Long-term Documentation of the Utilization of Otezla® in Patients With Plaque Psoriasis Under Routine Conditions (LAPIS-Pso)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 391
- 试验地点
- 96
- 主要终点
- Change from baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at Visit 2 from baseline
研究概览
简要总结
The objective of this NIS is the collection of data on the utilization of Apremilast under routine conditions in Germany. Patients' quality-of-life and treatment satisfaction on treatment with Apremilast in daily practice will be documented. Moreover, physician's and patient's assessments of the effectiveness and safety of Apremilast will be recorded. FPI was 3rd August 2015, LPO was 14th of June 2018. A total of 391 patients have been enrolled.
详细描述
The objective of this NIS (according to section 4(23) of the German Medicinal Products Act) is the documentation of data on the effectiveness and tolerability of an Apremilast treatment under routine clinical conditions in German patients with plaque psoriasis.
This NIS is intended to reflect the apremilast treatment of patients with plaque psoriasis who have received at least one prior conventional, systemic therapy or, if a contraindication is present, did not receive a systemic therapy so far, and who were diagnosed by their treating physicians to be eligible for an apremilast treatment. The treatment of Apremilast will be documented for a period of approximately 52 weeks.
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
- •The decision for a therapy with Apremilast was made before enrolment and independent of this study.
- •Patient ≥ 18 years of age
- •Diagnosis of moderate to severe plaque psoriasis
- •Inadequate response or intolerance to a previous systemic treatment, or contraindication for systemic therapies.
- •Written informed consent by the patient for data recording, statistical analysis, filing and forwarding of the data
排除标准
- •Pregnancy
- •Hypersensitivity to apremilast or any of the excipients of the film-coated tablet
- •Other criteria according to the Summary of product characteristics (SmPC).
结局指标
主要结局
Change from baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at Visit 2 from baseline
时间窗: Approximately 4 months
DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
次要结局
- Change in the Patient's Global Assessment (PaGA)(Up to approximately 52 weeks)
- Percent Change in the Psoriasis Area Severity Index (PASI) Score(Up to approximately 52 weeks)
- Change in Itch (Pruritus) (Visual Analogue Scale; VAS)(Up to approximately 52 weeks)
- Change in Scalp Involvement -Physician's Global Assessment (PGA)(Up to approximately 52 weeks)
- Change in Pain (Visual Analogue Scale; VAS)(Up to approximately 52 weeks)
- Adverse Events (AEs)(Up to approximately 52 weeks)
- Change in Nail Involvement Fingernail - Patient's Global Assessment (PaGA)(Up to approximately 52 weeks)
- Change in Palmoplantar involvement - Palmoplantar physician's global assessment (PGA)(Up to approximately 52 weeks)
- Change from Baseline in the Dermatology Life Quality Index (DLQI) ≤ 5 or improvement in DLQI by ≥ 5 points at all other visits from baseline.(Up to approximately 52 weeks)
- Patient Preference Questionnaire (PPQ)(Approximately 4 months)
- Patient Satisfaction (Systemic Therapy Adherence Questionnaire, STAQ)(Approximately 13 months)
- Change in the Physician Global Assessment (PGA) Score(Up to approximately 52 weeks)
- Percent Change in Percent of Affected Body Surface Area (BSA)(Up to approximately 52 weeks)
- Change in Scalp Involvement - Patient's Global Assessment (PaGA)(Up to approximately 52 weeks)
- Change in Nail Involvement - Target Nail Psoriasis Severity Index (NAPSI)(Up to approximately 52 weeks)
- Change in Palmoplantar involvement - Palmoplantar patient's global assessment (PaGA)(Up to approximately 52 weeks)