Clinical trial NCT05004727: Multi-Center PAMPA Study
Official title: Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2021-08-13
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 18 years old or older;
2. Both male \& female;
3. Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
4. Willing and able to provide informed consent;
5. 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

Exclusion Criteria:

1. Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
2. Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever);
3. RA seropositivity (mid-high RF/ACPA titers);
4. Current active malignancy;
5. History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
6. Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
7. Known hypersensitivity to the study agent.

Primary outcomes:
measure: Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2
timeFrame: Year 2
measure: Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 1
timeFrame: Year 1
measure: Severity of PsA at the time of synovio-entheseal development
timeFrame: Year 2
measure: Change in the ultrasound composite score of synovitis
timeFrame: Baseline, week 24
measure: Change in Madrid Sonographic Enthesis Index (MASEI) Score
timeFrame: Baseline, week 24
measure: Psoriasis Body Surface Area (BSA)
timeFrame: Week 24
measure: Achieved IGA mod 2011 Score
timeFrame: Week 24
measure: Change in Functional Assessment of Chronic Illness Therapy (FACIT) Scale
timeFrame: Week 24
measure: Change in EuroQol-5D (EQ-5D) Score
timeFrame: Baseline, Week 24
measure: Change in EuroQol-5D (EQ-5D) Score
timeFrame: Baseline, Year 2
measure: Change in International Dermatology Outcome Measures - Musculoskeletal -8 (IDEOM-MSK-8) Score
timeFrame: Baseline, Week 24
measure: Change in Ultrasound (US) Score
timeFrame: Baseline, Week 24
measure: Proportion of participants who achieved ≥ 50% improvement in US score at 24 weeks
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center (URMC)
state: New York
city: Saint John's
country: Canada
facility: Memorial University
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Women's College Research Institute, University of Toronto
state: Ontario
Study officials:
affiliation: NYU Langone Health
name: Jose Scher, MD
role: PRINCIPAL_INVESTIGATOR
References: