Plain English Summary
Background and study aims
Eczema (or dermatitis) is a dry skin condition that can affect people in different forms. It can lead to constant scratching, which causes the skin to split and bleed, and leaves it open to infection.
Eczema can be treated using “systemic immuno-modulators”. People with eczema have an overactive immune system that is inflamed. Immuno-modulators are used to suppress the immune system, which in turn reduces inflammation. As they are systemic, they affect the entire body, rather than just one specific area.
Since eczema is a long-term condition, it is important to understand how well such treatments work in terms of improvement in disease control, quality of life and safety over long periods of time. These treatments have undergone careful clinical trials, but the picture we get from clinical trials is not complete. This project aims to fill the gap in knowledge and collect information from patients using systemic immuno-modulators who attend regular dermatology clinics, to better understand the “real world” use of these medicines. It aims to look at side effects, especially for patients taking medication for other conditions, to increase understanding of the risk of using these therapies. It will also look at the "real cost" of these eczema treatments, to examine how much the therapies cost in the long term compared to how well they work.
Who can participate?
Patients with atopic eczema who are about to start a systemic immuno-modulator therapy.
What does the study involve?
Participants will be asked to complete questionnaires in addition to their usual clinic assessments. They will also be asked to donate an optional DNA sample. The study intends to set up a biorepository, which is where patients will be asked to provide optional blood and skin samples to help us better understand how eczema develops and why therapies work better for some people than others, or cause more side effects in others. Donation to the biorepository is a completely optional section of the study.
What are the possible benefits and risks of participating?
There are no additional clinical benefits to participants other than that the information obtained will help the dermatology community better understand the disease and develop more effective treatments in future. There are no known risks to participants taking part in the questionnaire section of the study. For the blood sample collection, the risks may be discomfort and potential bleeding or bruising. For the skin biopsy, the risks include discomfort, infection, scarring, a reaction to local anaesthetic or bleeding.
Where is the study run from?
The study is run from King’s College London and Guy’s and St Thomas’ NHS Foundation Trust.
13 centres across the UK and 1 in Ireland will be open to recruitment in the initial stage of this study, which may later expand. Guy’s an St Thomas’ NHS Foundation Trust is the lead centre.
When is the study starting and how long is it expected to run for?
July 2017 to August 2022. The study may be extended after this date.
Who is funding the study?
The British Skin Foundation (UK)
Who is the main contact?
1. Carsten Flohr (carsten.flohr@kcl.ac.uk)
2. Sonia Serrano (sonia.serrano@gstt.nhs.uk)
Trial website
Contact information
Type
Public
Primary contact
Ms Dorothee Boisfer
ORCID ID
Contact details
Unit for Population-Based Dermatology Research
St John’s Institute of Dermatology
1st Floor
C Staircase
South Wing
St. Thomas’ Hospital
Westminster Bridge
London
SE1 7EH
United Kingdom
02071887188 ext 57716
Dorothee.Boisfer@gstt.nhs.uk
Type
Scientific
Additional contact
Prof Carsten Flohr
ORCID ID
http://orcid.org/0000-0003-4884-6286
Contact details
St John's Insitute of Dermatology
1st floor
C Staircase
South Wing
Westminster Bridge Road
London
SE17EH
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
237309
Study information
Scientific title
The UK-Irish Atopic Eczema Systemic Therapy Register
Acronym
A-STAR
Study hypothesis
To establish the short- and long-term effectiveness of systemic immune-modulatory therapies in adults and children with atopic eczema
Ethics approval
Wales Research Ethics Committee 1, final ethical approval expected by 08/08/18, IRAS ID: 237309, REC ref. 18/WA/0200
Study design
Observational prospective multi-centre cohort clinical registry
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
http://astar-register.org/participants
Condition
Atopic Eczema
Intervention
During the observation period, participants will be assessed on a regular (3-6 monthly basis) to collect data on disease severity and other clinical outcomes (such as quality of life), adverse events, reasons for potential changes in therapy and key healthcare resource use (e.g. hospitalisations, specialist and GP visits, and drug use). The latter will form part of the health economic feasibility assessment, which will also examine the potential use of HES and CPRD data for health economic evaluation purposes.
