Atlas of the Evolution of Psoriasis Lesions Under Remicade® : A Dynamic Standardized Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 主要终点
- Dynamic Photographic PGA Score as Assessed by Two Dermatologists
研究概览
简要总结
This is a national, multi-center, observational, prospective photographic atlas study in subjects who are treated with infliximab for moderate-to-severe psoriasis in daily clinic according to local country regulations and reimbursement.
详细描述
Subjects will enter this study using a non-probability sampling method.
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
- •Male or female, age >=18 with moderate-to-severe psoriasis.
- •Patient for whom the physician has decided to initiate psoriasis treatment with infliximab in accordance with the terms of the European labeling.
- •Patient must demonstrate his/her willingness to participate in the observational study by signing a written consent.
排除标准
- •Patient unable to understand and answer a self administered questionnaire.
- •No specific non-inclusion criteria will be applied to eligible patients.
- •Contradiction and/or Precaution listed in the Summary of Product Characteristics.
结局指标
主要结局
Dynamic Photographic PGA Score as Assessed by Two Dermatologists
时间窗: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)
The dynamic PGA score resulted from the comparison of two sets of pictures/visits. The dynamic PGA was scored twice, at the middle and at the end of the observation period (comparison between picture sets of Week 0 (Visit 1) and Week 14 (Visit 4) visits and comparison between picture sets of Week 0 (Visit 1) and Week 30 (Visit 6) visits. Dynamic PGA was assessed by two dermatologists and the mean of the two readings was used. Clinical improvement was measured with a 10 centimeter (cm)-visual analogue scale (VAS) ranging from 0 (no improvement) to 10 (disappearance of lesions).
Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists
时间窗: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
Digital pictures of each participant's whole body were taken at each visit. Static PGA was assessed by two dermatologists on the basis of these pictures at a single point in time. The mean of the two readings from the dermatologists was used. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.
次要结局
- Psoriasis Area and Severity Index (PASI) Score(Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6))
- Dynamic PGA Score as Assessed by the Investigator(Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6))
- Percent Body Surface Area (BSA) Involved With Psoriasis(Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6))
- Static PGA Score as Assessed by the Investigator(Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6))
- Dynamic PGA Score as Assessed by the Participant(Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6))
- Nail Psoriasis Severity Index (NAPSI) Score(Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6))
- Static PGA Score as Assessed by the Participant(Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6))
- Dermatology Life Quality Index (DLQI) Score(Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6))
- Number of Participants With Satisfactory Health Status(Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6))