Trial of stopping or continuing biologics ahead of orthopaedic surgery

Not Applicable

Conditions: Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, forms of inflammatory arthritis
Musculoskeletal Diseases

Registration Number: ISRCTN17691638

Lead Sponsor: niversity of Leeds

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 394

Inclusion Criteria

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

Exclusion Criteria

1. Currently prescribed JAK inhibitors
2. Currently being treated with rituximab
3. Current use of systemic steroids (< 3 months) other than those on a stable dose of < = 5mg per day
4. Previous history of native/prosthetic joint infection
5. Undergoing revision surgery
6. Patients who are pregnant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported physical, mental, and social health measured using the Patient Reported Outcomes: Measurement Information System (PROMIS-29) questionnaire over the first 12 weeks (2, 4, 6, 9, and 12 weeks) post-surgery

Secondary Outcome Measures