Status:
WITHDRAWN
Do Nanobubbles Improve Joint Hypoxia?
Lead Sponsor:
University of Oxford
Conditions:
Rheumatoid Arthritis
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Inflamed joints in patients with rheumatoid arthritis and psoriatic arthritis are characterized by low oxygen levels and inflammation. We propose to investigate whether tiny bubbles (nanobubbles) when...
Eligibility Criteria
Inclusion
- • 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).
- 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).
- Women of child bearing potential who are willing to use effective contraception (i.e. barrier, oral contraceptive pill, implanted contraception, or previous hysterectomy, bilateral oophorectomy) for the duration of the study.
Exclusion
- • Currently on oxygen therapy.
- Current enrolment in any other clinical study involving an investigational study treatment.
- Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
- 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.
Key Trial Info
Start Date :
October 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04844008
Start Date
October 5 2021
End Date
May 17 2022
Last Update
May 24 2022
Active Locations (1)
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1
Oxford University Hospitals NHS Trust
Oxford, United Kingdom, OX3 7LD