The precise mechanisms driving onset and course are insufficiently understood, disease progression from a current patient state and/or the development of comorbidities are unpredictable, and the optimal type and time-point for intervention is as yet…
ID
Source
Brief title
Health condition
Atopic dermatitis, atopic eczema
Sponsors and support
Intervention
Outcome measures
Primary outcome
The combined efforts of BIOMAP will support the definition of endotypes, i.e. a more precise disease classification, a definition of biomarkers enabling patient stratification and patient-directed care strategies, and the early identification of the most suitable therapy for every patient. They will also stimulate future research on mechanisms and innovative treatments directed at endotype components.
Secondary outcome
-
Background summary
Atopic dermatitis (AD) and psoriasis (Pso) are common inflammatory skin disorders. They are heterogeneous diseases comprising a variety of subtypes, which share common clinical characteristics but arise from distinct and definable molecular and cellular mechanisms, i.e. endotypes, some of which might overlap. Understanding these shared and exclusive mechanisms will lead to the identification of biomarkers for patient stratification, and enable reasonably accurate prediction of disease onset, progression and response to therapy for appropriate selection of type and timing of intervention (decision support) to reach a high degree of disease control (across patients and within individuals). TREAT Germany, A*Star (UK) and TREAT NL are three sister registries assessing the same patient population and outcomes and collecting the same type of biosamples. The coordinating centers of these registries including AMC are partners within the EU-IMI BIOMAP project (Grant Agreement No. 821511). All three registries will provide data and samples to BIOMAP project. These samples will be used to screen for transcriptomic and proteomic biomarkers associated with disease, disease progression and response to therapies. The samples from TREATGermany, which is already running since several years, will be used for identification of potential biomarkers, while the samples from A*Star and BIOMAD NL will serve confirmation purposes.
Study objective
The precise mechanisms driving onset and course are insufficiently understood, disease progression from a current patient state and/or the development of comorbidities are unpredictable, and the optimal type and time-point for intervention is as yet unknown. Understanding relevant subtypes and lifetime trajectories of atopic dermatitis and their molecular underpinnings may enable intervention to prevent comorbidities, and may also make earlier use of therapies and/or use in moderate disease more cost-effective.
Study design
Baseline, 4 weeks, 3 months, 6 months, 12 months
Intervention
Collection of blood, skin biopsies, tape strips
Inclusion criteria
- Patient has a diagnosis of AD, based on the U.K. working party’s diagnostic criteria; - Starts with any type of phototherapy (e.g. UVB) or systemic immunomodulating therapy (e.g. ciclosporin, systemic glucocorticosteroids, azathioprine, methotrexate, mycophenolic acid, dupilumab); - Has voluntarily signed and dated an informed consent prior to any study related procedure or has a legal representative to do so and is willing to comply with the requirements of this study protocol.
Exclusion criteria
- Patient uses only (systemic) antibiotics or antihistamines; - Patient starts with systemic immunomodulating therapy for another indication than atopic dermatitis; - Insufficient understanding of the study by the patient or parent/legal representative; - Patient does not participate in the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8323 |
| CCMO | NL69586.018.19 |
| OMON | NL-OMON48036 |