Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
Recruiting · NCT07457580 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sanofi
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patient written or electronic informed consent or assent (for patients \< 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity.
- Patient received ≥ 1 day of teplizumab treatment as part of MAPs.
Exclusion criteria
- Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where it is running
14 locations listed.
- Investigational Site Number: 3800001 - Ancona, Italy
- Investigational Site Number: 8260001 - Birmingham, United Kingdom
- Investigational Site Number: 2500001 - Bron, France
- Investigational Site Number: 2760002 - Frankfurt, Germany
- Investigational Site Number: 2760001 - Hanover, Germany
- Investigational Site Number: 0560001 - Leuven, Belgium
- Investigational Site Number: 8260002 - London, United Kingdom
- Investigational Site Number: 7240001 - Madrid, Spain
- Investigational Site Number: 7240002 - Madrid, Spain
- Investigational Site Number: 3800003 - Palermo, Italy
- Investigational Site Number: 2500003 - Paris, France
- Investigational Site Number: 2500002 - Paris, France
- Investigational Site Number: 3800002 - Verona, Italy
- Investigational Site Number: 7240003 - Zaragoza, Spain