Actively Recruiting
Long-Term Outcomes of Teplizumab in Routine Clinical Care
Led by Sanofi · Updated on 2026-04-17
1000
Participants Needed
2
Research Sites
501 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Long-Term Outcomes of Teplizumab in Routine Clinical Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Participants who progress to Stage 3 T1D by Week 6 are still eligible, if they were in Stage 2 at first infusion.
- Participants or their legal guardians must provide written or electronic informed consent/assent as applicable.
You will not qualify if you...
- Participants who had participated in a previous clinical trial for teplizumab.
- Participants enrolled in a clinical trial within 6 months prior to study enrollment.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Investigational Site Number: 8400005
Sandy City, Utah, United States, 84093
Actively Recruiting
2
Investigational Site Number: 3760001
Ramat Gan, Israel, 5265601
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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