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

Last updated on December 11, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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.
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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Withdrawn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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Descriptive Information
Brief Title Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
Official Title Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
Brief Summary 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 All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as per the local product information for usage.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population pediatric patients (ages of 8~17)
Condition Pediatric Psoriasis
Intervention Drug: Enbrel group
will be decided by treating physicians
Study Groups/Cohorts Enbrel
The patients who are prescribed Enbrel for pediatric psoriasis
Intervention: Drug: Enbrel group
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: November 14, 2013)
0
Original Estimated Enrollment
 (submitted: September 8, 2011)
600
Estimated Study Completion Date September 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01432249
Other Study ID Numbers B1801135
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2013

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

BY EMAIL

Contact

[email protected]

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