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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02476084
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : May 20, 2022
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
University of Oxford

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Other: Musculoskeletal Ultrasound Imaging Other: Synovial biopsy Other: Biological samples collection Other: Questionnaires

Study Design
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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients: a Pilot Observational Study
Actual Study Start Date : October 13, 2014
Actual Primary Completion Date : October 1, 2021
Actual Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in synovial thickness and vascularity using a limited joint set musculoskeletal ultrasound examination in Rheumatoid Arthritis. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA

Blood and and Biologic samples collected will be processed in the CTU Translational Research Lab and stored within the Botnar Research Centre adhering to local guidelines on sample requirements, handling and storage. All biological samples will be available for future studies for biomarker profiling.

The following blood samples will be drawn in order:

  1. Two (10.0ml) K2EDTA tube
  2. One (5.0ml) SST tube
  3. One (3 ml) Tempus RNA tube
  4. One (6 ml) DNA EDTA tube (only during Visit 1)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rheumatoid Arthritis Patients
Criteria

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).
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476084


Locations
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United Kingdom
Nuffield Orthopaedic Centre
Oxford, United Kingdom, OX3 7HE
Sponsors and Collaborators
University of Oxford
UCB Pharma
Investigators
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Principal Investigator: Peter C Taylor, PhD, FRCP Kennedy Institute of Rheumatology, University of Oxford
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02476084    
Other Study ID Numbers: 149600
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: October 2020
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases