Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
NCT00111436
Last updated date
ABOUT THIS STUDY
The purpose of this study is to evaluate the safety and tolerability of long-term
administration of etanercept in adults with psoriasis who have participated in previous
etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy
of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis
studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly
(if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72
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
- Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)
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
- Pregnant or breast-feeding females
- Evidence of skin conditions at the time of the screening visit (e.g., eczema) that
would interfere with evaluations of the effect of the investigational product on
psoriasis
NEED INFO?
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects | |||
| Official Title ICMJE | An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects | |||
| Brief Summary | The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Psoriasis | |||
| Intervention ICMJE | Drug: Etanercept
Enbrel 50 mg once weekly or 50 mg twice weekly | |||
| Study Arms ICMJE |
| |||
| 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 | 912 | |||
| Original Enrollment ICMJE | Not Provided | |||
| Actual Study Completion Date ICMJE | July 2005 | |||
| Actual Primary Completion Date | July 2005 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol) 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 | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00111436 | |||
| Other Study ID Numbers ICMJE | 20030115 | |||
| 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 |
| |||
| Investigators ICMJE |
| |||
| PRS Account | Amgen | |||
| Verification Date | April 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||