NCT01177800

A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type Psoriasis

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Infliximab in the Treatment of Chinese Subjects With Moderate to Severe Plaque-type Psoriasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo matched to infliximab given at Weeks 10, 12 and 16 in Infliximab arm and at Weeks 0, 2 and 6 in Placebo arm
DRUG	Infliximab	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.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-02-01
• Completion: 2010-09-01
• First posted: 2010-08-09
• Last updated: 2014-09-12
• Results posted: 2014-03-17

Locations

7 sites across 1 country: China