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Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis

Study Purpose

Osteoarthritis (OA) is a condition affecting the whole joint and is a major cause of pain and disability worldwide. Although OA is very common, the initial steps which lead to the development of pain and tissue damage are not fully understood. In this study participants will be investigated for markers in the blood, joint and urine in people who have a diagnosis of osteoarthritis or inflammatory arthritis and are receiving a steroid injection for their condition. Markers will be evaluated in participants with osteoarthritis compared with other types of arthritis, including rheumatoid arthritis and spondyloarthritis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Inclusion Criteria for OA patients:
  • - Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of knee osteoarthritis.
  • - Symptomatic knee pain.
  • - On usual care for knee osteoarthritis including paracetamol and/or NSAIDs.
Inclusion criteria for Inflammatory Arthritis Patients:
  • - Fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of inflammatory arthritis i.e. rheumatoid arthritis (Anti-CCP antibodies & Rheumatoid Factor checked ), psoriatic arthritis or spondyloarthropathy.
  • - Symptomatic knee pain.
  • - On usual care for arthritis including disease-modifying anti-rheumatic drugs (DMARDs), paracetamol and/or NSAIDs.

Exclusion Criteria:

  • - Other rheumatological diagnosis e.g. systemic lupus erythematosus, fibromyalgia, Polymyalgia Rheumatica, Gout, Giant Cell Arteritis, Sjogren's syndrome.
  • - History of uncontrolled depression.
  • - Recent surgery.
  • - Uncontrolled ischaemic heart disease.
  • - Uncontrolled diabetes mellitus.
  • - Alcohol consumption > 14 units/week as per UK National guidelines.
- Participants unable to give full informed consent

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03533569
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 St George's, University of London
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Nidhi Dr Sofat, MD, PhD
Principal Investigator Affiliation St George's, University of London
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Knee, Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis
Additional Details

Osteoarthritis (OA) is the most common form of arthritis worldwide. OA causes major disability and pain and places a huge financial burden on healthcare worldwide. In recent work, the gene expression profile of bone marrow lesions (BML) in osteoarthritis has been evaluated. BML in OA have a novel gene expression profile which includes genes involved in inflammation, neurogenesis and matrix turnover. The plan is to investigate the functional significance of the genes found at the protein biomarker level in studies of joint tissue, blood and urine from participants with knee OA and compare these changes with participants who have other forms of arthritis, including rheumatoid arthritis and spondyloarthritis. A study amendment was added in April 2020 due to Covid-19. We are studying up to 150 additional participants with or without inflammatory conditions who are being treated with immunomodulatory drugs compared with participants who are not on immunomodulators. We will be evaluating the course of Covid-19 infection in people without autoimmune inflammatory conditions, compared with people who have autoimmune inflammatory diseases who are on immunomodulators.

Arms & Interventions

Arms

: Osteoarthritis

Participants with an established diagnosis of knee osteoarthritis

: Rheumatoid arthritis

Participants with an established diagnosis of rheumatoid arthritis

: Spondyloarthritis or psoriatic arthritis

Participants with an established diagnosis of spondyloarthritis or psoriatic arthritis

: Case controls

Participants with no arthritis or knee pain as controls

Interventions

Procedure: - Intra-articular corticosteroid injection

Participants with arthritis will undergo usual care with knee synovial fluid aspiration followed by intra-articular corticosteroid injection

Contact a Trial Team

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International Sites

St George's Healthcare NHS Trust, London, United Kingdom

Status

Recruiting

Address

St George's Healthcare NHS Trust

London, , SW17 0RE

Site Contact

Abiola Ms Harrison, BSc

oharriso@sgul.ac.uk

4402082666474

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