DR14 DataRelease
Release Date: 06/14/2015
| SDY67: Bioinformatics Approach to 2010-2011 TIV Influenza A/H1N1 Vaccine Immune Profiling | |||||||||||||||||||||||||
| Status: | New | ||||||||||||||||||||||||
| Description: | Aim 1: Characterize Immune Profiles Over Time, Aim 2: Correlate Immune Profiles with Vaccine Immunogenicity,Aim 3: Replication of Immune Profiles and Verification of Models | ||||||||||||||||||||||||
| Program/Contract: |
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| DOI: | 10.21430/M3OYWCJHO1 | ||||||||||||||||||||||||
| Subjects: | 159 | ||||||||||||||||||||||||
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| Clinical Assessments: | None | ||||||||||||||||||||||||
| SDY524: AbATE ITN027AI: Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes | |||||||
| Status: | New | ||||||
| Description: | Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks insulin-producing beta cells in the pancreas. Without these cells, the body cannot maintain proper blood glucose levels in response to daily activities, such as eating or exercise. Generally, at the time of type 1 diabetes diagnosis, 60% to 85% of the diabetic person's beta cells have already been destroyed. However, between 15% and 40% of these cells remain and are able to produce insulin. Treatment that slows the destruction of additional beta cells may be able to decrease a patient's reliance on insulin and improve their quality of life. Anti-CD3 mAb is genetically engineered and directed against the CD3 antigen on T cells; this antibody selectively attacks the immune cells responsible for beta cell destruction. In a small exploratory clinical trial, patients with newly diagnosed type 1 diabetes who received a single, 2-week treatment with anti-CD3 mAb had preserved beta cell function and significantly lower insulin requirements than untreated patients for up to two years after therapy. This study will investigate whether a second course of anti-CD3 mAb administered one year after the first administration is able to prolong or improve the effects of the biologic in people who have recently diagnosed type 1 diabetes mellitus. Participants will be randomly assigned to one of two groups. The Experimental Group will receive anti-CD3 mAb treatment plus Diabetes Standard of Care Treatment; the Active Comparator Group will receive Diabetes Standard of Care Treatment. The Experimental Group will be treated with the antibody for the first 14 days of the study and again one year later. These participants will be admitted to the hospital for the first 5 days of a treatment cycle. Participants who live within 1 hour of the hospital may receive the remainder of a treatment cycle as an outpatient, but those who live farther away will be hospitalized for 14 days. For the first treatment cycle, there will be study visits on the 3 consecutive days after the treatment cycle and at Months 1, 2, 3, 6, 9, and 12. For the second treatment cycle, there will be study visits on the 3 consecutive days after the treatment cycle and at Months 13, 16, 19, 21, and 24.The Active Comparator Group will have 12 study visits over two years. At study entry, all participants will receive daily iron supplementation, either as ferrous sulfate or a multivitamin with iron. Participants will be followed for up to 2 years to assess their overall diabetes health and to capture laboratory measures of beta cell and immune system function. Medication history and adverse event assessment will occur at all visits. A physical exam, vital signs measurement, and blood collection will occur at most visits. Medical history and urine collection will occur at selected visits. | ||||||
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| DOI: | 10.21430/M3YQ7O1CPL | ||||||
| Subjects: | 83 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY565: IL2-RAPA ITN018AI: Proleukin and Rapamune in Type 1 Diabetes Mellitus | |||||||
| Status: | New | ||||||
| Description: | At the time of diagnosis, type 1 diabetes patients have 15-40 percent of their beta cells may remain active and healthy in the pancreas. This Phase I study for individuals 18-45 years of age and diagnosed with type 1 diabetes in the past 3-48 months will be treated with Proleukin (subcutaneously) 3 times per week for 28 days and Rapamune (orally, daily) for 12 weeks. The trial will test whether the combination of Proleukin and Rapamune can be safely administered and whether treatment halts the autoimmune destruction of remaining beta cells. | ||||||
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| DOI: | 10.21430/M3CRD72E92 | ||||||
| Subjects: | 9 | ||||||
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| Clinical Assessments: | None | ||||||
