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
This trial does not accept healthy volunteersQualifiers
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 population
Patients diagnosed with Stage 2 T1D who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment. Approximately 1000 participants, in 85 sites across 19 countries will be enrolled over 5 years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Teplizumab
DrugThis study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Patients with Stage 2 Type 1 Diabetes (T1D) who received Teplizumab1 intervention
Trial outcomes
Primary outcomes
1
Time from teplizumab infusion start to the onset of Stage 3 T1D
Time frame
From start of infusion to maximum of 10 yearsSecondary outcomes
1
Proportion of participants who complete teplizumab treatment course
Time frame
Up to end of infusion, maximum of 5 years2
Number of participants with adverse events during the infusion period
Time frame
Till 6 weeks post last infusion, maximum of 5 years3
Number of participants with adverse events of special interest and serious adverse events
Time frame
From 6 weeks post last infusion through the follow-up, maximum of 10 years4
Number of participants with T1D-related complications
Including but not limited to the following: diabetic ketoacidosis, severe hypoglycemia, retinopathy, nephropathy, neuropathy, cardiovascular events
Time frame
From infusion up to end of study, maximum of 10 years Source ClinicalTrials.gov