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

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

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: adalimumab
* Biological: placebo
* Biological: adalimumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Double Blind<br> | Biological: adalimumab<br>* 80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29<br>* Other names: Humira;Biological: placebo<br>* 2 injections Day 1, 1 injection Days 15 and 29<br>|
| Experimental: Open Label<br> | Biological: adalimumab<br>* 40 mg adalimumab every other week<br>* Other names: Humira;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples for Influenza A & B antibody Assay |  | Baseline (Day 1), Day 36 or premature discontinuation | 
| Blood Samples for Pneumococcal Antibody Assay |  | Baseline (Day 1), Day 36 or premature discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory assessments |  | Screening, Week 15, Day 36, Month 3 and Month 6 | 
| Vitals signs |  | Screening - Month 6 | 
| Adverse events |  | Screening - Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccines with adalimumab dosing