Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients
NCT ID: NCT02476084
Last Updated: 2022-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
43 participants
OBSERVATIONAL
2014-10-13
2021-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Conventional synthetic DMARD naïve
Naive RA patients commencing Methotrexate and Hydroxychloroquine.
Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires.
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.
DMARD-IR: anti-TNF
Conventional synthetic DMARD inadequate responders commencing Anti-TNF
Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires.
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.
DMARD-IR: anti-IL6
Conventional synthetic DMARD inadequate responders commencing anti-IL6
Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires.
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.
DMARD-IR: anti-CTLA-4
Conventional synthetic DMARD inadequate responders commencing anti-CTLA-4
Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires.
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.
DMARD-IR: anti-CD20
Conventional synthetic DMARD inadequate responders commencing anti-CD20
Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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).
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Peter C Taylor, PhD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Kennedy Institute of Rheumatology, University of Oxford
Locations
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Nuffield Orthopaedic Centre
Oxford, , United Kingdom
Countries
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Other Identifiers
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149600
Identifier Type: -
Identifier Source: org_study_id
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