BioDay Registry: Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Registration Number
- NCT03549416
- Lead Sponsor
- UMC Utrecht
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry
- Patients are not eligible for enrolment in case of presumed inability to answer questionnaires or not willing to answer questionnaires and will be excluded.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. To study drug survival and identify factors that affect drug survival.
Assessment of effectiveness 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.
Side effects 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.
- Secondary Outcome Measures
Name Time Method Characterization of population Yearly from baseline up to 5 years To characterize patient populations treated with new AD treatments in daily practice.
Laboratory monitoring 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).
Characterization of side effects Yearly from baseline up to 5 years To collect data from daily practice regarding side effects (incidence, severity, risk factors, treatment options, etc.).
Long-term safety Yearly from baseline up to 5 years To study the long-term safety risks including malignancies, pregnancy/paternity-related conditions, infections, and autoimmune diseases.
Comorbidities 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).
Dose tapering Yearly from baseline up to 5 years To assess whether dose reduction of biologics can be achieved in patients with low AD activity.
Trial Locations
- Locations (14)
Reinier de Graaf ziekenhuis
🇳🇱Delft, Netherlands
Haga ziekenhuis
🇳🇱Den Haag, Netherlands
Catharina ziekenhuis
🇳🇱Eindhoven, Netherlands
Spaarne Gasthuis
🇳🇱Haarlem, Netherlands
St Antonius ziekenhuis
🇳🇱Utrecht, Netherlands
Medisch Centrum Leeuwarden
🇳🇱Leeuwarden, Friesland, Netherlands
Isala Dermatologisch Centrum
🇳🇱Zwolle, Overijssel, Netherlands
Radboud University Medical Center
🇳🇱Nijmegen, Gelderland, Netherlands
IJsselland Ziekenhuis
🇳🇱Capelle Aan Den IJssel, Zuid-Holland, Netherlands
Meander Medisch Centrum
🇳🇱Amersfoort, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Maastricht Univeristy Medical Center
🇳🇱Maastricht, Netherlands
Diakonessenhuis
🇳🇱Utrecht, Netherlands
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands