Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion
Brief Summary: Primary Objective:

- To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI \[Cutaneous Lupus Erythematosus Disease Area and Severity Index\] activity score is ≥4) concomitant treatment with or without corticosteroid.

Secondary Objectives:

* To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of once daily regiment of HCQ versus placebo as the reference group in patients with CLE and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant treatment with or without corticosteroid.
* To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in patients with CLE and SLE with active skin manifestation concomitant treatment with or without corticosteroid.
* To investigate the safety and efficacy of 52 weeks long-term treatment of once daily regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with corticosteroid
* To investigate efficacy of once daily regimen of HCQ on systemic symptoms, musculoskeletal symptoms and immunological parameters in SLE patients.


Options:
A: A change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) activity score (from baseline (at visit 2) to 16 weeks treatment (at visit 6))
B: Safety and tolerability of MEDI-545 will be assessed primarily by summarizing adverse events. (Day 84)
C: 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)
D: Percentage of Participants Achieving a Response in Systemic Lupus Erythematosus Responder Index 4 (SRI [4]) (Day 365); Percentage of Participants Achieving a Positive Response in SRI (4) in 4-Gene Interferon Test High Participants (Day 365)

Answer: A