Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Multi-Center, Randomized, Open Label, Trial to Evaluate the Safety, Tolerability, and Biological Activity of 2 Dosing Schedules of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)
Brief Summary: The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.


Options:
A: Number of Participants With the Indicated Type of Adverse Event (AEs) and Serious Adverse Event (SAEs) (Approximately up to 13 years); Adverse Event (AE) Rates by System Organ Class (SOC) During the Study (Approximately up to 13 years); SAE Rates by System Organ Class (SOC) During the Study (Approximately up to 13 years); Change From Baseline in Activated Partial Thromboplastin Time (APTT) and Prothrombin Time (PT) at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils Segmented and Platelets at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Erythrocytes at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Hematocrit at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Hemoglobin at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Albumin and Protein at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Calcium, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium and Sodium at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Creatinine, Urate and Bilirubin at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in BUN/Creatinine at the Indicated Time Points (Baseline and approximately up to 13 years); Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) at the Indicated Time Points (Baseline and approximately up to 13 years)
B: To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE. (Days 0-105)
C: SLE Responder Index (SRI) Response Rate at Week 52 (Baseline, 52 Weeks)
D: Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. (Up to 24 weeks); Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24 (Baseline, 24 weeks); Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24. (Baseline, 24 Weeks); Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24 (Baseline, 24 weeks); Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24 (Baseline, 24 weeks); Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 (Baseline, 24 Weeks); Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 (Baseline, 24 Weeks); Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 (Baseline, 24 Weeks); Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 (Baseline, 24 Weeks)

Answer: D