A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease affecting approximately 1% of the adult population. The disease is characterised by inflammation of synovial tissue (ST) in multiple joints, which often leads to destruction of joint integrity, contributing to serious functional impairment and disability. The contributors to its pathology include joint inflammation, abnormal cellular and humoral responses, and synovial hyperplasia. Ultrasonography is a powerful, non−invasive, and feasible way to evaluate synovial hyperplasia and guide its collection by biopsy.
Although RA is a systemic disease, it is not clear whether the gene expression profile exhibited by circulated peripheral blood cells and that expressed by the inflamed synovium mirror one another. Understanding this relationship would be useful not only in potentially having a relatively non−invasive means to predict response to therapy but it might be useful in better understanding differences in RA expression amongst patients with this disease, thus perhaps assisting in target identification through a better understanding of disease processes.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood|
- Whether peripheral blood markers from patients with rheumatoid arthritis correlate to findings on ultrasound images and synovium (joint lining). [ Time Frame: Initial visit ] [ Designated as safety issue: No ]
- Whether the gene expression pattern of synovium in treatment naive rheumatoid arthritis patients correlates to that found in their circulating blood cells and if these are affected (or not)by disease modifying therapy (DMARD). [ Time Frame: Visits 1, 2 and 3 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||November 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
12 treatment naive patients who fulfil the American College of Rheumatology (ACR) criteria for RA with active disease defined by a Disease Activity Score (DAS)28 score of more than 3.2.
6 RA patients in remission on a stable dose of methotrexate with a DAS28 score lower than 2.6
12 patients who fulfill the ACR criteria for RA and are being treated with methotrexate but still have active disease, defined as a DAS28 score of more than 3.2
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781469
|Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Peter C Taylor, PhD||Imperial College London|