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Идёт набор NCT04846959

Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications

— Наблюдательное Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment

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: Risankizumab, Comparator.
Кому может быть актуально
Состояния в реестре: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment. 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
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Официальное название

Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring

Обзор

The objective of this registry is to compare outcomes of risankizumab-exposed pregnancies with those of pregnancies that were not exposed to risankizumab among women with plaque psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), or other conditions for which risankizumab is an FDA-approved treatment. The registry is designed to estimate the association between risankizumab and maternal, fetal, and infant outcomes by comparing the prevalence rates of these outcomes in the exposed and unexposed populations. Approximately 818 female participants with pregnancy will be enrolled (409 participants exposed to risankizumab and 409 without exposure) at multiple sites across the United States. Participants will not receive risankizumab as part of this study. Maternal and fetal outcomes during pregnancy for female participants who received risankizumab or other treatment will be followed for and up to 1 year after delivery There may be a higher burden for participants in this study compared to standard of care. Participants will attend visits determined by HCPs during the study at a hospital or clinic. The pregnancy outcomes including side effects will be collected during routine clinical care.

Вмешательства

  • Препарат Risankizumab
    Subcutaneous Injection
  • Препарат Comparator
    Subcutaneous or Intravenous Injection

Первичные конечные точки

  • Number of Participants with Major Congenital Malformation (MCM) [Срок оценки: Up to 9 months]
Вторичные конечные точки (10)
  • Number of Participants with Minor Congenital Malformation [Срок оценки: Up to approximately 2 years (1 year post delivery)]
  • Number of Participants with Stillbirth [Срок оценки: Up to 9 months]
  • Number of Participants with Spontaneous Abortion (SAB) [Срок оценки: Up to 9 months]
  • Number of Participants with Elective Termination of Pregnancy [Срок оценки: Up to 9 months]
  • Number of Participants with Preterm Birth [Срок оценки: Up to 9 months]
  • Number of Participants who are Small for Gestational Age (SGA) [Срок оценки: Up to 9 months]
  • Number of Participants with Neonatal Death [Срок оценки: Up to approximately 10 months (one month post delivery)]
  • Number of Participants with Serious Infection in the First 6 Months of Life [Срок оценки: Up to approximately 2 years (1 year post delivery)]
  • Number of Participants with Postnatal Growth Deficiency [Срок оценки: Up to approximately 2 years (1 year post-delivery)]
  • Number of Participants with Infant Developmental Delay [Срок оценки: Up to approximately 2 years (1 year post delivery)]

Критерии участия

Критерии включения

Risankizumab-Exposed Cohort

  • US resident.
  • Current pregnancy.
  • Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.
  • Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).

Diseased Comparison Cohort

  • US resident.
  • Current pregnancy.
  • Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.
  • Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).

Критерии исключения

Risankizumab-Exposed Cohort

  • Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).
  • Occurrence of pregnancy outcome prior to enrollment in the registry

Diseased Comparison Cohort

  • Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).
  • Occurrence of pregnancy outcome prior to enrollment in the registry

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 2 центра
  • Evidera, a PPD Business Unit /ID# 238688 — Morrisville
  • PPD Development, LP /ID# 232134 — Wilmington

Идентификаторы

NCT: NCT04846959 · P20-036

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