Human Tumor Necrosis Factor Alpha (TNFa)-Induced Pre-B Cell Bone Marrow Emigrants
Recruitment status was Recruiting
The purpose of the study is to determine the effects of TNF (tumor necrosis factor; a mediator of inflammation) on B cells in patients with rheumatoid arthritis. TNF and B cells are important in rheumatoid arthritis because they both appear to be involved in causing rheumatoid arthritis.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Human TNFa-Induced Pre-B Cell Bone Marrow Emigrants|
- The primary objective of the study is to quantify early B cell bone marrow emigrants in the peripheral blood of adults with rheumatoid arthritis (RA) before and after etanercept therapy. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Secondary objectives will include granulocyte numbers, serum cytokine (CRP, IL-1β and TNFα) levels, rheumatoid arthritis disease activity and changes in anti-CCP and RF levels before and after etanercept therapy. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Etanercept 50 mg SQ qweek
Other Name: ENBREL
Primary Objective: The primary objective of the study is to identify early B cell bone marrow emigrants in the peripheral blood of adults with rheumatoid arthritis (RA) receiving etanercept.
Hypotheses: We believe that the peripheral blood of RA patients contain early B cell bone marrow emigrants. We believe that these early B cell bone marrow emigrants are induced by TNFα.
Primary Endpoint: The primary endpoint of the study is quantification of CD34+/CD19+ early B cell bone marrow emigrants in the peripheral blood of subjects.
Study Design: Open-label, One Arm, Phase IV study of 12 RA patients with active disease receiving etanercept.
|Contact: Marc C Levesque, MD, PhD||412-648-9385||MCL40@pitt.edu|
|United States, Pennsylvania|
|University of Pittsburgh - Oakland Falk Clinic||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Marc C Levesque, MD, PhD|
|Principal Investigator:||Marc C Levesque, MD, PhD||University of Pittsburgh|