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RECRUITING
NCT07360080

Long-Term Outcomes of Teplizumab in Routine Clinical Care

Sponsor: Sanofi

View on ClinicalTrials.gov

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

DRUG

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