Long-term outcomes of teplizumab in routine care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational cohort following people who receive teplizumab as part of routine clinical care across multiple sites. Enrolled participants must have received at least one teplizumab infusion within six weeks before enrollment and were classified as Stage 2 T1D at the time of first infusion; they will be followed for up to 10 years depending on enrollment timing. The study will collect clinical outcomes, timing of progression to Stage 3 T1D, and patient-reported outcomes addressing emotional and psychosocial aspects of living with T1D. Exclusion criteria include prior participation in a teplizumab clinical trial or enrollment in a clinical trial within six months before joining this cohort.

Why it matters

Who can join: the full rules

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.

Where it's running

• Investigational Site Number: 8400006
  Washington D.C., District of Columbia, United States Recruiting
• Investigational Site Number: 8400003
  Atlanta, Georgia, United States Recruiting
• Investigational Site Number: 8400004
  Atlanta, Georgia, United States Recruiting
• Investigational Site Number: 8400001
  New York, New York, United States Recruiting
• Investigational Site Number: 8400002
  Syosset, New York, United States Recruiting
• Investigational Site Number: 8400005
  Sandy City, Utah, United States Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.