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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01432249
First received: August 5, 2011
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Pediatric Psoriasis
Drug: Enbrel group
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety measured by discontinuation due to adverse events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a 50% and 75% improvement from baseline in PASI (Psoriasis Area-and-Severity Index) over 12 weeks and 24 weeks [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Enbrel
The patients who are prescribed Enbrel for pediatric psoriasis
Drug: Enbrel group
will be decided by treating physicians

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

pediatric patients (ages of 8~17)

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432249

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01432249     History of Changes
Other Study ID Numbers: B1801135
Study First Received: August 5, 2011
Last Updated: November 14, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Pfizer:
pediatric psoriasis
enbrel
safety
efficacy

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 23, 2014