PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|