Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis

Inclusion criteria

• Male/Females at least 20 years of age.
• Females post-menopausal for at least 1 year, surgically sterile, or practicing acceptable methods of birth control.
• Females have a negative pregnancy test at screening.
• Diagnosis of RA and met ACR criteria.
• Must discontinue any TNF at least 2 months prior to baseline.
• In condition of general good health.

Exclusion criteria

• History of significant sensitivity to any drug; clinically significant drug or alcohol abuse within the past year; active infection with Listeria or TB; lymphoma or leukemia; sickle-cell disease, splenectomy, other malignancy within 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of skin or localized carcinoma in situ of the cervix.
• History of current acute inflammatory joint disease.
• Use of TAMIFLU or Symmetrel within 3 months of study drug administration.
• Recent (3 month) history of influenza or pneumococcal bacterial infection.
• Known positive human immunodeficiency virus (HIV) status.
• Positive hepatitis B or hepatitis C virus.
• Positive PPD >5 mm.
• Chest x-ray with calcified granulomas and/or pleural scarring or significant abnormalities.