AN OBSERVATIONAL, LONG-TERM SAFETY STUDY OF TZIELD® (TEPLIZUMAB-MZWV) IN PATIENTS WITH STAGE 2 TYPE 1 DIABETES
J
Jamie Felton
Primary Investigator
Enrolling By Invitation
100 years or below
All
Phase
N/A
1 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
The purpose of this research is to collect general information on patients with stage 2 type 1 diabetes (T1D) and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants will be identified by the study team through their IUH medical record. Patients will either be approached at their clinic follow up visit at the Riley Outpatient Clinic or during the appointment reminder phone call.
Detailed description of study
What will happen during the study?
- This is an observational study of patients with Stage 2 T1D treated with TZIELD in a post- marketing setting as per standard of care. All patients in the study will receive care according to standard clinical practice. The choice of ongoing medical treatment for the duration of the study will be made independently by the site
PI or HCP in the regular course of practice and will not be influenced by participation in this study. HCPs are free to add or withdraw any medication. No additional visits or investigations will be performed beyond standard of care. - A comparator group of Stage 2 T1D patients not treated with TZIELD will also be evaluated. Patients will be treated according to normal clinical practice, with no protocol-mandated visits, treatments, or examinations.
- Laboratory testing will follow standard of care.
- Data will be collected from the initiation of TZIELD treatment (or informed consent, in the case of patients not treated with TZIELD).
- Data will be collected for all patients until withdrawal of consent, loss to follow-up, death, or the end of the study, whichever comes first.
- The study is designed to collect at least 10 years of data for all patients.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Diabetes Type 1, T1D, Riley
-
Age: 100 years or below
-
Gender: All
Inclusion Criteria:
TZIELD-Exposed Cohort
1. Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD
treatment according to the currently approved label or who have initiated TZIELD
treatment within 6 months prior to enrollment:
− Day 1: 65 μg/m²
− Day 2: 125 μg/m²
− Day 3: 250 μg/m²
− Day 4: 500 μg/m²
− Days 5 through 14: 1,030 μg/m² per day
− Cumulative dose is approximately 11,240 μg/m²
2. Appropriate written informed consent/assent as applicable for the age of the patient
TZIELD-Unexposed Cohort
1. Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD
2. Appropriate written informed consent/assent as applicable for the age of the patient
Exclusion Criteria:
1. Patients who initiated TZIELD treatment more than 6 months prior to enrollment
2. Patients who had participated in a previous clinical trial for TZIELD
3. Patients in an ongoing clinical trial of an investigational product or who had ended
participation within 6 months prior to study enrollment; patients participating in other
observational studies may be enrolled.
TZIELD-Exposed Cohort
1. Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD
treatment according to the currently approved label or who have initiated TZIELD
treatment within 6 months prior to enrollment:
− Day 1: 65 μg/m²
− Day 2: 125 μg/m²
− Day 3: 250 μg/m²
− Day 4: 500 μg/m²
− Days 5 through 14: 1,030 μg/m² per day
− Cumulative dose is approximately 11,240 μg/m²
2. Appropriate written informed consent/assent as applicable for the age of the patient
TZIELD-Unexposed Cohort
1. Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD
2. Appropriate written informed consent/assent as applicable for the age of the patient
Exclusion Criteria:
1. Patients who initiated TZIELD treatment more than 6 months prior to enrollment
2. Patients who had participated in a previous clinical trial for TZIELD
3. Patients in an ongoing clinical trial of an investigational product or who had ended
participation within 6 months prior to study enrollment; patients participating in other
observational studies may be enrolled.
Updated on
18 Feb 2025.
Study ID: PENDO-SANOFI-OBS18117, 23904
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
