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BioDay Registry: Data Collection Regarding Dupixent in Patients With Atopic Dermatitis in Daily Practice (BioDay)

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ClinicalTrials.gov Identifier: NCT03549416
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
Academisch Ziekenhuis Groningen
Radboud University
Information provided by (Responsible Party):
Dr M.S. de Bruin-Weller, UMC Utrecht

Brief Summary:

Atopic Dermatitis (AD) is the most common chronic inflammatory skin disease in the Netherlands with more than 400.000 patients suffering from this disease. For patients with difficult to treat AD, treatment options are limited. Although the Dutch AD Guideline recommends oral immunosuppressive drugs in difficult to treat AD, both label and off-label, daily practice studies show high rates of discontinuation of treatment due to side effects and/or ineffectiveness. Dupixent® (dupilumab) as first biological developed for AD is commercially available in the Netherlands since January 2018. Although large phase 3 trials show very positive results and limited side effects, effectiveness and safety data from daily practice are necessary to study long-term effectiveness and safety in a less selected population compared to clinical trials. A well designed high quality prospective registry can provide these essential data.

Dupixent®(dupilumab) treatment may also ameliorate AD-related comorbidities, such as asthma. It is therefore clinically relevant to include asthma-related outcomes in the BioDay registry for the subpopulation of patients that have concomitant asthma.


Condition or disease
Atopic Dermatitis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: BioDay Registry: Data Collection Regarding Dupixent in Patients With Atopic Dermatitis in Daily Practice
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema




Primary Outcome Measures :
  1. Drug survival of dupilumab [ Time Frame: Drug survival will be reported after one year ]
    Drug survival is the length of time the patient is treated with dupilumab. Drug survival is a well-recognized measure of drug effectiveness, which encompasses factors such as side effects, ineffectiveness, non-compliance and others.

  2. Number and type of side effects [ Time Frame: The number and type of side effects will be reported after one year ]
    Side effects will be registered every visit

  3. Occurence of infections (both skin and in general) [ Time Frame: Occurence of infections will be reported after one year ]
    Physical examination will be performed every visit to check for infections

  4. Occurence of malignancies (both skin and in general) [ Time Frame: Occurence of malignancies will be reported after one year ]
    Physical examination will be performed every visit to check for malignancies


Secondary Outcome Measures :
  1. Percentage of patients with clinical response [ Time Frame: This will be reported after one year ]
    responder (>50% decrease from baseline EASI and/or IGA 0-2) Good responder (>75% decrease from baseline EASI and/or IGA 0-1)

  2. Percentage of patients with consistent clinical response [ Time Frame: This will be reported after one year ]
    Patients who respond at 60% of the visits: consistent response Patients who respond at 80% of the visits: highly consistent response Patients who respond at 100% of the visits: completely sustained response

  3. The effect of dupilumab on asthma in atopic dermatitis patients treated for this comorbidity [ Time Frame: This will be reported after one year ]
    ACQ score (questionnaire)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with difficult to treat atopic dermatitis, who are treated with dupilumab in daily practice according to the Dutch atopic dermatitis guideline (after failure of at least 1 oral immunosuppressive drug or a contra-indication for oral immunosuppressive drugs).
Criteria

Inclusion Criteria:

  • Adult patients with difficult to treat atopic dermatitis, who are treated with dupilumab in daily practice according to the Dutch atopic dermatitis guideline (after failure of at least 1 oral immunosuppressive drug or a contra-indication for oral immunosuppressive drugs).

Exclusion Criteria:

  • Patients who are not able or not willing to fill in the questionnaires.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549416


Contacts
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Contact: Ischa Kummeling, PhD +31887550930 i.kummeling@umcutrecht.nl
Contact: Jorien van der Schaft, MD, PhD j.vanderschaft-5@umcutrecht.nl

Locations
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Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Marijke Kamsteeg, MD, PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Marie Loiuse Schuttelaar, MD, PhD         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Ischa Kummeling, PhD    +31887550930    i.kummeling@umcutrecht.nl   
Contact: Jorien van der Schaft, MD, PhD         
Sponsors and Collaborators
UMC Utrecht
Academisch Ziekenhuis Groningen
Radboud University

Additional Information:

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Responsible Party: Dr M.S. de Bruin-Weller, M.S. de Bruin-Weller, dermatologist, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT03549416     History of Changes
Other Study ID Numbers: 18/239
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr M.S. de Bruin-Weller, UMC Utrecht:
Atopic dermatitis
Dupilumab
Dupixent
BioDay
Daily practice
Real world
Atopic Diseases Registry
Registry
Multi center

Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases