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
Summary
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 AssayBlood Samples for Pneumococcal Antibody Assay
Secondary outcome: Laboratory assessmentsVitals signs Adverse events
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: October 2003
Ending date: February 2005
Last updated: March 31, 2008
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