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 a 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 24 (Week 24)
B: Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16 (Baseline to Week 16 (end of phase))
C: Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks); Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks) (Baseline to 20 Weeks)
D: 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)

Answer: D