BioDay Registry: Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: from 0 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BioDay Registry: Prospective, Observational Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Diseases in Daily Practice
Overview
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.
Primary outcome measures
- Assessment of effectiveness [Time frame: Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)]
- 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.]
- Side effects [Time frame: Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)]
Secondary outcome measures (6)
- Characterization of population [Time frame: Yearly from baseline up to 5 years]
- Characterization of side effects [Time frame: Yearly from baseline up to 5 years]
- Laboratory monitoring [Time frame: Yearly from baseline up to 5 years]
- Long-term safety [Time frame: Yearly from baseline up to 5 years]
- Comorbidities [Time frame: Yearly from baseline up to 5 years]
- Dose tapering [Time frame: Yearly from baseline up to 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Netherlands · 14 centers
- Radboud University Medical Center — Nijmegen
- Isala Dermatologisch Centrum — Zwolle
- Medisch Centrum Leeuwarden — Leeuwarden
- University Medical Center Groningen — Groningen
- IJsselland Ziekenhuis — Capelle aan den IJssel
- University Medical Center Utrecht — Utrecht
- Meander Medisch Centrum — Amersfoort
- Reinier de Graaf ziekenhuis — Delft
- … and 6 more centers
Publications
- Clabbers J, Boesjes C, Spekhorst L, van Gisbergen MW, Maas E, Marshall J, Janssen R, Janssen M, Zuithoff N, Steijlen P, de Graaf M, van Geel M, de Bruin-Weller M, Gostynski A. Influence of pathogenic filaggrin variants on dupilumab treatment in atopic dermatitis. J Allergy Clin Immunol. 2024 Apr;153(4):1155-1161.e4. doi: 10.1016/j.jaci.2023.12.027. Epub 2024 Jan 23. PMID 38272373
Identifiers
NCT: NCT03549416 · 18/239