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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
| Medical College of Wisconsin | OTHER |
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The purpose of this study is to identify early immune markers associated with response to treatment with abatacept in individuals with Type 1 diabetes (T1D). In this open label mechanistic study, participants who were recently diagnosed with T1D (males or females, ages 6-45 and <7months from T1D diagnosis) will be treated with a short-course of abatacept (weekly subcutaneous injections for 3 months). Participants will undergo baseline and repeated mixed meal tolerance testing (MMTT) to assess disease progression and blood samples will be obtained at frequent intervals to measure changes in immune markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept | Experimental | Abatacept will be given by a subcutaneous (SC) formulation weekly for three months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | Abatacept will be administered by subcutaneous injections weekly for 3 months. Dosing is according to body weight at screening visit and will be administered as follows: up to 25 kg receive 50 mg (0.4 mL); 25 to <50 kg receive 87.5 mg (0.7 mL), and > 50 kg receive 125 mg (1.0 mL) per dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in insulin antibody titers (NIDDK units/mL) | Insulin antibody titers | 0 to 2 weeks |
| Change in frequency of B cells within total PBMC (%) | % of B cells | 0 to 2 weeks |
| Change in inflammatory Index by serum transcriptional exposure assay (composite score) | Inflammatory Index (359). This is an inflammatory index based on transcription of 359 probe sets (I.I.359) calculated by dividing the average signal intensity of the 103 probe sets generally annotated as 'inflammatory' by the average signal intensity of the 256 probe sets generally annotated as 'regulatory' | 0 to 2 weeks |
| Change in B-cell transcriptional module (CD19.mod) (composite score) | CD19 mod is composite score of B cell transcripts. | 0 to 2 weeks |
| Change in islet-specific exhausted CD8 T cells (%) | % of CD8+ T cells (CD8+PD-1+KLRG1+CD57-) | 0 to 2 weeks |
| Change in EOMES CD8 whole blood gene expression signature (composite score) | Gene transcript score for EOMES module | 0 to 2 weeks |
| Change in frequency of TfH within total CD4 T cells (%) | % of TfH cells within CD4+ T cells | 0 to 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carla Greenbaum, MD | Benaroya Research Institute at Virginia Mason | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benaroya Research Institute | Seattle | Washington | 98101 | United States | ||
| Medical College of Wisconsin |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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|
|
| Milwaukee |
| Wisconsin |
| 53226 |
| United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |