Clinical Trials Logo
  1. Home
  2. Pediatric Psoriasis
  3. NCT01432249
  4. Details
NCT01432249 Clinical Trial

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

Pediatric Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01432249
Other study ID # B1801135
Secondary ID
Status Withdrawn
Phase Phase 4
First received August 5, 2011
Last updated November 14, 2013
Start date March 2013
Est. completion date September 2013

Study information
Verified date November 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 17 Years
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Enbrel group
will be decided by treating physicians

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Safety measured by discontinuation due to adverse events 6 month Yes
Secondary 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 No
Secondary Proportion of subjects achieving a 50% and 75% improvement from baseline in PASI (Psoriasis Area-and-Severity Index) over 12 weeks and 24 weeks 6 month No

External Links