Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional synthetic DMARD naïve | Naive RA patients commencing Methotrexate and Hydroxychloroquine. Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. |
| |
| DMARD-IR: anti-TNF | Conventional synthetic DMARD inadequate responders commencing Anti-TNF Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. |
| |
| DMARD-IR: anti-IL6 | Conventional synthetic DMARD inadequate responders commencing anti-IL6 Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. |
| |
| DMARD-IR: anti-CTLA-4 | Conventional synthetic DMARD inadequate responders commencing anti-CTLA-4 Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Musculoskeletal Ultrasound Imaging | Other | B-mode and PD musculoskeletal ultrasound examination of selected joints. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in synovial thickness and vascularity using a limited joint set musculoskeletal ultrasound examination in Rheumatoid Arthritis. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the distribution of cell populations in biological samples from Rheumatoid Arthritis patients using CyTOF. | 3 years | |
| Changes in gene expression in biological samples from Rheumatoid Arthritis patients using gene profiling. | 3 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Rheumatoid Arthritis Patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter C Taylor, PhD, FRCP | Kennedy Institute of Rheumatology, University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuffield Orthopaedic Centre | Oxford | OX3 7HE | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
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:
| DMARD-IR: anti-CD20 | Conventional synthetic DMARD inadequate responders commencing anti-CD20 Musculoskeletal Ultrasound imaging, synovial biopsy, biological samples collection, questionnaires. |
|
| 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. |
|
| Changes in cytokines' concentration in biological samples from Rheumatoid Arthritis patients using ELISA and transcriptome analysis. | 3 years |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |