Understanding drug-free remission in rheumatoid arthritis
| ISRCTN | ISRCTN11237203 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11237203 |
| IRAS number | 334887 |
| Secondary identifying numbers | 10275, CPMS 66836 |
- Submission date
- 16/11/2024
- Registration date
- 28/01/2025
- Last edited
- 12/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Rheumatoid arthritis is a common disease affecting 1 in 100 adults in the UK. It occurs when the immune system mistakenly attacks the joints, causing pain, stiffness, fatigue, and potentially leading to joint damage and disability. Modern arthritis drugs help over a third of patients achieve remission, but these drugs can have side effects and require regular blood tests. This study aims to understand how some patients can stop taking arthritis drugs without their symptoms returning, known as "drug-free remission," and how this affects their feelings and future health.
Who can participate?
Patients who have previously stopped taking arthritis drugs in earlier studies will be invited to participate.
What does the study involve?
Participants will be asked to donate a small blood sample. Researchers will study the white blood cells and their protein markers to understand immune system changes in drug-free remission. Participants will also answer questions about their feelings and experiences, such as whether they feel cured and how stopping the drugs affects their hopes and concerns for their future health.
What are the possible benefits and risks of participating?
The study may help identify new ways to treat and prevent arthritis flare-ups and provide valuable information to support patients before and after drug withdrawal. However, as with any study, there may be risks associated with blood sample collection and sharing personal health information.
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 for?
November 2024 to January 2026.
Who is funding the study?
Foundation for Research in Rheumatology (UK)
Who is the main contact?
Dr Kenneth Baker, kenneth.baker@ncl.ac.uk
Contact information
Public, Scientific, Principal Investigator
Translational and Clinical Research Institute
Room M4.089, Leech Building, Medical School
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
 ORCID ID |
0000-0002-6735-2911 |
|---|---|
| Phone | +44 191 208 2754 |
| kenneth.baker@ncl.ac.uk |
Study information
| Study design | Single visit observational study with optional qualitative interview |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other, Quality of life |
| Participant information sheet | To follow |
| Scientific title | SustaINed drug-Free remissiON in rheumatoId Arthritis |
| Study acronym | SINFONIA |
| Study objectives | 1. To characterise the immune phenotype and function of patients with rheumatoid arthritis in sustained drug-free remission 2. To identify, characterise and understand patients’ experience of sustained drug-free remission over time |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | Immunological phenotyping and qualitative interview |
| Intervention type | Other |
| Primary outcome measure | At a single time point: 1. Characterisation of CD4+ regulatory T cell and B cell phenotype in patients in sustained drug-free remission using conventional and spectral flow cytometry 2. Quantification of CD4+ regulatory T cell function in sustained drug-free remission through the use of in vitro autologous T cell suppression assays |
| Secondary outcome measures | To identify, characterise and understand patients’ experience of sustained drug-free remission by interview at a single time point |
| Overall study start date | 16/11/2024 |
| Completion date | 31/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Diagnosis of rheumatoid arthritis according to the 1987 American College of Rheumatology (ACR) (Appendix B) or 2010 ACR/European Alliance of Associations for Rheumatology (EULAR) classification criteria (Appendix C) applied at any time since diagnosis. 2. Previous or current use of a disease-modifying anti-rheumatic drug (conventional synthetic, targeted synthetic, or biological) |
| Key exclusion criteria | 1. Unable to read or communicate in English 2. Inability to provide informed consent 3. Age less than 18 years 4. Current pregnancy |
| Date of first enrolment | 01/03/2025 |
| Date of final enrolment | 19/12/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Hospital/treatment centre
Newcastle Joint Research Office, 1st Floor Regent point, Regent Farm Road
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 1912336161 |
|---|---|
| nuth.nuthsponsorship@nhs.net | |
| Website | https://newcastlejro.com/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- FOREUM
- Location
- Switzerland
Results and Publications
| Intention to publish date | 01/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | We aim to publish results from this study in medical journals and present them at medical and scientific conferences, as well as local and national patient organisations. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
12/02/2025: Internal review.
20/11/2024: Trial's existence confirmed by Newcastle upon Tyne Hospitals NHS Foundation Trust.
