Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis
Brief Summary: This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Options:
A: Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks (16 weeks)
B: Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at Week 12 (Baseline and Week 12); Percentage of American College of Rheumatology [ACR] 20 Criteria Responders During the Extension Phase (Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124); Percentage of American College of Rheumatology [ACR] 50 Criteria Responders During the Extension Phase (Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124); Percentage of American College of Rheumatology [ACR] 70 Criteria Responders During the Extension Phase (Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124); Change From Baseline in Disease Activity Score (DAS) 28 During the Extension Phase (Baseline and Weeks 24, 72 and 112)
C: Percentage of patients with ACR 20 response (Week 24)
D: Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations (Days 1-169); Short-term Period: Number of Participants With AEs of Special Interest (Days 1-169); Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria (Days 1-169); Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria (Days 1-169); Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria (Days 1-169); Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria (Days 1-169); Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure (Day 1 (Baseline) -Day 169); Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA) (Days 1-169); Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Number of Participants With AEs of Special Interest (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in Hematocrit Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in Erythrocytes Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in Platelets (PLT) Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in White Blood Cells Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time (BL, Day 365, Day 729); LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time (BL, Day 365, Day 729); Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Mean Heart Rate (HR) Over Time (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Mean Temperature (T) Over Time (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept)

Answer: C