BioDay Registry: Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Dermatitis

NCT03549416 · tracked via the Priya Life Science Netherlands tracker

Sponsor

UMC Utrecht

Phase

Observational

Started

2018-01-01

Last updated

2025-03-28

Condition(s) studied

Atopic Dermatitis

Study summary

The BioDay Registry aims to address the need for daily practice data regarding the effectiveness and safety of new systemic treatment options (like biologics and Janus kinase inhibitors) in patients with atopic dermatitis and effect on other atopic comorbidities in a multicenter setting. The registry already consists of several additional modules concerning atopic comorbidities, like food allergy and asthma, and a module for conjunctivitis during biologic treatment.

Eligibility

Sex

ALL

Min age

0 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry Exclusion Criteria: * Patients are not eligible for enrolment in case of presumed inability to answer questionnaires or not willing to answer questionnaires and will be excluded.

Primary outcome measure(s)

Assessment of effectiveness — Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
To assess the effectiveness of new treatments in adult and pediatric patients with AD using physician measured clinical eczema scores as well as patient-reported outcome measures.
Drug survival — Drug survival analysis, which is the length of time a patient continues to take a particular drug, will be performed every year, with cumulative results over the years.
To study drug survival and identify factors that affect drug survival.
Side effects — Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
To register objective and subjective side effects and to identify potential risk factors.

Trial sites (14)

Facility	City	Region	Status
Radboud University Medical Center	Nijmegen	Gelderland	Recruiting
Isala Dermatologisch Centrum	Zwolle	Overijssel	Recruiting
Medisch Centrum Leeuwarden	Leeuwarden	Provincie Friesland	Recruiting
University Medical Center Groningen	Groningen	Provincie Groningen	Recruiting
IJsselland Ziekenhuis	Capelle aan den IJssel	South Holland	Recruiting
University Medical Center Utrecht	Utrecht	Utrecht	Recruiting
Meander Medisch Centrum	Amersfoort	Netherlands	Recruiting
Reinier de Graaf ziekenhuis	Delft	Netherlands	Recruiting
Catharina ziekenhuis	Eindhoven	Netherlands	Recruiting
Spaarne Gasthuis	Haarlem	Netherlands	Recruiting
Maastricht Univeristy Medical Center	Maastricht	Netherlands	Recruiting
Haga ziekenhuis	The Hague	Netherlands	Recruiting
Diakonessenhuis	Utrecht	Netherlands	Recruiting
St Antonius ziekenhuis	Utrecht	Netherlands	Recruiting

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Other trials for the same condition

A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis Recruiting

The UPDATE Trial (Uvb Phototherapy in Dermatology for ATopic Eczema) Active, not recruiting

DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema Recruiting

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting

Platform Study to Evaluate the Efficacy and Safety of Investigational Compound(s) in Patients With Moderate to Severe Atopic Dermatitis Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03549416 on ClinicalTrials.gov ↗ ← All trials in the Netherlands