ORAL Surveillance was a 4 year randomised, open-label, non-inferiority, safety end-point trial, in which patients of 50 years of age or older with active RA despite MTX treatment, and with at least one additional cardiovascular risk factor, were randomly assigned in a 1:1:1 ratio to receive TOFA at a dose of 5 mg or 10 mg twice daily or a subcutaneous TNF inhibitor, i.e., etanercept or adalimumab [35]. This evidence concerns the gene TNF and rheumatoid arthritis.