Phase 3
N=182
Pediatric Open-Label Extension Study of Etanercept in Patients With Plaque Psoriasis
Pediatric Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00141921 ↗Enrolled (actual)
182
Serious AEs
3.9%
Results posted
Feb 2017
Primary outcome: Primary: Number of Participants With Adverse Events — 161; 149; 140; 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Etanercept (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
161; 149; 140; 14; 5; 5 | — |
| SECONDARY Number of Participants With Injection Site Reactions |
16; 6; 4; 3; 2; 2 | — |
| SECONDARY Exposure-adjusted Adverse Event Rates |
215.8; 115.9; 97.3; 2.6 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs |
— | — |
| SECONDARY Number of Participants With Grade 3 and 4 Laboratory Toxicities |
1; 1; 1; 1; 1; 0 | — |
| SECONDARY Number of Participants Who Developed Anti-etanercept Antibodies |
18; 0 | — |
| SECONDARY Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) |
89.5; 89.3; 89.1; 88.6; 87.0; 91.9 | — |
| SECONDARY Percentage of Participants With a PASI 75 Response |
67.4; 67.3; 60.9; 62.3; 69.6; 64.9 | — |
| SECONDARY Percentage of Participants With a PASI 90 Response |
35.4; 32.7; 29.7; 28.1; 35.9; 36.5 | — |
| SECONDARY Percent Improvement From Study 20030211 Baseline in PASI Score |
74.429; 78.286; 77.546; 75.355; 75.052; 77.815 | — |
| SECONDARY Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) |
53.6; 48.8; 47.5; 45.6; 47.8; 50.0 | — |
| SECONDARY Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score |
59.492; 54.978; 59.229; 57.549; 61.084; 64.059 | — |
| SECONDARY Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score |
54.869; 55.366; 53.792; 51.005; 55.430; 53.302 | — |
| SECONDARY Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score |
51.088; 50.546; 51.792; 50.792; 48.686; 59.031 | — |
| SECONDARY Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score |
31.616; 32.585; 36.149; 29.825; 29.457; 32.063 | — |
| SECONDARY Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score |
45.452; 49.797; 50.895; 54.669; 48.346; 51.206 | — |
| SECONDARY Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score |
36.646; 36.057; 31.597; 34.596; 32.940; 29.538 | — |
| SECONDARY Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score |
23.085; 13.268; 18.634; 23.383; 17.969; 17.778 | — |
| SECONDARY Improvement From Study 20030211 Baseline in Joint Pain |
1.5; 2.3; 2.4; 1.5; 1.5; 1.3 | — |
Summary
The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.
Eligibility Criteria
Inclusion Criteria
- Enrollment on previous Amgen study 20030211 (NCT00078819)
Exclusion Criteria
- Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept
Data sourced from ClinicalTrials.gov (NCT00141921). 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.