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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00649922
First Posted: April 1, 2008
Last Update Posted: April 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
March 28, 2008
April 1, 2008
April 1, 2008
October 2003
December 2004   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • Biological: adalimumab
    40 mg adalimumab every other week
    Other Names:
    • ABT-D2E7
    • Humira
  • Placebo Comparator: Double Blind
    Interventions:
    • Biological: adalimumab
    • Biological: placebo
  • Experimental: Open Label
    Intervention: Biological: adalimumab
Burmester GR, Landewé R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
226
February 2005
December 2004   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00649922
M03-600
No
Not Provided
Not Provided
Lawrence McNamee, Sr. Clinical Research Manager, Abbott
Abbott
Not Provided
Not Provided
Abbott
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP