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Clinical Trial Details

Trial ID: L3544
Source ID: NCT03929601
Associated Drug: Rituximab-Pvvr
Title: Rituximab-pvvr and Abatacept Vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes
Acronym: TN25
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Rituximab-pvvr|DRUG: Abatacept|DRUG: Sterile Sodium Chloride
Outcome Measures: Primary: C-Peptide Response to 2-hr MMTT at 24 months post-randomization, The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab compared to those participants treated with Rituximab and placebo 24 months after enrollment., 48-months from Day 0 | Secondary: C-peptide AUC Means, C-peptide AUC Mean at 0, 6, 12, 18, 24, 30, 36, 42 and 48 months using the ANCOVA model., Day 0 and every 6 months to trial end (up to 4 years)|Analysis of changes in immune responses to known diabetes antigens and a neoantigen over time by treatment group, Analysis of changes in immune responses to known diabetes antigens and a neoantigen. The investigators will compare the effects of drug treatments on the titers of autoantibodies: anti-insulin, anti-GAD65, anti-IA-2, anti-ZnT8. The investigators will also compare the effects of drug treatments on the response to Keyhole Limpet Hemocyanin (KLH) for which standardized immunological responses have been characterized., Day 0, month 2, 4, 5, 6, 12, 13, 18, 24, 25, 30, and 36
Sponsor/Collaborators: Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Collaborators: National Institutes of Health (NIH)
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE2
Enrollment: 74
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-10-30
Completion Date: 2029-10
Results First Posted:
Last Update Posted: 2024-10-01
Locations: Childrens Hospital of Orange County, Orange, California, 92868, United States|Stanford University, Palo Alto, California, 94304, United States|University of California San Francisco, San Francisco, California, 94158, United States|Barbara Davis Center for Childhood Diabetes, Aurora, Colorado, 80045, United States|Yale University, New Haven, Connecticut, 06520, United States|University of Florida, Gainesville, Florida, 32610, United States|University of Miami, Maimi, Florida, 33136, United States|Indiana University - Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|The Children's Mercy Hospital, Kansas City, Kansas, 64114, United States|Joslin Diabetes Center, Boston, Massachusetts, 02215, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Columbia University, New York, New York, 10032, United States|University of Pittsburg, Pittsburg, Pennsylvania, 15224, United States|Sanford Children's Specialty Clinic, Sioux Falls, South Dakota, 57105, United States|Vanderbilt Eskind Diabetes Center, Nashville, Tennessee, 37232, United States|University of Texas Southwestern, Dallas, Texas, 75390, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States|Queensland Children's Hospital, South Brisbane, Queensland, 4101, Australia|Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, 3050, Australia
URL: https://clinicaltrials.gov/show/NCT03929601