Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate
Brief Summary: The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.


Options:
A: 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)
B: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Day 169 in Short Term Period (Day 169); Percentage of Participants With Sustained American College of Rheumatology (ACR) Response at Day 533 in Long Term Period - All Randomized and Treated Participants During the Long Term Period (Day 533); Mean Change From Baseline in HAQ-DI Score at Day 533 in Long Term Period (Baseline to Day 533); Percentage of Participants With Health Assessment Questionnaire (HAQ) Response at Day 533 in Long Term Period (Day 533); Mean Change in DAS28-CRP From Baseline at Day 533 in Long Term Period (Baseline to Day 533)
C: DAS28-ESR remission at 24 weeks (at 24 week); Changes over time in the number of patients maintaining discontinuation (maintenance rate) (Week 52 to Week 104)
D: Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169 (Day 169); Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population (Days 85, and 169 and postvisits on Days 28, 56, and 85)

Answer: D