Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Safety (Special situation, adverse event, symptom, or disease occurring during treatment with Poteligeo)
研究概览
简要总结
The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Exclusion Criteria
- •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
排除标准
- 未提供
结局指标
主要结局
Safety (Special situation, adverse event, symptom, or disease occurring during treatment with Poteligeo)
时间窗: From first administration of Poteligeo through 90 days after the last dose
Number of participants who experience any adverse event or special situation during Poteligeo treatment and up to 90 days after the last dose, as recorded in CRFs based on medical examinations or spontaneous reports.
次要结局
- Change from baseline to after 8th administration in Global Response Score (GRS)(Baseline (Day 1, prior to first dose) and Week 24 (after completion of 8th administration))