Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis
NCT00333034
Last updated date
ABOUT THIS STUDY
The primary objective is to assess the efficacy and safety of etanercept 50 mg administered
once weekly in subjects with psoriasis over 12 weeks.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
-Adults greater than or equal to 18 years of age with clinically stable plaque psoriasis involving greater than or equal to 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening. -Failure to respond to, or have a contraindication to, or intolerant to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX), Acitretin, Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and Ultraviolet A (PUVA), Fumarate
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
-Previous treatment with etanercept, antibody to TNF or other
TNF inhibitors. -Active guttate, erythrodermic, or pustular psoriasis at the time of the
screening or baseline.
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Advanced Information
| Descriptive Information | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis | |||||||||||||||||||||||||||||||||
| Official Title ICMJE | A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis | |||||||||||||||||||||||||||||||||
| Brief Summary | The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks. | |||||||||||||||||||||||||||||||||
| Detailed Description | Not Provided | |||||||||||||||||||||||||||||||||
| Study Type ICMJE | Interventional | |||||||||||||||||||||||||||||||||
| Study Phase ICMJE | Phase 3 | |||||||||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||||||||||||||||||||||||||||||||
| Condition ICMJE | Psoriasis | |||||||||||||||||||||||||||||||||
| Intervention ICMJE | Drug: Etanercept | |||||||||||||||||||||||||||||||||
| Study Arms ICMJE | Not Provided | |||||||||||||||||||||||||||||||||
| Publications * | Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. | |||||||||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||||||||||||||||||||||||||
| Recruitment Information | ||||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | |||||||||||||||||||||||||||||||||
| Estimated Enrollment ICMJE | 120 | |||||||||||||||||||||||||||||||||
| Original Enrollment ICMJE | Same as current | |||||||||||||||||||||||||||||||||
| Actual Study Completion Date ICMJE | May 2007 | |||||||||||||||||||||||||||||||||
| Primary Completion Date | Not Provided | |||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: -Adults greater than or equal to 18 years of age with clinically stable plaque psoriasis involving greater than or equal to 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening. -Failure to respond to, or have a contraindication to, or intolerant to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX), Acitretin, Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and Ultraviolet A (PUVA), Fumarate Exclusion Criteria: -Previous treatment with etanercept, antibody to TNF or other TNF inhibitors. -Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline.
 | |||||||||||||||||||||||||||||||||
| Sex/Gender ICMJE |
| |||||||||||||||||||||||||||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers ICMJE | Yes | |||||||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||||||||||||||
| Listed Location Countries ICMJE | Austria, Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain | |||||||||||||||||||||||||||||||||
| Removed Location Countries | ||||||||||||||||||||||||||||||||||
| Administrative Information | ||||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00333034 | |||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 0881A6-318 | |||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||||||||||||||||||||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||||||||||||||
| Responsible Party | Not Provided | |||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||||||||||||||
| Collaborators ICMJE | Amgen | |||||||||||||||||||||||||||||||||
| Investigators ICMJE |
| |||||||||||||||||||||||||||||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||||||||||||||
| Verification Date | December 2007 | |||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||||||||||||||||||||||||||