Stratified medicine in primary Sjogren’s syndrome
| ISRCTN | ISRCTN16054712 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16054712 |
| IRAS number | 264215 |
| Secondary identifying numbers | IRAS 264215, CPMS 48622 |
- Submission date
- 31/07/2023
- Registration date
- 08/08/2023
- Last edited
- 05/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Primary Sjögren’s syndrome (PSS) is a chronic, complex immune-mediated disease with no effective treatment available. The effects vary greatly among PSS sufferers with some reporting disabling fatigue, some unbearable pain and dryness, while others report fewer symptoms. Some PSS patients develop lymphoma or major extra-glandular organ damage while some have disease confined to the exocrine glands. Although many biological abnormalities have been described in PSS, their relationships with specific clinical manifestations remain unclear. This creates challenges in finding appropriate ways of measuring the effectiveness of therapies and the burden of disease. Using detailed clinical data from 600 PSS patients from the UK, researchers have identified four clinical PSS subtypes which differ in characteristics. The data suggest that outcome and response to therapies may differ depending on the patient's subtype.
The aim of this study is to develop a PSS-specific patient-reported questionnaire that captures the disease burden/impact in each of the PSS subtypes.
Who can participate?
Patients aged 18 years and over with PSS and clinicians across Sweden, Norway and France
What does the study involve?
Completing questionnaires about quality of life and disease impact at baseline and follow-up.
What are the possible benefits and risks of participating?
There are no direct benefits and no risks of taking part.
Where is the study run from?
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run?
January 2019 to October 2024
Who is funding the study?
European Commission
Who is the main contact?
Professor Wan-Fai Ng, wan-fai.ng@newcastle.ac.uk
Contact information
Principal Investigator
Translational & Clinical Research Institute
Faculty of Medical Sciences
Newcastle University
Newcastle upon Tyne
NE1 4LP
United Kingdom
| Phone | +44 (0)1912820070 |
|---|---|
| wan-fai.ng@newcastle.ac.uk |
Public
Freeman Hospital
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)191 2137341 |
|---|---|
| victoria.macrae@newcastle.ac.uk |
Study information
| Study design | Observational multicentre mixed methods study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Home, Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Stratified medicine in primary Sjogren’s syndrome: a mixed methods quantitative/qualitative study to develop a patient-reported questionnaire looking at disease burden within the Primary Sjogren's Syndrome subtypes |
| Study acronym | FOREUM |
| Study hypothesis | This study aims to further characterise the clinical significance and the underpinning pathotypes of the 4 primary Sjogren’s syndrome (PSS) subtypes. The researchers will develop a patient questionnaire that enables them to quantitatively measure the impact and disease burden of PSS within the different subtypes. |
| Ethics approval(s) |
Approved 09/04/2021, East of England - Cambridge East Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, United Kingdom; +44 (0)2071048096; cambridgeeast.rec@hra.nhs.uk), ref: 21/EE/0069 |
| Condition | Primary Sjogren's Syndrome |
| Intervention | The aim of the study is to collect information on the disease impact and burden of PSS on patients. This information will be collected using questionnaires due to the large cohort (600 participants) across numerous countries. Patient public involvement is crucial to the design of the study. Patient representatives from each country are involved in the steering committee with the clinicians and will work together to develop the questionnaire. The main categories of the questionnaire were decided at an initial face-to-face meeting with clinicians, academics, statisticians and patient representatives. These categories form the phases of the questionnaire development. The four phases will be discussed in more detail to establish questions suitable to collect the data for the categories. These discussions will take place by teleconference between the patient representatives, chief investigator, health economist and project manager. Opinions on the draft questionnaire will first be sought from PSS patient support groups in Norway, Sweden, France and the UK. The completed questionnaire will then be submitted to REC for approval and piloted first in the UK. This will then be enrolled out to the other EU sites (Norway, Sweden and France) to complete the subtype data collection (600 participants, 150 in each subgroup). Baseline data will be collected and a follow-up questionnaire administered. Questionnaires will be posted or given in clinic to complete at home. The timing of the follow-up will depend on the questions of interest identified for the categories during the development process. Questionnaire development and recruitment will take place over a period of two years to allow one year for data analysis. Participants will be identified from established PSS registries across the centres. The participants of these registries have already consented to receive future invitations for PSS research. A letter of invitation, patient information sheet and written consent form will be posted to the patient or given during clinic by the clinical research team. If the participant consents then the questionnaire will be posted to them. |
| Intervention type | Other |
| Primary outcome measure | The following data is collected through a one off questionnaire by post. 1. Quality of life measured using EQ5D 2. Wellbeing measured using ICECAPA 3. Anxiety and depression measured using HADs 4. Sjogren's symptoms measured using ESSPRI 5. Fatigue is measured using PROFAD 6. Patient developed measure to include to include; Clinical Health Services (primary and secondary), extra services not covered by the health service – such as cost of prescriptions, dental, opticians, and alternative therapies, employment, family life and activities – such as holidays. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 10/01/2019 |
| Overall study end date | 31/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 600 |
| Participant inclusion criteria | 1. Age ≥18 years 2. Confirmed diagnosis of primary Sjögren’s syndrome 3. Willing and able to provide informed written consent 4. Registered within a PSS registry |
| Participant exclusion criteria | 1. Unable to provide written consent |
| Recruitment start date | 01/03/2021 |
| Recruitment end date | 31/10/2023 |
Locations
Countries of recruitment
- England
- France
- Norway
- Sweden
- United Kingdom
Study participating centre
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Hospital/treatment centre
Joint Research Office
Regent Point
Regent Farm Road
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 (0)1912824926 |
|---|---|
| nuth.genericqueries@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Other
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 31/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in peer-reviewed scientific journals. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon request from Victoria Macrae (victoria.macrae@newcastle.ac.uk) |
Editorial Notes
05/09/2023: Internal review.
07/08/2023: Trial's existence confirmed by East of England - Cambridge East Research Ethics Committee.
