An Open-Label, Real World Study Evaluating the Long-Term Quality of Life of Tildrakizumab in Adult Patients With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale
研究概览
简要总结
This is a Phase 4 multicenter, uncontrolled open-label study design. There will be a total of 10 study visits at Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Week 28, Week 40, Week 52 and Week 64, with subjects receiving tildrakizumab injections at Week 0, Week 4, Week 16, Week 28, Week 40, and Week 52. The total study duration will be approximately 64 weeks, excluding a screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects are non-immunocompromised males or females 18 years of age or older.
- •Subjects have ≥3% total body surface area plaque psoriasis.
- •Subjects are candidates for phototherapy or systemic therapy.
- •Subject must be diagnosed at least 6 months prior to entering the study.
- •Females must be surgically sterile, postmenopausal for >5 years, or using a highly effective form of birth control (<1% failure rate), for at least 30 days prior to test article exposure, with a negative serum pregnancy test.
排除标准
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject is younger than 18 years of age.
- •Subjects with uncontrolled mental illness or active suicidal ideations based on baseline mental health questionnaire of choice.
- •Subject is known, or suspected of being unable to comply with the study protocol, in the opinion of the investigator.
- •Subject is currently enrolled in an investigational drug or device study.
研究组 & 干预措施
tildrakizumab 100 mg
干预措施: Injections of tildrakizumab (Drug)
结局指标
主要结局
Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale
时间窗: baseline, week 28 and week 52
The Psychological General Well-Being scale is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients. The values reported are change in score from baseline.
次要结局
- Improvement in Quality of Life Measured by Change From Baseline in Psychological General Well-Being Scale Over Time(baseline, weeks 4, 8, 12, 16, 40, 64)
- Change From Baseline in Itch-Numeric Rating Scale(baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64)
- Changes From Baseline Psoriasis Area Severity Index (% of Psoriasis Area Severity Index Improvement From Baseline, Absolute Psoriasis Area Severity Index ) Over Time(baseline, weeks 4,16, 28 and 52)
- Assessment of Patient Happiness With Psoriasis Control Over Time Using Numerical Rating Scale(weeks 4, 8, 12, 16, 28, 40, 52, 64)
- Improvement in Quality of Life Measured by Change From Baseline in Dermatology Life Quality Index Over Time(week 64)
- Proportion of Subjects With Dermatology Life Quality Index Score ≤ 5(Baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64)
- Proportion of Subjects With a Reduction of ≥ 5 Points in Dermatology Life Quality Index From Baseline(baseline, weeks 4, 8, 12, 16, 28, 40, 52, and 64)
- Proportion of Subjects With Dermatology Life Quality Index Score of 0 or 1(baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64)
- Changes From Baseline in Percent Affected Body Surface Area(Weeks 4, 8, 12, 16, 28, 40, 52, and 64)
- Change From Baseline in Static Physician's Global Assessment(Weeks 4, 8, 12, 16, 28, 40, 52, and 64)
- Changes From Baseline Body Surface Area x Physician's Global Assessment Over Time(weeks 4, 8, 12, 16, 28, 40, 52, 64)
- Proportion of Patients With Pain Score of 0(Weeks 4, 8, 12, 16, 28, 40, 52, and 64)
- Assessment of Patient Satisfaction With Treatment Measured by Change From Baseline in Treatment Satisfaction Questionnaire for Medication Over Time(baseline, weeks 4, 8, 12, 16, 28, 40, 52, 64)
- Improvement From Baseline in Work Productivity Measured by Change in Work Productivity and Activity Impairment Scale Over Time(baseline, weeks 16, 28, 40, 52, 64)
- Change From Baseline in Scaling-Numeric Rating Scale(Weeks 4, 8, 12, 16, 28, 40, 52, and 64)
- Change From Baseline in Pain-Numeric Rating Scale(Weeks 4, 8, 12, 16, 28, 40, 52, and 64)
- Assessment of Tildrakizumab Overall Satisfaction Over Time Using Numerical Rating Scales(weeks 4, 8, 12, 16, 28, 40, 52, 64)
- Proportion of Patients With Itch Score of 0(weeks 4, 8, 12, 16, 28, 40, 52, and 64)
- Proportion of Patients With Scaling Score of 0(Weeks 4, 8, 12, 16, 28, 40, 52, and 64)