![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | September 6, 2007 | ||||
Last Updated Date | April 30, 2009 | ||||
Start Date † | July 2007 | ||||
Current Primary Outcome Measures † |
The primary analysis for the study is the proportion of patients achieving a Physician's Global Assessment (PGA) of minimal (1) or clear (0) at Week 10. [ Time Frame: Week 10 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00527072 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Some major secondary analyses include the proportion of patients: with PGA of 1 or 0 at Weeks 1, 2, 4, 6, 14, 22, and 26; achieving PASI 50, PASI 75, PASI 90, and PASI 100 at Weeks 10 and 26; achieving a DLQI score of 0 or 1 at Weeks 10 and 26. [ Time Frame: Through Week 26 ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept | ||||
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®) | ||||
Brief Summary | The purpose of this study is to test the safety and effectiveness of infliximab in patients with plaque psoriasis who have been receiving the drug etanercept for treatment of their plaque psoriasis for at least four months, without enough improvement in their psoriasis symptoms. |
||||
Detailed Description | The most common form of psoriasis is plaque-type psoriasis, which is characterized by recurrent flaring of thickened, red, scaly patches of skin. Although psoriasis is usually not life threatening, these physical discomforts combined with the potential psychological effects of the disease may interfere with everyday activities and negatively impact an individual's quality of life. Infliximab is an antibody made in a laboratory. Antibodies are proteins that fight other substances in the body that may cause infections or diseases. A substance called "tumor necrosis factor" (TNF) naturally occurs in the body. TNF is related to the itchy patches of skin (or plaques) of psoriasis. Infliximab stops the TNF from working. Other studies have shown that stopping the TNF may reduce the plaques. To address the unmet medical need for effective chronic therapies, TNFalpha blockers have recently been used to treat patients with moderate to severe plaque psoriasis. Etanercept also works by stopping the TNF, but in a different way than infliximab. This multi-center, open-label study is designed to test whether or not patients with plaque psoriasis who have not responded well to etanercept treatment may benefit from treatment with infliximab. Key effectiveness measurements will include the time to onset of symptom improvement and health-related quality of life. Safety will be assessed throughout the study. Two weeks after their last dose of etanercept, all eligible patients will receive open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22. |
||||
Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Psoriasis | ||||
Intervention † | Biological: infliximab | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 210 | ||||
Estimated Completion Date | April 2009 | ||||
Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 18 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
|
||||
Location Countries † | United States, Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00527072 | ||||
Responsible Party | Sr. Director, Clinical Research - Medical Affairs, Centocor Inc. | ||||
Secondary IDs †† | C0168Z04 | ||||
Study Sponsor † | Centocor, Inc. | ||||
Collaborators †† | |||||
Investigators † |
|
||||
Information Provided By | Centocor, Inc. | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |