Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

— BMUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476084
• Other study ID #: 149600
• Status: Completed
• Start date: October 13, 2014
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2020
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Nuffield Orthopaedic Centre	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	UCB Pharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in synovial thickness and vascularity using a limited joint set musculoskeletal ultrasound examination in Rheumatoid Arthritis.		3 years
Secondary	Changes in the distribution of cell populations in biological samples from Rheumatoid Arthritis patients using CyTOF.		3 years
Secondary	Changes in gene expression in biological samples from Rheumatoid Arthritis patients using gene profiling.		3 years
Secondary	Changes in cytokines' concentration in biological samples from Rheumatoid Arthritis patients using ELISA and transcriptome analysis.		3 years