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Multi-Center PAMPA Study

Study acronym: PAMPA
StatusRecruiting
PhasePhase 4
Started2022-02-16
View on ClinicalTrials.gov ↗

Amendment history

2026-03-24
Study Status v13
Completion date2028-07-31→2028-11-02
2025-05-27
Study Status, Study Description, Outcome Measures, Contacts/Locations v12
Secondary endpoints11 to 13 entries
Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2 Change in Ultrasound (US) Score Proportion of participants who achieved ≥ 50% improvement in US score at 24 weeks
Primary endpoints2 to 1 entries
Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2
Study sitescontacts updated at 2 of 5 sites
2024-12-16
Study Status, Study Design v11
Primary completion date2025-12-31→2026-12-31
Completion date2026-03-01→2028-07-31
Enrollment target350→176
2024-01-04
Study Status, Contacts/Locations v10
Primary completion date2025-03-01→2025-12-31
Completion date2025-09-01→2026-03-01
2023-02-15
Study Status, Sponsor/Collaborators v9
Collaborators+31 characters
Janssen Scientific Affairs, LLC
Show 8 earlier versions
2022-09-29
Study Status, Contacts/Locations v8
Study sitesdetails revised at 2 of 5 sites
2022-09-21
Study Status, Outcome Measures v7
Secondary endpoints9 to 11 entries
Change in International Dermatology Outcome Measures - Musculoskeletal -8 (IDEOM-MSK-8) Score Change in Ultrasound Score
2022-08-29
Study Status, Contacts/Locations v6
Study sitesdetails revised at 1 of 5 sites
2022-06-02
Study Status, Contacts/Locations v5
Study sitescontacts updated at 1 of 5 sites
2022-05-11
Study Status, Contacts/Locations v4
Study sitescontacts updated at 1 of 5 sites
2022-04-13
Study Status, Contacts/Locations v3
Study sitesdetails revised at 1 of 5 sites
2022-03-28
Study Status, Contacts/Locations v2
Start dateestimated 2021-10-18→confirmed 2022-02-16
Study sitescontacts updated at 3 of 5 sites
2021-10-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2021-10-01→2021-10-18
Study sitesdetails revised at 5 of 5 sites
2021-08-06
Original filing
NYU Langone Health
394 trials monitored
See 18 trials at risk
Psoriasis
418 trials monitored
See 17 trials at risk
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.
Trial Details
NCT Number NCT05004727
Lead Sponsor NYU Langone Health
Collaborators: Janssen Scientific Affairs, LLC
Conditions Psoriasis
Enrollment 176 participants
Start Date 2022-02-16
Primary Completion 2026-12-31 (estimated)
Study Completion 2028-11-02 (estimated)
Updated on ClinicalTrials.gov 2026-03-30