Clinical trial NCT00078819: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Pediatric Psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-03-09
Enrollment: 211
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis.

Detailed description: On enrollment, participants underwent randomization in a 1:1 ratio to receive placebo or etanercept during the initial double-blind period. Participants could enter an escape group and receive open-label etanercept until week 12 if, at or after week 4, their Psoriasis Area and Severity Index (PASI) score either increased by more than 50% over baseline and by a minimum of 4 points at one visit or increased by more than 25% and by a minimum of 4 points at each of two consecutive visits.

During the open-label treatment period, all patients (including those who entered the escape group) received open-label etanercept. Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 could discontinue the study or add topical standard-of-care therapy (low-to-moderate-potency topical corticosteroids) and continue to receive open-label etanercept until week 48.

At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were randomly assigned to placebo or etanercept for 12 weeks in the withdrawal period. Participants in whom PASI 75 was lost resumed open-label etanercept through week 48 in the re-treatment period.

Eligibility criteria: * Patients with plaque psoriasis
* Patient may not receive certain psoriasis medications during the study

Primary outcomes:
measure: Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI 75) at Week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Percentage of Participants Achieving a ≥ 50% Improvement in PASI Score (PASI 50) at Week 12
timeFrame: Baseline and week 12
measure: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) at Week 12
timeFrame: Week 12
measure: Percent Improvement From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 12
timeFrame: Baseline and week 12
measure: Percentage of Participants Achieving a ≥ 90% Improvement in PASI Score (PASI 90) at Week 12
timeFrame: Baseline and week 12
measure: Number of Participants With Adverse Events During the Double-blind Treatment Period
timeFrame: 12 weeks
measure: Etanercept Serum Concentration
timeFrame: Day 1 (predose), week 12, week 24, and week 48
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Langley RG, Kasichayanula S, Trivedi M, Aras GA, Kaliyaperumal A, Yuraszeck T, Gibbs J, Gibbs M, Kricorian G, Paller AS. Pharmacokinetics, Immunogenicity, and Efficacy of Etanercept in Pediatric Patients With Moderate to Severe Plaque Psoriasis. J Clin Pharmacol. 2018 Mar;58(3):340-346. doi: 10.1002/jcph.1029. Epub 2017 Nov 6.
citation: Landells I, Paller AS, Pariser D, Kricorian G, Foehl J, Molta C, Freundlich B. Efficacy and safety of etanercept in children and adolescents aged > or = 8 years with severe plaque psoriasis. Eur J Dermatol. 2010 May-Jun;20(3):323-8. doi: 10.1684/ejd.2010.0911. Epub 2010 Feb 25.
citation: Langley RG, Paller AS, Hebert AA, Creamer K, Weng HH, Jahreis A, Globe D, Patel V, Orlow SJ. Patient-reported outcomes in pediatric patients with psoriasis undergoing etanercept treatment: 12-week results from a phase III randomized controlled trial. J Am Acad Dermatol. 2011 Jan;64(1):64-70. doi: 10.1016/j.jaad.2010.02.060. Epub 2010 Jul 8.
citation: Paller AS, Eichenfield LF, Langley RG, Leonardi CL, Siegfried EC, Creamer K, Kricorian G. Subgroup analyses of etanercept in pediatric patients with psoriasis. J Am Acad Dermatol. 2010 Aug;63(2):e38-41. doi: 10.1016/j.jaad.2009.11.001. No abstract available.
citation: Paller AS, Siegfried EC, Langley RG, Gottlieb AB, Pariser D, Landells I, Hebert AA, Eichenfield LF, Patel V, Creamer K, Jahreis A; Etanercept Pediatric Psoriasis Study Group. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med. 2008 Jan 17;358(3):241-51. doi: 10.1056/NEJMoa066886.
citation: Siegfried EC, Eichenfield LF, Paller AS, Pariser D, Creamer K, Kricorian G. Intermittent etanercept therapy in pediatric patients with psoriasis. J Am Acad Dermatol. 2010 Nov;63(5):769-74. doi: 10.1016/j.jaad.2009.10.046. Epub 2010 Sep 15.
citation: Varni JW, Globe DR, Gandra SR, Harrison DJ, Hooper M, Baumgartner S. Health-related quality of life of pediatric patients with moderate to severe plaque psoriasis: comparisons to four common chronic diseases. Eur J Pediatr. 2012 Mar;171(3):485-92. doi: 10.1007/s00431-011-1587-2. Epub 2011 Sep 30.