Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Lenalidomide (REVLIMID®) in Cutaneous LE: A Prospective, Non Controlled, Open Label Pilot Study to Evaluate the Off-Label Use of the FDA-approved Drug Lenalidomide (REVLIMID®) in Patients With Cutaneous Lupus Erythematosus
Brief Summary: This study is being conducted to evaluate the safety and effectiveness of lenalidomide (Revlimid®) in subjects with Cutaneous Lupus Erythematosus (CLE). The study drug will be used in an off-label indication to treat 6 subjects for 12 months each. Men and women over the age of 18, who have a biopsy proven diagnosis of CLE and who have failed standard treatment, will be included in the study.


Options:
A: Cutaneous Lupus Area and Severity Index (CLASI) (Weeks 0 through 52)
B: SLE response (Various timepoints through Week 52)
C: Number of participants with adverse events (Up to 26 weeks); Pharmacokinetic profile of CNTO 136 (Up to 22 weeks); Physical examinations (Up to 26 weeks); Electrocardiograms (ECGs) (Up to 26 weeks); Sitting blood pressure (Up to 26 weeks); Heart rate (Up to 26 weeks); Respiration rate (Up to 26 weeks); Oral temperature (Up to 26 weeks); Hemoglobin (Up to 26 weeks); Hematocrit (Up to 26 weeks); Platelets and total white blood cells (WBC) (Up to 26 weeks); Albumin and total protein (Up to 26 weeks); Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) (Up to 26 weeks); Blood urea nitrogen (BUN), calcium, creatinine, and total bilirubin (Up to 26 weeks); Chloride, potassium, and sodium (Up to 26 weeks); Bicarbonate (Up to 26 weeks); Creatine kinase (Up to 26 weeks); Gamma-glutamyl-transferase (Up to 26 weeks); Glucose (Up to 26 weeks); Lymphocytes and neutrophils (Up to 26 weeks); Inorganic phosphate (Up to 26 weeks); Fasting Lipid Panel (Up to 8 weeks)
D: 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)

Answer: A