Atopic Dermatitis
Conditions
Brief summary
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.
Interventions
DRUGDupilumab
This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8 | 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 | 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. | 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 | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Dermatology Life Quality Index (DLQI)/Children's DLQI total score. | Baseline to week 24 | DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patients more than equal to \[≥\] 17 years of age) and the CDLQI for patients 12-17 years of age. Each question is scored on a four-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease. |
| Proportion of Participants Achieving More than Equal to 4-point Improvement in DLQI/CDLQI Minimal Clinically Important Difference (MCID) | Week 24 | DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patients more than equal to \[≥\] 17 years of age) and the CDLQI for patients 12-17 years of age. Each question is scored on a four-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease. |
| Proportion of Participants with Impacted Psychological Status using Dermatological Cumulative Life Course Impairment-Prospective (DermCLCI-p) | Baseline to up to Week 24 | DermCLCI-p is the predictive tool of 30 questions that assesses the current cumulative life course impairment (CLCI) status and future risk. This tool consists of 30 items, items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very). |
| Proportion of Participants with Impacted Professional Life/Education Status using DermCLCI-p | At Baseline and Week 24. | DermCLCI-p is the predictive tool of 30 questions that assesses the current cumulative life course impairment (CLCI) status and future risk. This tool consists of 30 items, items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very). |
Countries
Qatar, Saudi Arabia, United Arab Emirates
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed