NCT04844008

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2022

Completed
Last Updated

May 24, 2022

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

March 30, 2021

Last Update Submit

May 17, 2022

Conditions

Rheumatoid ArthritisPsoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change in Synovial fluid pO2

    Change in synovial fluid pO2 between day 1 and day 28

Secondary Outcomes (2)

  • Change in hypoxia-inducible factor 1α (HIF-1α) protein levels in synovial tissues

    Change in hypoxia-inducible factor 1α (HIF-1α) protein between day 1 and day 28

  • Treatment Satisfaction Questionnaire for Medication (C)

    Day28

Other Outcomes (2)

  • Change from baseline in the absolute and relative cell count in synovial fluid and synovial biopsy

    day 28

  • Change from baseline of synovial fibroblast protein expression

    day 28

Study Arms (2)

Nanobubble

EXPERIMENTAL

Sports drink nanobubble drink

Dietary Supplement: Nanobubble drink

control

PLACEBO COMPARATOR

Flavoured drink- no active ingredients

Dietary Supplement: Nanobubble drink

Interventions

Nanobubble drinkDIETARY_SUPPLEMENT

Commercially available sports drink

Nanobubblecontrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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).
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford University Hospitals NHS Trust

Oxford, OX3 7LD, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis, Psoriatic

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesPsoriasisSkin Diseases, PapulosquamousSkin Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 14, 2021

Study Start

October 5, 2021

Primary Completion

May 17, 2022

Study Completion

May 17, 2022

Last Updated

May 24, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)