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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Laura Coates
+44 (0)1865 737838
laura.coates@ndorms.ox.ac.uk


Study Location:

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Be Part of Research - Trial Details - Can we predict which patients with psoriatic arthritis will respond to treatment using precision medicine?

Can we predict which patients with psoriatic arthritis will respond to treatment using precision medicine?

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Arthritis that affects some people with the skin condition psoriasis


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Psoriatic arthritis (PsA) is a type of arthritis that affects some people with the skin condition psoriasis. It typically causes affected joints to become swollen, stiff and painful.
PsA is an inflammatory arthritis that develops in around 15% of people with psoriasis, causing swollen and painful joints. For patients who do not respond to standard arthritis drugs, two classes of biologic drugs are available (TNF or IL-17 blockers). A similar proportion of patients respond to both with around 50% achieving a good response. However, we do not know how to predict which patient will respond best to each drug.
Our aim is to test whether we can predict if people with psoriatic arthritis (PsA) will respond to certain biologic drugs using blood tests. We will test if high levels of a type of T cells (activated Th17 cells) or other laboratory tests predict response. We will use statistical tests to estimate how effective these approaches would be for each individual. If successful, this approach could ensure that patients receive their best option first, ensuring their disease is controlled and quality of life improved, while avoiding unnecessary drug use. This is likely to save money for the NHS.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jan 2022 31 Dec 2024

Publications

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37770264/ (added 29/09/2023)

Participants will have a blood sample taken to measure their activated Th17 cells. The patients will be allocated to receive either TNF or IL-17 blocking biologics. We will measure how well they respond after 6 months of treatment and test whether the initial blood test result could have predicted their response.


Patients aged 18 years or older, with PsA about to start their first biologic treatment will be invited to join the study.

You can take part if:


Current inclusion criteria as of 15/08/2022:
1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, age 18 years or over
3. Diagnosis of PsA confirmed by the CASPAR criteria
4. Is planned to have biologic therapy for psoriatic arthritis using NICE/SMC criteria (failure of ≥2 csDMARDs and ≥3 tender and ≥3 swollen join


You may not be able to take part if:


1. Contraindications to either TNF inhibitor or secukinumab:1.1. History of previous demyelinating disease including multiple sclerosis1.2. Heart failure (NYHA class 3 or 4)1.3. Serious infections: active tuberculosis (TB), chronic viral infections (including hepatitis B, C and HIV), recent serious bacterial infections1.4. Latent TB unless they have received appropriate anti-tuberculous treatment as per local guidelines1.5. Active symptomatic inflammatory bowel disease1.6. History of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ1.7. Hypersensitivity to active ingredient or excipients2. Current or previous treatment with biologic DMARDs or targeted synthetic DMARDs3. Use of investigational therapies within 1 month or 5 half-lives (whichever is longer) of baseline4. Women who are pregnant, lactating or planning pregnancy during the following 12 months


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St Thomas's Hospital
    249 Westminster Bridge Road
    London
    SE1 7EH
  • Royal Berkshire Hospital
    Royal Berkshire NHS Foundation Trust London Road
    Reading
    RG1 5AN
  • Walsgrave General Hospital
    Clifford Bridge Road
    Coventry
    CV2 2DX
  • St George’s Hospital
    Blackshaw Road
    London
    SW17 0QT
  • King’s College Hospital
    Denmark Hill
    London
    SE5 9RS
  • Royal United Hospital
    Combe Park
    Bath
    BA1 3NG
  • John Radcliffe Hospital
    Oxford University Hospitals NHS Foundation Trust Headley Way
    Oxford
    OX3 9DU
  • Gartnavel Royal Hospital
    NHS Greater Glasgow and Clyde 1055 Great Western Road
    Glasgow
    G12 0XH
  • St Georges Hospital
    Midlands Partnership NHS Foundation Trust Corporation Street
    Stafford
    ST16 3SR
  • Cardiff and Vale University Health Board
    UHB Headquarters Woodlands House 2nd Floor Maes y Coed Rd Heath Park
    Cardiff
    CF14 4HH

Participants are not expected to benefit directly from participating in the study however they should see an improvement in their PsA symptoms from the treatment they receive. Study visits have been aligned with routine NHS visits to minimise burden and inconvenience but will take longer and participants will be asked to complete extra questionnaires. Participants will need to have additional blood samples taken which may result in bruising but research samples will be taken at the same time as routine NHS blood tests wherever possible.
Participants at 3 sites (Oxford, Glasgow, & St Guys & St Thomas's) will be asked to attend a short additional visit to enable the collection of an additional blood sample. Travel costs will be reimbursed for this additional visit to minimise any financial burden.
There are no additional risks from the treatment as the study uses the same treatments that would be prescribed routinely for these patients.


The study is sponsored by University of Oxford and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR129023; National Institute for Health Research (NIHR) (UK).




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Read full details for Trial ID: ISRCTN17228602

Or CPMS 48066

Last updated 06 December 2024

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