Clinical trial NCT03549416: BioDay Registry: Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Dermatitis
Official title: BioDay Registry: Prospective, Observational Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Diseases in Daily Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Academisch Ziekenhuis Groningen
name: Sanofi
name: AbbVie
name: Eli Lilly and Company
name: LEO Pharma
First posted: 2018-06-08
Enrollment: 1200
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry

Brief 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 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.

Primary outcomes:
measure: Assessment of effectiveness
timeFrame: Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
measure: Drug survival
timeFrame: 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.
measure: Side effects
timeFrame: Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
Secondary outcomes:
measure: Characterization of population
timeFrame: Yearly from baseline up to 5 years
measure: Characterization of side effects
timeFrame: Yearly from baseline up to 5 years
measure: Laboratory monitoring
timeFrame: Yearly from baseline up to 5 years
measure: Long-term safety
timeFrame: Yearly from baseline up to 5 years
measure: Comorbidities
timeFrame: Yearly from baseline up to 5 years
measure: Dose tapering
timeFrame: Yearly from baseline up to 5 years
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Friesland
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
city: Zwolle
country: Netherlands
facility: Isala Dermatologisch Centrum
state: Overijssel
city: Capelle Aan Den IJssel
country: Netherlands
facility: IJsselland Ziekenhuis
state: Zuid-Holland
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Delft
country: Netherlands
facility: Reinier de Graaf ziekenhuis
city: Den Haag
country: Netherlands
facility: Haga ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Maastricht
country: Netherlands
facility: Maastricht Univeristy Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
city: Utrecht
country: Netherlands
facility: St Antonius ziekenhuis
Study officials:
affiliation: UMC Utrecht
name: Marjolein de Bruin-Weller, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: