Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users
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: Anifrolumab.
- Кому может быть актуально
- Состояния в реестре: Systemic Lupus Erythematosus. Базовые параметры: Без ограничений · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users): The AstraZeneca Pregnancy Study for Anifrolumab
Обзор
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. This study will fulfil an FDA post-marketing requirement.
Подробное описание
PRIMULA Preg (Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users) is a US-based, prospective, observational cohort study designed to evaluate the association between anifrolumab exposure during pregnancy and subsequent adverse maternal, fetal, and infant outcomes. The objective of the pregnancy registry is to compare adverse maternal, fetal, and infant outcomes of pregnant individuals with moderate/severe systemic lupus erythematosus (SLE) who are exposed to anifrolumab during pregnancy with outcomes in an internal comparison cohort of pregnant individuals with moderate/severe SLE who are not exposed to anifrolumab during pregnancy. Participation in the registry is voluntary and participants can withdraw their consent to participate at any time. The study is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are documented in patients' medical records during medical care will be actively collected. No additional laboratory tests or HCP assessments will be required as part of this registry. This study will fulfil an FDA post-marketing requirement.
Вмешательства
- Препарат Anifrolumab
Anifrolumab is a human monoclonal antibody that binds to subunit 1 of the type 1 interferon receptor, which was developed based on the evidence supporting the role of type 1 interferon pathway in SLE. Clinical trial evidence from TULIP 1 and TULIP 2 have showed that monthly intravenous administration of anifrolumab led to a higher percentage of patients with a response, assessed with the British Isles Lupus Assessment Group-based Composite Lupus Assessment, compared with patients receiving place
Первичные конечные точки
- Composite outcome of all major congenital malformations (MCMs) [Срок оценки: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births]
Вторичные конечные точки (12)
- Composite outcome of all minor congenital malformations [Срок оценки: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births]
- Worsening of underlying disease [Срок оценки: From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy]
- Premature rupture of membranes [Срок оценки: From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy]
- Pregnancy-induced hypertension [Срок оценки: From 20 gestational weeks to pregnancy outcome, up to 42 weeks of pregnancy]
- Composite outcome of preeclampsia/eclampsia [Срок оценки: From 20 gestational weeks to pregnancy outcome, up to 42 weeks of pregnancy]
- Maternal hospitalization for serious illness [Срок оценки: From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy]
- Spontaneous abortion [Срок оценки: From date of conception (DOC) to <20 gestational weeks]
- Elective termination [Срок оценки: From date of conception (DOC) to pregnancy outcome, up to 24 weeks of pregnancy]
- Emergency caesarean section [Срок оценки: From date of conception (DOC) to pregnancy outcome, up to 42 weeks of pregnancy]
- Preterm birth [Срок оценки: From date of conception (DOC) up to 37 gestational weeks]
- Small for gestational age [Срок оценки: At delivery of live birth]
- Postnatal growth deficiency [Срок оценки: At 4 and 12 months of infant age]
Критерии участия
Критерии включения
Exposed cohort
- Currently or recently (within 1 year of pregnancy outcome) pregnant
- Diagnosis of moderate/severe SLE
- Consent to participate
- Authorization for their HCP(s) to provide data to the registry
- Exposure to at least 1 dose of anifrolumab at any time during pregnancy
Unexposed cohort
- Currently or recently pregnant
- Diagnosis of moderate/severe SLE
- Consent to participate
- Authorization for their HCP(s) to provide data to the registry
- Exposure to other products for the treatment of moderate/severe SLE
Критерии исключения
Exposed cohort
- Occurrence of pregnancy outcome prior to first contact (for enrollment) with the Virtual Research Coordination Center (retrospectively enrolled)
- Exposure to known teratogens and/or investigational medications during pregnancy
Unexposed cohort
- Occurrence of pregnancy outcome prior to first contact with the Virtual Research Coordination Center (retrospectively enrolled)
- Exposure to known teratogens and/or investigational medications during pregnancy
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 · 1 центр
- Research Site — Wilmington
Идентификаторы
NCT: NCT06659029 · D3461R00051