Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Poteligeo 20mg.
- Кому может быть актуально
- Состояния в реестре: Mycosis Fungoides, Sezary Syndrome. Базовые параметры: от 19 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.
Подробное описание
This post-marketing surveillance (PMS) is designed as an all-case investigation in accordance with the Korean Ministry of Food and Drug Safety (MFDS) re-examination requirements. It targets adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy and are treated with mogamulizumab (POTELIGEO® Injection 20 mg) under the approved indication in Korea.
Primary Objective: To assess the safety of mogamulizumab for patients treated under the approved indication in Korea.
Secondary Objective: To assess the effectiveness of mogamulizumab for patients treated under the approved indication in Korea.
Exploratory Objective: To perform additional subgroup and exploratory analyses of effectiveness, including evaluation in special populations such as elderly patients, patients with renal or hepatic impairment, and those with a history of hematopoietic stem cell transplantation, treated under the approved indication in Korea
Вмешательства
- Препарат Poteligeo 20mg
Poteligeo 20mg
Первичные конечные точки
- Safety (Special situation, adverse event, symptom, or disease occurring during treatment with Poteligeo) [Срок оценки: From first administration of Poteligeo through 90 days after the last dose]
Вторичные конечные точки (1)
- Change from baseline to after 8th administration in Global Response Score (GRS) [Срок оценки: Baseline (Day 1, prior to first dose) and Week 24 (after completion of 8th administration)]
Критерии участия
Критерии включения
- Adults 19 years of age or older
- Individuals who are confirmed to have received administration of the study drug for the purpose of "the treatment for adult patients with fungoidal granuloma or Sezary syndrome who have received one or more systemic therapies," or who are considered to require administration of the study drug in the investigator's opinion
- Individuals who (or whose legally acceptable representatives) signed the Consent to Use of Personal Information of their own free will for participation in this use-result surveillance
Критерии исключения
- Patients with hypersensitivity to any ingredients of this drug
- Patients who intend to use this drug for non-approved indications
- Patients who participated in a pre-market clinical trial of the study drug and received administration of the study drug
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
South Korea · 6 центров
- Kosin University Gospel Hospital — Busan
- Chung-Ang University Hospital — Seoul
- Ewha Womans University Mokdong Hospital — Seoul
- Samsung Medical Center — Seoul
- Seoul National University Hospital — Seoul
- Seoul National University Hospital — Seoul
Идентификаторы
NCT: NCT07132567 · Poteligeo PMS