A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo; Infliximab
Intervention description: Placebo matched to infliximab given at Weeks 10, 12 and 16 in Infliximab arm and at Weeks 0, 2 and 6 in Placebo arm; 5 mg/kg infusion given intravenously at Week 0,2,6 (induction treatment phase) and at Week 14 and 22 in maintenance phase in infliximab arm and at Week 12 and 16 in Placebo arm.
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Psoriasis; Infliximab; Remicade

Summary:

      The purpose of this study is to determine the superiority and efficacy of infliximab
      induction therapy in chinese participants with moderate to severe plaque-type psoriasis
      (scaly skin rash) compared with placebo (an inactive substance that is compared with a drug
      to test whether the drug has a real effect in a clinical trial).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The body weight should be less than or equal to 80 kilogram

          -  Participants who had a diagnosis of plaque-type psoriasis (scaly skin rash) greater
             than or equal to 6 months before Screening (participants with concurrent psoriatic
             arthritis [joint pain] may be enrolled)

          -  Participants who had plaque-type psoriasis covering greater than or equal to 10
             percent of total body surface area, Psoriasis Area Severity Index (PASI) score greater
             than or equal to 12 at Screening and at the Baseline

          -  Participants who are candidates for systemic treatment of psoriasis

          -  Females of childbearing potential and all men must be using adequate birth control
             measures and agree to use these measures and should not become pregnant (carrying an
             unborn baby) or plan to become pregnant up to 6 months after receiving last infusion
             of study drug

        Exclusion Criteria:

          -  Participants who have nonplaque forms of psoriasis ( for example, erythrodermic,
             guttate, or pustular), or have current drug-induced psoriasis (for example, a new
             onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel
             blockers, or lithium)

          -  Participants who are pregnant, nursing or planning to become pregnant within one year
             while enrolled in the study

          -  Participants who had previous treatment with infliximab

          -  Participants who have received agents targeted at reducing tumour necrosis factor or
             any biologic treatment within the previous 3 months

          -  Participants who have used any investigational drug within the previous 4 weeks or 5
             times the half-life of the investigational agent, whichever is longer