Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
211 participants
INTERVENTIONAL
2004-09-08
2007-06-01
Brief Summary
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Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
Participants received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).
At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were re-randomized to placebo or etanercept in the 12-week double-blind, withdrawal-retreatment period (weeks 37 to 48).
Placebo
Placebo matching to etanercept administered by subcutaneous injection once a week
Etanercept
Participants received 0.8 mg/kg etanercept administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Participants with a \> 50% worsening (ie, increase) in Psoriasis Area and Severity Index (PASI) score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, could escape to etanercept 0.8 mg/kg once a week up to week 12.
Participants received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36).
At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were re-randomized to placebo or etanercept in the 12-week double-blind, withdrawal-retreatment period (weeks 37 to 48).
Etanercept
Etanercept 0.8 mg/kg (up to an intended dose of 50 mg) by subcutaneous injection once a week
Interventions
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Etanercept
Etanercept 0.8 mg/kg (up to an intended dose of 50 mg) by subcutaneous injection once a week
Placebo
Placebo matching to etanercept administered by subcutaneous injection once a week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient may not receive certain psoriasis medications during the study
4 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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AmgenTrials clinical trials website
Notice regarding posted summaries of trial results
To access clinical trial results information click on this link
FDA-approved Drug Labeling
Other Identifiers
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20030211
Identifier Type: -
Identifier Source: org_study_id
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