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

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: adalimumab; Biological: placebo

• Registration Number: NCT00649922
• Lead Sponsor: Abbott

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 available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2004-12
• Study Completion: 2005-02
• Status Verified: 2008-03
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-31
• Last Update Submitted: 2008-03-31
• Study First Posted: 2008-04-01
• Last Update Posted: 2008-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double Blind	adalimumab	-
Double Blind	placebo	-
Open Label	adalimumab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Laboratory assessments	Screening, Week 15, Day 36, Month 3 and Month 6
Vitals signs	Screening - Month 6
Adverse events	Screening - Month 6