Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares
Brief Summary: The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.


Options:
A: Double Blind Period (DB); Number of Participants Experiencing a New SLE Flare (From start of corticosteroid taper to Day 365); Open Label Period (OL); Number of Participants Who Died, Experienced Adverse Events (AEs), Serious AEs, Drug Related AEs or SAEs and Discontinued Due to AEs (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With Significant AEs of Special Interest (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With Marked Abnormalities (MAs) in Hematology: Hemoglobin, Hematocrit, Erythrocytes and Platelet Count (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With MAs in Hematology: Leukocytes, Neutrophils + Bands (Absolute), Lymphocytes (Absolute), Monocytes (Absolute), Basophils (Absolute) and Eosinophils (Absolute) (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With MAs in Serum Chemistry: Alkaline Phosphatase (ALP), Aspartate-aminotransferase (AST), Alanine-aminotransferase (ALT), Gamma-glutamyl Transferase (GGT), Bilirubin(Total), Blood Urea Nitrogen (BUN), Creatinine (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With MAs in Serum Chemistry: Sodium (Serum), Potassium (Serum), Chloride (Serum), Calcium (Total), Protein (Total) (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With MAs in Serum Chemistry: Glucose (Serum), Glucose (Fasting Serum), Albumin, Cholesterol (Total), Triglycerides, Fasting Triglycerides (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period); OL; Number of Participants With MAs in Urinalysis (From start of study drug therapy in open-label period (Day 365) up to 56 days after the last dose of open-label period)
B: Safety and tolerability of MEDI-545 will be assessed primarily by summarizing adverse events. (Day 84)
C: Cutaneous Lupus Area and Severity Index (CLASI) (Weeks 0 through 52)
D: SLE response (Various timepoints through Week 52)

Answer: A