Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
NCT01432249
ABOUT THIS STUDY
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Adult Trials: 18+ Years
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
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)
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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| Recruitment Status | Withdrawn | |||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 | 0 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | November 2013 | |||