Etanercept (Enbrel®) in Psoriasis - Pediatrics
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00078819
First received: March 5, 2004
Last updated: December 22, 2010
Last verified: December 2010
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Purpose
This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis.
This is a Phase 3 blinded, placebo-controlled study.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: Enbrel® Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Placebo-controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS) |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PASI 50 response at week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- PASI 90 response at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Clear or almost clear status of sPGA (Static Physician Global Assessment of psoriasis) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Percent improvement from baseline in CDLQI (Children's Dermatology Life Quality Index) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 211 |
| Study Start Date: | August 2004 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
100 subjects - 12 weeks
|
Drug: Placebo
0.8 mg/kg (up to an intended dose of 50 mg) once weekly
|
|
Experimental: Enbrel
100 subjects
|
Drug: Enbrel®
0.8 mg/kg (up to an intended dose of 50 mg) once weekly
|
Eligibility| Ages Eligible for Study: | 4 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- Patients with plaque psoriasis - Patient may not receive certain psoriasis medications during the study
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00078819 History of Changes |
| Other Study ID Numbers: | 20030211 |
| Study First Received: | March 5, 2004 |
| Last Updated: | December 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Pediatric Psoriasis |
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 16, 2013