Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: adalimumab (Biological); placebo (Biological); adalimumab (Biological)
Phase: Phase 4
Sponsored by: Abbott
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal
virus in subject with RA receiving adalimumab or placebo
Official title: Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Blood samples for Influenza A & B antibody Assay
Blood Samples for Pneumococcal Antibody Assay
Minimum age: 20 Years.
Maximum age: N/A.
- 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.
- 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
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Starting date: October 2003
Last updated: March 31, 2008