NCT03621137|Recruiting
TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry: Dutch National Registry for Patients With Moderate-to-severe Atopic Eczema on Photo- or Systemic Therapies
TREAT NL
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TREAT NL
Sponsor study identifier
observational
500
1 country
1
Study Start
November 1, 2017
Actual (reported)Primary Completion
October 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The TREAT NL (TREatment of ATopic eczema, the Netherlands) registry is a national registry for children and adults with moderate-to-severe atopic eczema aiming to gather data on their prescribed photo- and systemic immunomodulating therapies. Atopic eczema is a common, chronic, itchy, inflammatory skin disease that can have a major impact on the quality of life of patients and their immediate surroundings. Serious atopic eczema patients are treated by means of photo- or systemic immunomodulating therapy. Of these mostly off-label applied therapies, there is insufficient evidence on the short and long term for their effectiveness, safety and cost-effectiveness. Moreover, good comparative research and real-life data are lacking. With the arrival of new expensive treatments it is crucial to get insight into these treatments in order to improve quality of care. By means of a prospective registry these data can be collected and help to obtain information for clinical practice, for answering research questions, for reducing costs and implementing the results by guidelines and decision aids.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2017
Actual (reported)July 6, 2018
Actual (reported)August 8, 2018
Actual (reported)October 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Mean change in EASI (Eczema Area and Severity Index) score
Investigator-assessed outcome measure for disease severity at physical examination
5 years
Mean change in IGA (Investigator's Global Assessment) score
Investigator-assessed outcome measure for global disease severity
5 years
Mean change in POEM (Patient-Oriented Eczema Measure) score
Patient-reported outcome measure for symptoms of atopic eczema
5 years
Mean change in PGA (Patient's Global Assessment) score
Patient-reported outcome measure for global disease severity
5 years
Adult and pediatric patients that start treatment with phototherapy or systemic immunomodulating therapy for their atopic eczema
Treatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients of participating centres that meet the predefined in- and exclusion criteria.
Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands
Amsterdam, North Holland, Netherlands
Gerbens LA, Boyce AE, Wall D, Barbarot S, de Booij RJ, Deleuran M, Middelkamp-Hup MA, Roberts A, Vestergaard C, Weidinger S, Apfelbacher CJ, Irvine AD, Schmitt J, Williamson PR, Spuls PI, Flohr C. TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries. Trials. 2017 Feb 27;18(1):87. doi: 10.1186/s13063-016-1765-7.
Spuls PI, Gerbens LAA, Apfelbacher CJ, Wall D, Arents BWM, Barbarot S, Roberts A, Deleuran M, Middelkamp-Hup MA, Vestergaard C, Weidinger S, Schmitt J, Irvine AD, Flohr C. The International TREatment of ATopic Eczema (TREAT) Registry Taskforce: An Initiative to Harmonize Data Collection across National Atopic Eczema Photo- and Systemic Therapy Registries. J Invest Dermatol. 2017 Sep;137(9):2014-2016. doi: 10.1016/j.jid.2017.05.014. Epub 2017 May 27. No abstract available.
TREAT NL biobank substudy
Phyllis I. Spuls, prof.dr.
Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands
First Submitted
July 6, 2018
First Posted
August 8, 2018
Study Start
November 1, 2017
Actual (reported)Primary Completion
October 31, 2027
EstimatedMean change in DLQI (Dermatology Life Quality Index) score
Patient-reported outcome measure for skin-related quality of life
5 years
Mean time to reach a change in EASI (Eczema Area and Severity Index) score of 50%
Investigator-assessed outcome measure for disease severity at physical examination
5 years
The occurrence of severe adverse events
Any undesirable experience of severe nature occurring to a subject is reported
5 years
Drug survival of the therapies
Assessment of the duration until discontinuation of a drug together with the reason thereof
5 years
Contact the study team to confirm eligibility.
Gerbens LAA, Apfelbacher CJ, Irvine AD, Barbarot S, de Booij RJ, Boyce AE, Deleuran M, Eichenfield LF, Hof MH, Middelkamp-Hup MA, Roberts A, Schmitt J, Vestergaard C, Wall D, Weidinger S, Williamson PR, Flohr C, Spuls PI; international TREAT Registry Taskforce. TREatment of ATopic eczema (TREAT) Registry Taskforce: an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema photo- and systemic therapy registries. Br J Dermatol. 2019 Apr;180(4):790-801. doi: 10.1111/bjd.16714. Epub 2018 Aug 3.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 31, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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