Clinical Trial: Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis

Brief Summary: This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.

Detailed Summary:

Orencia may regulate apoptosis and apoptosis related genes in vivo in rheumatoid arthritis (RA) patient's cells. To date, no studies have been performed to evaluate the effect of Orencia on apoptosis in RA patients.

Primary: To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.

Secondary: To evaluate the association between the changes in apoptosis to changes in disease activity measures (DAS28/ESR) over 6 months of treatment with subcutaneous injection of abatacept.


Sponsor: University of California, Los Angeles

Current Primary Outcome: To measure the change in apoptosis of T cells, B cells and antigen presenting (APC) cells in Rheumatoid Arthritis between the baseline, 3 months and at 6 months time points [ Time Frame: Base line, 3 and 6 months ]

To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.


Original Primary Outcome: Same as current

Current Secondary Outcome: To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points [ Time Frame: Baseline, 3 and 6 months ]

To measure the changes in disease activity score joint count (DAS28/ESR)


Original Secondary Outcome: Same as current

Information By: University of California, Los Angeles

Dates:
Date Received: October 24, 2012
Date Started: December 2012
Date Completion: November 2014
Last Updated: May 9, 2016
Last Verified: May 2016