Skip to main content
OpenTrials
Completed

NCT Number: NCT02476084

Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients

The purpose of this study is to determine the kinetics of change in quantitative measures of joint inflammation by state of the art power Doppler vascular imaging and to identify biomarkers in biological samples (synovial biopsies, DNA, RNA, PBMC, serum, plasma, urine and stool samples) from parallel cohorts of RA patients undergoing different treatments. This will be achieved implementing MSUS assessments, standard laboratories techniques (such as ELISAs, gene profiling, transcriptome analysis etc.) and the novel CyTOF™ technology.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nuffield Orthopaedic Centre

Oxford, OX3 7HE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written confirmed diagnosis of Rheumatoid Arthritis as per ACR/EULAR 2010 criteria.
  • If patient is on oral corticosteroids, dose must be stable for 6 weeks prior to baseline visit.
  • Willingness and ability to comply with all the study procedures.

Exclusion criteria

  • Any systemic inflammation conditions (other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data. Examples include psoriatic arthritis, reactive arthritis, gout, systemic lupus erythematosus (SLE), polymyalgia rheumatic and/or temporal arteritis, Lyme's disease, fibromyalgia and chronic fatigue syndromes.
  • Major surgery planned within 8 weeks prior to screening or planned surgery throughout the study period.
  • Treatment with any investigational agent ≤ 4 weeks prior to baseline (or 5 ≤ half-lives of the investigational drug, whichever is the longer).
  • Intramuscular/intra-articular glucocorticoids for 6 weeks prior to baseline visit.
  • Active infection.
  • Septic arthritis within a native joint within the last 12 months.
  • Sepsis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ.
  • Known HIV or hepatitis B/C infection.
  • Latent TB infection unless they have completed adequate antibiotic prophylaxis.
  • Malignancy (other than basal cell carcinoma) within the last 10 years.
  • New York Heart Association (NYHA) grade 3 or 4 congestive cardiac failure.
  • Demyelinating disease.
  • Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening).
  • Known recent substance abuse (drug or alcohol).

Treatment and study plan

Musculoskeletal Ultrasound Imaging

Other

B-mode and PD musculoskeletal ultrasound examination of selected joints.

Synovial biopsy

Other

US guided synovial biopsy of an inflamed joint including wrists, MCP joints and knees.

Biological samples collection

Other

Draw of research blood samples.

questionnaires

Other

Administration of validated patients' questionnaires.

Primary outcomes

  1. Changes in synovial thickness and vascularity using a limited joint set musculoskeletal ultrasound examination in Rheumatoid Arthritis.

    Time frame: 3 years

Secondary outcomes

  1. Changes in the distribution of cell populations in biological samples from Rheumatoid Arthritis patients using CyTOF.

    Time frame: 3 years

  2. Changes in gene expression in biological samples from Rheumatoid Arthritis patients using gene profiling.

    Time frame: 3 years

  3. Changes in cytokines' concentration in biological samples from Rheumatoid Arthritis patients using ELISA and transcriptome analysis.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • UCB Pharma

Registry information

Official study title

Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients: a Pilot Observational Study

Acronym: BMUS

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2015
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.