ChangE From Any Systemic psoriasiS therapY to Raptiva

Study Overview
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Brief Summary
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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.

Official Title
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A Phase IV Open Label Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Transitioning From Previous Systemic Antipsoriasis Therapies (Methotrexate, Cyclosporine, Retinoids or Psoralen-Ultraviolet Light A (PUVA), Narrow-Band Ultraviolet Light B (NBUVB) to Raptiva 1mg/kg/ Week Therapy.

Conditions
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Chronic Plaque Psoriasis

Intervention / Treatment
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* Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are at least 18 years old. Have plaque psoriasis with an sPGA score of at least moderate or severe at time of initiation of previous systemic treatment. Are transitioning from methotrexate, cyclosporine, retinoids, PUVA or NBUVB and initiating treatment with Raptiva according to the decision of the investigator and in accordance with the indication and the recommendations of the Raptiva Investigator Brochure, i.e. to which they have failed to respond, have a contraindication to or are intolerant of other systemic therapies. Agree to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study. Have given written informed consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care. Women of childbearing potential must use appropriate contraception during treatment and up to the last study visit (safety follow-up visit). For men, it is also mandatory to practice contraception during participation in the trial, as there are no existing data on the effect of Raptiva on spermatogenesis. Discontinuation of any investigational drug or treatment 3 months prior to study start or as per washout requirements from previous protocol. No primary vaccinations (e.g., tetanus, booster, influenza vaccine) for at least 14 days prior to first dose of study drug.For the purposes of this trial, women of childbearing potential is defined as: All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive. Exclusion Criteria: Any contra-indication to Raptiva, according to the Investigator Brochure, or as follows: Hypersensitivity to Raptiva or to any of the excipients. Subjects with history of malignancies. History of active tuberculosis (TB) or currently undergoing treatment for TB. Purified Protein Derivative (PPD) testing or chest X-ray is required for high-risk subjects. Subjects with a positive PPD (not due to BCG vaccination) or chest X-ray will be excluded. Subjects with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis. Subjects with immunodeficiencies. Simultaneous participation in another clinical trial. Subjects experiencing a psoriasis exacerbation during screening period. Subjects who have previously been on Raptiva treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (vaccination, or infection) then the subject can be included in this study. History of hepatitis B, hepatitis C or human immunodeficiency virus (HIV). History of thrombocytopenia, haemolytic anaemia or clinically significant anaemia. Hepatic enzyme levels =/>3 times the upper limit of normal or serum creatinine level =/>2 times the upper limit of normal. Pregnant or breast-feeding. Any medical condition (prior or existing) that, in the judgment of the investigator or sponsor, could jeopardize the subject's safety following exposure to study drug.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Efalizumab<br> | Drug: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematology - Hematocrit | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Hematology - Hemoglobin | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Hematology - Red Blood Cell Count | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Hematology - White Blood Cell Count | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Hematology - Neutrophils | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Hematology - Eosinophils | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Hematology - Basophils | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Hematology - Monocytes | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Hematology - Lymphocytes | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Hematology - Platelet Count | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Biochemistry - Sodium | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Biochemistry - Potassium | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Biochemistry - Creatinine | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Biochemistry - Total Bilirubin | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Biochemistry - Aspartate Transaminase (AST) | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Biochemistry - Alanine Transaminase (ALT) | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Biochemistry - Alkaline Phosphatase | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Biochemistry - Glutamyl Transferase | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination | 
| Biochemistry - Urea | Blood samples were taken for clinical laboratory testing | 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 | Week 12 / Early Termination | 
| Urinalysis - pH | Urine samples were taken for clinical laboratory testing | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Week 12 / Early Termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 Weeks/Early Termination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efalizumab, Chronic Plaque Psoriasis, Transition from systemic therapies on to Efalizumab