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

Primary Purpose

Apoptotic DNA Damage, Rheumatoid Arthritis, T-cell Lymphocytosis

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Group 1 or Orencia treated group
Group 2 (DMARDS treated group)
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apoptotic DNA Damage focused on measuring Apoptosos, Rheumatoid Arthritis, T cells, B cells, DAS28, Clinical Disease activity Index, CDAI

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univerity of California at Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm 1

Arm 2 or group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
October 24, 2012
Last Updated
May 9, 2016
Sponsor
University of California, Los Angeles
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01717846
Brief Title
Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis
Acronym
RA
Official Title
In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The PI has left UCLA and we do not plan to pursue this study.
Study Start Date
December 2012 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apoptotic DNA Damage, Rheumatoid Arthritis, T-cell Lymphocytosis
Keywords
Apoptosos, Rheumatoid Arthritis, T cells, B cells, DAS28, Clinical Disease activity Index, CDAI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2 or group 2
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Group 1 or Orencia treated group
Other Intervention Name(s)
Abatacept
Intervention Description
Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months.
Intervention Type
Other
Intervention Name(s)
Group 2 (DMARDS treated group)
Other Intervention Name(s)
Arm 2 or group 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Base line, 3 and 6 months
Secondary Outcome Measure Information:
Title
To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points
Description
To measure the changes in disease activity score joint count (DAS28/ESR)
Time Frame
Baseline, 3 and 6 months
Other Pre-specified Outcome Measures:
Title
To measure the change in clinical disease activity index between base line, at 3 months and 6 months time points.
Description
To measure the Clinical Disease Activity Index (CDAI), and Health Assessment Questionnaire (HAQ)
Time Frame
Baseline, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over age 18 Meeting ACR Criteria 1987 for RA diagnosis Naïve to treatment with abatacept Must be able to understand information in the Informed Consent Exclusion Criteria: Pregnancy or breast feeding Previous exposure to abatacept. History of a concomitant autoimmune disease (eg. SLE, PsA etc.) Patients with history of cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ram P Singh, MS, Ph.D.
Organizational Affiliation
University of California at Los Angeles, UCLA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mihaela Taylor, MD
Organizational Affiliation
University of California at Los Angeles (UCLA)
Official's Role
Study Director
Facility Information:
Facility Name
Univerity of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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