Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
NCT00111449
Last updated date
ABOUT THIS STUDY
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.
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
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Advanced Information
| 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 | 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 * |
| |||
* 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 | |||
| Enrollment ICMJE | 600 | |||
| Original Enrollment ICMJE | Not Provided | |||
| Study Completion Date ICMJE | Not Provided | |||
| Primary Completion Date | Not Provided | |||
| 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 | |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | United States | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00111449 | |||
| Other Study ID Numbers ICMJE | 20030117 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Amgen | |||
| Study Sponsor ICMJE | Amgen | |||
| Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | Amgen | |||
| Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||