Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes (NCT03929601)

🧪 Interventions in This Study

• Rituximab-pvvr (DRUG)
• Abatacept (DRUG)
• Sterile Sodium Chloride (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Age ≥ 8 and ≤ 45 years old at time of signing informed consent.
2. Fulfill the ADA criteria for diagnosis of T1D within 100 days of randomization.
3. Must be willing to provide informed consent or assent with a parent or legal guardian providing informed consent if \< 18 years of age.
4. Positive for at least one islet cell autoantibody; GAD65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A
5. Must have stimulated C-peptide of ≥0.2 pmol/mL measured during mixed-meal tolerance test (MMTT) conducted at least 21 days after the diagnosis of diabetes.
6. Enrollees must be willing to comply with intensive diabetes management.
7. Body weight must be ≥ 20.0 kg for study agent administration.
8. Subjects who are CMV and/or EBV seronegative at screening must be CMV and/or EBV PCR negative and may not have had signs or symptoms of a CMV and/or EBV compatible illness prior to randomization.
9. Female participants with reproductive potential must have a negative pregnancy test at screening and be willing to avoid pregnancy for the duration of treatment and until 3 months after the last dose of Abatacept. Female participants with reproductive potential who are sexually active will be instructed to use a highly effective contraceptive method until one year after the last dose of rituximab-pvvr.
10. Male participants of reproductive age must use an adequate contraceptive method for the duration of rituximab-pvvr treatment and 12 months following the last dose of rituximab-pvvr.
11. The following additional inclusion criteria regarding vaccines must be met:
12. More than 4 weeks from immunization with a live viral vaccine

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (19 Sites)

• Childrens Hospital of Orange County — Orange, California
• Stanford University — Palo Alto, California
• University of California San Francisco — San Francisco, California
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado
• Yale University — New Haven, Connecticut
• University of Florida — Gainesville, Florida
• University of Miami — Maimi, Florida
• Indiana University - Riley Hospital for Children — Indianapolis, Indiana
• The Children's Mercy Hospital — Kansas City, Kansas
• Joslin Diabetes Center — Boston, Massachusetts
• University of Minnesota — Minneapolis, Minnesota
• Columbia University — New York, New York
• University of Pittsburg — Pittsburgh, Pennsylvania
• Sanford Children's Specialty Clinic — Sioux Falls, South Dakota
• Vanderbilt Eskind Diabetes Center — Nashville, Tennessee
• University of Texas Southwestern — Dallas, Texas
• Benaroya Research Institute — Seattle, Washington
• Queensland Children's Hospital — South Brisbane, Queensland
• Walter and Eliza Hall Institute of Medical Research — Melbourne, Victoria

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Type 1 Diabetes Mellitus clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.