A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED)

Inclusion Criteria

• Patients received placebo in main double-blind study (P04280, NCT00202852)
• Patients received Infliximab-containing regimen showing clinical response at week 30 in main double-blind study (P04280)

[Main double-blind study (P04280, NCT00202852) inclusion criteria]

• Diagnosis of rheumatoid arthritis (RA) according to the revised 1987 criteria of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed >6 months prior to screening.
• Active disease at the time of screening and pre-infusion as defined by:
• >=6 swollen joints
• >=6 tender joints and
• 2 of the following:
• morning stiffness >=45 min
• erythrocyte sedimentation rate (ESR) >=28 mm/h
• C-reactive protein (CRP) >=20 mg/L
• Men and women, >=18 to 3 months with no break(s) in treatment of >2 weeks total during this period. Patients must have been on a stable dose of >=12.5 mg/wk (maximum 20 mg/wk) for at >4 weeks prior to screening.
• Must be on a stable dose of folic acid prophylaxis for >4 weeks prior to screening.
• Patients using oral corticosteroids, must have been on a stable dose of 4 weeks prior to screening. If currently not using corticosteroids the patient must have not received corticosteroids for >4 weeks prior to screening.
• If using nonsteroidal anti-inflammatory drugs (NSAIDs), patients should have been on a stable dose for >4 weeks prior to screening.
• The screening laboratory tests must meet the following criteria:
• Hemoglobin >=5.3 mmol/L (>=8.5 g/dL), providing a low hemoglobin level is not due to nutritional deficiencies or due to diseases other than chronic RA
• white blood cell (WBC) >=3.5 x 10^9/L (>=3.5 x 10^3/mm^3)
• Neutrophils >=1.5 x 10^9/L (>=1.5 x 103/mm^3)
• Platelets >=100 x 10^9/L (>=100 x 103/mm^3)
• Serum transaminase <=2 times the upper limit of normal
• Alkaline phosphatase levels <=2 times the upper limit of normal
• Serum creatinine <=150 µmol/L (<=1.7 mg/dL)
• Must be able to adhere to the study visit schedule and other protocol requirements.
• Must be capable of giving informed consent and the consent must have been obtained prior to any study procedures including wash-out period.

Exclusion Criteria

• Exclusion criteria below of main double-blind study (P04280, NCT00202852)

[Main double-blind study (P04280, NCT00202852) exclusion criteria]

• Pregnant women, nursing mothers, or a planned pregnancy within 1.5 years of enrollment.
• Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.
• Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from infliximab, eg Lyme disease, or a rheumatic disease other than RA.
• Use of disease modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to screening. (If a patient had prior exposure to leflunomide within the past 6 months, cholestyramine 8 g should be given 3 times daily for 11 days to rapidly lower the plasma level of leflunomide.)
• Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. ACTH) within 4 weeks prior to screening.
• Have been previously treated with infliximab or genetic recombinant therapy with RA (e.g. etanercept, adalimumab)
• Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline or thalidomide) within the previous 3 months.
• Treatment with any investigational drug within the previous 3 months.
• Prior use of cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents.
• History of any clinically significant adverse reaction to murine or chimeric proteins, including but not limited to allergic reactions.
• History of infected joint prosthesis within previous 5 years.
• Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months.
• Chronic infectious disease such as chronic renal infection, chronic chest infection with