Human Tumor Necrosis Factor Alpha (TNFa)-Induced Pre-B Cell Bone Marrow Emigrants
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|ClinicalTrials.gov Identifier: NCT01009879|
Recruitment Status : Withdrawn (No subjects were enrolled)
First Posted : November 9, 2009
Last Update Posted : July 2, 2013
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Etanercept||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Human TNFa-Induced Pre-B Cell Bone Marrow Emigrants|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Etanercept 50 mg SQ qweek
Other Name: ENBREL
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009879
|United States, Pennsylvania|
|University of Pittsburgh - Oakland Falk Clinic|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Marc C Levesque, MD, PhD||University of Pittsburgh|