|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 20, 2005 | ||||
| Last Updated Date | July 17, 2008 | ||||
| Start Date ICMJE | June 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment. | ||||
| Original Primary Outcome Measures ICMJE |
*The measure of the effect of etanercept 50 mg bi-weekly compared to placebo in adult subjects with psoriasis. | ||||
| Change History | Complete list of historical versions of study NCT00111449 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
*Long term safety and tolerability of etanercept in adults with psoriasis. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis | ||||
| Official Title ICMJE | A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis | ||||
| Brief Summary | The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly. |
||||
| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Psoriasis | ||||
| Intervention ICMJE | Drug: Etanercept | ||||
| 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 600 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis |
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00111449 | ||||
| Responsible Party | Global Development Leader, Amgen Inc. | ||||
| Study ID Numbers ICMJE | 20030117 | ||||
| Study Sponsor ICMJE | Amgen | ||||
| Collaborators ICMJE | Wyeth | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Amgen | ||||
| Verification Date | July 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||