A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study measures how much guselkumab (TREMFYA) gets into breast milk. It is for breastfeeding women already taking this medicine as part of their usual care for an approved condition. All study activities, including visits and breast milk collection, can be done from home.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have medical records showing psoriasis (a skin disease), psoriatic arthritis (joint swelling linked to psoriasis), ulcerative colitis, or Crohn’s disease (diseases that cause swelling in the gut).
- Have stable health, based on a review of your health history by the study team.
- Already be on regular guselkumab treatment and have received at least 2 maintenance doses as shots under the skin before Day 1.
- Have decided to take guselkumab and breastfeed before agreeing to join the study, separate from your decision to join.
- Have given birth at least 5 weeks before Day 1.
- Have an established breast milk supply and feed your baby only breast milk, or give no more than 1 bottle of formula per day, when you join.
- Plan to keep breastfeeding throughout the study.
Who can't join
- Have a current or past illness that the study doctor thinks could affect the results or prevent or limit study tests.
- Have a history of drug or alcohol abuse within the year before screening, based on standard medical criteria.
- Have used an experimental drug or vaccine, or an experimental device placed inside the body, within 1 month before joining.
- Have received or plan to receive a vaccine made with weakened live germs within 12 weeks before a guselkumab dose. Approved or emergency-authorized vaccines without live germs, such as some COVID-19 vaccines, are allowed.
- Have a positive urine pregnancy test on Day 1.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
NC
- University of North Carolina at Chapel Hill · Chapel Hill, NC 27599More trials in Chapel Hill