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Long-Term Outcomes of Teplizumab in Routine Clinical Care

Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows people who received teplizumab during regular care for Stage 2 type 1 diabetes, an early stage of the disease. It looks at long-term results, including whether treatment delays Stage 3, a later stage of the disease. It also asks people how treatment affects their quality of life, feelings, and social well-being.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You received at least one teplizumab infusion (medicine given into a vein) in the 6 weeks before joining.
  • Your treating doctor confirmed Stage 2 type 1 diabetes when you received your first infusion. You may still join if you reached Stage 3 by week 6.
  • You or your legal guardian must give written or electronic agreement to join, based on your age and local rules.

Who can't join

  • You took part in a previous clinical trial of teplizumab.
  • You were enrolled in a clinical trial in the 6 months before joining. Other observational studies, which follow people without assigning treatment, are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 participant and as per local regulations. Exclusion Criteria - * Participants who had participated in a previous clinical trial for teplizumab. * Participants enrolled in a clinical trial within 6 months prior to study enrollment. (Note: Participants enrolled in other observational studies may be included.) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study sites (5)

GA

NY

UT