ChangE From Any Systemic psoriasiS therapY to Raptiva
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb)
Intervention description: 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.
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Efalizumab; Chronic Plaque Psoriasis; Transition from systemic therapies on to Efalizumab

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Are at least 18 years old.

          2. Have plaque psoriasis with an sPGA score of at least moderate or severe at time of
             initiation of previous systemic treatment.

          3. 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.

          4. 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.

          5. Have given written informed consent with the understanding that consent may be
             withdrawn at any time without prejudice to future medical care.

          6. 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.

          7. 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:

          1. 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.

          2. Simultaneous participation in another clinical trial.

          3. Subjects experiencing a psoriasis exacerbation during screening period.

          4. 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.

          5. History of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).

          6. History of thrombocytopenia, haemolytic anaemia or clinically significant anaemia.

          7. Hepatic enzyme levels =/>3 times the upper limit of normal or serum creatinine level
             =/>2 times the upper limit of normal.

          8. Pregnant or breast-feeding.

          9. 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.