Prospective Longitudinal Effects of Intra-articular Corticosteroid Injection on Synovial Fluid Oxygen (POLO)

Inflammatory arthritis such as rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are characterized by synovial inflammation of joints, potentially leading to joint destruction and functional disability. Inflamed joints have lower oxygen levels. Studying how oxygen level within the joint affect inflammation may lead to new treatments for patients with arthritis. Anti-inflammatory corticosteroid injection into the joint is well tolerated and widely used in clinical practice but its effects on oxygen level within joints is unknown. Therefore, patients who require corticosteroid injection into the joint as routine clinical care will have biological samples collected before and after the injection. This will give new information to put into context the biological effects within the joint, and accelerate development of new treatment approaches in the future.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7HE
      • Nuffield Orthopaedic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult participants with rheumatoid arthritis or psoriatic arthritis who require intra-articular corticosteroid injection, and swollen joint suitable for ultrasound guided synovial biopsy.

Description

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Fulfil American College of Rheumatology/European League Against Rheumatism criteria (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria or fulfil Classification Criteria for Psoriatic Arthritis 2006 (CASPAR).
• Participant has been selected for intra-articular corticosteroid injection as part of their routine clinical care.
• Selected joint for biopsy must be minimum Grade 2 synovial thickening for large joint (knee) and medium joint (wrist), or minimum Grade 3 synovial thickening for small joint (metacarpophalangeal).

Exclusion Criteria:

• Current enrolment in any other clinical study involving an investigational study treatment.
• Intramuscular, intravenous or intra-articular administration of corticosteroid within 4 weeks prior to baseline visit.
• Oral corticosteroid > 10 mg/day prednisolone or equivalent within 4 weeks prior to baseline visit.
• Oral corticosteroid dose not stable for at least 4 weeks prior to baseline visit.
• Oral non-steroidal anti-inflammatory drugs (including aspirin > 75 mg/ day and selective-cyclooxygenase inhibitors) dose not stable for at least 4 weeks prior to baseline visit.
• Disease modifying anti-rheumatic drugs (DMARDs) dose not stable for at least 4 weeks prior to baseline visit.
• History of septic arthritis.
• Participants on warfarin, heparin, low molecular weight heparin, direct oral anticoagulants. Oral anti-platelet agents are permitted.
• History of haemophilia.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Rheumatoid arthritis and psoriatic arthritis; Patients with rheumatoid arthritis or psoriatic arthritis, who require an intra-articular corticosteroid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of intra-articular corticosteroid injection on joint oxygen tension in patients with rheumatoid and psoriatic arthritis	Change from Baseline Synovial fluid partial pressure of oxygen at Day 28	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of intra-articular corticosteroid injection on joint hypoxia in patients with rheumatoid and psoriatic arthritis	Hypoxia-inducible factor 1α (HIF-1α) protein levels in synovial tissues	Day 1 and 28
Effects of intra-articular corticosteroid injection on synovial fibroblast protein expression	Change from baseline protein expression levels in synovial fibroblasts at Day 28	Day 28
Effects of intra-articular corticosteroid injection on patient satisfaction	Treatment Satisfaction Questionnaire (TSQM)©	Day 28

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Shing Law, BM BCh, University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): January 24, 2023
• Study Completion (Actual): January 24, 2023

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Psoriatic
• Other Study ID Numbers: 15303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No