Status:
COMPLETED
A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type Psoriasis
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01177800
Start Date
February 1 2009
End Date
September 1 2010
Last Update
September 12 2014
Active Locations (7)
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1
Beijing, China
2
Beijng, China
3
Dalian, China
4
Jinan, China