Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Multicentre, Double Blind, Placebo-controlled, Parallel Group 52-week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate
Brief Summary: Patients will be assigned to one of three treatment groups. Study medication is administered over a 52 week study duration.


Options:
A: Number of patients who achieve a DAS28 < 3.2 (0, 1, 3, 6, 9, 12 and 24 months (DAS28))
B: 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)
C: To assess the efficacy of CDP870 in combination with Methotrexate in the treatment of Rheumatoid Arthritis and prevention of structural damage by measuring the ACR20 response at week 24 and change from Baseline
D: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)

Answer: C