Clinical trial NCT00141921: Pediatric Open-Label Extension Study of Etanercept in Patients With Plaque Psoriasis
Official title: An Open-Label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pediatric Plaque Psoriasis
Keywords: Immunex
Amgen
Pediatric,
plaque psoriasis
clinical trial
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 182
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study was a multicenter, open-label extension study for pediatric patients who participated in Study 20030211 (NCT00078819).

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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 264 Weeks
Secondary outcomes:
measure: Number of Participants With Injection Site Reactions
timeFrame: 264 weeks
measure: Exposure-adjusted Adverse Event Rates
timeFrame: 264 weeks
measure: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: 264 weeks
measure: Number of Participants With Grade 3 and 4 Laboratory Toxicities
timeFrame: 264 weeks
measure: Number of Participants Who Developed Anti-etanercept Antibodies
timeFrame: 264 weeks
measure: Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50)
timeFrame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
measure: Percentage of Participants With a PASI 75 Response
timeFrame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
measure: Percentage of Participants With a PASI 90 Response
timeFrame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
measure: Percent Improvement From Study 20030211 Baseline in PASI Score
timeFrame: Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264
measure: Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1)
timeFrame: Weeks 12, 48, 96, 144, 192, 240 and 264
measure: Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score
timeFrame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
measure: Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score
timeFrame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
measure: Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score
timeFrame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
measure: Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score
timeFrame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
measure: Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score
timeFrame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
measure: Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score
timeFrame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
measure: Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score
timeFrame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
measure: Improvement From Study 20030211 Baseline in Joint Pain
timeFrame: Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Paller AS, Siegfried EC, Eichenfield LF, Pariser D, Langley RG, Creamer K, Kricorian G. Long-term etanercept in pediatric patients with plaque psoriasis. J Am Acad Dermatol. 2010 Nov;63(5):762-8. doi: 10.1016/j.jaad.2010.04.004. Epub 2010 Jun 3.
citation: Paller AS, Siegfried EC, Pariser DM, Rice KC, Trivedi M, Iles J, Collier DH, Kricorian G, Langley RG. Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis. J Am Acad Dermatol. 2016 Feb;74(2):280-7.e1-3. doi: 10.1016/j.jaad.2015.09.056.