Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate
Brief Summary: This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.


Options:
A: Number of Subjects Experiencing Any Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Serious Adverse Event (throughout entire study (61 +/- 28.9 weeks on average)); Number of Subjects Experiencing Any Infection (throughout entire study (61 +/- 28.9 weeks on average))
B: Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes (Baseline (Week 3) and Week 8 (5 weeks post-vaccination))
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: 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)

Answer: B