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.
This is a fully remote (virtual) study. Participants can complete all study-related activities, including consent, study visits, and breast milk sample collection, from home without attending an in-person study site.
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
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
Parallel
Breast Milk Sample Collection
Procedure/SurgeryBreast milk samples will be collected as per the schedule specified in protocol.
Guselkumab
DrugGuselkumab 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.
Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen)
Guselkumab concentration at steady state in the breast milk of lactating participants receiving guselkumab Q4W maintenance regimen will be reported.
Guselkumab Concentrations at Steady State in Breast Milk (Q8W Maintenance Regimen)
Guselkumab concentration at steady state in the breast milk of lactating participants receiving guselkumab Q8W maintenance regimen will be reported.
Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance Regimen
The estimated daily infant dosage of guselkumab Q4W maintenance regimen will be reported.
Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance Regimen
The estimated daily infant dosage of guselkumab Q8W maintenance regimen will be reported.
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