Long-Term Outcomes of Teplizumab in Routine Clinical Care
NCT07360080 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000
Last updated 2026-04-17
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.
Conditions
Interventions
- DRUG
-
Teplizumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-19
- Primary Completion
- 2035-10-29
- Completion
- 2035-10-29
- FDA Drug
- Yes
Countries
- United States
- Israel
Study Locations
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