- Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) — Recruiting • Diabetes / Metabolic • NCT07457580.
- What is being tested: Teplizumab, an anti-CD3 monoclonal antibody, is being evaluated in real-world clinical practice through managed access programs to assess its effectiveness in slowing Type 1 diabetes progression and characterize actual patient monitoring and treatment patterns.
- Patient eligibility overview: This retrospective observational study includes patients with Type 1 diabetes who received teplizumab through managed access programs across multiple countries and centres, with data collected via chart review to capture diverse real-world patient populations and relevant comorbidities.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.