Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
NCT07457580 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60
Last updated 2026-04-17
Summary
This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.
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
- 2026-03-16
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
- FDA Drug
- Yes
Countries
- Italy
- Spain
- United Kingdom
Study Locations
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