Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Intravenously, in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Brief Summary: The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.


Options:
A: Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24 (Week 20 and Week 24)
B: Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 (Week 0 to Week 14)
C: Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports (Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug); Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Extension Period: Number of Participants With Laboratory Test Abnormalities (Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)); Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis (Includes AEs for every visit and up to 999 days after last dose of study drug); Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib (Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period)
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: B