Routine Clinical Practice in Spain: Evaluation of the Use of Apremilast in Patients With Psoriatic Arthritis, Naïve to Biological Treatment (PREVAIL Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 119
- 试验地点
- 20
- 主要终点
- Treatment persistence at 6 months after initiating apremilast treatment
研究概览
简要总结
Observational, prospective and multicenter study in approximately 25 sites nationwide. The investigators participating in this study will be rheumatologists specializing in this pathology.
The study will include patients diagnosed with PsA (according to the CASPAR diagnosis criteria), naïve to biological treatments, who have - following the routine practice in their centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration.
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, which will not occur earlier than 6 months (± 4 weeks after treatment start). Therefore, the choice of the therapeutic strategy will be made independently by the physician.
Before entering the study, all patients shall sign an informed consent to participate in the study, including permission to retrieve data from their medical records and to complete questionnaires regarding their quality of life.
To avoid recruitment biases and obtain a homogeneous cohort regarding treatment duration, all consecutive patients who attend to a routine follow-up visit and have been prescribed apremilast 6 months (+/- 4 weeks) before the baseline visit, will be offered to enter the study. All consecutive patients who can be contacted 6 months (+/- 4 weeks) following initiation of treatment with apremilast will be approached for entry to minimize bias in patient selection
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
- •Men and women older than 18 years.
- •Patients diagnosed with psoriatic arthritis according to the CASPAR criteria*.
- •Patients who, following the routine clinical practice, initiated treatment with apremilast 6 months (±4 weeks) before their inclusion in the study.
- •Patients naive to biologic treatments.
排除标准
- •Patients who reject to sign the informed consent.
- •Patients enrolled in a clinical trial within the 4 weeks preceding the baseline visit or for the duration of apremilast treatment.
研究组 & 干预措施
Psoriatic Arthritis patients on Apremilast
Patients diagnosed with PsA (according to the CASPAR diagnosis criteria), naïve to biological treatments, who have - following the routine practice in their centers - initiated treatment with apremilast 6 months (±1 months) before their inclusion in the study, irrespective of treatment duration.
干预措施: Apremilast (Drug)
结局指标
主要结局
Treatment persistence at 6 months after initiating apremilast treatment
时间窗: Up to approximately 6 months
Percentage of patients still being treated with apremilast after 6 months of initiating treatment
次要结局
- To assess the disease activity at 6 and 12 months of treatment with apremilast.(At 6 and 12 months)
- Changes on clinical enthesitis and dactilitis(UP to approximately 12 months)
- Tender joints count(Up to approximately 12 months)
- Swollen joints count(UP to approximately 12 months)
- Physician Global Assessment of Disease Activity (PGA).(Up to approximately 12 months)
- The VITACORA-19 questionnaires(UP to approximately 12 months)
- Demographic characteristics(Up to approximately 6 months)
- To describe the characteristics of apremilast treatment (i.e., dosage and regimen) in patients with PsA who start treatment according to the routine clinical practice.(Up to approximately 12 months)
- To assess the persistence of apremilast treatment after 12 months of treatment start(Up to approximately 12 months)
- Changes in the plasma concentration of C-reactive protein.(Up to approximately 12 months)
- To assess the presence of erosive changes after 6 and 12 months of treatment with apremilast.(UP to approximately 12 months)
- The Psoriatic Arthritis Impact of Disease (PsAID)-9 questionnaires(UP to approximately 12 months)
- Adverse events (AEs)(Up to approximately 12 months)
- Assessment of changes on affected joints(Up to approximately 12 months)
- Assessment of DAPSA/cDAPSA scores(Up to approximately 12 months)
- To assess the relationship between the count of affected joints DAPSA/cDAPSA score after 6 and 12 months of treatment with apremilast.(Up to approximately 12 months)
- To assess the changes in patient's assessment of disease activity after 6 and 12 months of apremilast treatment.(UP to approximately 12 months)