Long-term Documentation on the Use of Apremilast in Patients With Psoriatic Arthritis in Practice Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 526
- 试验地点
- 2
- 主要终点
- Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visit 3 compared to baseline on the Physician's Global Assessment scale (PGA; scale from 0-4)
研究概览
简要总结
A total of approximately 500 patients with active psoriatic arthritis in an estimated 80 to 100 trial centers are to be enrolled. Selection of centers will be made by the sponsor's medical section. To increase the quality of the data and to reduce distribution of the data collected, centers to be included will be those which can enroll at least 5 patients. Care will be taken to ensure a balanced regional distribution. The proposed observation period for the trial is approx. 52 weeks per patient. Estimated patient enrolment is also 52 weeks. The duration of the follow-up period will be extended from approx. 52 weeks to approx. 100 weeks to gain further information about the long-term use of Otezla®. For this extension of the follow-up period 2 new visits (visits 6 and 7) are proposed.Thus, proposed duration from first patient in (FPI) to last patient out (LPO) is 36 months-
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 to treat with Otezla® has been made independently before inclusion in this study
- •Patient age ≥ 18 years
- •Existing diagnosis of active psoriatic arthritis
- •At least moderately severe psoriatic arthritis (Physician's Global Assessment (PGA) scale ≥ 2)
- •Insufficient response or intolerance to previous Disease-Modifying Anti-Rheumatic Drug (DMARD) treatment (disease modifying anti-rheumatic drugs)
- •A written informed consent statement by the patient permitting data collection, evaluation, storage and transfer
排除标准
- •Pregnancy
- •Hypersensitivity to apremilast or one of the other ingredients in the film tablets
- •Other criteria according to the summary of product characteristics Breast-feeding
结局指标
主要结局
Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visit 3 compared to baseline on the Physician's Global Assessment scale (PGA; scale from 0-4)
时间窗: Up to approximately 7 months
Physician's global assessment (PGA) will be measured on a VAS scale ranging from 0 to 4. Primary endpoint is the percentage of patients with an improvement of minimum 1 point on this VAS scale after about 6 months (visit 3)
次要结局
- Hannover Functional Ability Questionnaire (FFbH) on visits 1, 2, 3, 5 and 7 compared to baseline(Up to approximately 104 weeks)
- Patient Preference Questionnaire (PPQ) on visits 3, 5 and 7(Up to approximately 104 weeks)
- Adverse Events (AEs)(Up to approximately 104 weeks)
- Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Enthesitis(Up to approximately 104 weeks)
- Percentage of patients with an improvement of ≥ 1 points on the Patient Global Assessment (PaGA) scale on visits 1 to 7 compared to baseline(Up to approximately 104 weeks)
- Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visits 1, 2, 4, 5, 6, 7 compared to baseline(Up to approximately 104 weeks)
- Efficacy of the treatment with regard to rheumatic changes measured with Tender Joint Count (TJC) on visits 1 to 7 compared to baseline(Up to approximately 104 weeks)
- Efficacy of the treatment with regard to rheumatic changes measured with Swollen Joint Count (SJC) on visits 1 to 7 compared to baseline(Up to approximately 104 weeks)
- Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Pain(Up to approximately 104 weeks)
- Psoriatic arthritis Impact of Disease (PsAID) questionnaire on visits 1, 2, 3, 5 and 7 compared to baseline(Up to approximately 104 weeks)
- Assessment of psoriatic skin changes (Body Surface Area, BSA) on visits 1 to 7(Up to approximately 104 weeks)
- Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Joints(Up to approximately 104 weeks)