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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04804449
Acronym
POLO
Enrollment
10
Registered
2021-03-18
Start date
2021-10-04
Completion date
2023-01-24
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis, Rheumatoid Arthritis

Brief summary

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.

Interventions

None listed

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Effects of intra-articular corticosteroid injection on joint oxygen tension in patients with rheumatoid and psoriatic arthritisDay 28Change from Baseline Synovial fluid partial pressure of oxygen at Day 28

Secondary

MeasureTime frameDescription
Effects of intra-articular corticosteroid injection on joint hypoxia in patients with rheumatoid and psoriatic arthritisDay 1 and 28Hypoxia-inducible factor 1α (HIF-1α) protein levels in synovial tissues
Effects of intra-articular corticosteroid injection on synovial fibroblast protein expressionDay 28Change from baseline protein expression levels in synovial fibroblasts at Day 28
Effects of intra-articular corticosteroid injection on patient satisfactionDay 28Treatment Satisfaction Questionnaire (TSQM)©

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026