Rheumatoid Arthritis Clinical Trial
Official title:
Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
Verified date | March 2008 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo
Status | Completed |
Enrollment | 226 |
Est. completion date | February 2005 |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood samples for Influenza A & B antibody Assay | Baseline (Day 1), Day 36 or premature discontinuation | No | |
Primary | Blood Samples for Pneumococcal Antibody Assay | Baseline (Day 1), Day 36 or premature discontinuation | No | |
Secondary | Laboratory assessments | Screening, Week 15, Day 36, Month 3 and Month 6 | No | |
Secondary | Vitals signs | Screening - Month 6 | No | |
Secondary | Adverse events | Screening - Month 6 | No |
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