A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea

Официальное название

Post-Marketing Surveillance (Usage Results Study) of Vedolizumab Subcutaneous Injection in Patients With Ulcerative Colitis or Crohn's Disease in South Korea

Обзор

The main aim of the study is to observe adult participants in South Korea that are being treated with vedolizumab injected just under the skin (subcutaneous or SC) to treat ulcerative colitis (UC) or Crohn's disease (CD) who have had an in-adequate response with, lost response to, or had too many side effects in response to either conventional therapy or a Tumor Necrosis Factor-alpha (TNF-α) antagonist. This study will observe the side effects and potential benefit to UC and CD participants related to vedolizumab SC treatment with data collection from medical files. There is no treatment involved in this study, this is only an observational review of current collected data relating to adults in South Korea with UC or CD treated with vedolizumab SC.

Подробное описание

This is a prospective, non-interventional, post-marketing study of adult participants with moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a TNF-α antagonist. This study will evaluate the safety and effectiveness of vedolizumab SC in a routine clinical practice setting under real world condition.

This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group:

• Participants with UC or CD

This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.

Первичные конечные точки

• Percentage of Participants With Serious Adverse Events (SAEs) [Срок оценки: Up to Week 52]
• Percentage of Participants With Adverse Drug Reactions (ADRs) [Срок оценки: Up to Week 52]
• Percentage of Participants With Serious Adverse Drug Reactions (SADRs) [Срок оценки: Up to Week 52]
• Percentage of Participants With Adverse Events of Special Interest (AESIs) [Срок оценки: Up to Week 52]
• Percentage of Participants With Unexpected Adverse Events (AEs) [Срок оценки: Up to Week 52]
• Percentage of Participants With Unexpected ADRs [Срок оценки: Up to Week 52]

Вторичные конечные точки (3)

• Percentage of Participants With UC and CD Who Achieved Clinical Response [Срок оценки: Up to Week 52]
• Percentage of Participants With UC and CD Who Achieved Clinical Remission [Срок оценки: Up to Week 52]
• Percentage of Participants With UC and CD Who Achieved Mucosal Healing [Срок оценки: Up to Week 52]

Критерии участия

Критерии включения

• With moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
• With evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions

Критерии исключения

• With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients
• With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML)
• For whom vedolizumab SC is contraindicated as per product label

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Donggguk University Ilsan Hospital — Goyang-si

Идентификаторы

NCT: NCT05428345 · VedolizumabSC-4003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