Clincosm LogoSign in Get a demo

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

Sponsor
University of Oxford (Other)
Overall Status
Recruiting
CT.gov ID
NCT04804449
Collaborator
(none)
10
Enrollment
1
Location
29.9
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Prospective Longitudinal Effects of Intra-articular Corticosteroid Injection on Synovial Fluid Oxygen
    Actual Study Start Date :
    Oct 4, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2024
    Anticipated Study Completion Date :
    Apr 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Rheumatoid arthritis and psoriatic arthritis

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. Effects of intra-articular corticosteroid injection on patient satisfaction [Day 28]

      Treatment Satisfaction Questionnaire (TSQM)©

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nuffield Orthopaedic Centre Oxford Oxfordshire United Kingdom OX3 7HE

    Sponsors and Collaborators

    • University of Oxford

    Investigators

    • Principal Investigator: Shing Law, BM BCh, University of Oxford

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT04804449
    Other Study ID Numbers:
    • 15303
    First Posted:
    Mar 18, 2021
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Psoriatic

    Study Results

    No Results Posted as of May 18, 2022