Arthritis, Psoriatic, Colitis, Ulcerative, Crohn Disease, Psoriasis
Conditions
Brief summary
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.
Interventions
PROCEDUREBreast Milk Sample Collection
Breast milk samples will be collected as per the schedule specified in protocol.
DRUGGuselkumab
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.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen) | Up to Day 29 | 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) | Up to Day 57 | 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 | Up to Day 29 | The estimated daily infant dosage of guselkumab Q4W maintenance regimen will be reported. |
| Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance Regimen | Up to Day 57 | The estimated daily infant dosage of guselkumab Q8W maintenance regimen will be reported. |
Countries
United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed