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Spots Global Cancer Trial Database for Human Tumor Necrosis Factor Alpha (TNFa)-Induced Pre-B Cell Bone Marrow Emigrants

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Trial Identification

Brief Title: Human Tumor Necrosis Factor Alpha (TNFa)-Induced Pre-B Cell Bone Marrow Emigrants

Official Title: Human TNFa-Induced Pre-B Cell Bone Marrow Emigrants

Study ID: NCT01009879

Interventions

Etanercept

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Pittsburgh - Oakland Falk Clinic, Pittsburgh, Pennsylvania, United States

Contact Details

Name: Marc C Levesque, MD, PhD

Affiliation: University of Pittsburgh

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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