Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate
Brief Summary: The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.


Options:
A: Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration (169 days); Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration (211 days); Plasma concentrations of golimumab following IV administration (169 days); Plasma concentrations of golimumab following SC administration (211 days)
B: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
C: DB; Adjusted Mean Change From Baseline to Day 197 in Disease Activity Score (DAS) 28 Score (Erythrocyte Sedimentation Rate [ESR]) For ABA Versus PLA (Last Observation Carried Forward [LOCF] Analysis) (Baseline (Day 1), 6 months (Day 197)); OL; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, and AEs Leading to Discontinuation (From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)); OL; Number of Participants With AEs of Special Interest (From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)); OL; Number of Participants With Select Hematologic Laboratory Abnormalities (From Day 366 through end of OL (range from 1.9 months to 42.3 months)); OL; Number of Participants With Select Blood Chemistry Laboratory Abnormalities (From Day 366 through end of OL (range from 1.9 months to 42.3 months)); OL; Mean Change From Baseline to Day 365 in Hemoglobin, Total Protein, and Albumin (Baseline (Day 1), Day 365); OL; Mean Change From Baseline to Day 365 in Platelets (Baseline (Day 1), Day 365); OL; Mean Change From Baseline to Day 365 in Hematocrit (Baseline (Day 1), Day 365); OL; Mean Change From Baseline to Day 365 in White Blood Cells (Baseline (Day 1), Day 365); OL; Mean Change From Baseline to Day 365 in Erythrocytes (Baseline (Day 1), Day 365); OL; Mean Change From Baseline to Day 365 in Electrolytes (Baseline (Day 1), Day 365); OL; Mean Change From Baseline to Day 365 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid (Baseline (Day 1), Day 365); OL; Mean Change From Baseline to Day 365 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase (Baseline (Day 1), Day 365); OL; Mean Change From Baseline to Day 729 in Hemoglobin, Total Protein, and Albumin (Baseline (Day 1), Day 729); OL; Mean Change From Baseline to Day 729 in Platelets (Baseline (Day 1), Day 729); OL; Mean Change From Baseline to Day 729 in Hematocrit (Baseline (Day 1), Day 729); OL; Mean Change From Baseline to Day 729 in White Blood Cells (Baseline (Day 1), Day 729); OL; Mean Change From Baseline to Day 729 in Erythrocytes (Baseline (Day 1), Day 729); OL; Mean Change From Baseline to Day 729 in Electrolytes (Baseline (Day 1), Day 729); OL; Mean Change From Baseline to Day 729 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid (Baseline (Day 1), Day 729); OL; Mean Change From Baseline to Day 729 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase (Baseline (Day 1), Day 729); OL; Mean Change From Baseline to Day 1121 in Hemoglobin, Total Protein, and Albumin (Baseline (Day 1), Day 1121); OL; Mean Change From Baseline to Day 1121 in Platelets (Baseline (Day 1), Day 1121); OL; Mean Change From Baseline to Day 1121 in Hematocrit (Baseline (Day 1), Day 1121); OL; Mean Change From Baseline to Day 1121 in White Blood Cells (Baseline (Day 1), Day 1121); OL; Mean Change From Baseline to Day 1121 in Erythrocytes (Baseline (Day 1), Day 1121); OL; Mean Change From Baseline to Day 1121 in Electrolytes (Baseline (Day 1), Day 1121); OL; Mean Change From Baseline to Day 1121 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid (Baseline (Day 1), Day 1121); OL; Mean Change From Baseline to Day 1121 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase (Baseline (Day 1), Day 1121); OL; Mean Change From Baseline to Day 1513 in Hemoglobin, Total Protein, and Albumin (Baseline (Day 1), Day 1513); OL; Mean Change From Baseline to Day 1513 in Platelets (Baseline (Day 1), Day 1513); OL; Mean Change From Baseline to Day 1513 in Hematocrit (Baseline (Day 1), Day 1513); OL; Mean Change From Baseline to Day 1513 in White Blood Cells (Baseline (Day 1), Day 1513); OL; Mean Change From Baseline to Day 1513 in Erythrocytes (Baseline (Day 1), Day 1513); OL; Mean Change From Baseline to Day 1513 in Electrolytes (Baseline (Day 1), Day 1513); OL; Mean Change From Baseline to Day 1513 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid (Baseline (Day 1), Day 1513); OL; Mean Change From Baseline to Day 1513 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase (Baseline (Day 1), Day 1513); OL; Mean Systolic (SBP) and Diastolic (DBP) Blood Pressure During Open Label Period (Days 365, 729, 1121, and 1513); OL; Mean Heart Rate (HR) During Open Label Period (Days 365, 729, 1121, and 1513); OL; Mean Temperature (T) During Open Label Period (Days 365, 729, 1121, and 1513)
D: Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR (Day 85); Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A (Length of study (through Day 85))

Answer: C