Most rheumatoid arthritis patients seen in the "real world" do not qualify for clinical trials for the treatment of rheumatoid arthritis

Objectives: We analyzed rheumatoid arthritis (RA) patients seen in a cohort from Brooklyn, NY over the last three years to determine what percentage of patients would fulfill common inclusion criteria for RA clinical trials at any time during their care. Patients and Methods: One hundred and twenty-three consecutive patients with RA, seen between April 2001 and December 2003 by a single rheumatologist, were included. Patients were analyzed according to whether they met four common inclusion criteria in most recent RA trials, and according to the inclusion criteria for the recent anti-tumor necrosis factor alpha (anti-TNF alpha) trial involving etanercept and methotrexate in early RA (ERA trial) and the STAR (Safety Trial of Adalimumab in Rheumatoid arthritis) trial. All visits were analyzed to identify any visit where patients fulfilled the inclusion criteria. Results: When the most common inclusion criteria for RA clinical trials were applied, 3/146 (2.1%) visits and two of 72 (2.8%) patients fulfilled these criteria. The inclusion criteria for the ERA and STAR trials were met in 4/123 (3.3%) and 17/123 (13.8%) patients, respectively. Conclusion: A large majority of RA patients seen in this cohort would not have qualified for the most common RA clinical trials and the recent anti-TNFa. trials. It is timely to consider new inclusion criteria for RA clinical trials to reflect the current characteristics of most RA patients. This would increase the applicability of the results of these important and usually very expensive studies and therapies.