Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD
Brief Summary: The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.


Options:
A: Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28 (Day -7 (Baseline), Day 28); Change From Baseline in Protein Expression of Tumor Necrosis Factor Alpha (TNFalpha), Interleukin-6 (IL-6), Interleukin-17a (IL-17a) and Interleukin-10 (IL-10) at Day 28 (Baseline (Day -7), Day 28); Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28 (Baseline (Day -7), Day 28); Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7) (Baseline (Day -7)); Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28 (Day 28); Blood Cytokine Level at Pre-dose on Day 1 (Pre-dose on Day 1); Blood Cytokine Level at 1 Hour Post-dose on Day 1 (1 hour post-dose on Day 1); Blood Cytokine Level at 4 Hours Post-dose on Day 1 (4 hours post-dose on Day 1); Blood Cytokine Level at Pre-dose on Day 10 (Pre-dose on Day 10); Blood Cytokine Level at Pre-dose on Day 28 (Pre-dose on Day 28); Blood Cytokine Level at 1 Hour Post-dose on Day 28 (1 Hour Post-dose on Day 28); Blood Cytokine Level at 4 Hours Post-dose on Day 28 (4 Hours Post-dose on Day 28); Blood Cytokine Level at 8 Hours Post-dose on Day 28 (8 Hours Post-dose on Day 28); Blood Cytokine Level at 24 Hours Post-dose on Day 28 (24 Hours Post-dose on Day 28); Blood Cytokine Level at Pre-dose on Day 35 or Early Termination (Pre-dose on Day 35 or Early Termination); Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1 (Pre-dose on Day 1); Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1 (1 Hour Post-dose on Day 1); Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1 (4 Hours Post-dose on Day 1); Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10 (Pre-dose on Day 10); Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28 (Pre-dose on Day 28); Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28 (1 Hour Post-dose on Day 28); Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28 (4 Hours Post-dose on Day 28); Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28 (8 Hours Post-dose on Day 28); Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28 (24 Hours Post-dose on Day 28); Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination (Pre-dose on Day 35 or Early Termination); Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1 (Pre-dose on Day 1); Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1 (1 Hour Post-dose on Day 1); Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1 (4 Hours Post-dose on Day 1); Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10 (Pre-dose on Day 10); Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28 (Pre-dose on Day 28); Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28 (1 Hour Post-dose on Day 28); Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28 (4 Hours Post-dose on Day 28); Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28 (8 Hours Post-dose on Day 28); Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28 (24 Hours Post-dose on Day 28); Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination (Pre-dose on Day 35 or Early Termination); Parathyroid Hormone (PTH) Level at Pre-dose on Day 1 (Pre-dose on Day 1); Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 1 (1 Hour Post-dose on Day 1); Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 1 (4 Hours Post-dose on Day 1); Parathyroid Hormone (PTH) Level at Pre-dose on Day 10 (Pre-dose on Day 10); Parathyroid Hormone (PTH) Level at Pre-dose on Day 28 (Pre-dose on Day 28); Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 28 (1 Hour Post-dose on Day 28); Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 28 (4 Hours Post-dose on Day 28); Parathyroid Hormone (PTH) Level at 8 Hours Post-dose on Day 28 (8 Hours Post-dose on Day 28); Parathyroid Hormone (PTH) Level at 24 Hours Post-dose on Day 28 (24 Hours Post-dose on Day 28); Parathyroid Hormone (PTH) Level at Pre-dose on Day 35 or Early Termination (Pre-dose on Day 35 or Early Termination); Osteoprotegerin (OPG) Level at Pre-dose on Day 1 (Pre-dose on Day 1); Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 1 (1 Hour Post-dose on Day 1); Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 1 (4 Hours Post-dose on Day 1); Osteoprotegerin (OPG) Level at Pre-dose on Day 10 (Pre-dose on Day 10); Osteoprotegerin (OPG) Level at Pre-dose on Day 28 (Pre-dose on Day 28); Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 28 (1 Hour Post-dose on Day 28); Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 28 (4 Hours Post-dose on Day 28); Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28 (8 Hours Post-dose on Day 28); Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28 (24 Hours Post-dose on Day 28); Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination (Pre-dose on Day 35 or Early Termination); Plasma Level of Matrix Metallopeptidase (MMP13) (Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28); Plasma Level of Interleukin-34 (IL-34) and Interleukin-18 (IL-18) (Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28); Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1 (Pre-dose on Day 1); Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1 (1 Hour Post-dose on Day 1); Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1 (4 Hours Post-dose on Day 1); Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10 (Pre-dose on Day 10); Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28 (Pre-dose on Day 28); Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28 (1 Hour Post-dose on Day 28); Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28 (4 Hours Post-dose on Day 28); Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28 (8 Hours Post-dose on Day 28); Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28 (24 Hours Post-dose on Day 28); Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination (Pre-dose on Day 35 or Early Termination); Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1 (Pre-dose on Day 1); Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1 (1 Hour Post-dose on Day 1); Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1 (4 Hours Post-dose on Day 1); Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10 (Pre-dose on Day 10); Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28 (Pre-dose on Day 28); Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28 (1 Hour Post-dose on Day 28); Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28 (4 Hours Post-dose on Day 28); Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28 (8 Hours Post-dose on Day 28); Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28 (24 Hours Post-dose on Day 28); Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination (Pre-dose on Day 35 or Early Termination); Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 1 (Pre-dose on Day 1); Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 10 (Pre-dose on Day 10); Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 28 (Pre-dose on Day 28); Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28 (24 Hours Post-dose on Day 28); Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination (Pre-dose on Day 35 or Early Termination)
B: American College of Rheumatology (ACR)-20 responder rate at Week 24 (24 weeks)
C: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)
D: Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12

Answer: B