Clinical trial NCT04844008: Do Nanobubbles Improve Joint Hypoxia?
Official title: An Investigation of Whether Orally Delivered Nanobubbles Have a Physiological Effect on Joint Hypoxia?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 given in a drink can alter oxygen level in joints. These nanobubbles are so small that they can enter the bloodstream when given as a drink. This information will give new information on the role of oxygen in joint inflammation and could possibly lead to 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).
  * 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 Criteria:

* • 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.

Primary outcomes:
measure: Change in Synovial fluid pO2
timeFrame: Change in synovial fluid pO2 between day 1 and day 28
Secondary outcomes:
measure: Change in hypoxia-inducible factor 1α (HIF-1α) protein levels in synovial tissues
timeFrame: Change in hypoxia-inducible factor 1α (HIF-1α) protein between day 1 and day 28
measure: Treatment Satisfaction Questionnaire for Medication (C)
timeFrame: Day28
Other outcomes:
measure: Change from baseline in the absolute and relative cell count in synovial fluid and synovial biopsy
timeFrame: day 28
measure: Change from baseline of synovial fibroblast protein expression
timeFrame: day 28
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
Study officials:
References: