TRUST Study: Raptiva ® in Hand & Foot Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Efalizumab - anti CD11a recombinant human monoclonal antibody; Placebo
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 1.0 mg/kg/week. The treatment period will be 24 weeks divided into two phases: 1) double-blind for 12 weeks, and 2) open-label for 12 additional weeks, in which all subjects from the placebo group and those subjects from the Raptiva ® group with ≥ 50% of improvement will be allocated to extended treatment with Raptiva ® for 12 additional weeks while non-responders to Raptiva ® (improvement ≤ 50%) will be followed in an observational manner for 12 additional weeks without treatment.; Placebo will be administered at Study Day (SD) 1, Week (W) 1, W 4, W 8 and W 12. Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1.0 mg/kg/week for 12 weeks (double-blind phase)
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Efalizumab,; Chronic plaque psoriasis; moderate to severe; involving; hands; feet

Summary:

      To evaluate the safety and efficacy of Raptiva ® compared with placebo to control chronic
      moderate to severe plaque psoriasis involving the hands and/or feet scoring Physician's
      Global Assessment (PGA - H&F) greater-than or equal to 3 in subjects not suitable for other
      systemic therapies including cyclosporine, methotrexate, and Psoralen-Ultraviolet Light A
      (PUVA).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject with chronic (disease history of at least 6 months from diagnosis) moderate to
             severe plaque psoriasis involving the hands and/or feet (PGA - H&F ratings of 3 or 4)
             at screening, who have failed to respond to, or who have a contraindication to, or are
             intolerant to other systemic therapies including cyclosporin, methotrexate and PUVA.
             Subjects will be outpatients.

          2. Stable disease at study entry (i.e. no exacerbation of psoriasis during the screening
             period).

          3. At least 18 years old.

          4. For women of childbearing potential, 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. For men, during
             the participation, it is mandatory to practice birth control, as there are not
             existing data on the effect of Raptiva ® on spermatogenesis.

          5. Discontinuation of any systemic psoriasis treatment at study entry. No washout period
             is required for these traditional systemic psoriasis agents prior to starting study
             treatment.

          6. Discontinuation of all biological agents at least 3 months prior to first study
             injection.

          7. Discontinuation of any investigational drug or treatment at least 3 months prior to SD
             1 or as per washout requirements from previous protocol.

          8. Willingness and ability to comply with the protocol requirements for the duration of
             the study.

          9. Written informed consent, given prior to any study-related procedure not part of
             normal medical care, with the understanding that the subject may withdraw his/her
             consent at any time without prejudice to future medical care.

        Exclusion Criteria:

          1. Hypersensitivity to efalizumab or to any of the excipients

          2. Current use of any prohibited therapy (systemic or topical treatments for psoriasis,
             immunosuppressive drugs, any other experimental drug, etc)

          3. Previous or current exposure to Raptiva®

          4. History of or ongoing alcohol or drug abuse

          5. History of or an ongoing opportunistic infection (e.g. systemic fungal infection,
             parasites) or any other serious infection. This includes diagnoses that required more
             than 2 weeks of therapy, such as endocarditis and osteomyelitis, that have been
             treated in the past 6 months. In addition, if the subject is currently receiving
             antibiotics, antivirals, or antifungals for an infection or for suppression or
             prophylaxis for any diagnosis, the subject will be excluded.

          6. Seropositivity for hepatitis B antigen, hepatitis C antibody, or human
             immunodeficiency virus (HIV). Subjects will undergo testing during screening, and any
             subjects who are seropositive for hepatitis B antigen, hepatitis C antibody, or HIV
             will be excluded.

          7. History of active or latent tuberculosis within one year prior to screening (to be
             determined by assessment according to national and/or local recommendation).

          8. Presence or history of malignancy, including lymphoproliferative disorders.

          9. Pregnancy or breast-feeding

         10. History of hepatic cirrhosis, regardless of cause or severity

         11. History of thrombocytopenia, haemolytic anaemia, clinically significant anaemia, a
             white blood cell count <4,000 cells/μL or >14,000 cells/μL, a haematocrit (HCT) <30%
             or a haemoglobin (Hgb) level <11 g/dL, a platelet count <150,000 cells/μL

         12. Hepatic enzyme levels ≥3 times the upper limit of normal or serum creatinine level ≥2
             times the upper limit of normal

         13. Vaccination with a live or live-attenuated virus or live or live-attenuated bacteria
             vaccine within the 14 days prior to the first dose of Raptiva®

         14. Any medical condition that, in the judgment of the Investigator, would jeopardise the
             subject's safety following exposure to investigational medicinal product (Raptiva® or
             placebo equivalent) or would significantly interfere with the Subject's ability to
             comply with the provisions of this protocol.

         15. Other specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as
             sole or predominant for of psoriasis.

         16. Immunodeficiencies.