A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically

StatusRecruiting
PhasePhase 4
Started

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Record History

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  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Eligibility criteria expanded, about 12 words
    • Study title expanded, about 2 words
  2. Recruitment opened
    • Start date changed from estimate of Oct 1, 2026 to Aug 7, 2026
    • Site details revised
    v4
  3. Start date: Jun 15, 2026 to Oct 1, 2026v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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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.
Trial Details
NCT Number NCT07654751
Lead Sponsor Janssen Research & Development, LLC
Conditions
(from sponsor)		 Psoriasis, Colitis, Ulcerative, Crohn Disease, Arthritis, Psoriatic
Related terms Arthritis, Psoriatic, Colitis, Ulcerative, Crohn Disease, Psoriasis
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov