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| ID | Type | Description | Link |
|---|---|---|---|
| IM101-356 | Other Identifier | BMS |
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The PI has left UCLA and we do not plan to pursue this study.
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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 | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 or Orencia treated group | Drug | Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months. |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ram P Singh, MS, Ph.D. | University of California at Los Angeles, UCLA | Principal Investigator |
| Mihaela Taylor, MD | University of California at Los Angeles (UCLA) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univerity of California at Los Angeles | Los Angeles | California | 90095 | United States |
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| Group 2 (DMARDS treated group) | Other | 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. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
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