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

Atopic Dermatitis Clinical Trial

— BioDay  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03549416
• Other study ID #: 18/239
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: UMC Utrecht
• Contact: Marlies de Graaf, MD, PhD
• Phone: +31887571134
• Email: M.deGraaf-10[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. The registry already consists of several additional modules concerning atopic comorbidities, like food allergy and asthma, and a module for conjunctivitis during biologic treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Netherlands	Meander Medisch Centrum	Amersfoort
Netherlands	IJsselland Ziekenhuis	Capelle Aan Den IJssel	Zuid-Holland
Netherlands	Reinier de Graaf ziekenhuis	Delft
Netherlands	Haga ziekenhuis	Den Haag
Netherlands	Catharina ziekenhuis	Eindhoven
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Spaarne Gasthuis	Haarlem
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Friesland
Netherlands	Maastricht Univeristy Medical Center	Maastricht
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland
Netherlands	Diakonessenhuis	Utrecht
Netherlands	St Antonius ziekenhuis	Utrecht
Netherlands	University Medical Center Utrecht	Utrecht
Netherlands	Isala Dermatologisch Centrum	Zwolle	Overijssel

Sponsors (6)

Lead Sponsor	Collaborator
UMC Utrecht	AbbVie, Academisch Ziekenhuis Groningen, Eli Lilly and Company, LEO Pharma, Sanofi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
Primary	Drug survival	To study drug survival and identify factors that affect 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.
Primary	Side effects	To register objective and subjective side effects and to identify potential risk factors.	Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
Secondary	Characterization of population	To characterize patient populations treated with new AD treatments in daily practice.	Yearly from baseline up to 5 years
Secondary	Characterization of side effects	To collect data from daily practice regarding side effects (incidence, severity, risk factors, treatment options, etc.).	Yearly from baseline up to 5 years
Secondary	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).	Yearly from baseline up to 5 years
Secondary	Long-term safety	To study the long-term safety risks including malignancies, pregnancy/paternity-related conditions, infections, and autoimmune diseases.	Yearly from baseline up to 5 years
Secondary	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).	Yearly from baseline up to 5 years
Secondary	Dose tapering	To assess whether dose reduction of biologics can be achieved in patients with low AD activity.	Yearly from baseline up to 5 years