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

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

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Osteoarthritis, Knee; Psoriatic Arthritis; Spondyloarthritis
• Intervention / Treatment: Procedure: Intra-articular corticosteroid injection

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW17 0RE
    • Recruiting
    • St George's Healthcare NHS Trust
    • Contact: Abiola Ms Harrison, BSc; Phone Number: 4402082666474; Email: oharriso@sgul.ac.uk
    • Principal Investigator: Nidhi Dr Sofat, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population includes participants with an established diagnosis of knee osteoarthritis, rheumatoid arthritis, spondyloarthritis or psoriatic arthritis. A control group without arthritis or knee pain serves as the comparator group

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Osteoarthritis; Participants with an established diagnosis of knee osteoarthritis	Procedure: Intra-articular corticosteroid injection; 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	Procedure: Intra-articular corticosteroid injection; 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	Procedure: Intra-articular corticosteroid injection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: St George's, University of London
• Collaborators: Wellcome Trust; Rosetrees Trust
• Investigators: Principal Investigator: Nidhi Dr Sofat, MD, PhD, St George's, University of London

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Anticipated): April 2, 2021
• Study Completion (Anticipated): April 2, 2022

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: pain; inflammation
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Osteoarthritis; Psoriasis; Bone Diseases, Infectious; Arthritis; Osteoarthritis, Knee; Arthritis, Psoriatic; Spondylitis; Spondylarthritis
• Other Study ID Numbers: 17.0192; 17/LO/1894 (Other Identifier: Integrated Research Application System (UK))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All data will be published and open access after completion of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No