An Observational Study to Evaluate the Cost of the Treatments of the Refractory Psoriatic Arthritis to the Conventional Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Mean Cost Per Participant Per Month at Month 12
研究概览
简要总结
The purpose of this study is to conduct an economic analysis on the cost of conventional therapy as compared to biologic therapy and the direct/indirect costs of disease management in patients with refractory psoriatic arthritis (PsA). Primary outcomes are to qualify the economic burden of refractory PsA care. The secondary outcomes are to assess efficacy, safety, and cost effectiveness of different therapies.
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
- •Eighteen years of age or older
- •Inflammatory arthropathy associated with psoriasis meet the ACR criteria for PsA
- •Patients with diagnosis of active and progressive PsA who have failure with conventional treatments
排除标准
- •Significant concurrent medical diseases including cancer or a history of cancer, uncontrolled congestive heart failure, myocardial infarctions within 12 months or other clinically significant cardiovascular diseases, immunodeficiency syndromes or concomitant infectious diseases.
结局指标
主要结局
Mean Cost Per Participant Per Month at Month 12
时间窗: Month 12
Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.
Mean Cost Per Participant Per Month at Month 60
时间窗: Month 60
Overall cost per participant per month was evaluated as part of health economics evaluation to quantify burden of Refractory PsA and its treatment, resources absorbed by the disease and its care into monetary terms. Overall cost was defined as sum of direct and indirect costs (productivity losses). Direct costs included cost of following cost variables: pharmacological treatment; hospitalizations; diagnostic examinations, laboratory analysis and specialist visits; transports.
Incremental Cost-effectiveness Ratio (ICER)
时间窗: Baseline up to Month 60
ICER: ratio of the incremental cost of treatment over the incremental effectiveness. Incremental cost = difference in cost between baseline and month 60. Effectiveness was defined as quality adjusted life year (QALY) gained, i.e. difference in Euro Quality of Life 5 Dimension (EQ-5D)- health state profile utility score between baseline and month 60. (EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Total score range -0.594 to 1.000; higher score indicates a better health state.)
次要结局
- Number of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 Response(Month 6, Month 12, Month 18, Month 24, Month 60)
- Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)(Month 6, Month 12, Month 18, Month 24, Month 60)
- Psoriasis Area and Severity Index (PASI)(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Bath Ankylosing Spondylitis Radiology Index (BASRI)(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Modified Schober's Test(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Chest Expansion Measurement(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Occiput-to-wall Distance(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Maastricht Ankylosing Spondylitis Enthesis Score (MASES)(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Number of Swollen and Tender Joints(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response(Month 6, Month 12, Month 18, Month 24, Month 60)
- Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response(Month 6, Month 12, Month 18, Month 24, Month 60)
- Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response(Month 6, Month 12, Month 18, Month 24, Month 60)
- Radiographic Score Based on Wassenberg(Baseline, Month 12, Month 24, Month 60)
- Patient Global Assessment (PtGA) of Disease Activity Score(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Physician Global Assessment (PGA) of Disease Activity(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Visual Analogue Scale for Pain (VAS-pain)(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Erythrocyte Sedimentation Rate (ESR)(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- C-reactive Protein (CRP)(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Duration of Morning Stiffness(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Health Assessment Questionnaire (HAQ)(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Euro Quality of Life (EQ-5D)- Health State Profile Utility Score(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)
- 36-Item Short-Form Health Survey (SF-36)(Baseline, Month 6, Month 12, Month 18, Month 24, Month 60)