Observational Study Evaluating the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 102
- 试验地点
- 19
- 主要终点
- The rate of achieving Low Disease Activity (LDA)
研究概览
简要总结
This will be a Canadian observational study utilizing a prospective cohort design. Patients with active psoriatic arthritis (PsA) for whom the treating physician has decided, prior to and independently of enrollment in the study, to initiate treatment with Otezla® will be considered for participation in the study.
Patients will be enrolled from the practices of predominantly community rheumatologists and will be followed for 12 months from the time of initiation of treatment with Otezla® In line with the observational nature of the study, there will be no protocol imposed tests or assessments. However, recommended follow up visits will be at 4, 8 and 12 months. In addition, patients may be asked to voluntarily complete self-administered questionnaires.
The 24-month assessment will be aimed to determine whether or not treatment with Otezla® has been maintained, and if not, to ascertain the reason for discontinuation and what new treatment was initiated following discontinuation of Otezla®
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
- •Active psoriatic arthritis (PsA) as per the Classification criteria for Psoriatic Arthritis (CASPAR) criteria, based on the investigator's clinical judgement.
- •Adult patients (≥18 years of age) with PsA
- •Prescribing physician has decided to initiate treatment with Otezla®, and this decision was prior to and independent of patient enrollment in the study.
- •Access to commercially available Otezla®
排除标准
- •Patients who are pregnant, breastfeeding, or who are planning on becoming pregnant during the course of the study
- •Participation in Investigational Clinical Trial within the last 60 days.
研究组 & 干预措施
Psoriatic Arthritis patients treated with Apremilast
Active PsA as per the CASPAR criteria, based on the investigator's clinical judgement with access to commercially available Otezla
干预措施: Apremilast (Drug)
结局指标
主要结局
The rate of achieving Low Disease Activity (LDA)
时间窗: Up to approximately 1 year
Is defined as Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) \< 14. cDAPSA is calculated as the sum of TJC - 68, SJC - 66, PtGA (10-cm VAS) and Pain (10-cm VAS).
次要结局
- Medical Outcomes Study Short- Form 36 (SF-36)(Up to approximately 1 year)
- Tender Joint Count (TJC)(Up to Approximately 1 year)
- Patient-reported adherence with PsA treatment from the last visit.(Up to approximately 1 year)
- Proportion of patients in Patient Acceptable Symptom State (PASS)(Up to approximately 1 year)
- Adverse Events (AEs)(From enrollment until at least 28 days after completion of study treatment)
- Swollen Joint Count (SJC)(Up to Approximately 1 year)
- Assessment of Body Surface Area (BSA)(Up to approximately 1 year)
- Health Assessment Questionnaire Disability Index (HAQ-DI)(Up to approximately 1 year)
- Physician global assessment of disease activity (MDGA)(Up to approximately 1 year)
- The rate of achieving Low Disease Activity (LDA)(Up to approximately 8 months)
- Assessment of Enthesitis (Leeds Enthesitis Index (LEI)(Up to Approximately 1 year)
- Assessment of Dactylitis (Leeds Dactylitis Index)(Up to approximately 1 year)
- Patient global assessment of disease activity (PtGA)(Up to approximately 1 year)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(Up to approximately 1 year)
- Patient subjective assessment of Pain using a 100mm VAS(Up to approximately 1 year)
- Psoriatic Arthritis (WPAI:PsA)(Up to approximately 1 year)