Rheumatoid Arthritis Clinical Trial
Official title:
Phase 4 Study of Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Patients With Rheumatoid Arthritis Undergoing Treatment With Anti-TNF Therapy
This study will be an open label observational prospective study assessing the clinical
efficacy of antiTNFα therapy and the alteration/impact on the synovial tissue, with specific
regard to lymphoid aggregation, over a period of 12 months in patients with rheumatoid
arthritis.
Rheumatoid arthritis (RA) is one of the most important chronic inflammatory disorders in the
UK. It affects approximately 1% of adults and causes considerable morbidity, substantially
reduces quality of life and has a significant mortality. It results in large direct medical
costs as well as extensive indirect social costs. Despite the significant therapeutic
progress following the introduction of antiTNFα, a cure for RA is still elusive. At present
the reasons for the variation in clinical response are not known. The main aim of this study
is to test the hypothesis that there are distinct molecular and cellular phenotypes present
within the synovial tissue that define specific disease subsets and provide characteristic
prognostic implications. In particular, the aim is to assess the relationship between the
presence of ectopic lymphoneogenesis (ELN) within the rheumatoid synovial membrane and
response to antiTNFα therapy.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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