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

Purpose

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

Condition	Intervention	Phase
Apoptotic DNA Damage Rheumatoid Arthritis T-cell Lymphocytosis	Drug: Group 1 or Orencia treated group Other: Group 2 (DMARDS treated group)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Abatacept

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

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 [ Time Frame: Base line, 3 and 6 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
To measure the changes in disease activity score joint count (DAS28/ESR)

Other Outcome Measures:

To measure the change in clinical disease activity index between base line, at 3 months and 6 months time points. [ Time Frame: Baseline, 3 and 6 months ] [ Designated as safety issue: Yes ]
To measure the Clinical Disease Activity Index (CDAI), and Health Assessment Questionnaire (HAQ)

Estimated Enrollment:	24
Study Start Date:	December 2012
Estimated Study Completion Date:	November 2014
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Abatacept
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 Name: Arm 2 or group 2

Arms

Assigned Interventions

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 Name: Abatacept

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 Name: Arm 2 or group 2

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717846

Contacts

Contact: Ram P Singh, MS, Ph.D.	310 267 5749	rpsingh@mednet.ucla.edu
Contact: Mihaela Taylor, MD	310-825-6301	mitaylor@mednet.ucla.edu

Locations

United States, California
Univerity of California at Los Angeles	Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Mihaela Taylor, MD 310-825-6301 mitaylor@mednet.ucla.edu
Contact: Ami B Artzi, MD 310-825-6301 abenartzi@mednet.ucla.edu
Sub-Investigator: John Fitz Gerald, MD, Ph.D.

Sponsors and Collaborators

University of California, Los Angeles

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)

More Information

No publications provided

Responsible Party:	Ram Singh, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT01717846 History of Changes
Other Study ID Numbers:	IM101-356, IM101-356
Study First Received:	October 24, 2012
Last Updated:	October 30, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

Apoptosos
Rheumatoid Arthritis
T cells, B cells

DAS28
Clinical Disease activity Index
CDAI

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Lymphocytosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Leukocytosis

Leukocyte Disorders
Hematologic Diseases
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013

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