Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised-controlled Trial of Switching to Alternative Tumour-necrosis Factor (TNF)-Blocking Drugs or Abatacept or Rituximab in Patients With Rheumatoid Arthritis Who Have Failed an Initial TNF-blocking Drug
Brief Summary: The principal aim of this study is to fill a clear knowledge gap and provide guidance for rheumatologists and reassurance to the patient group on a management challenge faced daily in rheumatology practice. Specifically, it aims to provide robust evidence on the optimal management of patients with established RA that have failed an anti-TNF therapy (the first of the biological therapies to be introduced); in particular, the investigators wish to address whether the currently licensed but non NICE-approved treatment options, TNF-blocking drug or abatacept, are equivalent to the NICE-approved treatment, rituximab. If so, the intention is to broaden treatment options and target these specific therapies to disease sub-groups.


Options:
A: Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12
B: 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)
C: Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 (Week 24)
D: Change in disease activity. (6 months)

Answer: D