Apoptotic DNA Damage, Rheumatoid Arthritis, T-cell Lymphocytosis
Conditions
Keywords
Apoptosos, Rheumatoid Arthritis, T cells, B cells, DAS28, Clinical Disease activity Index, CDAI
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.
Interventions
DRUGGroup 1 or Orencia treated group
Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months.
OTHERGroup 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.
Sponsors
Bristol-Myers Squibb
University of California, Los Angeles
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Base line, 3 and 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points | Baseline, 3 and 6 months | To measure the changes in disease activity score joint count (DAS28/ESR) |
Other
| Measure | Time frame | Description |
|---|---|---|
| To measure the change in clinical disease activity index between base line, at 3 months and 6 months time points. | Baseline, 3 and 6 months | To measure the Clinical Disease Activity Index (CDAI), and Health Assessment Questionnaire (HAQ) |
Countries
United States
Outcome results
None listed