Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care
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.
Description
Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria - * Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. * Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab. (Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.) • Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participan…
Interventions
- DrugTeplizumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Locations (2)
- Investigational Site Number: 8400005Sandy City, Utah
- Investigational Site Number: 3760001Ramat Gan