Not yet recruiting NCT07654751
A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breast Milk Sample Collection, Guselkumab.
- Who it may be relevant to
- Registry conditions: Psoriasis, Colitis, Ulcerative, Crohn Disease, Arthritis, Psoriatic. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- 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.
Primary outcome measures
- Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen) [Time frame: Up to Day 29]
- Guselkumab Concentrations at Steady State in Breast Milk (Q8W Maintenance Regimen) [Time frame: Up to Day 57]
- Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance Regimen [Time frame: Up to Day 29]
- Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance Regimen [Time frame: Up to Day 57]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of North Carolina at Chapel Hill — Chapel Hill
Identifiers
NCT: NCT07654751 · CNTO1959ISD4001 · CNTO1959ISD4001