PAMPA Study

The primary objective of our 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: a) Diminish MSKPDUS findings at 24 weeks, and b) Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2. The primary efficacy variable is change from baseline in the MSK-PDUS composite score. The primary analysis time point will be at week 24. The co-primary efficacy variable is difference in % of patients transitioning to PsA by modified-CASPAR criteria at 2 years. 1. Transition to PsA at year 1 (Arm 1 vs Arm 2) 2. Severity of PsA at the time of synovio-entheseal development at year 2 (Arms 1+2 vs Arm 3): severity will be categorized as mild, moderate, or severe and additionally by continuous variables (joint and enthesis counts, etc.) 3. Change from baseline in the ultrasound composite score of synovitis at week 24 (Arm 1 vs Arm 2) 4. Change from baseline in the ultrasound composite score of enthesitis at week 24 (Arm 1 vs Arm 2) 5. Change from baseline in BSA at week 24 (Arm 1 vs Arm 2) 6. Achieved IGA mod 2011 score of 0 or 1 (yes, no) at week 24 (Arm 1 vs Arm 2) 7. Change from baseline MSK8 score at 24 weeks (Arm 1 vs Arm 2) 8. Changes in baseline ultrasound, total score at Week 24 (Arm 1 vs. Arm 2+3) 9. Changes in baseline FACIT score at weeks 24 (Arm 1 vs. Arm 2) 10. Change in baseline EQ5D at weeks 24 (Arm 1 vs Arm 2) 11. Change in baseline EQ5D at year 2 (Arm 1 + Arm 2 vs Arm 3)

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Medical Research
• Age: - 99 Years
• Gender: All