[REC Ref. No. 10/H0801/47]
Status: Closed to recruitment
The main aim of this study is to assess the relationship between the presence of ectopic
lymphoneogenesis (ELN) within the rheumatoid synovial membrane and clinical disease activity.
We hypothesised that ELN evolves over time and may correlate with clinical disease activity. This study provided an opportunity to document that change and relate it to patient’s clinical progression during an established, active phase of their disease. Patients at this juncture often require more aggressive therapy, such as anti-TNF agents. We planned to enroll patients at this stage of their disease and perform a synovial biopsy at Visit 1 (-4 - -1 weeks) and at Visit 5 (week 12). Patients were treated with either certolizumab or etanercept. Results of the study can be found here.
74 patients were recruited to this study. A synovial biopsy was performed prior to anti-TNF treatment and at week 12. Samples bio-banked include FFPE synovial tissue (pre- and post-treatment) and blood.