Prospective Longitudinal Effects of Intra-articular Corticosteroid Injection on Synovial Fluid Oxygen
- Conditions
- Rheumatoid ArthritisPsoriatic Arthritis
- Registration Number
- NCT04804449
- Lead Sponsor
- University of Oxford
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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).
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effects of intra-articular corticosteroid injection on joint oxygen tension in patients with rheumatoid and psoriatic arthritis Day 28 Change from Baseline Synovial fluid partial pressure of oxygen at Day 28
- Secondary Outcome Measures
Name Time Method Effects of intra-articular corticosteroid injection on synovial fibroblast protein expression Day 28 Change from baseline protein expression levels in synovial fibroblasts at Day 28
Effects of intra-articular corticosteroid injection on patient satisfaction Day 28 Treatment Satisfaction Questionnaire (TSQM)©
Effects of intra-articular corticosteroid injection on joint hypoxia in patients with rheumatoid and psoriatic arthritis Day 1 and 28 Hypoxia-inducible factor 1α (HIF-1α) protein levels in synovial tissues
Trial Locations
- Locations (1)
Nuffield Orthopaedic Centre
🇬🇧Oxford, Oxfordshire, United Kingdom