Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis
NCT00195507
Last updated date
ABOUT THIS STUDY
This study will provide a direct comparison of 'continuous therapy' and 'intermittent
therapy' with withdrawal and retreatment upon return of psoriasis.
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
- Stable, active plaque psoriasis
- Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Evidence of skin conditions other than psoriasis that would interfere with evaluations
of the effect of the study
- Systemic psoriasis therapy within 28 days prior
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Advanced Information
| Descriptive Information | ||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Etanercept in the Treatment of Subjects With Psoriasis | |||||||||||||||||||||||||||||||||
| Official Title ICMJE | A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis | |||||||||||||||||||||||||||||||||
| Brief Summary | This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis. | |||||||||||||||||||||||||||||||||
| Detailed Description | Not Provided | |||||||||||||||||||||||||||||||||
| Study Type ICMJE | Interventional | |||||||||||||||||||||||||||||||||
| Study Phase ICMJE | Phase 4 | |||||||||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||||||||||||||||||||||||||||||||
| Condition ICMJE | Psoriasis | |||||||||||||||||||||||||||||||||
| Intervention ICMJE | Drug: Etanercept | |||||||||||||||||||||||||||||||||
| Study Arms ICMJE | Not Provided | |||||||||||||||||||||||||||||||||
| Publications * |
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* 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 | |||||||||||||||||||||||||||||||||
| Actual Enrollment ICMJE | 720 | |||||||||||||||||||||||||||||||||
| Original Enrollment ICMJE | 700 | |||||||||||||||||||||||||||||||||
| Actual Study Completion Date ICMJE | February 2007 | |||||||||||||||||||||||||||||||||
| Primary Completion Date | Not Provided | |||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||||||||||||||||||||||||||||||||
| 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 | Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom | |||||||||||||||||||||||||||||||||
| Removed Location Countries | ||||||||||||||||||||||||||||||||||
| Administrative Information | ||||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00195507 | |||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 0881A6-101764 | |||||||||||||||||||||||||||||||||
| 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 | Not Provided | |||||||||||||||||||||||||||||||||
| Investigators ICMJE |
| |||||||||||||||||||||||||||||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||||||||||||||
| Verification Date | April 2010 | |||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||||||||||||||||||||||||||