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

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ClinicalTrials.gov Identifier: NCT00649922
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : April 1, 2008
Sponsor:
Information provided by:
Abbott

Brief Summary:
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: adalimumab Biological: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
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
Study Start Date : October 2003
Primary Completion Date : December 2004
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lawrence McNamee, Sr. Clinical Research Manager, Abbott
ClinicalTrials.gov Identifier: NCT00649922     History of Changes
Other Study ID Numbers: M03-600
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2008

Keywords provided by Abbott:
Vaccines with adalimumab dosing

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents