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

  • STATUS
    Recruiting
  • End date
    Apr 29, 2024
  • participants needed
    10
  • sponsor
    University of Oxford
Updated on 29 May 2022
arthritis
rheumatism
rheumatoid arthritis
psoriatic arthritis

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.

Details
Condition Rheumatoid Arthritis, Psoriatic Arthritis
Clinical Study IdentifierNCT04804449
SponsorUniversity of Oxford
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

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
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