Atopic DermatitisBioDayNCT03549416
BioDay Registry: Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Dermatitis
An observational study of Atopic Dermatitis, run by UMC Utrecht at 14 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 1,200 participants
- Where
- 14 sitesNetherlands
- Study dates
- 1 Jan 2018to 31 Dec 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry
Who may be able to join
- All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry
Who cannot join
- Patients are not eligible for enrolment in case of presumed inability to answer questionnaires or not willing to answer questionnaires and will be excluded.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ilona de Ridder contact
14 sites in 1 country
Netherlands14 sites, 14 recruiting
- Recruiting
Meander Medisch Centrum
Amersfoort
Anneke van Lynden- van Nes
- Recruiting
IJsselland Ziekenhuis
Capelle aan den IJssel, South Holland
Shiarra Stewart
- Recruiting
Reinier de Graaf ziekenhuis
Delft
Inge Haeck
- Recruiting
Catharina ziekenhuis
Eindhoven
Wouter Touwslager
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 GZ
Marie Loiuse Schuttelaar, MD, PhD
- Recruiting
Spaarne Gasthuis
Haarlem
Bert Oosting
- Recruiting
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland
Klaziena Politiek
- Recruiting
Maastricht Univeristy Medical Center
Maastricht
Paula van Lumig
- Recruiting
Radboud University Medical Center
Nijmegen, Gelderland, 6525 GA
Marijke Kamsteeg, MD, PhD
- Recruiting
Haga ziekenhuis
The Hague
Annemoon Tuyll van Serooskerken
- Recruiting
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
Marjolein de Bruin-Weller, PhD, +31887550930, m.s.debruin-weller@umcutrecht.nl
Jorien van der Schaft, MD, PhD, j.vanderschaft-5@umcutrecht.nl
- Recruiting
Diakonessenhuis
Utrecht
Annebeth Flinterman
- Recruiting
St Antonius ziekenhuis
Utrecht
Ron Tupker
- Recruiting
Isala Dermatologisch Centrum
Zwolle, Overijssel
Wianda Christoffers
About this study
Official title: BioDay Registry: Prospective, Observational Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Diseases in Daily Practice
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.
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Dupilumab, Dupixent, BioDay, Daily practice, Real world, Atopic Diseases Registry, Registry, Multi center, Biologics, Janus kinase inhibitors, Baricitinib, Upadacitinib, Abrocitinib, Tralokinumab
- Medical subject headings
- Dermatitis, Atopic
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of effectiveness
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.
Measured: Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
Drug survival
To study drug survival and identify factors that affect drug survival.
Measured: 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
To register objective and subjective side effects and to identify potential risk factors.
Measured: Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
Secondary outcomes (6)
Characterization of population
To characterize patient populations treated with new AD treatments in daily practice.
Measured: Yearly from baseline up to 5 years
Characterization of side effects
To collect data from daily practice regarding side effects (incidence, severity, risk factors, treatment options, etc.).
Measured: Yearly from baseline up to 5 years
Laboratory monitoring
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).
Measured: Yearly from baseline up to 5 years
Long-term safety
To study the long-term safety risks including malignancies, pregnancy/paternity-related conditions, infections, and autoimmune diseases.
Measured: Yearly from baseline up to 5 years
Comorbidities
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).
Measured: Yearly from baseline up to 5 years
Dose tapering
To assess whether dose reduction of biologics can be achieved in patients with low AD activity.
Measured: Yearly from baseline up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Ziekenhuis Groningen, Sanofi, AbbVie, Eli Lilly and Company, LEO Pharma
- Responsible party
- Principal investigator, Dr M.S. de Bruin-Weller, UMC Utrecht
- Investigators
- Marjolein de Bruin-Weller, Md, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549416
- Sponsor's protocol ID
- 18/239
- Acronym
- BioDay
- Status last verified
- Mar 2025
- First submitted
- 25 May 2018
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38272373
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioDay Registry: Prospective, Observational Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Diseases in Daily Practice
- ClinicalTrials.gov ID
- NCT03549416
- Acronym / sponsor ID
- BioDay / 18/239
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Dupilumab, Dupixent, BioDay, Daily practice, Real world, Atopic Diseases Registry, Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Academisch Ziekenhuis Groningen, Sanofi, AbbVie, Eli Lilly and Company, LEO Pharma
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry
Key inclusion criteria (1 listed)
- All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry
Key exclusion criteria (1 listed)
- Patients are not eligible for enrolment in case of presumed inability to answer questionnaires or not willing to answer questionnaires and will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 38272373Clabbers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilona de Ridder contact
Marjolein de Bruin-Weller, Md, PhD principal investigator
UMC Utrecht
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by UMC Utrecht at 14 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlies de Graaf, MD, PhD (+31887571134, M.deGraaf-10@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of effectiveness (time frame: Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03549416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.