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.

Study Overview

• Status: Withdrawn
• Conditions: Pediatric Psoriasis
• Intervention / Treatment: Drug: Enbrel group

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

pediatric patients (ages of 8~17)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Enbrel; The patients who are prescribed Enbrel for pediatric psoriasis	Drug: Enbrel group; will be decided by treating physicians

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	6 month

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: August 5, 2011
• First Submitted That Met QC Criteria: September 8, 2011
• First Posted (Estimate): September 12, 2011

Study Record Updates

• Last Update Posted (Estimate): November 18, 2013
• Last Update Submitted That Met QC Criteria: November 14, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: safety; efficacy; pediatric psoriasis; enbrel
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: B1801135