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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
10
Breast milk samples will be collected as per the schedule specified in protocol.
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.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGGuselkumab 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.
Time frame: Up to Day 29
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.
Time frame: Up to Day 57
Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance Regimen
The estimated daily infant dosage of guselkumab Q4W maintenance regimen will be reported.
Time frame: Up to Day 29
Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance Regimen
The estimated daily infant dosage of guselkumab Q8W maintenance regimen will be reported.
Time frame: Up to Day 57
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.