Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

The purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis (RA) showing an insufficient response to MTX.

Inclusion Criteria:

• Patients with active RA in spite of stable dose of MTX

Exclusion Criteria:

• Having received infliximab in the past
• Having a history of serious infection which caused hospitalization within 6 months before the registration
• Having an active tuberculosis
• Having a complication or a history of malignancy within 5 years before the registration