Phase 3
Completed N=211
Etanercept (Enbrel®) in Psoriasis - Pediatrics
Source: ClinicalTrials.gov NCT00078819 ↗Enrolled (actual)
211
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI 75) at Week 12 — 11.0; 57.0 percentage of participants — p=<0.0001
◆ Published Evidence
Highly cited
388citations · ~22 / year
Etanercept treatment for children and adolescents with plaque psoriasis.
Summary
This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis.
Linked Publications
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Etanercept treatment for children and adolescents with plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI 75) at Week 12 |
11.0; 57.0 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a ≥ 50% Improvement in PASI Score (PASI 50) at Week 12 |
23; 75 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) at Week 12 |
13; 53 | <0.0001 sig |
| SECONDARY Percent Improvement From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 12 |
17.5; 52.3 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a ≥ 90% Improvement in PASI Score (PASI 90) at Week 12 |
7; 27 | <0.0001 sig |
| SECONDARY Number of Participants With Adverse Events During the Double-blind Treatment Period |
62; 68; 16; 46; 42; 9 | — |
| SECONDARY Etanercept Serum Concentration |
1.50; 1614; 2104; 1650 | — |
Eligibility Criteria
- Patients with plaque psoriasis
- Patient may not receive certain psoriasis medications during the study
Data sourced from ClinicalTrials.gov (NCT00078819) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.