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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Breast Milk Collection: Guselkumab Once Every 4 Weeks (Q4W) Regimen 		Participants who have been on guselkumab maintenance therapy and received at least 2 maintenance doses of guselkumab Q4W for any of the approved indications: ulcerative colitis (UC) or Crohn's Disease (CD), will be enrolled. On Day 1 of the study, participants will receive their scheduled guselkumab maintenance dose of 200 mg every 4 weeks. A total of 4 breast milk samples will be collected. The total study duration per participant will be 8 weeks.
  • Procedure: Breast Milk Sample Collection
    Breast milk samples will be collected as per the schedule specified in protocol.
  • Drug: 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.
Experimental
Breast Milk Collection: Guselkumab Once Every 8 Weeks (Q8W) Regimen 		Participants who have been on guselkumab maintenance therapy and received at least 2 maintenance doses of guselkumab Q8W regimen for any of the approved indications: psoriasis, psoriatic arthritis (pSA) or UC or CD, will be enrolled. On Day 1 of the study, the participants will receive their scheduled guselkumab maintenance dose of 100 mg every 8 weeks. A total of 5 breast milk samples will be collected. The total study duration per participant will be 8 weeks.
  • Procedure: Breast Milk Sample Collection
    Breast milk samples will be collected as per the schedule specified in protocol.
  • Drug: 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.

Recruiting Locations

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.