Early Biomarkers for ARthritic PAIN to Guide Improved Treatments for Arthritis

NCT03533569 | Unknown

• 2 other identifiers: 17.019217/LO/1894
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Rheumatoid Arthritis; Spondyloarthritis; Psoriatic Arthritis

Keywords

pain; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Biomarkers 3 months following treatment

  Baseline (Visit 1) and 3 months after treatment (Visit 2)

Study Arms (4)

Osteoarthritis

Participants with an established diagnosis of knee osteoarthritis

Procedure: Intra-articular corticosteroid injection

Rheumatoid arthritis

Participants with an established diagnosis of rheumatoid arthritis

Procedure: Intra-articular corticosteroid injection

Spondyloarthritis or psoriatic arthritis

Participants with an established diagnosis of spondyloarthritis or psoriatic arthritis

Procedure: Intra-articular corticosteroid injection

Case controls

Participants with no arthritis or knee pain as controls

Interventions

Intra-articular corticosteroid injection PROCEDURE

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

Osteoarthritis; Rheumatoid arthritis; Spondyloarthritis or psoriatic arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St George's, University of London: lead
• Wellcome Trust: collaborator
• Rosetrees Trust: collaborator

Study Sites (1)

St George's Healthcare NHS Trust

London, SW17 0RE, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for protein and DNA analysis

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis, Rheumatoid; Spondylarthritis; Arthritis, Psoriatic; Pain; Inflammation

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylitis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Nidhi Dr Sofat, MD, PhD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nidhi Dr Sofat, MD, PhD

CONTACT

4402087250042; nsofat@sgul.ac.uk

Abiola Ms Harrison, BSc

CONTACT

4402082666474; oharriso@sgul.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 23, 2018
• Study Start: April 2, 2018
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2022
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

GB (1)