Phase 3
Completed N=129
A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type Psoriasis
Source: ClinicalTrials.gov NCT01177800 ↗Enrolled (actual)
129
Serious AEs
3.9%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI) — 81; 2.2 percentage of participants — p=<0.001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI) |
81; 2.2 | <0.001 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10 |
14.4; 14.4; -8.0; -1.5 | <0.001 sig |
| SECONDARY Percentage of Participants With Static Physician Global Assessment (PGA) Score Less Than Equal to 1 at Week 10 |
88.1; 6.7 | <0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT01177800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.