Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options
Brief Summary: The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.


Options:
A: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
B: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
C: Short-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations (Days 1-169); Short-term Period: Number of Participants With AEs of Special Interest (Days 1-169); Short-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria (Days 1-169); Short-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria (Days 1-169); Short-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria (Days 1-169); Short-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria (Days 1-169); Short-term Period: Mean Change From Baseline in Systolic and Diastolic Blood Pressure (Day 1 (Baseline) -Day 169); Short-term Period: Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA) (Days 1-169); Long-term Period: Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuations, AEs, Related AEs, or AEs Leading to Discontinuations (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Number of Participants With AEs of Special Interest (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Number of Participants With Liver and Kidney Function Laboratories Meeting MA Criteria (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Number of Participants With Electrolyte Laboratories Meeting MA Criteria (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Change From Baseline in Hemoglobin (HGB), Total Protein, and Albumin Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in Hematocrit Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in Erythrocytes Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in Platelets (PLT) Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in White Blood Cells Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and G-Glutamyl Transferase (GGT) Over Time (BL, Day 365, Day 729); Long-term Period: Change From Baseline in Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, Calcium (Ca), Phosphorus (P), Serum Glucose (Glu), and Uric Acid Over Time (BL, Day 365, Day 729); LT; Change From Baseline in Sodium (Na), Potassium (K), Chloride (Cl) Over Time (BL, Day 365, Day 729); Long-term Period: Mean Sitting Systolic Blood Pressure (SBP) Over Time (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Mean Sitting Diastolic Blood Pressure (DBP) Over Time (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Mean Heart Rate (HR) Over Time (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept); Long-term Period: Mean Temperature (T) Over Time (From Day 169 through Day 813, including up to 56 days after the last dose of long-term period abatacept)
D: Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years (From first dose of CZP to the end of the open-label study (approximately 7 years)); Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study (From Entry Visit (Week 0) to the end of the study (approximately 6.5 years))

Answer: C