A Clinical Trial to Study the Effects of Revamilast in Patients With Rheumatoid Arthritis

Inclusion Criteria

• •1. Male or female ≥18 to ≤ 65 years of age
• •2. Documented history of RA; diagnosed according to the revised American College of Rheumatology criteria (ACR)
• •3. Active RA defined as patients with:
• •* 6 swollen joint counts
• •* 6 tender/painful joint counts, and
• •* At least two of the three following criteria:
• •* Rheumatoid Factor positive or Anti CCP positive
• •* CRP ≥1.2 times upper limit of normal reference range or ESR \>28 mm/hr
• •* Morning stiffness lasting \>45 min for at least last4 weeks
• •4. DAS-28 CRP values ≥ 4.5 at screening (visit 1)
• •5. Patients must have been on stable (15 mg to 25 mg) or maximum tolerated dose of MTX for at least 12 weeks prior to screening
• •6. The patient's written informed consent to participate in the study
• •7. Female participants must have a negative serum pregnancy test at screening visit.
• •8. Males must agree to use barrier while on study medication and for 90 days after taking the last dose of study medication
• •9. Must meet the following laboratory criteria:
• •* Hemoglobin ≥ 9 g/dL
• •* White blood cell (WBC) count; ≥3.0 X 109/L
• •* Platelet count ≥ 100,000 /L (100 X 109/L)
• •* Serum creatinine \<1.5 mg/dL (or 133mol/L)
• •* Total bilirubin \<2.0 mg/dL
• •* AST \& ALT\<1.5 times upper limit of normal