Chronic Plaque Psoriasis Clinical Trial
Official title:
A Phase IV Multicentre, Randomized Double-blind, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Raptiva in the Treatment of Subjects With Moderate to Severe Chronic Plaque Psoriasis Involving Palms and/or Soles, With or Without Pustules.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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