NCT Number: NCT03549416
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.
Interested in participating?
Request Info0 year and older
All sexes
Observational
Radboud University Medical Center, Nijmegen, Gelderland, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Yearly from baseline up to 5 years
To characterize patient populations treated with new AD treatments in daily practice.
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.).
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).
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.
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).
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.
Interested in participating?
Request InfoUMC Utrecht
Other
BioDay Registry: Prospective, Observational Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Diseases in Daily Practice
Acronym: BioDay
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.
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