Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIB Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess Short-term Changes in Synovitis and Structural Damage Outcomes in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate, Treated With Abatacept Versus Placebo on a Background Therapy With Methotrexate
Brief Summary: The only trial in participants who are methotrexate-inadequate responders and have active Rheumatoid Arthritis, in which gadolinium-enhanced Magnetic Resonance Imaging; Bone Mineral Density; and biochemical markers of bone, cartilage, and synovial tissue metabolism are used to evaluate early effects (4 months) of Abatacept on inflammation/structural damage. Study will provide valuable mechanism-of-action information on how Abatacept exerts its effects (including on bone) through new techniques.


Options:
A: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
B: Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 (Week 88)
C: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
D: 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)

Answer: C