The primary purpose of the study is to evaluate the safety and efficacy of Raptiva® compared to placebo in controlling moderate to severe chronic plaque psoriasis involving palms and/or soles scoring Palmo-plantar Pustular Psoriasis Area and Severity Index (PPPASI) ≥5 in subjects that are candidates for phototherapy or systemic therapies. The rational of the trial is that psoriasis involving palms and/or soles is a painful condition associated with fissuring, scaling and in some instances with pustulation. Because of its localization, it is a disabling condition that limits dexterity and affects social interaction, leading to compromised quality of life; and this confers additional severity to that of plaque psoriasis on the body. The therapeutic approach for palm and sole plaque-type psoriasis usually begins with topical corticosteroid treatment. If the disease reaches a certain extent, the next step involves the addition of systemic treatments. Substances like methotrexate, retinoids and cyclosporine have shown to be efficacious, but their long-term usage is often limited by toxicity. Biologic treatments for psoriasis avoid this toxicity and offer a new therapeutic approach. The therapeutic potential of Raptiva® to treat palm and sole psoriasis refractory to systemic treatments has been described in numerous case reports and in one placebo-controlled phase IV study. However, in all cases, the number of subjects included was low, and in most cases the trials were not prospectively designed. Since the efficacy of Raptiva® on psoriasis of palms and soles must be determined using the validated PPPASI measure, it is necessary for scientific and ethical reasons to include a placebo arm during the first 12 weeks. Finally, as the clinical response may sometimes take longer than 12 weeks, subjects must be treated and evaluated during an additional 12-week open-label extended treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
6
Double-blind phase 0.7mg/kg subcutaneously (sc), followed by 1mg/kg/wk sc for 12 weeks. Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks.
Double-blind phase sc Placebo for 12 weeks. Open label extension 0.7mg/kg sc Raptiva followed by 1mg/kg/wk sc for a further 12 weeks.
Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI)
Minimum possible score 0, maximum possible score 72.
Time frame: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Static Physician Global Assessment Hands and Feet (sPGA - H&F)
Minimum possible score 0, maximum possible score 4.
Time frame: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20 visits and Early Termination Visit
Psoriasis Area and Severity Index (PASI)
Minimum possible score 0, maximum possible score 72.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Static Physician Global Assessment (SPGA)
The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse
Time frame: Measured at Screening, Day 0 and Day 7
Dynamic Physician's Global Assessment of Change (dPGA)
The global response of all psoriatic lesions to therapy compared with the baseline condition using Study Day 0 Body Diagrams will be evaluated using the following categories: Cleared (100% improvement), Excellent (75-99 improvement), Good (50-74% improvement), Fair (25-49% improvement), Slight (1-24% improvement), Unchanged, or Worse
Time frame: Measured at Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Participants With Direct Physical Examination Abnormalities
Physical examination included Lymph node palpation, Abdominal palpation, Auscultation of the lung, heart and intestinum
Time frame: Measured at at screening, Day 0, Week 4, Week 12, and Early Termination visits
Complaint Directed Physical Examinations
Number of participants undergoing complaint directed physical examinations
Time frame: Measure at (Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits)
Heart Rate
Time frame: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits
Arterial Blood Pressure
Time frame: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits
Temperature
Time frame: Measure at Day 0, Day 7, Week 8, Week 16 and Follow Up and Early Termination visits
Weight Measurements
Time frame: Measured at Screening, Day 0, Day 7, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Haemoglobin
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Haematocrit
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Red Cell Count
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - White Cell Count
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Platelets
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Neutrophils
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Lymphocytes
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Monocytes
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Eosinophils
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Haematology Laboratory Assessments - Basophils
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Sodium
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Potassium
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Urea
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Creatinine
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Total Bilirubin
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Total Protein
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Calcium
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Aspartate Transaminase
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Alanine Transaminase
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Gamma Glutamyl Transpeptidase
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - Alkaline Phosphatase
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Clinical Chemistry Laboratory Assessments - C Reactive Protein
Participants with abnormal laboratory values considered by the Investigator to be clinically significant reported as adverse events.
Time frame: Measured at Screening, Day 0, Week 4, Week 8, Week 12, Week 16, Week 20, and Early Termination visits
Negative Serum Human Chorionic Gonadotrophin (hCG) Pregnancy Test
A serum human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.
Time frame: Measured at screening (Day -14 to Day -1)
Negative Urinary Human Chorionic Gonadotrophin (hCG) Pregnancy Test
A urinary human chorionic gonadotrophin (hCG) pregnancy test will be conducted for all female subjects of childbearing potential prior to entering the study.
Time frame: Measured at screening (Day -14 to Day -1)
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