A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis

Inclusion criteria

• Age greater than or equal to 18 and less than or equal to 80
• Diagnosis of Rheumatoid Arthritis for at least six weeks
• Taking an NSAID
• If female: using adequate contraception
• Willingness to stop current NSAID until criteria reached to begin study drug
• Able to provide written informed consent

Exclusion criteria

• Intolerance or hypersensitivity to NSAIDs or ingredients of trial drug
• Pregnancy, lactating
• Use of investigational drug within 30 days prior to entering the trial
• History of peptic ulcer or of gastrointestinal hemorrhage except simple hemorrhoidal bleeding
• History of cerebrovascular or other bleeding disorder
• Severe hypertension
• Other disease that might interfere with safety of the patient or evaluation of trial drug (investigator's opinion)
• RA of functional class IV
• Synovectomy in any large joint within the past 6 months prior to entering the trial or planned during trial
• Concomitant therapy with anticoagulant, therapeutic doses of aspirin, phenothiazines, lithium, chronic GI-medication, analgesic drug (except acetaminophen up to 4 grams/day)
• DMARDs initiated within past three months or dose changed less than two months before entering the trial
• Therapy with corticosteroids exceeding 10 mg/day prednisone equivalent or change in dose within 1 month before trial
• Concomitant therapy with ACTH within past month before entering the trial.
• History of narcotic or alcohol abuse (past 12 months)
• Abnormal laboratory values
• Previous participation in the present trial