To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks.
Probity Medical Research
City Waterloo, Ontario, Canada
Hematology - Hematocrit
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Hematology - Hemoglobin
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Hematology - Red Blood Cell Count
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Hematology - White Blood Cell Count
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Hematology - Neutrophils
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Hematology - Eosinophils
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Hematology - Basophils
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Hematology - Monocytes
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Hematology - Lymphocytes
Blood samples were taken for clinical laboratory testing
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Time frame: Week 12 / Early Termination
Hematology - Platelet Count
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Biochemistry - Sodium
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Biochemistry - Potassium
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Biochemistry - Creatinine
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Biochemistry - Total Bilirubin
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Biochemistry - Aspartate Transaminase (AST)
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Biochemistry - Alanine Transaminase (ALT)
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Biochemistry - Alkaline Phosphatase
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Biochemistry - Glutamyl Transferase
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Biochemistry - Urea
Blood samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Biochemistry - C-Reactive Protein (CRP)
Blood samples were taken for clinical laboratory testing of the numbers of participants with CRP values \<3 mg/L, 3-6 mg/L, and \>6 mg/L
Time frame: Week 12 / Early Termination
Urinalysis - pH
Urine samples were taken for clinical laboratory testing
Time frame: Week 12 / Early Termination
Urinalysis - Protein
Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine
Time frame: Week 12 / Early Termination
Urinalysis - Ketones
Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine
Time frame: Week 12 / Early Termination
Urinalysis - Glucose
Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine
Time frame: Week 12 / Early Termination
Urinalysis - Blood
Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine
Time frame: Week 12 / Early Termination
Urinalysis - Nitrite
Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine
Time frame: Week 12 / Early Termination
Urinalysis - Leukocytes Esterase
Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine
Time frame: Week 12 / Early Termination
Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis
Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above
Time frame: Week 12 / Early Termination
Static Physician's Global Assessment (sPGA)
Number of subjects who achieve an Static Physician's Global Assessment (sPGA) rating of clear; minimal; mild; moderate; severe; or very severe at Week 12 (Day 85).
Time frame: 12 Weeks/Early Termination