Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03549416

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Medical Center, Nijmegen, Gelderland, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Assessment of effectiveness

    Time frame: 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.

  2. Drug survival

    Time frame: 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.

  3. Side effects

    Time frame: 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.

Secondary outcomes

  1. Characterization of population

    Time frame: Yearly from baseline up to 5 years

    To characterize patient populations treated with new AD treatments in daily practice.

  2. Characterization of side effects

    Time frame: Yearly from baseline up to 5 years

    To collect data from daily practice regarding side effects (incidence, severity, risk factors, treatment options, etc.).

  3. Laboratory monitoring

    Time frame: Yearly from baseline up to 5 years

    To study the usefulness of laboratory monitoring during treatment in daily practice, with emphasis on subpopulations (e.g. elderly patients, patients with pre-existing liver and/or renal disease).

  4. Long-term safety

    Time frame: Yearly from baseline up to 5 years

    To study the long-term safety risks including malignancies, pregnancy/paternity-related conditions, infections, and autoimmune diseases.

  5. Comorbidities

    Time frame: Yearly from baseline up to 5 years

    To prospectively collect data from daily practice regarding the effect of new treatment options for AD on comorbidities (for example atopic diseases like asthma, food allergy and rhinoconjunctivitis can improve from these new drugs as many target the Th2 axis).

  6. Dose tapering

    Time frame: Yearly from baseline up to 5 years

    To assess whether dose reduction of biologics can be achieved in patients with low AD activity.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilona de Ridder

CONTACT

[email protected]

Marlies de Graaf, MD, PhD

CONTACT

[email protected]

+31887571134

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • AbbVie
  • Academisch Ziekenhuis Groningen
  • Eli Lilly and Company
  • LEO Pharma
  • Sanofi

Registry information

Official study title

BioDay Registry: Prospective, Observational Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Diseases in Daily Practice

Acronym: BioDay

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2018
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.