Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

Tracking Information
First Submitted Date  ICMJE March 28, 2008
First Posted Date  ICMJE April 1, 2008
Last Update Posted Date April 1, 2008
Study Start Date  ICMJE October 2003
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
Official Title  ICMJE Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
Brief Summary To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Double Blind
    Interventions:
    • Biological: adalimumab
    • Biological: placebo
  • Experimental: Open Label
    Intervention: Biological: adalimumab
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2008)
226
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2005
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00649922
Other Study ID Numbers  ICMJE M03-600
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lawrence McNamee, Sr. Clinical Research Manager, Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Abbott
Verification Date March 2008

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