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

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

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

Study Overview

• Status: Withdrawn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

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Univerity of California at Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 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.	Drug: Group 1 or Orencia treated group; Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months.; Other Names: Abatacept
Other: Arm 2 or group 2; 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.	Other: 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.; Other Names: Arm 2 or group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Base line, 3 and 6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the change in clinical disease activity index between base line, at 3 months and 6 months time points.	To measure the Clinical Disease Activity Index (CDAI), and Health Assessment Questionnaire (HAQ)	Baseline, 3 and 6 months

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Ram P Singh, MS, Ph.D., University of California at Los Angeles, UCLA; Study Director: Mihaela Taylor, MD, University of California at Los Angeles (UCLA)

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): November 1, 2013
• Study Completion (Anticipated): November 1, 2014

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 30, 2012
• First Posted (Estimate): October 31, 2012

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 9, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; DAS28; CDAI; Apoptosos; T cells, B cells; Clinical Disease activity Index
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Leukocyte Disorders; Leukocytosis; Arthritis; Arthritis, Rheumatoid; Lymphocytosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Immune Checkpoint Inhibitors; Abatacept
• Other Study ID Numbers: IM101-356 (Other Identifier: BMS)