Anti-TNF Agents for the Treatment of Rheumatoid Arthritis - Full Text View - ClinicalTrials.gov

Anti-TNF Agents for the Treatment of Rheumatoid Arthritis
This study is currently recruiting participants.

Verified by National Institute of Allergy and Infectious Diseases (NIAID), March 2011

First Received: February 3, 2009 Last Updated: March 2, 2011 History of Changes

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier: NCT00837434

Purpose
Rheumatoid arthritis (RA) is a chronic disease that leads to inflammation and progressive joint damage. RA is a systemic inflammatory autoimmune disorder affecting almost 1% of the United States population. Current therapies target the immune system early in the disease process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents. The primary purpose of this study is to determine the effectiveness of two TNF inhibitors, etanercept and adalimumab, on memory B lymphocytes (B-cells) in the peripheral blood of participants with RA.

Additionally, there are 4 optional sub-studies as part of the trial:

•B-Cell Kinetic Sub-Study to look at changes in B-cell subsets over time and how quickly reductions in B-cell memory occur.
•Vaccine Response Sub-Study to assess B cell memory in response to immunization with hepatitis B,-hepatitis A, and diphtheria/tetanus vaccines, and to determine whether T-cell vaccine responses are altered with TNF blockade.
•Tonsil Biopsy Sub-Study to evaluate how TNF blockade affects memory B-cells in the tonsil dendritic cells and germinal cells.
•Synovial Biopsy Sub-Study to evaluate how TNF blockade affects changes in memory B-cells in lymphoid tissue.

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Anti-TNF Agents for the Treatment of Rheumatoid Arthritis - Full Text View - ClinicalTrials.gov