Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis

Rheumatoid Arthritis Clinical Trial

— ARPAIN  

Official title:

Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis (ARPAIN) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03533569
• Other study ID #: 17.0192
• Secondary ID: 17/LO/1894
• Status: Recruiting
• Start date: April 2, 2018
• Est. completion date: April 2, 2022

Study information

• Verified date: October 2020
• Source: St George's, University of London
• Contact: Nidhi Dr Sofat, MD, PhD
• Phone: 4402087250042
• Email: nsofat[@]sgul.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2, 2022
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Osteoarthritis, Knee
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondyloarthritis

Intervention

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

Locations

Country	Name	City	State
United Kingdom	St George's Healthcare NHS Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
St George's, University of London	Rosetrees Trust, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Numerical Rating Scale (NRS) for pain in target knee after 3 months	Pain outcome measure. The Numerical Rating Scale for pain has a range of 0 - 10, with the lowest score being 0 and the highest rating at 10.The pain rating will be reported by the participants for their symptomatic knee	Baseline (Visit 1) and 3 months after treatment (Visit 2)
Secondary	Change in Biomarkers 3 months following treatment	Protein measurements in serum, urine and synovial fluid for type II collagen degradation products in the samples. The levels of type II collagen degradation products may range from 0 to greater than 500 ng/mmol, depending on the stage and severity of the condition	Baseline (Visit 1) and 3 months after treatment (Visit 2)