A Prospective Non-interventional Study (Nis) Of The Routine Use Of Etanercept In The Long-term Treatment Of Patients With Plaque-type Psoriasis In Everyday Practice: An Efficacy, Safety, And Health Economic Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 926
- 试验地点
- 1
- 主要终点
- Duration of Drug-Free Interval Prior to Treatment Cycle 2
研究概览
简要总结
This prospective observational cohort study will assess the average duration of the drug free interval between etanercept treatment cycles in usual care settings in Germany.
详细描述
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
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
- •Subjects with moderate to severe plaque psoriasis on etanercept treatment according to the Summary of Product Characteristics (SmPC), and applicable local guidelines
- •Subjects for whom the decision has already been made to initiate treatment with etanercept
排除标准
- •Sepsis or risk of sepsis
- •Current or recent infections, including chronic or localized, e.g. tuberculosis (TB) infection
- •Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study
- •Pre-existing or recent onset CNS demyelinating disease.
- •Class III or IV congestive heart failure as defined by the New York Heart Association classification or uncompensated congestive heart failure.
- •Previous or ongoing treatment with etanercept
- •Participation in other clinical or observational studies.
- •Patients with psoriatic arthritis requiring continuous etanercept treatment.
研究组 & 干预措施
A
Patients with moderate to severe plaque psoriasis
干预措施: etanercept (Enbrel®) (Drug)
结局指标
主要结局
Duration of Drug-Free Interval Prior to Treatment Cycle 2
时间窗: Cycle 1 Week 24 up to Cycle 2 Week 0
Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 5
时间窗: Cycle 4 Week 24 up to Cycle 5 Week 0
Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 6
时间窗: Cycle 5 Week 24 up to Cycle 6 Week 0
Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 3
时间窗: Cycle 2 Week 24 up to Cycle 3 Week 0
Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
Duration of Drug-Free Interval Prior to Treatment Cycle 4
时间窗: Cycle 3 Week 24 up to Cycle 4 Week 0
Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.
次要结局
- Psoriasis Area and Severity Index (PASI) Score(Week 0, 12, 24 of Cycle 1 to 6)
- Percentage of Body Surface Area (BSA) Affected by Psoriasis(Week 0, 12, 24 of Cycle 1 to 6)
- Static Physician Global Assessment (sPGA) of Disease Activity(Week 0, 12, 24 of Cycle 1 to 6)
- Physician Global Assessment of Efficacy(Week 24 of Cycle 1 to 6)
- Patient Global Assessment of Efficacy(Week 24 of Cycle 1 to 6)
- Number of Injections Per Year(Year 1, 2, 3, 4, 5)
- Cumulative Dose of Etanercept Per Year(Year 1, 2, 3, 4, 5)
- Percentage of Time on Treatment in First Year(Year 1)
- Percentage of Time on Treatment Over Entire Period(Cycle 1 up to Cycle 6)
- Patient's Global Assessment of Disease Activity (PatGA)(Week 0, 12, 24 of Cycle 1 to 6)
- Dermatology Life Quality Index (DLQI) Score(Week 0, 12, 24 of Cycle 1 to 6)
- Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)(Week 0, 12, 24 of Cycle 1 to 6)
- Number of Participants With at Least 1 Concomitant Medication(Cycle 1 Week 0 up to Cycle 6 Week 24)
- Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)(Week 0, 12, 24 of Cycle 1 to 6)
- Annual Costs for Treatment With Etanercept(Year 1, 2, 3, 4, 5)
- Average Cost of Treatment by Disease Severity(Year 1, 2, 3, 4, 5)
- Amount of Annual Cost for Participants Arising From Out-of-Pocket Payment and Concomitant Medications(Prior to study, Year 1, 2, 3, 4, 5)
- Effect of Drug-Free Interval on Patient's Global Assessment of Disease Activity (PatGA)(Week 0, 12, 24 of Cycle 1 to 6)
- Effect of Drug-Free Interval on Dermatology Life Quality Index (DLQI) Score(Week 0, 12, 24 of Cycle 1 to 6)
- Effect of Drug-Free Interval on Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade-Off (TTO)(Week 0, 12, 24 of Cycle 1 to 6)
- Participant Perception of Drug-Free Interval: Length of Drug-Free Interval(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Reason for Returning to Practice(Before Cycle 2, 3, 4, 5, 6)
- Participant Perception of Drug-Free Interval: Liking of Drug-Free Interval(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Duration(Before Cycle 2, 3, 4, 5, 6)
- Participant Perception of Drug-Free Interval: Relapse of Symptoms(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Effective Therapy After Drug-Free Interval(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Disease Activity(Before Cycle 2, 3, 4, 5, 6)
- Participant Perception of Drug-Free Interval: Satisfaction With Skin Condition(Before Cycle 2, 3, 4, 5, 6)
- Participant Perception of Drug-Free Interval: Risk for Adverse Drug Reactions(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Reminder of Disease(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Comfort in Everyday Life(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Preference to Continuous Therapy(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Participant Perception of Drug-Free Interval: Recommendation of Therapy(Before Cycle 2, 3, 4, 5, 6, after Cycle 1, 2, 3, 4, 5)
- Criteria for Treatment Resumption(Before Cycle 2, 3, 4, 5, 6)
- Number of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)(Cycle 1 Week 0 up to 30 days after end of study (where end of study was Cycle 6 Week 24))