Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients

• Drug: valdecoxib
  valdecoxib 10 mg tablet once daily for 12 weeks
• Drug: naproxen
  naproxen 500 mg capsule twice daily for 12 weeks
• Drug: placebo
  placebo tablet every morning and capsule every evening for 12 weeks

• Active Comparator: Arm 2
  Intervention: Drug: naproxen
• Placebo Comparator: Arm 3
  Intervention: Drug: placebo
• Active Comparator: Arm 1
  Intervention: Drug: valdecoxib

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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