A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Inclusion criteria

• Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits >10 swollen joints, >12 tender joints.
• Subjects must have failed prior treatment with one or more DMARDs.
• A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
• Body weight less than or equal to 100 kg

Exclusion criteria

• A history of, or current, acute inflammatory joint disease of different origin from RA.
• Prior treatment with any TNF antagonist, including adalimumab.
• Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
• Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.