Participants will be involved in the study for as long as possible but for a minimum of 1 year. We have incorporated different types for study withdrawal for patients who may not want to attend study visits, but allow us to link their data with healthcare providers, so indirect participation may continue for a long period.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Treatment effectiveness will be assessed at the baseline, after 4 weeks, 12 weeks, 6 months, 9 months, 12 months and every 3-6 months thereafter using the following:
1. Physician-assessed severity measures assessed through changes in the following at the baseline, after 4 weeks, 12 weeks, 6 months, 9 months, 12 months and every 3-6 months thereafter:
1.1. EASI (Eczema Area and Severity Index)
1.2. EASI-50
1.3. EASI-75
1.4. IGA (Investigator's Global Assessment)
2. Patient-reported severity measures, assessed through changes in the following at the baseline, 12 weeks and every 6 months thereafter:
2.1. POEM score (Patient Oriented Eczema Measure)
2.2. Quality of life (DLQI/CDLQI/IDQOL) (Dermatology/Children’s Dermatology Life Quality Index)/EQ-5D)
2.3. ACQ score (Asthma control Questionnaire) in patients with a diagnosis of eczema
3. Disease control, assessed as totally or well controlled weeks at the baseline, after 4 weeks, 12 weeks, 6 months, 9 months, 12 months and every 3-6 months thereafter
4. Drug survival and long-term control of disease (time to discontinuation of treatment), assessed using the Kaplan-Meier survival technique and Cox regression analysis.
Secondary outcome measures
1. Pharmacovigilance/safety reporting: All (S)AEs will be recorded at the baseline, after 4 weeks, 12 weeks, 6 months, 9 months, 12 months and every 3-6 months thereafter. Long term linkage data will be used for this purpose as well.
2. Cost-effectiveness analysis: We will calculate the mean costs and assess generic quality of life with the EQ-5D, assessed at the baseline, after 12 weeks, 12 months and every 6 months after, for each treatment group/pathway to inform the development of an economic model. This will be in adherence to NICE (2013) methods guidance – whose objective is to estimate (i) long-term cost and QALYs for each treatment options, and (ii) incremental cost-effectiveness estimates to assess the value for money of each intervention. Value of information analysis will be used to identify those areas for further research which have the highest return in terms of population health
3. Standardised biorepository: blood, leukocytes, serum, skin and swabs collected at the baseline, after 4 weeks, 12 weeks and 12 months.
Overall trial start date
13/07/2017
Overall trial end date
30/08/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Paediatric and adult patients with atopic eczema who due to the severity of their disease and/or impact on quality of life are commencing on or switching to another systemic immuno-modulatory agent (e.g. CyA, AZA, MTX or biologic treatments).
2. Written informed consent for study participation obtained from the patient or parents / legal guardian, with assent as appropriate by the patient, depending on the level of understanding.
3. Consent to participate in long-term follow up and access to all medical records, including hospital admission records and linkage to data held by NHS bodies or other national providers of healthcare data.
4. Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria.
5. Willingness to comply with all study requirements.
6. Competent use of English language, according to patient’s age (capable of understanding patient questionnaires).
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Insufficient understanding of the study by the patient and/or parent/guardian.
2. Patients who are currently participating in a randomised clinical trial.
Recruitment start date
01/09/2018
Recruitment end date
30/08/2021
Locations
Countries of recruitment
Ireland, United Kingdom
Trial participating centre
Guy's and St Thomas' NHS Foundation Trust
Trust Offices
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Trial participating centre
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle
NE7 7DN
United Kingdom
Trial participating centre
University Hospital Southampton NHS Foundation Trust
Mailpoint 18
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Trial participating centre
Great Ormond Street Hospital for Children NHS Foundation Trust
Great Ormond Street
London
WC1N 3JH
United Kingdom
Trial participating centre
Manchester University NHS Foundation Trust
Corbett House
Oxford Road
Manchester
M13 9WL
United Kingdom
Trial participating centre
Sheffield Teaching Hospitals NHS Foundation Trust
Northern General Hospital
Herries Road
Sheffield South
S5 7AU
United Kingdom
Trial participating centre
Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield South
S10 2TH
United Kingdom
Trial participating centre
University Hospitals Bristol NHS Foundation Trust
Marlborough Street
Bristol Avon
BS1 3NU
United Kingdom
Trial participating centre
Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital
Headley Way
Headington Oxford
OX3 9DU
United Kingdom
Trial participating centre
Royal Hospital for Children
West Glasgow Ambulatory Care Hospital
Dalnair Street
Yorkhill
Glasgow
G3 8SJ
United Kingdom
Trial participating centre
University of Dundee
Dundee
DD1 4HN
United Kingdom
Trial participating centre
University of Edinburgh
Department of Dermatology
Lauriston Building
Lauriston Place
Edinburgh
EH3 9HA
United Kingdom
Trial participating centre
University Hospital of Wales
Cardiff
CF14 4XW
United Kingdom
Trial participating centre
Trinity College Dublin
Dublin
8
Ireland
Sponsor information
Organisation
King's College London
Sponsor details
Room 5.31 James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
Sponsor type
University/education
Website
Organisation
Guy's and St Thomas' NHS Foundation Trust
Sponsor details
16th floor
Tower Wing
Great Maze Pond
London
SE19RT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
British Skin Foundation
Alternative name(s)
BSF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The study results will be published in peer-reviewed journals and presented at national and international meetings, as well as in the study website (http://astar-register.org). A publication policy will be drawn up in due course to adequately reflect individual collaborators contributions.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
30/08/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list