Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.
Brief Summary: During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.


Options:
A: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 (Week 78)
B: Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169 (Day 169); Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365 (Day 365); Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365 (BL (Day 0), Day 365); Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period (Day 365 to Day 2,185); Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period (Day 365 to Day 2,185); Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period (Day 365 to Day 2,185); Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period (Day 365 to Day 2,185); Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period (Day 365 to Day 2,185); Mean BL Immunoglobulins Over Time in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093); Mean Change From BL in Immunoglobulins in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093); Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period (Day 1 to Day 1,821); Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period (Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.); Number of Participants Experiencing AEs of Special Interest in the OL Period (Day 365 to Day 2,185); Mean BL Hematocrit in the OL Period (Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean Change From BL in Participant Hematocrit in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean BL Platelet Count in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean Change From BL in Participant Platelet Count in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean BL White Blood Cells in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean Change From BL in White Blood Cells in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean BL Liver Function Parameters in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean Change From BL in Liver Function Parameters in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean BL Select Laboratory Parameters in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean Change From BL in Select Laboratory Parameters in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean BL Serum Electrolytes in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185); Mean Change From BL in Serum Electrolytes in the OL Period (BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185)
C: 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)
D: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)

Answer: D