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

Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: adalimumab (Biological); placebo (Biological); adalimumab (Biological)

Phase: Phase 4

Status: Completed

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

Clinical Details

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Blood samples for Influenza A & B antibody Assay

Blood Samples for Pneumococcal Antibody Assay

Secondary outcome:

Laboratory assessments

Vitals signs

Adverse events


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


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


Locations and Contacts

Additional Information

Starting date: October 2003
Ending date: February 2005
Last updated: March 31, 2008

Page last updated: June 20, 2008

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