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Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis

NCT ID: NCT01432249

Last Updated: 2013-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-09-30

Brief Summary

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Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new indication should be provided at minimum 600 subjects administered in the setting of routine practice during the initial 4 years after new indication approved.

Detailed Description

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All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as per the local product information for usage.

Conditions

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Pediatric Psoriasis

Keywords

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pediatric psoriasis enbrel safety efficacy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Enbrel

The patients who are prescribed Enbrel for pediatric psoriasis

Enbrel group

Intervention Type DRUG

will be decided by treating physicians

Interventions

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Enbrel group

will be decided by treating physicians

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Children and adolescents aged 8 years to 17 years at time of consent
2. Chronic severe psoriasis patients who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies

Exclusion Criteria

1. Patients with known hypersensitivity to Enbrel or any component of the product
2. Patients with active infections including chronic or localized infections such as tuberculosis (Treatment of Enbrel should not be initiated)
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801135&StudyName=Post%20Marketing%20Surveillance%20To%20Observe%20Safety%20And%20Efficacy%20Of%20Enbrel%20In%20Pediatric%20Patients%20With%20Psoriasis

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1801135

Identifier Type: -

Identifier Source: org_study_id