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

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

Detailed Description
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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.

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

Conditions
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Apoptotic DNA Damage, Rheumatoid Arthritis, T-cell Lymphocytosis

Intervention / Treatment
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* Drug: Group 1 or Orencia treated group
* Other: Group 2 (DMARDS treated group)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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<br>* Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months.<br>* Other names: Abatacept;|
| Other: Arm 2 or group 2<br>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)<br>* 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.<br>* Other names: Arm 2 or group 2;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apoptosos, Rheumatoid Arthritis, T cells, B cells, DAS28, Clinical Disease activity Index, CDAI