NCT05004727RecruitingPhase 4
Multi-Center PAMPA Study
Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care. The primary objective of the proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will: 1. Diminish MSKPDUS findings at 24 weeks, and 2. Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- First submitted
- 6 Aug 2021
- Start date
- 16 Feb 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- NYU Langone Health
- Diseases
- Psoriasis
- NCT number
- NCT05004727
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 176
- From 16 Feb 2022 to the primary completion date, 31 Dec 2026
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever);
Other illness
- Current active malignancy;
- History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
- Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
- Known hypersensitivity to the study agent.
Other
- Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
- RA seropositivity (mid-high RF/ACPA titers);
Who the study is looking for
- 18 years old or older;
- Both male \& female;
- Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
- Willing and able to provide informed consent;
- Fulfillment of HR-PsO criteria (Psoriasis (PsO) patients will meet the definition of HR if they fulfill the following criteria: a) PsO duration \>2 years and Psoriasis Body Surface Area (BSA) \>3% and positive imaging findings in MSKPDUS defined as a RM-PsASon score of \>3.36
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial University Coordinator of this site? Confirm its status | St. John's | Canada | Recruiting |
| Women's College Research Institute, University of Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Rochester Medical Center (URMC) Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.