Long-Term Outcomes of Teplizumab in Routine Clinical Care

Официальное название

Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care

Обзор

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.

Подробное описание

Enrolled participants will be followed for up to 10 years depending on the time the participants are included after initiating teplizumab treatment.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Proportion of participants who complete teplizumab treatment course [Срок оценки: Up to end of infusion, maximum of 5 years]
• Number of participants with adverse events during the infusion period [Срок оценки: Till 6 weeks post last infusion, maximum of 5 years]
• Number of participants with adverse events of special interest and serious adverse events [Срок оценки: From 6 weeks post last infusion through the follow-up, maximum of 10 years]
• Number of participants with T1D-related complications [Срок оценки: From infusion up to end of study, maximum of 10 years]
• Glycemic control assessment values [Срок оценки: From baseline through follow-up, maximum of 10 years]
• Change from baseline in glycated hemoglobin (HbA1c) [Срок оценки: From baseline through follow-up, maximum of 10 years]
• Proportion of participants achieving target HbA1c ≤ 6.5% [Срок оценки: From baseline through follow-up, maximum of 10 years]
• Proportion of participants using home glycemic control assessments (eg, SMBG, CGM) [Срок оценки: From baseline through follow-up, maximum of 10 years]
• Proportion of participants using glycemic control assessments in-clinic (eg, OGTT, FPG, MMTT, RPG) [Срок оценки: From baseline through follow-up, maximum of 10 years]
• Mean change from baseline in Time in range (TIR) (70 to 180 mg/dL [3.9 to 10 mmol/L]) [Срок оценки: From baseline through follow-up, maximum of 10 years]
• Mean change from baseline in Time in tight range (TITR) (70 to 140 mg/dL [3.9 to 7.8 mmol/L]) [Срок оценки: From baseline through follow-up, maximum of 10 years]
• Mean change from baseline in Time above tight range (TATR): >140 mg/dL (>7.8 mmol/L) [Срок оценки: From baseline through follow-up, maximum of 10 years]

Критерии участия

Inclusion Criteria -

• 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.

(Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)

• Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participant and as per local regulations.

Exclusion Criteria -

• Participants who had participated in a previous clinical trial for teplizumab.
• Participants enrolled in a clinical trial within 6 months prior to study enrollment.

(Note: Participants enrolled in other observational studies may be included.)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 4 центра

• Investigational Site Number: 8400003 — Atlanta
• Investigative Site Number: 8400004 — Atlanta
• Investigative Site Number: 8400002 — Syosset
• Investigational Site Number: 8400005 — Sandy City

Израиль · 3 центра

• Investigative Site Number: 3760003 — Petah Tikva
• Investigative Site Number: 3760002 — Ramat Gan
• Investigational Site Number: 3760001 — Ramat Gan

ОАЭ · 1 центр

• Investigative Site Number: 7840001 — Abu Dhabi

Идентификаторы

NCT: NCT07360080 · OBS18569 · U1111-1317-7939

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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