Long-Term Outcomes of Teplizumab in Routine Clinical Care

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Sanofi
Study ID
NCT07360080
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Teplizumab — DRUG
    This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Study Details

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.

Key Dates

Start date
Mar 19, 2026
Status verified
May 2026
Primary completion
Oct 29, 2035
Completion
Oct 29, 2035

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab

Primary Outcome Measure

Time from teplizumab infusion start to the onset of Stage 3 T1D [ Time Frame: From start of infusion to maximum of 10 years ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
Investigational Site Number: 8400003AtlantaGeorgia30318-2538-
Investigative Site Number: 8400004AtlantaGeorgia30329-3102-
Investigative Site Number: 8400002SyossetNew York11791-
Investigational Site Number: 8400005Sandy CityUtah84093-

Find similar trials in Atlanta, GA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
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