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

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NCT01432249

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pediatric Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
8-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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)

NCT01432249
Pfizer
Withdrawn
Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis

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Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
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.
All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as per the local product information for usage.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
pediatric patients (ages of 8~17)
Pediatric Psoriasis
Drug: Enbrel group
will be decided by treating physicians
Enbrel
The patients who are prescribed Enbrel for pediatric psoriasis
Intervention: Drug: Enbrel group
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2013
September 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01432249
B1801135
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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