Long-Term Outcomes of Teplizumab in Routine Clinical Care
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSanofi
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Participants who had participated in a previous clinical trial for teplizumab.
Participants enrolled in a clinical trial within 6 months prior to study enrollment.
Trial design
Treatments tested in this trial
- Teplizumab
Treatment groups
1,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov