The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis in Gulf Countries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 184
- 试验地点
- 9
- 主要终点
- Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8
研究概览
简要总结
This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have moderate to severe AD with signs and symptoms of anxiety and/or depression.
- •Participants who initiate dupilumab therapy within 30 days of enrolment, based on the treating physician's decision, independently of study participation
- •Participants and/or their legally approved representatives (LAR in case of the minor subject) must agree to sign an informed consent or an assent.
排除标准
- •Females who are pregnant, lactating, or planning/intending to be pregnant in the next 6 months.
- •Participants who are participating in another trial.
- •Participants with active chronic or acute infection requiring systemic treatment.
- •Participants who are diagnosed with active endoparasite infection or are suspected of being at high risk of infection.
- •Participants with human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.
- •Participants on antidepressants/anti-anxiety within 6 months of enrolment or those who are planning to receive antidepressants/anti-anxiety. In addition, those who will use antidepressants/anti-anxiety medications throughout the study will be excluded from the analysis.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8
时间窗: Week 24
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety.
Proportion of Participants with HADS Depression (HADS-D) Sub-scores of less than 8
时间窗: Week 24
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of depression.
Change from Baseline in HADS Total Score.
时间窗: Baseline to up to Week 24
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.
Proportion of Participants with More Than or Equal to 4-point Improvement in POEM Total Score
时间窗: Week 24
The Patient Oriented Eczema Measure (POEM) is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.
Change from Baseline in POEM Total Score.
时间窗: Baseline to up to Week 24
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.
次要结局
- Change from Baseline in Dermatology Life Quality Index (DLQI)/Children's DLQI total score.(Baseline to week 24)
- Proportion of Participants Achieving More than Equal to 4-point Improvement in DLQI/CDLQI Minimal Clinically Important Difference (MCID)(Week 24)
- Proportion of Participants with Impacted Psychological Status using Dermatological Cumulative Life Course Impairment-Prospective (DermCLCI-p)(Baseline to up to Week 24)
- Proportion of Participants with Impacted Professional Life/Education Status using DermCLCI-p(At Baseline and Week 24.)