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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: March 28, 2008
Last updated: March 31, 2008
Last verified: March 2008
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo

Condition Intervention Phase
Rheumatoid Arthritis Biological: adalimumab Biological: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Blood samples for Influenza A & B antibody Assay [ Time Frame: Baseline (Day 1), Day 36 or premature discontinuation ]
  • Blood Samples for Pneumococcal Antibody Assay [ Time Frame: Baseline (Day 1), Day 36 or premature discontinuation ]

Secondary Outcome Measures:
  • Laboratory assessments [ Time Frame: Screening, Week 15, Day 36, Month 3 and Month 6 ]
  • Vitals signs [ Time Frame: Screening - Month 6 ]
  • Adverse events [ Time Frame: Screening - Month 6 ]

Enrollment: 226
Study Start Date: October 2003
Study Completion Date: February 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Double Blind Biological: adalimumab
80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29
Other Names:
  • ABT-D2E7
  • Humira
Biological: placebo
2 injections Day 1, 1 injection Days 15 and 29
Experimental: Open Label Biological: adalimumab
40 mg adalimumab every other week
Other Names:
  • ABT-D2E7
  • Humira


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lawrence McNamee, Sr. Clinical Research Manager, Abbott Identifier: NCT00649922     History of Changes
Other Study ID Numbers: M03-600
Study First Received: March 28, 2008
Last Updated: March 31, 2008

Keywords provided by Abbott:
Vaccines with adalimumab dosing

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on September 20, 2017