Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine.
Primary outcome is the percentage of patients with primary non-response to second-line treatment. Defined as fail to achieve EASI-75 (a 75% improvement in EASI score) at week 16 of follow-up. A 12-month recruitment period is planned and about 150 patients with moderate-severe atopic dermatitis will be recruited. The study is divided into two cohorts. All patients diagnosed with moderate to severe atopic dermatitis who are going to receive second-line systemic treatment at the Dermatology Department of La Paz University Hospital are selected in cohort 1. Patients will receive the starting dose used in routine clinical practice. All patients diagnosed with moderate to severe atopic dermatitis who are receiving second-line systemic treatment at the Dermatology Department of La Paz University Hospital will be selected in cohort 2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: patients who are about to initiate treatment | Other | Patients will receive the dose used in routine clinical practice. Once the patient is included in the clinical trial their therapeutic management will be conducted according to standard clinical practice, but some additional procedures will be performed:
|
|
| Cohort 2: patients who are already receiving second-line systemic treatment | Other | If the patient is receiving second-line therapy at the moment of the inclusion, data will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Second-line systemic treatment | Drug | Patients with moderate to severe atopic dermatitis refractory to topical medication, who also have previous experience with cyclosporine and an unsatisfactory response, or in whom the use of cyclosporine is considered inappropriate due to contraindication or intolerance, are candidates for treatment with other alternatives (Dupilumab, Tralokinumab, Upadacitinib, Baricitinib, Abrocitinib). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with primary non-response to second-line treatment. | Fail to achieve EASI-75 (a 75% improvement in Eczema Area and Severity Index [EASI] score). The minimum EASI score is 0 and the maximum EASI score is 72. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving EASI-75 | Fail to achieve EASI-75 (a 75% improvement in Eczema Area and Severity Index [EASI] score). The minimum EASI score is 0 and the maximum EASI score is 72. | Week 6 |
| Time to treatment failure after week 16 |
Not provided
Inclusion Criteria:
Cohort 1:
Cohort 2:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene García, MD | Contact | +34-912071466 | irene.ucicec@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Irene García, MD | Hospital La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital La Paz | Recruiting | Madrid | 28046 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase IV, low-intervention clinical trial to develop prediction models that allow to determine the most appropriate therapeutic strategy in patients diagnosed with atopic dermatitis that need second-line systemic treatment.
Not provided
Not provided
Not provided
Not provided
|
|
| Folllow-up of second-line systemic treatment already started | Other | If the patient is receiving second-line therapy at the moment of the inclusion, data will be collected from clinical records from treatment start until study inclusion and prospectively after study inclusion. |
|
Time to treatment failure with cyclosporine defined as Eczema Area and Severity Index (EASI) ≤ 50 during follow-up after week 16.
| Week 16 |
| Mean percentage of change in Eczema Area and Severity Index (EASI) score | Mean percentage of change in EASI score from baseline to week 16. | Week 16 |
| Percentage of change in SCORAD (SCORing Atopic Dermatitis) | Is the score of the severity of atopic dermatitis. It includes the evaluation of the affected areas. The intensity of the lesions and the subjective symptoms of the patient. Classifies AD as Mild >25, Moderate 25-50, and Severe >50 | Week 16 |
| Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis) | Percentage of patients experiencing an improvement of at least 75% in SCORAD from the baseline value. The SCORAD for that individual is A/5 + 7B/2 + C. The total area is 'A', which has a possible maximum of 100%. The intensity scores are added together to give 'B' (maximum 18). The subjective symptoms is 'C' (maximum 20). | Through study completion, an average of 1 year |
| Change of IGA (Investigator Global Assessment) | Investigator Global Assessment (IGA) is a simple objective measure providing an overall evaluation. It uses a 5-point scale (clear=0; almost clear=1; mild=2; moderate=3; severe=4). | Week 16 |
| Time to IGA score of 0/1 (Investigator Global Assessment) | Time to IGA score of 0/1 (clear or almost clear). | Through study completion, an average of 1 year |
| Change of BSA (Body surface area) | Change of BSA (Body surface area) involment | Week 16 |
| Change in NRS | Change in NRS (numerical rating scale). The NRS is comprised of one item and represents the numbers 0 ("no itch") to 10 ("worst imaginable itch"). | Week 16 |
| Change in RECAP | RECAP (Recap of atopic eczema) is used to assess the control of different degrees of eczema severity through 7 items. | Week 16 |
| Percentage of patients having a variation of 4 points in their improvement in DLQI | Dermatology Life Quality Index is a validated and widely used 10-item questionnaire with paediatric versions (0-3 and 4-16 years). A variation of 4 points is considered a clinically meaningful endpoint. | Through study completion, an average of 1 year |
| Change in POEM (Patient-Oriented Eczema Measure) | The Patient-Oriented Eczema Measure (POEM): is a validated tool in which the patient self-assesses how many days they experienced seven distinct items (itch, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, dryness of the skin) during a period of 1 week. The maximum score is 28 points. | Week 16 |
| Rate of adverse events associated to second-line systemic treatment | Any untoward medical occurrence in a patient or clinical trial participant, which does not necessarily have a causal relationship with the research procedures or the investigational medicinal product. | Through study completion, an average of 1 year |
| Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage) | Percentage of patients reaching 90 percentage (EASI-90) improvement from baseline during follow-up. The minimum EASI (Eczema Area and Severity Index) score is 0 and the maximum EASI score is 72. | Through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
| C574065 | tralokinumab |
| C000613732 | upadacitinib |
| C000596027 | baricitinib |
| C000634427 | abrocitinib |
Not provided
Not provided
Not provided