Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
This study is not yet open for participant recruitment.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01432249
First received: August 5, 2011
Last updated: May 14, 2013
Last verified: May 2013
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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 ]
| Estimated Enrollment: | 600 |
| Study Start Date: | May 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:
- 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)
Contacts and Locations 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: | May 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 May 19, 2013