Trial of stopping or continuing biologics ahead of orthopaedic surgery

PERI-operative biologic DMARD management: Stoppage or COntinuation during orthoPaEdic operations: The PERISCOPE trial

Registry ID
ISRCTN17691638
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
University of Leeds
Enrollment
296
Start date
2023-05-05
Completion date
2027-08-31
Last update
2026-08-17

Conditions

Summary

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

Detailed description

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 biologic: Participants will continue their biologic as normal ahead of surgery and throughout the peri-operative period. PERISCOPE is a multi-centre, 296-patient, superiority randomised controlled trial with parallel groups, with an internal pilot, economic evaluation and nested qualitative study. Blinding: Blinding is not possible given the nature of the intervention. Intervention arm: Continuation of the named bDMARDs throughout the peri-operative period as prescribed prior to surgery. All other aspects of care will continue as per usual practice, including concomitant non-bDMARDs and post-surgical rehabilitation. Usual care arm: Stoppage of bDMARDs prior to surgery and recommencing treatment after wound healing and removal of sutures/clips, according to BSR recommendations. Given the pragmatic nature of the PERISCOPE trial, for any instances where a participant's surgery may be delayed (for medical or non-medical reasons), it will be at the clinician's discretion as to whether a participant needs to recommence bDMARDS whilst the surgery is rescheduled as per current clinical practice. Data collection: Following baseline assessments and randomisation, participants will be scheduled for their orthopaedic surgery and will complete follow-up assessments at 2, 4, 6, 9, 12, 26, and 52 weeks post-surgery. Participants recruited after February 2026 will be followed to the 12‑week primary time point as a minimum. All outcome measures collected from patients are validated measures. The visits and the data collected are summarised below: Screening: Confirmation of the participant's eligibility, including the type of inflammatory arthritis and biologic. This is collected by investigator CRF and review of patient medical history. This is a face-to-face visit in the clinic. Baseline: P

Interventions

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

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

Locations

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