week 4 and Week 12)
- Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Injects Right Amount of Drug Every Time(Baseline, Week 4 and Week 12)
- Confidence in Injection Device Based on Response to Question Concerning Confidence That Participant Can Inject Properly With Device(Baseline, Week 4 and Week 12)
- Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Control Over Injection Process(Baseline, Week 4 and Week 12)
- Confidence in Injection Device Based on Response to Question Concerning Confidence Regarding Successful Injection(Baseline, Week 4 and Week 12)
- Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Injections(Baseline, Week 4 and Week 12)
- Assessment of Fear of Device Based on Response to Question Concerning Nervousness About Inserting Needle Into Skin(Baseline, Week 4 and Week 12)
- Assessment of Fear of Device Based on Response to Question Concerning Dislike Towards Injecting With Device(Baseline, Week 4 and Week 12)
- Assessment of Fear of Device Based on Response to Question Concerning Emotional Distress or Anxiety About Injection(Baseline, Week 4 and Week 12)
- Device Characteristics Based on Response to Question Concerning Look of Device(Baseline, Week 4 and Week 12)
- Device Characteristics Based on Response to Question Concerning Feel of Device(Baseline, Week 4 and Week 12)
- Device Characteristics Based on Response to Question Regarding Comfort to Use Device Based on Looks(Baseline, Week 4 and Week 12)
- Short Form State-Trait Anxiety Inventory (SF STAI) Global Score(Baseline, Week 4 and Week 12)
- Influence of Age on Participant Perception(Baseline)
- Influence of Gender on Participant Perception(Baseline)
- Influence of Socio-educational Status on Participant Perception(Baseline)
- Influence of Psychological Status Assessed by Hospital Anxiety Depression (HAD) Score on Participant Perception(Baseline)
- Influence of Willingness to Self Manage Assessed by Patient Activation Measure (PAM) on Participant Perception(Baseline)
- Influence of Prior Injection Experience on Participant Perception(Baseline)
- Influence of Prior Self-injection Experience on Participant Perception(Baseline)
- Influence of Duration of Psoriasis on Participant Perception(Baseline)
- Influence of Physician Global Assessment (PGA) of Psoriasis on Participant Perception(Baseline)
- Influence of Psoriasis Area Severity Index (PASI) on Participant Perception(Baseline)
- Influence of Participant's Assessment of General Health on Participant Perception(Baseline)
- Influence of Participant's Global Assessment of Psoriasis on Participant Perception(Baseline)
- Influence of Dermatology Life Quality Index (DLQI) on Participant Perception(Baseline)
- Influence of Co-morbidities on Participant Perception(Baseline)
- Influence of Prior Systemic Treatment or Topical Medication for Psoriasis on Participant Perception(Baseline)
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