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Multi-Center PAMPA Study
Sponsor: NYU Langone Health
Summary
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.
Official title: Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
176
Start Date
2022-02-16
Completion Date
2028-11-02
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Guselkumab
Guselkumab 100 mg 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (month 0 to month 24 for arm 1; week 24 to month 24 for arm 2).
Placebo
• Placebo to Guselkumab 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (Month 0 to Week 20 for Arm 2).
Locations (5)
Brigham and Women's Hospital
Boston, Massachusetts, United States
NYU Langone Health
New York, New York, United States
University of Rochester Medical Center (URMC)
Rochester, New York, United States
Memorial University
St. John's, Newfoundland and Labrador, Canada
Women's College Research Institute, University of Toronto
Toronto, Ontario, Canada