DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: adalimumab (Biological); placebo (Biological); adalimumab (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Abbott

Summary

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

Clinical Details

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Blood samples for Influenza A & B antibody Assay

Blood Samples for Pneumococcal Antibody Assay

Secondary outcome:

Laboratory assessments

Vitals signs

Adverse events

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: October 2003
Ending date: February 2005
Last updated: March 31, 2008

Page last updated: June 20, 2008

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014