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

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

To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo

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.