Phase 4 Psoriatic Arthritis Trial, Not Yet Recruiting NCT07654751 Sponsor: Janssen Research & Development, LLC Condition: Psoriatic Arthritis
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Phase 4 Psoriatic Arthritis Trial, Not Yet Recruiting

NCT07654751
Not Yet Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been officially diagnosed with at least one condition that guselkumab is approved to treat — these include psoriasis, psoriatic arthritis, ulcerative colitis (UC), or Crohn's disease (CD) — as confirmed by your medical records
  • You are generally in a stable state of health, based on a review of your medical history at the screening visit
  • You are already on a regular guselkumab maintenance treatment and have received at least 2 maintenance injections (given under the skin) before the study start date
  • You had already decided — on your own, before joining the study — to take guselkumab and to breastfeed your baby
  • It has been at least 5 weeks since you gave birth by the time the study begins
  • You are breastfeeding well and are either exclusively breastfeeding or giving your baby no more than one bottle of formula per day
  • You plan to continue breastfeeding for the entire duration of the study

Who may not be able to join:

  • You have a current or past illness that, in the study doctor's opinion, could affect the study results or interfere with the required assessments (confirm with trial site)
  • You have a history of drug or alcohol misuse within the past year, as defined by standard medical guidelines
  • You have taken part in another clinical trial or used an experimental drug or device within the past month
  • You have received a live vaccine (such as certain flu or other vaccines) within the 12 weeks before your guselkumab dose — note that non-live vaccines like COVID-19 vaccines are generally allowed
  • You have a positive pregnancy test on the study start date

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
15 June 2026
Est. completion
31 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen); Guselkumab Concentrations at Steady State in Breast Milk (Q8W Maintenance Regimen); Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance Regimen; Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance Regimen

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov