PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept
|ClinicalTrials.gov Identifier: NCT00527072|
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : June 24, 2010
Last Update Posted : September 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis||Biological: infliximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||217 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label Study to Assess the Efficacy and Safety of Infliximab (REMICADE�) Therapy in Patients With Plaque Psoriasis Who Had an Inadequate Response to Etanercept (ENBREL�)|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||October 2009|
infliximabOpen-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
- Number of Patients Who Achieve a Physician Global Assessment (PGA) Score of Minimal (1) or Clear (0) [ Time Frame: Week 10 ]Patients who did not have a PGA score at Week 10 will be treated as not having achieved a PGA score of minimal (1) or clear (0) at Week 10. Specifically, treatment failures prior to Week 10 will be classified as not having a minimal (1) or clear (0).
- Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 10 [ Time Frame: Week 10 ]A PASI 50 responder is defined as a patient who has achieved at least a 50% improvement in the overall PASI score from baseline. PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A score less than 10 signifies a mixture of mild and moderate disease; a score greater than 10 but less than or equal to 30 signifies moderate disease; and a score greater than 30 signifies severe disease.
- Number of Patients Achieved Psoriasis Area Activity Index (PASI) 50 Response at Week 26 [ Time Frame: Week 26 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527072
|Study Director:||Centocor Ortho Biotech Services, L.L.C. Clinical Trial||Centocor Ortho Biotech Services, L.L.C.|