Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)
Brief Summary: The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.


Options:
A: To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE. (Days 0-105)
B: Percentage of Participants With a State of Disease Control at Week 52 (Week 52)
C: Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) (Up to Week 440); AE Rates by System Organ Class (SOC) During the Study (Up Week 440); SAE Rates by System Organ Class (SOC) During the Study (Up to Week 440); Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points (Up to Week 440); Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Neutrophils Segmented and Platelets at the Indicated Time Points (Up to Week 440); Change From Baseline in Erythrocytes at the Indicated Time Points (Up to Week 440); Change From Baseline in Hematocrit at the Indicated Time Points (Up to Week 440); Change From Baseline in Hemoglobin at the Indicated Time Points (Up to Week 440); Change From Baseline in Albumin and Protein at the Indicated Time Points (Up to Week 440); Change From Baseline in Blood Urea Nitrogen, Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points (Up to Week 440); Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points (Up to Week 440); Change From Baseline in Creatinine Clearance at the Indicated Time Points (Up to Week 440); Change From Baseline in BUN/Creatinine at the Indicated Time Points (Up to Week 440); Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points (Up to Week 432); Number of Participants With the Indicated Immunogenic Response (Up to Week 440); Systolic Blood Pressure and Diastolic Blood Pressure at Indicated Time Points. (Up to Week 432); Percentage of Participants With at Least 25% Increase From Baseline in Creatinine at Indicated Time Points. (Up to Week 440); Percentage of Participants With at Least 25% Reduction From Baseline in Creatinine at Indicated Time Points. Amongst Subjects With Abnormal (>124 Umol/L) Creatinine at Baseline by Year Interval. (Up to Week 440)
D: Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. (Baseline, 24 weeks); Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) (0 to 52 weeks)

Answer: B