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).
This is a double-blind (neither physician nor participant knows the treatment that the participant receives), multicenter (when more than one hospital or medical school team work on a medical research study) and placebo-controlled study of infliximab in participants with moderate to severe plaque-type psoriasis. All the eligible participants will be randomly assigned to infliximab and placebo groups. The infliximab group will receive 5 milligram per kilogram (mg/kg) infliximab infusions (a fluid or a medicine delivered into a vein by way of a needle) intravenously (into a vein) at Week 0, 2 and 6 in the induction treatment phase followed by maintenance regimen of the intervention every 8 weeks up to 26 weeks. Placebo infusions will also be given at Week 10, 12 and 16. The placebo group will receive placebo infusion at Week 0, 2, 6, 14 and 22. At Week 10, participants in placebo group will then receive infliximab induction therapy. Efficacy of the participants will primarily be evaluated by percentage of participants who achieve a Psoriasis Area and Severity Index 75 (PASI) response at Week 10. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
129
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.
Unnamed facility
Beijing, China
Unnamed facility
Beijng, China
Unnamed facility
Dalian, China
Unnamed facility
Jinan, China
Unnamed facility
Nanjing, China
Percentage of Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI)
The PASI score is based on the assessment of the erythema (e), induration (I), scaling (S), and the body is divided into 4 regions head, trunk, upper extremities, lower extremities. The assessment was done on 4-point scale (where, 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe). The total possible score ranges from 0 (no disease) to 72 (maximal disease). Participants with no less than 75 percent relative Baseline improvement in the PASI scores are considered to be PASI 75 responders.
Time frame: Week 10
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10
The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.
Time frame: Baseline and Week 10
Percentage of Participants With Static Physician Global Assessment (PGA) Score Less Than Equal to 1 at Week 10
The Static physician global assessment (PGA) determines psoriasis lesions overall at given time point. Overall lesions graded for I (0= no evidence of plaque elevation to 5= severe plaque elevation), E (0 = no evidence of E, hyperpigmentation may be present to 5=dusky to deep red coloration), S (0 = no evidence of S to 5 = severe; very thick tenacious scale predominates). Sum of 3 scales divided by 3 gives final PGA score. Range for final score is 0 = cleared, except for residual discoloration, 1 = minimal, 2 = mild, 3=moderate, 4= marked and 5= severe; Scores should be rounded to the nearest whole number. If total ≤1.49, score = 1; if total≥ 1.50, score = 2. Percentage of participants with static PGA score \<= 1 at week 10 were reported.
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Unnamed facility
Shanghai, China
Unnamed facility
Xi'an, China
Time frame: Week 10