Clinical trial NCT04804449: Prospective Longitudinal Effects of Intra-articular Corticosteroid Injection on Synovial Fluid Oxygen
Official title: Prospective Longitudinal Effects of Intra-articular Corticosteroid Injection on Synovial Fluid Oxygen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effects of intra-articular corticosteroid injection on joint oxygen tension in patients with rheumatoid and psoriatic arthritis
timeFrame: Day 28
Secondary outcomes:
measure: Effects of intra-articular corticosteroid injection on joint hypoxia in patients with rheumatoid and psoriatic arthritis
timeFrame: Day 1 and 28
measure: Effects of intra-articular corticosteroid injection on synovial fibroblast protein expression
timeFrame: Day 28
measure: Effects of intra-articular corticosteroid injection on patient satisfaction
timeFrame: Day 28
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Shing Law, BM BCh
role: PRINCIPAL_INVESTIGATOR
References: