Moderate-to-severe Atopic EczemaTREAT NLNCT03621137
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
An observational study of Moderate-to-severe Atopic Eczema, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Moderate-to-severe Atopic Eczema
- What is being tested?
- No study-specific intervention
- How many people
- 500 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2017to 31 Oct 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients of participating centres that meet the predefined in- and exclusion criteria.
Who may be able to join
- Patient has a diagnosis of atopic eczema, based on the U.K. working party's diagnostic criteria;
- Starts with any type of phototherapy (e.g. UVB) or systemic immunomodulating therapy (e.g. cyclosporin, systemic glucocorticosteroids, azathioprine, methotrexate, mycophenolic acid, dupilumab);
- Has voluntarily signed and dated an informed consent prior to any study related procedure or has a legal representative to do so and is willing to comply with the requirements of this study protocol.
Who cannot join
- Patient uses only (systemic) antibiotics or antihistamines;
- Patient starts with systemic immunomodulating therapy for another indication than atopic eczema;
- Insufficient understanding of the study by the patient or parent/legal representative.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
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
Ariënna Hyseni
Angela Bosma
About this study
Official title: TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry
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.
- Conditions
- Moderate-to-severe Atopic Eczema
- Being tested
- No study-specific intervention
- Keywords
- Atopic Eczema, Atopic Dermatitis, Registries, Systemic therapies, Off-label use, Phototherapy, Child, Adult
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study-specific interventionOther
Treatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Patients with moderate-to-severe atopic eczema | Adult and pediatric patients that start treatment with phototherapy or systemic immunomodulating therapy for their atopic eczema Receives: Other: No study-specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in EASI (Eczema Area and Severity Index) score
Investigator-assessed outcome measure for disease severity at physical examination
Measured: 5 years
Mean change in IGA (Investigator's Global Assessment) score
Investigator-assessed outcome measure for global disease severity
Measured: 5 years
Mean change in POEM (Patient-Oriented Eczema Measure) score
Patient-reported outcome measure for symptoms of atopic eczema
Measured: 5 years
Mean change in PGA (Patient's Global Assessment) score
Patient-reported outcome measure for global disease severity
Measured: 5 years
Mean change in DLQI (Dermatology Life Quality Index) score
Patient-reported outcome measure for skin-related quality of life
Measured: 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
Measured: 5 years
The occurrence of severe adverse events
Any undesirable experience of severe nature occurring to a subject is reported
Measured: 5 years
Drug survival of the therapies
Assessment of the duration until discontinuation of a drug together with the reason thereof
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Nov 2017
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Moderate-to-severe Atopic EczemaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Bosma, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Phyllis I. Spuls, prof.dr., Principal investigator, Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621137
- Sponsor's protocol ID
- TREAT NL registry
- Acronym
- TREAT NL
- Status last verified
- Jan 2024
- First submitted
- 6 Jul 2018
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28241851Spuls 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.
PubMed 28558913Gerbens 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.
PubMed 29761486
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry
- ClinicalTrials.gov ID
- NCT03621137
- Acronym / sponsor ID
- TREAT NL / TREAT NL registry
- Conditions
- Moderate-to-severe Atopic Eczema
- Keywords
- Atopic Eczema, Atopic Dermatitis, Registries, Systemic therapies, Off-label use, Phototherapy, Child, Adult
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with moderate-to-severe atopic eczema | – | Other: No study-specific interventionAdult and pediatric patients that start treatment with phototherapy or systemic immunomodulating therapy for their atopic eczema |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients of participating centres that meet the predefined in- and exclusion criteria.
Key inclusion criteria (3 listed)
- Patient has a diagnosis of atopic eczema, based on the U.K. working party's diagnostic criteria;
- Starts with any type of phototherapy (e.g. UVB) or systemic immunomodulating therapy (e.g. cyclosporin, systemic glucocorticosteroids, azathioprine, methotrexate, mycophenolic acid, dupilumab);
- Has voluntarily signed and dated an informed consent prior to any study related procedure or has a legal representative to do so and is willing to comply with the requirements of this study protocol.
Key exclusion criteria (3 listed)
- Patient uses only (systemic) antibiotics or antihistamines;
- Patient starts with systemic immunomodulating therapy for another indication than atopic eczema;
- Insufficient understanding of the study by the patient or parent/legal representative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No study-specific interventionTreatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice | Other | Patients with moderate-to-severe atopic eczema |
Primary outcome
Mean change in EASI (Eczema Area and Severity Index) score
Time frame: 5 years
Investigator-assessed outcome measure for disease severity at physical examination
Mean change in IGA (Investigator's Global Assessment) score
Time frame: 5 years
Investigator-assessed outcome measure for global disease severity
Mean change in POEM (Patient-Oriented Eczema Measure) score
Time frame: 5 years
Patient-reported outcome measure for symptoms of atopic eczema
Mean change in PGA (Patient's Global Assessment) score
Time frame: 5 years
Patient-reported outcome measure for global disease severity
Mean change in DLQI (Dermatology Life Quality Index) score
Time frame: 5 years
Patient-reported outcome measure for skin-related quality of life
Mean time to reach a change in EASI (Eczema Area and Severity Index) score of 50%
Time frame: 5 years
Investigator-assessed outcome measure for disease severity at physical examination
The occurrence of severe adverse events
Time frame: 5 years
Any undesirable experience of severe nature occurring to a subject is reported
Drug survival of the therapies
Time frame: 5 years
Assessment of the duration until discontinuation of a drug together with the reason thereof
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 28241851Gerbens 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.
- Background: PubMed 28558913Spuls 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.
- Background: PubMed 29761486Gerbens 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.
- Website of the international TREAT Registry TaskforceLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phyllis I. Spuls, prof.dr. principal investigator
Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate-to-severe Atopic Eczema, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angela L. Bosma (+31205662757, a.l.bosma@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in EASI (Eczema Area and Severity Index) score (time frame: 5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621137, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.