Anti-TNF Agents for the Treatment of Rheumatoid Arthritis
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Autoimmunity Centers of Excellence Rho Federal Systems Division, Inc.