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

Phase 4

Withdrawn

• Conditions: Apoptotic DNA Damage; Rheumatoid Arthritis; T-cell Lymphocytosis
• Interventions: Other: Group 2 (DMARDS treated group); Drug: Group 1 or Orencia treated group

• Registration Number: NCT01717846
• Lead Sponsor: University of California, Los Angeles

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 Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-10-30
• Study First Posted: 2012-10-31
• Study Start: 2012-12
• Primary Completion: 2013-11
• Study Completion: 2014-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-09
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Over age 18
2. Meeting ACR Criteria 1987 for RA diagnosis
3. Naïve to treatment with abatacept
4. Must be able to understand information in the Informed Consent

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Exclusion Criteria

1. Pregnancy or breast feeding
2. Previous exposure to abatacept.
3. History of a concomitant autoimmune disease (eg. SLE, PsA etc.)
4. Patients with history of cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 or group 2	Group 2 (DMARDS treated group)	Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept.
Arm 1	Group 1 or Orencia treated group	Orencia Group is for RA patients who have not received any other biologic treatment, including abatacept previously, and whose doctor has determined that it is appropriate to treat their RA with Abatacept. If you are in Group 1, you will receive the study drug, Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form. Abatacept, given in an intravenous injection is approved by the FDA for the treatment of RA.

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points	Baseline, 3 and 6 months	To measure the changes in disease activity score joint count (DAS28/ESR)

Trial Locations

Locations (1)

Univerity of California at Los Angeles; 🇺🇸 Los Angeles, California, United States