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Longitudinal variation of blood based biomarkers in moderate-to-severe atopic dermatitis patients, a prospective cohort study

Longitudinal variation of blood based biomarkers in moderate-to-severe atopic dermatitis patients, a prospective cohort study - BIOMAD study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51834
Enrollment
260
Registered
2022-05-02
Start date
2022-05-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atopic dermatitis eczema

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Adult patients with moderate-to-severe atopic dermatitis - An intention to start cyclosporine A, dupilumab, tralokinumab, oral JAK-inhibitor (abrocitinib or upadacitinib) treatment according to the NVDV guideline - Documented recent history (last 6 months) of eligibility for treatment with immunosuppressants, biologicals and JAK-inhibitors.

Exclusion criteria

Exclusion criteria: - Children and adolescents (

Design outcomes

Primary

MeasureTime frame
To investigate longitudinal variation of blood based biomarkers, their integration with disease severity, comorbidities, their association with standard care and characterization of adequate and inadequate responders to standard care in a longitudinal observational study in subjects with moderate-to-severe atopic dermatitis (AD).

Secondary

MeasureTime frame
• Investigator*s Global Assessment (IGA)1 score at all visits. • Eczema Area and Severity Index (EASI)2 score at all visits. • At least 50% reduction in EASI score (EASI50; yes/no) at all visits. • Patient-Oriented Eczema Measure (POEM)3 score at all visits. • Dermatology Life Quality Index (DLQI)4 at all visits. • Numerical Rating Scale pruritus (NRS pruritus)5 score at all visits • Monitoring asthma and rhinitis disease activity and medication.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)