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: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year (When all participants complete the 1 year visit)
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: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8 .
D: 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)

Answer: D