A Study to Evaluate Infliximab in Subjects With Moderate-to-Severe Psoriasis Not Responding to Standard or Biologic Therapy (Study P04612) (ESAQUALITY)
|ClinicalTrials.gov Identifier: NCT00687401|
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : December 24, 2010
Last Update Posted : April 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Biological: Infliximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||215 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Open Label Trial Evaluating the Efficacy , SAfety and the Impact on QUAlity of Life of Infliximab TherapY in Patients With Moderate-to-severe Psoriasis Not Responding to Standard or Biologic Therapy|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Experimental: Infliximab 5 mg/kg
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6, and 14.
Infliximab 5 mg/kg of body weight administered as an infusion at Weeks 0, 2, 6 (induction phase), and 14 (maintenance phase).
Other Name: Remicade, SCH 215596
- Number of Participants Who Achieve a Greater Than or Equal to 75% Improvement in Psoriasis Area and Severity Index (PASI) Score [ Time Frame: 10 weeks ]
PASI 75 response is defined as participants who achieved at least a
75% improvement in PASI score from Baseline to Week 10. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their responses to therapy. The PASI produces a numeric score that can range from 0 to 72 (the higher the number, the worse the disease).