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:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00649922

First received: March 28, 2008

Last updated: March 31, 2008

Last verified: March 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	March 28, 2008
Last Updated Date	March 31, 2008
Start Date ^ICMJE	October 2003
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 ] [ Designated as safety issue: No ] Blood Samples for Pneumococcal Antibody Assay [ Time Frame: Baseline (Day 1), Day 36 or premature discontinuation ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00649922 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 31, 2008)	Laboratory assessments [ Time Frame: Screening, Week 15, Day 36, Month 3 and Month 6 ] [ Designated as safety issue: No ] Vitals signs [ Time Frame: Screening - Month 6 ] [ Designated as safety issue: No ] Adverse events [ Time Frame: Screening - Month 6 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 adalimumab Biological: placebo 2 injections Day 1, 1 injection Days 15 and 29 Other Name: placebo Biological: adalimumab 40 mg adalimumab every other week Other Names: ABT-D2E7 Humira adalimumab
Study Arm (s)	Placebo Comparator: Double Blind Interventions: Biological: adalimumab Biological: placebo Experimental: Open Label Intervention: Biological: adalimumab
Publications *	Not Provided
* 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
Enrollment ^ICMJE	226
Completion Date	February 2005
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.
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00649922
Other Study ID Numbers ^ICMJE	M03-600
Has Data Monitoring Committee	No
Responsible Party	Lawrence McNamee, Sr. Clinical Research Manager, Abbott
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Abbott
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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