NCT05155098已完成不适用
2 Years Prospective Study to Collect Real-life Data On the Retention, Quality of Life, Effectiveness and Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial spondyloarthriTis (PROMPT)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Retention rate of secukinumab therapy
研究概览
简要总结
This is an observational, prospective primary data collection study. The duration of observation is 2 years after study enrolment date. Disease and treatment history will be retrospectively reviewed from medical record at enrollment with no time limits for the key diagnosis of enrolment (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthropathy).
详细描述
After the baseline visit, data will be collected for each patient prospectively every 6 months for up to 2 years. At each visit, effectiveness parameters, as well as the patients' QoL and treatment pattern will be documented.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent of the patient to participate in the study
- •Age 18-80 years.
- •Patients with an assured diagnosis by the treating physician of active moderate to severe plaque psoriasis or active PsA or active AS or active non-radiographic axial SpA.
- •Patients must have received the official approval to receive secukinumab in Dermatology Disease Prior Authorization (DDPA) or Rheumatology Disease Prior Authorization (RDPA) before study participation or the decision to treat patient's condition with secukinumab is happened before entering the study
- •Patients must receive the first dose of secukinumab during the study enrollment period.
- •Patients for whom the decision for a therapy with secukinumab is made by the attending treating physician, regardless of this non-interventional study.
- •Patients who have EQ-5D score before start the 1st dose secukinumab.
排除标准
- •Any medical or psychological condition in the treating physician's opinion which may prevent the patient from study participation for the 2 year study period.*
- •Patients participating in parallel in other interventional clinical trial.
- •Patients participated in an interventional clinical trial with secukinumab involvement in the past.
- •Note: For example, patients diagnosed with a terminal illness and those with cognitive impairment due to dementia and Alzheimer's disease.
结局指标
主要结局
Retention rate of secukinumab therapy
时间窗: 2 years
Retention rate is defined as percentage of patients who have not discontinued the medication.
次要结局
- Change in QoL by EQ-5D Visual Analog Scale (VAS)(Baseline, month 6, month 12, month 18, month 24)
- Patients with Ankylosing spondylitis: Patient's global assessment of disease activity(year 1, year 2)
- Patients with Ankylosing spondylitis: C-reactive protein (CRP) or high-sensitivity CRP (hsCRP)(year 1, year 2)
- Treatment pattern(Month 6, month 12, month 18, month 24)
- Work/school absenteeism(2 years)
- Patients with Psoriasis: Proportions of patients achieving a PASI 75, 90, and 100 responses(Month 6, month 12, month 18, month 24)
- Patients with Psoriasis: Proportion of patients achieving a DLQI 0/1 response(Month 6, month 12, month 18, month 24)
- Patients with Psoriatic Arthritis: Presence of any enthesitis(1 year, 2 years)
- Patients with Ankylosing spondylitis: Appearance or worsening of lesions at anterior sites of the vertebrae assessed by X-ray(year 1, year 2)
- Retention rate of secukinumab therapy by individual indication(year 1, year 2)
- Patients with Psoriasis: Absolute PASI scores(Month 6, month 12, month 18, month 24)
- Patients with Psoriatic Arthritis: Presence of any dactylitis(1 year, 2 years)
- Patients with Psoriatic Arthritis: Proportion of patients achieving a PASI 75, 90, and 100 response(month 6, month 12, month 18 and month 24)
- Patients with Psoriatic Arthritis: Changes between PASI response categories over time(2 years)
- Patients with Psoriatic Arthritis: Absolute PASI scores(month 6, month 12, month 18 and month 24)
- Patients with Psoriasis: Proportion of patients achieving a PGA 0/1 response(Month 6, month 12, month 18, month 24)
- Patients with Psoriasis: Correlation between PASI and DLQI score(2 years)
- Patients with Psoriatic Arthritis: 78 TJC and 76 SJC(1 year, 2 years)
- Patients with Psoriatic Arthritis: Changes in absolute and relative PASI scores over time(2 years)
- Ankylosing spondylitis and non-radiographic axial SpA: Changes of FACIT-Fatigue score compared to baseline(month 6, month 12, month 18 and month 24)
- Patients with Psoriasis: Changes between PASI response categories over time(2 Years)
- Patients with Psoriasis: Changes in absolute and relative PASI scores over time(Baseline, month 6, month 12, month 18, month 24)
- Patients with Psoriatic Arthritis: Physician's global assessment (PGA)(1 year, 2 years)
- Patients with Psoriatic Arthritis: Total patient pain assessed by visual analog scale (VAS)(1 year, 2 years)
- Patients with Psoriatic Arthritis: Appearance of new bone erosions or worsening of pre-existing erosions(1 year, 2 years)
- Patients with Psoriatic Arthritis: Changes of HAQ-DI score(month 6, month 12, month 18 and month 24)
- Patients with Ankylosing spondylitis: Total spinal pain assessed using VAS scale(year 1, year 2)
- Patients with Psoriatic Arthritis: Changes of FACIT-Fatigue score(month 6, month 12, month 18 and month 24)
- Patients with Psoriatic Arthritis: Correlation between effectiveness measures, HAQ-DI, and FACIT-Fatigue scores(2 years)
- Patients with Ankylosing spondylitis: Bath AS disease activity index (BASDAI) response(year 1, year 2)
- Patients with Ankylosing spondylitis: Presence of any enthesitis(2 years)
- Patients with Ankylosing spondylitis: Appearance or worsening of bone marrow edema (BME) in the spine and/or sacro-iliac joints assessed by magnetic resonance imaging (MRI)(year 1, year 2)
- Ankylosing spondylitis: Correlation between ASDAS, BASDAI, and FACIT-Fatigue scores(2 years)
研究者
研究点 (1)
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