Prospective Non-Interventional Study to Investigate the Durable Effectiveness of Risankizumab Using Digital and Remote Evaluation Tools in Moderate to Severe Psoriasis Patients - prIMMa Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 141
- 试验地点
- 11
- 主要终点
- Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1
研究概览
简要总结
Psoriasis is a chronic inflammatory skin condition that is characterized by symptoms such as pain, itching and discomfort. This can have severe impact on the quality of life including depression, embarrassment, and social isolation. The objective of this study is to evaluate how effective risankizumab is in changing the disease symptoms in adult participants with moderate to severe psoriasis.
Risankizumab is an approved drug being developed for the treatment of psoriasis. Adult participants who are prescribed risankizumab treatment according to the local label will be enrolled in this study. Approximately 125 adult participants with moderate to severe psoriasis will be enrolled at multiple sites across Israel.
Participants who are prescribed to receive subcutaneous risankizumab injection by their physician according to local label will be enrolled and will be followed for approximately 2 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, patient charts, questionnaires, and remote monitoring device (patch sensor).
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
- •Clinical diagnosis of moderate to severe psoriasis.
- •Prescribed risankizumab as the standard treatment for psoriasis, according to the local label. The decision to prescribe risankizumab will be made solely by the physician, based on his clinical judgment, and is done prior to any decision to approach the participant to participate in this study.
- •Willing to be involved in the study, to sign an informed consent form and complete study questionnaires.
- •Participants participating in digital component: Pruritus Numeric Rating Scale (PNRS) score >=4 at baseline.
排除标准
- •Participants participating in a concurrent clinical interventional study or within 30 days.
- •Participants treated with risankizumab prior to baseline visit.
结局指标
主要结局
Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1
时间窗: Week 52
DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment.
次要结局
- Change From Baseline in Average Nightly Nocturnal Scratch Activity(Baseline (Week 0) to Week 52)
- Change From Baseline in Medical Outcome Study Sleep Scale (MOS-SS)(Up to approximately 4 weeks)
- Change From Baseline in Psoriasis Symptoms Scale (PSS)(Up to approximately 104 weeks)
- Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) 0 or 1(Up to approximately 104 weeks)
- Percentage of Participants With Physician Assessment Static Psoriasis Global Assessment (sPGA) 0 or 1(Up to approximately 104 weeks)
- Percentage of Participants With Durability of Response Among sPGA Responders ar Week 24(Up to approximately 104 weeks)
- Change From Baseline in Dermatology Life Quality Index (DLQI)(Up to approximately 104 weeks)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI)(Up to approximately 104 weeks)
- Change From Baseline in Average Pruritus Numeric Rating Scale (PNRS)(Up to approximately 4 weeks)
- Percentage of Participants With Change From Baseline DLQI > Minimal Clinically Important Difference (MCID)(Up to approximately 104 weeks)
- Number of Participants With Adverse Events (AEs)(Up to approximately 104 weeks)