Post Marketing Surveillance To Observe Safety And Efficac... | NCT01432249

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

NCT01432249

Sponsor

Pfizer

Status

Withdrawn

Last Update Posted

Nov 18, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Pediatric Psoriasis

Interventions

Enbrel group

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Sep 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Aug 5, 2011

First Submission Date that Met QC Criteria

Sep 8, 2011

First Posted Date

Sep 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2013

Last Update Posted Date

Nov 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enbrel		The patients who are prescribed Enbrel for pediatric psoriasis	Drug: Enbrel group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enbrel group	Drug	will be decided by treating physicians	Enbrel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety measured by discontinuation due to adverse events		6 month

Secondary Outcomes

Measure	Description	Time Frame
Proportion of subjects achieving a status on the PGA (Physician's Global Assessment) of psoriasis of clear (0), clear/almost clear (0/1), or clear/almost clear/mild (0/1/2) at 12 weeks and 24 weeks		6 month
Proportion of subjects achieving a 50% and 75% improvement from baseline in PASI (Psoriasis Area-and-Severity Index) over 12 weeks and 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

pediatric patients (ages of 8~17)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

References Module

Citations

Not provided