| Original Study ID : 20030211 |
| NCT ID : NCT00078819 |
| Brief Title : Etanercept (Enbrel®) in Psoriasis - Pediatrics |
| Official Title : Placebo-Controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS) |
| Brief Summary :
This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with
Psoriasis.
This is a Phase 3 blinded, placebo-controlled study.
|
| Source : Amgen |
| Overall Status : Completed |
| Start Date : August 2004 |
| End Date : June 2007 |
| Completion Date : June 2007 |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 211 |
| Verification Date : September 2008 |
| First Received Date : March 5, 2004 |
| Trial Eligibility |
Criteria :
- Patients with plaque psoriasis - Patient may not receive certain psoriasis medications
during the study
|
| Gender : Both |
| Minimum Age : 4 Years |
| Maximum Age : 17 Years |
| Healthy Volunteers : No |
| OutComes |
| Primary OutComes |
| Measure : PASI (Psoriasis Area and Severity Index) 75 response at week 12, defined as a 75% or greater decrease in PASI score (i.e., improvement) from baseline at
week 12. |
| Time Frame : 12 weeks |
| Safety issue : No |
|
| Secondary OutComes |
| Measure : PASI 50 response at week 12 |
| Time Frame : 12 Weeks |
| Safety issue : No |
|
| Measure : PASI 90 response at week 12 |
| Time Frame : 12 weeks |
| Safety issue : No |
|
| Measure : Clear or almost clear status of sPGA (Static Physician Global Assessment of psoriasis) at week 12 |
| Time Frame : 12 weeks |
| Safety issue : No |
|
| Measure : Percent improvement from baseline in CDLQI (Children's Dermatology Life Quality Index) at week 12 |
| Time Frame : 12 weeks |
| Safety issue : No |
|
| Measure : Safety as measured by adverse events, infections, injection site reaction, lab toxicity, vital signs, antibodies to etanercept, and disease rebound
during the investigational product withdrawal period |
| Time Frame : 48 weeks |
| Safety issue : Yes |
|
| Measure : Pharmacokinetics |
| Time Frame : 48 weeks |
| Safety issue : No |
|
| Interventions |
| Type : Drug |
| Name : Enbrel® |
| Description : 0.8 mg/kg (up to an intended dose of 50 mg) once weekly |
|
| Type : Drug |
| Name : Placebo |
| Description : 0.8 mg/kg (up to an intended dose of 50 mg) once weekly |
|
