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

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

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
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Biological: adalimumab Biological: placebo
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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

Administrative Information
NCT ID ^ICMJE	NCT00649922
Responsible Party	Lawrence McNamee, Sr. Clinical Research Manager, Abbott
Study ID Numbers ^ICMJE	M03-600
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE
Investigators ^ICMJE
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