A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

Официальное название

CNTO1959ISD4001: A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

Обзор

The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications.

Вмешательства

• Процедура Breast Milk Sample Collection
  Breast milk samples will be collected as per the schedule specified in protocol.
• Препарат Guselkumab
  Guselkumab as prescribed by the participant's treating physician and obtained by the participant outside of the study per the treating physician's practice will be used.

Первичные конечные точки

• Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen) [Срок оценки: Up to Day 29]
• Guselkumab Concentrations at Steady State in Breast Milk (Q8W Maintenance Regimen) [Срок оценки: Up to Day 57]
• Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance Regimen [Срок оценки: Up to Day 29]
• Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance Regimen [Срок оценки: Up to Day 57]

Критерии участия

Критерии включения

• Has an active diagnosis of at least one approved indication for guselkumab (psoriasis, psoriatic arthritis \[PsA\], UC and CD) as confirmed by medical records
• Be medically stable on the basis of medical history review performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
• Currently is on established guselkumab maintenance therapy, that is, has received at least 2 guselkumab subcutaneous (SC) maintenance doses before Day 1
• Has made the decision to be treated with guselkumab and to breastfeed independently prior to the participant consenting to participate in this study
• Must be at least 5 weeks postpartum on Day 1
• Have well-established lactation; participant must be exclusively breastfeeding their infant(s) (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study
• Must plan to continue breastfeeding throughout the duration of the study

Критерии исключения

• Has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol specified assessments
• Has history of drug or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria within 1 year before screening
• Uses or has used an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month before enrolling in the study
• Has received or plans to receive any live, attenuated vaccine within 12 weeks prior to administration of guselkumab. Non-live vaccines approved or authorized for emergency use (for example, Coronavirus disease-19 \[COVID-19\]) by local health authorities are allowed
• Has a positive urine pregnancy test on Day 1

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of North Carolina at Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT07654751 · CNTO1959ISD4001 · CNTO1959ISD4001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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