Prospective Observational Study to Evaluate the Benefits for the Patient Associated With the Treatment of Plaque Psoriasis With Apremilast After Other Systemic Treatment in Conditions of Clinical Practice in Spain (APPROPRIATE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 153
- 试验地点
- 31
- 主要终点
- Percentage of subjects achieving PBI ≥ 1
研究概览
简要总结
Observational, prospective and multicenter study in approximately 30 sites nationwide. The investigators participating in this study will be dermatologists specializing in this pathology.
The present study will include adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study. Therefore, the choice of the therapeutic strategy will be made independently by the 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
- •Adult male and female (≥ 18 years).
- •Patients diagnosed with moderate to severe plaque psoriasis and for which treatment with apremilast is indicated according to the doctor's criteria (established before the patient enters the study) and according to the specifications of the medication's data sheet
- •Patients with available data regarding the PASI and DLQI assessments at the moment of initiating treatment with apremilast.
- •Patients for whom, according to the physician's criteria (established prior to patient's entry into the study) and according to the specifications of the drug's prescribing information, apremilast treatment is indicated.
- •All patients who, according to the routine clinical practice, initiated apremilast treatment for the first time 3 months (+/- 4 weeks) before their inclusion in the study (patients may or may not have completed 3 months of apremilast treatment).
- •Patients who have previously received at least one systemic treatment for moderate to severe plaque psoriasis.
- •Patients who have not previously been treated with a biological agent for moderate to severe plaque psoriasis.
- •Patients who agree to participate in the study by signing the informed consent.
- •Patients who are able to understand and complete the questionnaires specified in the study protocol.
排除标准
- •Patients participating in another study at the time of entering the study.
结局指标
主要结局
Percentage of subjects achieving PBI ≥ 1
时间窗: Approximately 7 months
Patient Benefit Index (PBI) is a measure of the benefit associated with a patient-reported treatment consisting of the administration of two questionnaires: the Patient needs questionnaire (PNQ), administered at baseline, and the patient benefit questionnaire (PBQ), administered during treatment
次要结局
- Describe the persistence of apremilast treatment(Approximately 7 months)
- Describe the changes in the quality of life associated with treatment with apremilast(Approximately 13 months)
- Describe changes in concomitant medication associated with management of moderate to severe plaque psoriasis during apremilast treatment(Approximately 13 months)
- Adverse Events (AEs)(Approximately 13 months)
- Clinical and demographic characteristics of plaque psoriasis patients: Body surface affected (BSA).(Approximately 7 months)
- Clinical and demographic characteristics of plaque psoriasis patients: Physician Global Assessment (PGA).(Approximately 7 months)
- Describe changes in the perception of pruritus intensity during apremilast treatment in patients with moderate to severe plaque psoriasis(Approximately 13 months)
- Describe the percentage of patients with moderate to severe plaque psoriasis who achieve a relevant minimum clinical benefit, defined as PBI ≥ 1(Approximately 13 months)
- Describe changes in cutaneous involvement of patients with psoriasis in severe intensity plaques that change to moderate intensity(Approximately 13 months)
- Clinical and demographic characteristics of plaque psoriasis patients: PGA x BSA(Approximately 7 months)