ARPAIN: Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis

Sponsor

St George's, University of London (Other)

Overall Status

Recruiting

CT.gov ID

NCT03533569

Collaborator

Wellcome Trust (Other), Rosetrees Trust (Other)

150

Enrollment

Location

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Rheumatoid Arthritis Spondyloarthritis Psoriatic Arthritis	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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 2, 2018

Anticipated Primary Completion Date :

Apr 2, 2021

Anticipated Study Completion Date :

Apr 2, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Change from Baseline Numerical Rating Scale (NRS) for pain in target knee after 3 months [Baseline (Visit 1) and 3 months after treatment (Visit 2)]
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

Secondary Outcome Measures

Change in Biomarkers 3 months following treatment [Baseline (Visit 1) and 3 months after treatment (Visit 2)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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