| SDY567: Shapiro ITN005CT: Islet Transplantation in Type 1 Diabetic Patients | |||||||
| Status: | New | ||||||
| Description: | The transplanting of islet cells has been studied in Type 1 diabetic patients whose blood sugar levels will not stay normal, despite intensive insulin therapy. A recent study conducted in Edmonton, Canada, was able to demonstrate that islet transplantation led to insulin independence in a majority of the patients treated. This study extends the results obtained from the Edmonton study, which used islet transplantation in Type 1 diabetic patients with steroid-free immunosuppression. | ||||||
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| DOI: | 10.21430/M3V0RG6S52 | ||||||
| Subjects: | 34 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY568: Orban ITN012AI: Evaluation of Diabetes Vaccine IBC-VSO1 in Newly Diagnosed Diabetics | |||||||
| Status: | New | ||||||
| Description: | This study will evaluate whether IBC-VSO1 vaccine, a synthetic metabolically inactive form of insulin designed to prevent pancreatic beta-cell destruction, protects against autoimmune attack in newly diagnosed type 1 diabetes patients. Halting beta-cell destruction may result in a prolonged remission and subsequent delay in diabetes related complications. Patients in this study must have been diagnosed with type 1 diabetes no more than 3 months prior to study enrollment. | ||||||
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| DOI: | 10.21430/M3IBWCGI97 | ||||||
| Subjects: | 12 | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY569: Herold II ITN007AI: Treatment with hOKT3-gamma-1 (Ala-Ala) in Type 1 Diabetes Mellitus | |||||||
| Status: | New | ||||||
| Description: | This open-label phase II trial involving 2 arms where treatment is 0 or 3 cycles of hOKT3gamma1 (Ala-Ala) 6 months apart over the first year of disease in participants with new onset T1DM. Cycles consist of 12 daily doses hOKT3gamma1 (Ala-Ala). | ||||||
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| DOI: | 10.21430/M3WGK6K01J | ||||||
| Subjects: | 11 | ||||||
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| Publications: | None | ||||||
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| Assays: | None | ||||||
| Clinical Assessments: | None | ||||||
| SDY91: Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (RAVE ITN021AI) | |||||||||||
| Status: | Updated | ||||||||||
| Description: | Current conventional therapies for ANCA-associated vasculitis (AAV) are associated with high incidences of treatment failure, disease relapse, substantial toxicity, and patient morbidity and mortality. Rituximab is a monoclonal antibody used to treat non-Hodgkin's lymphoma. This study will evaluate the efficacy of rituximab with glucocorticoids in inducing disease remission in patients with severe forms of AAV (WG and MPA). The study consists of two phases: a 6-month remission induction phase, followed by a 12-month remission maintenance phase. All participants will receive at least 1 g of pulse intravenous methylprednisolone or a dose-equivalent of another glucocorticoid preparation. Depending on the participant's condition, he or she may receive up to 3 days of intravenous methylprednisolone for a total of 3 g of methylprednisolone (or a dose-equivalent). During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit. Participants will then be randomly assigned to one of two arms. Arm 1 participants will receive rituximab (375 mg/m^2) infusions once weekly for 4 weeks and cyclophosphamide (CYC) placebo daily for 3 to 6 months. Arm 2 participants will receive rituximab placebo infusions once weekly for 4 weeks and CYC daily for 3 to 6 months. During the remission maintenance phase, participants in Arm 1 will discontinue CYC placebo and start oral azathioprine (AZA) placebo daily until Month 18. Participants in Arm 2 will discontinue CYC and start AZA daily until Month 18. Participants who fail treatment before Month 6 will be crossed over to the other treatment arm unless there are specific contraindications. Participants in either group who reach clinical remission before they complete 6 months of therapy may switch from CYC/placebo to AZA/placebo if directed by their physicians.All participants will be followed for at least 18 months. Initially, study visits are weekly, progressing to monthly and then quarterly visits as the study proceeds. Blood collection will occur at each study visit. |
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| DOI: | 10.21430/M3TK42R0QR | ||||||||||
| Subjects: | 197 | ||||||||||
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