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Pediatric Open-Label Extension Study of Etanercept in Patients With Plaque Psoriasis

NCT ID: NCT00141921

Last Updated: 2017-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-11

Study Completion Date

2017-08-16

Brief Summary

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The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.

Detailed Description

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This study was a multicenter, open-label extension study for pediatric patients who participated in Study 20030211 (NCT00078819).

Conditions

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Pediatric Plaque Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etanercept

Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection

Interventions

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Etanercept

Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Enbrel®

Eligibility Criteria

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Inclusion Criteria

* Enrollment on previous Amgen study 20030211 (NCT00078819)

Exclusion Criteria

* Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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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.

Reference Type BACKGROUND
PMID: 20605256 (View on PubMed)

Paller AS, Siegfried EC, Pariser DM, Rice KC, Trivedi M, Iles J, Collier DH, Kricorian G, Langley RG. Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis. J Am Acad Dermatol. 2016 Feb;74(2):280-7.e1-3. doi: 10.1016/j.jaad.2015.09.056.

Reference Type BACKGROUND
PMID: 26775775 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20050111

Identifier Type: -

Identifier Source: org_study_id