A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Condition: Candidates for Systemic Therapy for Psoriasis; Psoriasis
MeSH terms: Psoriasis
Intervention: Efalizumab
Intervention description: Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 189.0
Sex: All
Minimum age: 17 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      An open-label, multi-center study to establish psoriasis control of moderate to severe plaque
      psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A) In the opinion of the investigator, candidate for systemic therapy for psoriasis
             could include:

          -  Patients with moderate to severe plaque psoriasis defined by Psoriasis Area and
             Severity Index (PASI) less than (>) 10 and body surface area (BSA) greater than (>) 10

          -  Patients with the following may also be deemed to require systemic therapy in the
             judgement of the physician:

          -  Severe psychosocial disability (in the judgement of the physician), or

          -  Nail psoriasis, or

          -  Scalp psoriasis, or

          -  Palmar plantar psoriasis etc OR

          -  B) Subjects who have completed the CLEAR study investigational medicinal product (IMP)
             24011 (NCT00256139) and who wish to continue Raptiva (efalizumab) therapy.

          -  Body weight of 120 kg

          -  18 to 75 years old

          -  For women of childbearing potential and for men whose partner can become pregnant, use
             of an acceptable method of contraception to prevent pregnancy and agreement to
             continue to practice an acceptable method of contraception for the duration of their
             participation in the study up to 3 months after the last dose of Raptiva

          -  Willingness to hold sun exposure reasonably constant and to avoid use of tanning
             booths or other ultraviolet (UV) light sources during the study

          -  Agreement to participate in the study

          -  Signed informed consent

          -  Discontinuation of any systemic psoriasis treatment prior to commencement of the study
             drug. No washout period is required for these agents prior to starting study and
             receiving first dose of study drug (Raptiva)

          -  Discontinuation of all biologic agents (other than Raptiva) 3 months prior to
             receiving first dose of study drug (Raptiva)

          -  Discontinuation of Psoralen-ultraviolet light A (PUVA), Ultraviolet light B (UVB)
             treatment 28 days prior to commencement of receiving first dose of study drug.

          -  Discontinuation of any investigational drug or treatment 3 months prior to study Day 0
             or as per washout requirements from previous protocol

          -  No vaccinations (e.g., tetanus, booster, influenza vaccine) at least 14 days prior to
             first dose of study drug

          -  Treatment regimens of b-blockers, Angiotensin-converting enzyme (ACE) inhibitors,
             antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days
             prior to first dose of study drug

        Exclusion Criteria:

          -  Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis

          -  Active rebound of psoriasis during or following discontinuation of the previous
             Raptiva treatment( PASI >125% from baseline and/or new predominant morphology of
             psoriasis) when reason was adverse event or lack of efficacy of Raptiva. If it was due
             to another non drug reason (vaccination, or infection) then the patient can be
             included in this study.

          -  History of severe allergic or anaphylactic reactions to humanised monoclonal
             antibodies

          -  History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial
             infection

          -  History of opportunistic infections (e.g., systemic fungal infections, parasites)

          -  Seropositivity for human immunodeficiency virus (HIV). Patients will undergo mandatory
             testing at screening. Patients who are positive for HIV will be excluded.

          -  Pregnancy or lactation

          -  White blood cell (WBC) count <4000 per Liter (L) or >14,000/L

          -  Patient with a history of clinically significant thrombocytopenia, bleeding disorders
             or a platelet count < 00,000 cells/L

          -  Seropositivity for hepatitis B or C virus Patients will undergo testing at screening.
             Patients who are positive for hepatitis B antigen or hepatitis C antibody will be
             excluded.

          -  Hepatic enzymes >3 times the upper limit of normal

          -  History of active tuberculosis (TB) or currently undergoing treatment for TB within
             one year prior to study Day 0. Chest X-ray (within 3 months prior to Study Day 0) is
             required for high-risk patients. Patients with a positive chest X-ray will be
             excluded.

          -  Presence of malignancy within the past 5 years, including lymphoproliferative
             disorders. Patients with a history of fully resolved basal cell or squamous cell skin
             cancer may be enrolled.

          -  Diagnosis of hepatic cirrhosis, regardless of cause or severity

          -  Serum creatinine >2 times the upper limit of normal

          -  Hospital admission for cardiac disease, stroke, or pulmonary disease within the last
             year

          -  History of substance abuse within the last 5 years

          -  Any medical condition that, in the judgment of the investigator, would jeopardize the
             patient's safety following exposure to study drug