Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients (BMUS)

May 19, 2022 updated by: University of Oxford

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 7HE
        • Nuffield Orthopaedic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Rheumatoid Arthritis Patients

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conventional synthetic DMARD naïve

Naive RA patients commencing Methotrexate and Hydroxychloroquine.

Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires.
Other: Musculoskeletal Ultrasound Imaging
B-mode and PD musculoskeletal ultrasound examination of selected joints.
Other: Synovial biopsy
US guided synovial biopsy of an inflamed joint including wrists, MCP joints and knees.
Other: Biological samples collection
Draw of research blood samples.
Other: Questionnaires
Administration of validated patients' questionnaires.
DMARD-IR: anti-TNF

Conventional synthetic DMARD inadequate responders commencing Anti-TNF

Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires.
Other: Musculoskeletal Ultrasound Imaging
B-mode and PD musculoskeletal ultrasound examination of selected joints.
Other: Synovial biopsy
US guided synovial biopsy of an inflamed joint including wrists, MCP joints and knees.
Other: Biological samples collection
Draw of research blood samples.
Other: Questionnaires
Administration of validated patients' questionnaires.
DMARD-IR: anti-IL6

Conventional synthetic DMARD inadequate responders commencing anti-IL6

Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires.
Other: Musculoskeletal Ultrasound Imaging
B-mode and PD musculoskeletal ultrasound examination of selected joints.
Other: Synovial biopsy
US guided synovial biopsy of an inflamed joint including wrists, MCP joints and knees.
Other: Biological samples collection
Draw of research blood samples.
Other: Questionnaires
Administration of validated patients' questionnaires.
DMARD-IR: anti-CTLA-4

Conventional synthetic DMARD inadequate responders commencing anti-CTLA-4

Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires.
Other: Musculoskeletal Ultrasound Imaging
B-mode and PD musculoskeletal ultrasound examination of selected joints.
Other: Synovial biopsy
US guided synovial biopsy of an inflamed joint including wrists, MCP joints and knees.
Other: Biological samples collection
Draw of research blood samples.
Other: Questionnaires
Administration of validated patients' questionnaires.
DMARD-IR: anti-CD20

Conventional synthetic DMARD inadequate responders commencing anti-CD20

Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires.
Other: Musculoskeletal Ultrasound Imaging
B-mode and PD musculoskeletal ultrasound examination of selected joints.
Other: Synovial biopsy
US guided synovial biopsy of an inflamed joint including wrists, MCP joints and knees.
Other: Biological samples collection
Draw of research blood samples.
Other: Questionnaires
Administration of validated patients' questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in synovial thickness and vascularity using a limited joint set musculoskeletal ultrasound examination in Rheumatoid Arthritis.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in the distribution of cell populations in biological samples from Rheumatoid Arthritis patients using CyTOF.
Time Frame: 3 years
3 years
Changes in gene expression in biological samples from Rheumatoid Arthritis patients using gene profiling.
Time Frame: 3 years
3 years
Changes in cytokines' concentration in biological samples from Rheumatoid Arthritis patients using ELISA and transcriptome analysis.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

UCB Pharma

Investigators

  • Principal Investigator: Peter C Taylor, PhD, FRCP, Kennedy Institute of Rheumatology, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2014

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 149600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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