Long-Term Outcomes of Teplizumab in Routine Clinical Care
Start Date
3/19/2026
Completion Date
10/29/2035
Summary
This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.
Detailed Description
Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Teplizumab
Conditions
Locations
Investigational Site Number: 8400003
Atlanta, Georgia 30318-2538
United States
Investigative Site Number: 8400004
Atlanta, Georgia 30329-3102
United States
Investigative Site Number: 8400002
Syosset, New York 11791
United States
Investigational Site Number: 8400005
Sandy City, Utah 84093
United States
Investigative Site Number: 3760003
Petah Tikva, 4920235
Israel
Investigative Site Number: 3760002
Ramat Gan, 52621
Israel
Investigational Site Number: 3760001
Ramat Gan, 5265601
Israel
Investigative Site Number: 7840001
Abu Dhabi,
United Arab Emirates