Please select the outcome measures that correspond to the clinical trial below.
Title: Vascular Inflammation in Psoriasis - Extension Study
Brief Summary: VIP-E is a one-arm, open-label, 40-52 week extension study to continue or cross over subjects of the VIP study (# 814278) to active drug (adalimumab) to determine if there is sustained improvement in vascular inflammation, lipid metabolism, and inflammatory markers. VIP-E extends VIP study procedures for 40-52 weeks including questionnaires, physical exams, blood and urine samples, lab tests, one additional FDG-PET/CT scan, and adalimumab injections following FDA-approved psoriasis treatment regimen.


Options:
A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16); Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16)
B: Change in Vascular Inflammation (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Vascular Inflammation (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Total Cholesterol (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Cholesterol Efflux (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Insulin (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Adiponectin (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Leptin (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log C-reactive Protein (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - Log Interleukin 6 (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarker - GlycA (52 weeks (continuation group) or 64 weeks (crossover group)); Change in Cardiometabolic Biomarkers: - Total Cholesterol (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Cholesterol Efflux (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Insulin (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Adiponectin (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Leptin (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log C-reactive Protein (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - Log Interleukin 6 (52 weeks of adalimumab treatment); Change in Cardiometabolic Biomarker - GlycA (52 weeks of adalimumab treatment)
C: Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 (Week 12); Participants With IGA Mod 2011 0 or 1 at Week 12 (Week 12)
D: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)

Answer: B