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

NCT04804449 | Completed DMC

• 1 other identifier: 15303
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Effects of intra-articular corticosteroid injection on joint hypoxia in patients with rheumatoid and psoriatic arthritis

  Day 1 and 28

• Effects of intra-articular corticosteroid injection on synovial fibroblast protein expression

  Day 28

• Effects of intra-articular corticosteroid injection on patient satisfaction

  Day 28

Study Arms (1)

Rheumatoid arthritis and psoriatic arthritis

Patients with rheumatoid arthritis or psoriatic arthritis, who require an intra-articular corticosteroid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Nuffield Orthopaedic Centre

Oxford, Oxfordshire, OX3 7HE, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Study Officials

• Shing Law, BM BCh

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 18, 2021
• Study Start: October 4, 2021
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: January 26, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)