Clinical trials are essential to the development of effective treatments for chronic autoimmune arthritis. For ethical, practical, and financial reasons, researchers increasingly face the challenge of achieving proof-of-concept in early-phase clinical trials of limited size, limited duration, and minimal patient risk. Analysis of tissue from the synovium, the thin membrane lining the joint space and primary target of inflammation, provides a straightforward way to meet this challenge. This approach has been used extensively, and proven valuable, in studies of rheumatoid arthritis (RA).
Spondylarthritis (SpA) refers to a group of chronic autoimmune arthritic conditions, including ankylosing spondylitis (AS) and the arthritis associated with psoriasis and inflammatory bowel diseases, primarily affecting peripheral joints. For an international alliance of researchers, synovial tissue analysis presented an ideal vehicle for identifying biomarkers of SpA. Their findings, featured in the June 2006 issue of Arthritis & Rheumatism (http://www.interscience.wiley.com/journal/arthritis), hold the promise to facilitate the progress of clinical trials dedicated to improving the treatment of SpA.
Led by Dr. Dominique Baeten at the University of Amsterdam's Academic Medical Center, the 12-week study included 52 patients who met established criteria for SpA. Patients were randomly divided into three groups. Two groups were treated with a tumor necrosis factor (TNF) blockade 20 received infliximab and 20 received etanercept. None of these 40 patients was being treated with a disease-modifying antirheumatic drug (DMARD). The remaining 12 patients served as controls. At the study's inception and again at its culmination, each patient participated in a thorough assessment of disease symptoms and pain.
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