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

NCT03549416 | Recruiting DMC

• 1 other identifier: 18/239
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 14

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.)

• 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.

• 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 Outcomes (6)

• Characterization of population

  Yearly from baseline up to 5 years

• Characterization of side effects

  Yearly from baseline up to 5 years

• Laboratory monitoring

  Yearly from baseline up to 5 years

• Long-term safety

  Yearly from baseline up to 5 years

• Comorbidities

  Yearly from baseline up to 5 years

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry

You may not qualify if:

• Patients are not eligible for enrolment in case of presumed inability to answer questionnaires or not willing to answer questionnaires and will be excluded.

Sponsors & Collaborators

• UMC Utrecht: lead
• Academisch Ziekenhuis Groningen: collaborator
• Sanofi: collaborator
• AbbVie: collaborator
• Eli Lilly and Company: collaborator
• LEO Pharma: collaborator

Study Sites (14)

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Isala Dermatologisch Centrum

Zwolle, Overijssel, Netherlands

RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

RECRUITING

IJsselland Ziekenhuis

Capelle aan den IJssel, South Holland, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

RECRUITING

Meander Medisch Centrum

Amersfoort, Netherlands

RECRUITING

Reinier de Graaf ziekenhuis

Delft, Netherlands

RECRUITING

Catharina ziekenhuis

Eindhoven, Netherlands

RECRUITING

Spaarne Gasthuis

Haarlem, Netherlands

RECRUITING

Maastricht Univeristy Medical Center

Maastricht, Netherlands

RECRUITING

Haga ziekenhuis

The Hague, Netherlands

RECRUITING

Diakonessenhuis

Utrecht, Netherlands

RECRUITING

St Antonius ziekenhuis

Utrecht, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 38272373 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Marjolein de Bruin-Weller, Md, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlies de Graaf, MD, PhD

CONTACT

+31887571134; M.deGraaf-10@umcutrecht.nl

Ilona de Ridder

CONTACT

L.H.deRidder-2@umcutrecht.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.S. de Bruin-Weller, dermatologist, MD, PhD

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 8, 2018
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (14)