Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MLTA3698A in Combination With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Compared With Adalimumab in Combination With a DMARD in Patient With Active Rheumatoid Arthritis
Brief Summary: This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA).


Options:
A: Change From Baseline in Modified Total Sharp X-Ray Score at Week 26 (Baseline, Week 26)
B: Change in disease activity. (6 months)
C: 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)
D: Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR (Day 85); Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A (Length of study (through Day 85))

Answer: D