[ISRCTN reference: ISRCTN 18262002] [NIHR CRN Portfolio Study ID: 18893]
Status: Closed to recruitment
Preliminary data suggest that up-regulation of IL-17 and the Th17 pathway occurs in patients with rheumatoid arthritis (RA) who have been treated with anti-tumor necrosis factor-alpha (anti-TNFα) therapy but demonstrate an incomplete clinical response. A deeper understanding of this is required in order to determine whether IL-17 or the Th17 pathway is a valid target for intervention in this population to improve response outcomes.
The main aim of this study was to examine the relationship of IL-17 expression within blood and synovium of subjects with RA as relates to clinical response or non-response to anti-TNF therapy. Clinical assessments, ultrasound assessments, synovial tissue bio-markers obtained from the ultrasound-guided synovial biopsy, and study-specific blood sampling are being used to evaluate the pattern of activity shown in the Th17 pathway. Recruitment of 60 patients took place in 10 NHS Trusts.
Biological samples (tissue & fluids) were collected at five timepoints over a 24-week period and are linked to stringent clinical outcome measures. 60 patients were enrolled in this study, with 27 baseline and 20 follow-up synovial tissue biopsies collected. Blood samples have been collected for 280 time-points and include wholeblood, serum, peripheral blood mononuclear cells (PBMCs), and DNA. In addition, urine was collected at four timepoints.