Rheumatoid arthritis is an inflammatory synovial disease thought to in
volve T cells reacting to an antigen within the joint. Type II collage
n is the major protein in articular cartilage and is a potential autoa
ntigen in this disease. Oral tolerization to autoantigens suppresses a
nimal models of T cell-mediated autoimmune disease, including two mode
ls of rheumatoid arthritis. In this randomized, double-blind trial inv
olving 60 patients with severe, active rheumatoid arthritis, a decreas
e in the number of swollen joints and tender joints occurred in subjec
ts fed chicken type II collagen for 3 months but not in those that rec
eived a placebo. Four patients in the collagen group had complete remi
ssion of the disease. No side effects were evident. These data demonst
rate clinical efficacy of an oral tolerization approach for rheumatoid
arthritis.