MedDataX Logo

Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis

NCT ID: NCT03533569

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-02

Study Completion Date

2022-04-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis, Knee Rheumatoid Arthritis Spondyloarthritis Psoriatic Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Osteoarthritis

Participants with an established diagnosis of knee osteoarthritis

Intra-articular corticosteroid injection

Intervention Type PROCEDURE

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

Rheumatoid arthritis

Participants with an established diagnosis of rheumatoid arthritis

Intra-articular corticosteroid injection

Intervention Type PROCEDURE

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

Spondyloarthritis or psoriatic arthritis

Participants with an established diagnosis of spondyloarthritis or psoriatic arthritis

Intra-articular corticosteroid injection

Intervention Type PROCEDURE

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

Case controls

Participants with no arthritis or knee pain as controls

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intra-articular corticosteroid injection

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wellcome Trust

OTHER

Sponsor Role collaborator

Rosetrees Trust

OTHER

Sponsor Role collaborator

St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nidhi Dr Sofat, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St George's Healthcare NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nidhi Dr Sofat, MD, PhD

Role: CONTACT

[email protected]
4402087250042

Abiola Ms Harrison, BSc

Role: CONTACT

[email protected]
4402082666474

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Abiola Ms Harrison, BSc

Role: primary

[email protected]
4402082666474

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17/LO/1894

Identifier Type: OTHER

Identifier Source: secondary_id

17.0192

Identifier Type: -

Identifier Source: org_study_id