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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 Samantha Brady
samantha.gascoyne@york.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Trial of stopping or continuing biologics ahead of orthopaedic surgery

Trial of stopping or continuing biologics ahead of orthopaedic surgery

Medical Conditions

Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, forms of inflammatory arthritis


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.


Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are common forms of inflammatory arthritis. They are caused by an overactive immune system and are treated with medicines that reduce pain and inflammation. In recent years, special immune-suppressing medicines, called biologics, have been developed, which are very effective in controlling the arthritis disease process and symptoms but can increase the risk of some infections. People with inflammatory arthritis often need orthopaedic surgery (e.g. joint replacement) to relieve pain and improve function due to the damage caused by arthritis. The potential for increased risk for surgical site infections is a particular concern for patients undergoing orthopaedic surgery as these can be associated with long-term pain and the need for further surgery. Currently, biologics are usually stopped before any planned operation to try and reduce the risk of infection and other complications such as slow wound healing. However, stopping biologics increases the risk of painful and debilitating flares and delays recovery from surgery. Flares are often treated with steroids, which can increase the infection risk and delay wound healing. There are no randomised trials to support the current guidance on stopping biologics before surgery.

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:

05 May 2023 30 Sep 2026

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38910007/ (added 25/06/2024)

Participants will either be asked to stop taking their biologic medication or continue taking it ahead of their surgery; this will be decided at random by a computer.
Both groups of participants will then be followed up for 1 year after their surgery to see whether there was a difference in their quality of life, arthritis disease activity, infections, hospital admissions, and the cost of these treatments. Participants recruited after February 2026 will be followed to the 12‑week primary time point as a minimum.


Patients over the age of 18 who have inflammatory arthritis, are taking biologic medications, and are due to have orthopaedic surgery.

You can take part if:


Current inclusion criteria as of 11/10/2024:

1. Adults aged 18 years and over with RA, PsA, or AS (including juvenile onset of all three)
2. Currently prescribed one of the following bDMARDs: TNF inhibitors (e.g. adalimumab /etanercept/ golimumab/certolizumab pegol/infliximab); CTLA4-Ig (e.g. abatacept); IL-6 inhibitors (e.g. tocilizumab/sarilumab); IL-12/23 inhibitors (e.g. ustekinumab); IL-17 inhibitors (e.g. secukinumab/ixekizumab); IL-23 p19 inhibitors (e.g. guselkumab/risankizumab).
3. Deemed by the clinical care team to be fit for surgery and have no contraindications to continued bDMARD use
4. Scheduled to undergo elective orthopaedic surgery (Soft tissue, metalwork, or Joint replacement)
5. Able to consent and complete


You may not be able to take part if:


Current exclusion criteria as of 13/08/2025:

1. Currently prescribed JAK inhibitors2. Currently being treated with rituximab3. Current use of systemic steroids (< 3 months of surgery date) other than those on a stable dose of <= 15mg per day4. Previous history of native/prosthetic joint infection5. Undergoing revision surgery6. Patients who are pregnant

_____

Previous exclusion criteria:

1. Currently prescribed JAK inhibitors2. Currently being treated with rituximab3. Current use of systemic steroids (< 3 months) other than those on a stable dose of < = 5mg per day4. Previous history of native/prosthetic joint infection5. Undergoing revision surgery6. Patients who are pregnant


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

  • NHS Lothian
    Waverley Gate 2-4 Waterloo Place
    Edinburgh
    EH1 3EG
  • University Hospital Southampton NHS Foundation Trust
    Southampton General Hospital Tremona Road
    Southampton
    SO16 6YD
  • John Radcliffe Hospital
    Headley Way Headington
    Oxford
    OX3 9DU
  • Queens Medical Centre
    Derby Road
    Nottingham
    NG7 2UH
  • Northern General Hospital
    Herries Road
    Sheffield
    S5 7AU
  • St. James's University Hospital
    Beckett Street
    Leeds
    LS9 7TF
  • The Royal Wolverhampton NHS Trust
    New Cross Hospital Wolverhampton Road Heath Town
    Wolverhampton
    WV10 0QP
  • Liverpool University Hospitals NHS Foundation Trust
    Royal Liverpool University Hospital Prescot Street
    Liverpool
    L7 8XP
  • NHS Lanarkshire
    14 Beckford Street
    Hamilton
    ML3 0TA
  • Homerton University Hospital
    Homerton Row
    London
    E9 6SR
  • Belfast City Hospital
    51 Lisburn Rd
    Belfast
    BT9 7AB
  • Royal National Orthopaedic Hospital
    Brockley Hill
    Stanmore
    HA7 4LP
  • Lewisham and Greenwich NHS Trust
    University Hospital Lewisham Lewisham High Street
    London
    SE13 6LH
  • Northumbria Healthcare NHS Foundation Trust
    North Tyneside General Hospital Rake Lane
    North Shields
    NE29 8NH
  • Royal Orthopaedic Hospital
    The Woodlands Bristol Road South Northfield
    Birmingham
    B31 2AP
  • NHS Ayrshire and Arran
    PO Box 13, Boswell House 10 Arthur Street
    Ayr
    KA7 1QJ
  • Gartnavel Royal Hospital
    1055 Great Western Road
    Glasgow
    G12 0XH
  • Southport and Ormskirk Hospital NHS Trust
    Town Lane
    Southport
    PR8 6PN
  • Queen Elizabeth Hospital Kings Lynn
    Gayton Road Queen Elizabeth Hospital Site
    King's Lynn
    PE30 4ET

The results of this study will help us find out how best to treat patients with inflammatory arthritis who need orthopaedic surgery in the future. As with any treatment, there are possible risks and benefits. The risk for these treatments includes the potential for a flare of arthritis and the potential for an infection after surgery. Participating in this study will not harm or disadvantage participant's care and participants will be monitored regularly as part of usual NHS care.

Dr Samantha Brady
samantha.gascoyne@york.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Leeds and funded by National Institute for Health and Care Research.





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Read full details for Trial ID: ISRCTN17691638

Or CPMS: 55648

Last updated 25 March 2026

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