- A diagnosis of severe rheumatoid arthritis (RA) for at least 6 months
- The Rheumatoid Arthritis must have been treated with a stable regimen including a
non-steroidal anti-inflammatory drug (NSAID), as well as methotrexate for at least 12
weeks -OR- an NSAID (for at least 12 weeks plus a tumor necrosis factor inhibitor
(i.e., adalimumab [Humira®] for a minimum of 5 doses on a regular schedule, etanercept
[Enbrel®] for 6 weeks, infliximab (Remicade®) for 3 doses and currently on a stable
regimen of infusions not more than every 8 weeks)
- A diagnosis of any other inflammatory arthritis or a secondary, noninflammatory type
of arthritis (eg, osteoarthritis (OA) or fibromyalgia) that, in the investigator's
opinion, was symptomatic enough to interfere with the evaluation of the effect of
valdecoxib on the patient's primary diagnosis of Rheumatoid Arthritis were excluded
from the study