Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate Versus Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Brief Summary: Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667) in combination with methotrexate is better than methotrexate alone in participants that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.

Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.


Options:
A: Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20). (Week 12); Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score (Week 104)
B: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
C: 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)
D: ASAS 40 at week 12

Answer: C