Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes (NCT03929601)
π©Ί Plain-English Summary (8th-Grade Level)
The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. 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-pvvr compared to those treated with Rituximab-pvvr and placebo 24 months after enrollment.
Who can join: Review the eligibility criteria below.
Location: Childrens Hospital of Orange County β Orange, California
Age range: 8 Years to 45 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (19 Sites)
- Childrens Hospital of Orange County β Orange, California
- Stanford University β Palo Alto, California
- University of California San Francisco β San Francisco, California
- Barbara Davis Center for Childhood Diabetes β Aurora, Colorado
- Yale University β New Haven, Connecticut
- University of Florida β Gainesville, Florida
- University of Miami β Maimi, Florida
- Indiana University - Riley Hospital for Children β Indianapolis, Indiana
- The Children's Mercy Hospital β Kansas City, Kansas
- Joslin Diabetes Center β Boston, Massachusetts
- University of Minnesota β Minneapolis, Minnesota
- Columbia University β New York, New York
- University of Pittsburg β Pittsburgh, Pennsylvania
- Sanford Children's Specialty Clinic β Sioux Falls, South Dakota
- Vanderbilt Eskind Diabetes Center β Nashville, Tennessee
- University of Texas Southwestern β Dallas, Texas
- Benaroya Research Institute β Seattle, Washington
- Queensland Children's Hospital β South Brisbane, Queensland
- Walter and Eliza Hall Institute of Medical Research β Melbourne, Victoria
π° 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 Β§ 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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π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.