Status:
COMPLETED
Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
Lead Sponsor:
Abbott
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2005
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00649922
Start Date
October 1 2003
End Date
February 1 2005
Last Update
April 1 2008
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