Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, forms of inflammatory arthritis Musculoskeletal Diseases
Conditions
Interventions
Current interventions as of 25/03/2026:
Stoppage of biologic: Participants will stop their biologic ahead of surgery in line with the British Society of Rheumatology guidelines
Continuation of biolog
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 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 follow-up _____ Previous 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
Exclusion criteria: Current exclusion criteria as of 13/08/2025: 1. Currently prescribed JAK inhibitors 2. Currently being treated with rituximab 3. Current use of systemic steroids (< 3 months of surgery date) other than those on a stable dose of <= 15mg per day 4. Previous history of native/prosthetic joint infection 5. Undergoing revision surgery 6. Patients who are pregnant _____ Previous 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/02/2024: 1. Self-reported physical, mental, and social health measured using the Patient Reported Outcomes: Measurement Information System (PROMIS-29) questionnaire at 26 and 52 weeks post-surgery 2. Level of disbility measured using the PROMIS Health Assessment Questionnaire Disability Index (HAQ) at 2, 6, 12, 26, and 52 weeks post-surgery 3. Health-related quality of life measured using EQ-5D-5L at 2, 6, 12, 26, and 52 weeks post-surgery 4. Disease activity measured using a generic global numeric rating scale (NRS) at 2, 6, 12, 26, and 52 weeks post-surgery 5. Medication use measured using patient medical records at 2, 6, 12, 26, and 52 weeks post-surgery 6. Healthcare resource use measured using patient medical records at 2, 6, 12, 26, and 52 weeks post-surgery 7. Disease activity measured using a generic global numeric rating scale as assessed by the treating physician at 2, 6, 12, and 52 weeks post-surgery 8. Surgical site infection, defined by the 1992 CDC criteria, measured using patient medical records at 2,6,12,52 weeks post-surgery 9. Delayed wound healing, defined as a surgical incision that has healed by primary intention without any evidence of gaping or dehiscence. Any wound that has not healed fully by primary intention by 2 weeks post-surgery, will be considered as “delayed wound healing” confirmed at 2, 6, 12, 52 weeks post surgery 10. Disease-Specific outcomes are measured using the following methods at 2, 6, 12, and 52 weeks post surgery: 10.1. Clinical Disease Activity Index for Rheumatoid Arthritis (CDAI) 10.2. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 10.3. Bath Ankylosing Spondylitis Functional Index (BASFI) 10.4. Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) 10.5. 66/68 Joint count 10.6. Leeds Enthesitis Index (LEI) 10.7. Body surface area (BSA) for skin 10.8. Dactylitis Severity Score (DSS) 10.9. Numerical rating scale (NRS) _____ Previous secon | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed