Pediatric Open-Label Extension Study
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00141921
First received: August 31, 2005
Last updated: May 1, 2013
Last verified: May 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 31, 2005 | ||||
| Last Updated Date | May 1, 2013 | ||||
| Start Date ICMJE | August 2005 | ||||
| Estimated Primary Completion Date | November 2019 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE |
Subject incidence of adverse events, including infectious episodes, serious adverse events, and serious infectious episodes | ||||
| Change History | Complete list of historical versions of study NCT00141921 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pediatric Open-Label Extension Study | ||||
| Official Title ICMJE | An Open-Label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis | ||||
| Brief Summary | The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric subjects with moderate to severe psoriasis. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Pediatric Plaque Psoriasis | ||||
| Intervention ICMJE | Drug: Etanercept
open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given QW SC in 1 or 2 injections |
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| Study Arm (s) | Experimental: 1
Intervention: Drug: Etanercept |
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| Publications * | Paller AS, Siegfried EC, Eichenfield LF, Pariser D, Langley RG, Creamer K, Kricorian G. Long-term etanercept in pediatric patients with plaque psoriasis. J Am Acad Dermatol. 2010 Nov;63(5):762-8. doi: 10.1016/j.jaad.2010.04.004. Epub 2010 Jun 3. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 182 | ||||
| Estimated Completion Date | December 2019 | ||||
| Estimated Primary Completion Date | November 2019 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Enrollment on previous Amgen study 20030211 Exclusion Criteria: - Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept |
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00141921 | ||||
| Other Study ID Numbers ICMJE | 20050111 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Amgen | ||||
| Study Sponsor ICMJE | Amgen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Amgen | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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