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Long-Term Outcomes of Teplizumab in Routine Clinical Care
Sponsor: Sanofi
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.
Official title: Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2026-03-19
Completion Date
2035-10-29
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Teplizumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Locations (1)
Investigational Site Number: 3760001
Ramat Gan, Israel