A Real-world, Longitudinal Observational Study of the Impact of Tildrakizumab on Patient Reported Outcomes in Patients With Moderate-to-severe Psoriasis in Canada
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Chronicle Academy
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Evaluate the impact of tildrakizumab on the Dermatology Life Quality Index (DLQI and DLQI-R) in patients of Fitzpatrick skin type III and above to 16 weeks
概览
简要总结
This is a multi-centre, non-interventional, open-label, prospective observational study that will be conducted across Canada over 52-week duration. Approximately 80 patients who are initiating tildrakizumab as part of their routine care through the ILUMYA SUPPORT® Program and meet the study's eligibility criteria will be enrolled. Specifically, the study will enroll patients with Fitzpatrick scale skin types III and above.
The real-world impact, safety and effectiveness of tildrakizumab on patients with moderate-to-severe plaque psoriasis (PsO) remain largely undocumented in Canada, despite its approval in 2018. Given Canada's diverse population, this study presents an opportunity to evaluate tildrakizumab's quality of life, safety and effectiveness in specific demographic groups, particularly those patients with Fitzpatrick scale skin type III and above.
The findings from this study will help optimize care, address unmet needs, and ensure that treatment outcomes are inclusive and reflective of Canada's diverse population.
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
- •Adults aged 18 years or older.
- •Diagnosis of moderate-to-severe chronic plaque-type PsO with Fitzpatrick scale type III or above (BSA \>/=3%).
- •Candidate for phototherapy and/or systemic therapy.
- •Planning to initiate tildrakizumab as part of routine clinical care through the ILUMYA SUPPORT® Program for the treatment of plaque PsO but has not yet received their first dose.
- •a. Decision to treat with tildrakizumab must be made independently of and prior to study recruitment.
- •Must be able to read, understand, and communicate in English.
- •Must be willing to participate in the study and capable to provide informed consent
- •Able to comply with all study procedures and attend all study visits
排除标准
- •Known hypersensitivity to tildrakizumab, its excipients, or components of the container, as outlined in the Product Monograph.
- •Concurrently taking any oral medication for treatment of PsO (e.g. methotrexate, cyclosporin, acitretin)
- •Diagnosis of only palmoplantar psoriasis
- •Concurrent medical condition or significant comorbidities that, in the investigator's opinion, would prevent participation in the study or interfere with study assessments
- •Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding.
- •Prior (within 30 days) or actively participating in other interventional clinical trial(s).
- •Unable or unwilling to comply with study procedures including completing questionnaire.
- •Any other condition that, in the opinion of the investigator, could create a hazard to the participant's safety, endanger the study procedures, or interfere with the interpretation of study results
研究组 & 干预措施
Study Cohort
all participants
结局指标
主要结局
Evaluate the impact of tildrakizumab on the Dermatology Life Quality Index (DLQI and DLQI-R) in patients of Fitzpatrick skin type III and above to 16 weeks
时间窗: 16 weeks
DLQI consists of 10 items designed to assess multiple domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Patients respond to each item based on their experiences over the past week, using a four-point scale that ranges from: 0 (not at all or not relevant), 1 (a little), 2 (a lot), 3 (very much). Total DLQI score is calculated by summing the scores for all 10 items, resulting in a possible range from 0 to 30, where higher scores indicate greater impairment in QoL due to the skin condition. DLQI-Relevant adjusted for non-relevant answers
次要结局
- Evaluate the impact of tildrakizumab on DLQI and DLQI-R in patients of Fitzpatrick skin type III and above to 52 weeks(52 weeks)
- Evaluate efficacy of tildrakizumab using Psoriasis Area Severity Index (PASI) in patients with Fitzpatrick skin types III and above(Week 16, Week 52)
- Evaluate efficacy of tildrakizumab using Body Surface Area (BSA) in patients with Fitzpatrick skin types III and above(Week 16, Week 52)
- Evaluate efficacy of tildrakizumab using static Physician Global Assessment (sPGA) in patients with Fitzpatrick skin types III and above(Week 16, Week 52)
- Impact of tildrakizumab treatment on quality of life(Week 16, Week 52)
- Impact of tildrakizumab treatment on sleep(Week 16, Week 52)
- Impact of tildrakizumab treatment on discomfort(Week 16, Week 52)
- Impact of tildrakizumab on skin pain(Week 16, Week 52)
- Evaluate the correlation between clinical improvement (PASI, BSA, sPGA) and QoL outcomes, identifying how improvements in disease severity align with enhancements in QoL measures.(Week 16, Week 52)
- Evaluate the safety of tildrakizumab over the course of the study(Baseline to Week 52)
- Assess patient adherence and satisfaction with tildrakizumab treatment(Baseline to Week 52)