Anti-TNF Agents for the Treatment of Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis

What is the purpose of this trial?

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.


Participation Guidelines

Age:
18 Years - 75 Years
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Dates:
March 2009
Last Updated:
March 26, 2014
Study HIC#:
1112009414

Clinicaltrials.gov ID: NCT00837434