Etanercept (Enbrel®) in Psoriasis - Pediatrics

NCT00078819 | Completed Phase 3 Results

• 1 other identifier: 20030211
• Study Type: interventional
• Target: 211
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Psoriasis

Keywords

Pediatric Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI 75) at Week 12

  The percentage of participants who achieved 75% or greater improvement (decrease) from baseline in PASI score after 12 weeks of treatment. The PASI score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Participants who entered the escape arm or had missing data at week 12 were considered non-responders.

  Baseline and week 12

Secondary Outcomes (6)

• Percentage of Participants Achieving a ≥ 50% Improvement in PASI Score (PASI 50) at Week 12

  Baseline and week 12

• Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) at Week 12

  Week 12

• Percent Improvement From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 12

  Baseline and week 12

• Percentage of Participants Achieving a ≥ 90% Improvement in PASI Score (PASI 90) at Week 12

  Baseline and week 12

• Number of Participants With Adverse Events During the Double-blind Treatment Period

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Etanercept

EXPERIMENTAL

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).

Drug: Etanercept

Interventions

Etanercept DRUG

Etanercept 0.8 mg/kg (up to an intended dose of 50 mg) by subcutaneous injection once a week

Also known as: Enbrel®

Etanercept

Placebo DRUG

Placebo matching to etanercept administered by subcutaneous injection once a week

Placebo

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Amgen: lead

Related Publications (7)

• 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.

  PMID: 29106714 BACKGROUND

• 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.

  PMID: 20185386 BACKGROUND

• 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.

  PMID: 20619489 BACKGROUND

• 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.

  PMID: 20633781 BACKGROUND

• 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.

  PMID: 18199863 BACKGROUND

• 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.

  PMID: 20833444 BACKGROUND

• 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.

  PMID: 21960290 BACKGROUND

Related Links

• 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

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2004
• First Posted: March 9, 2004
• Study Start: September 8, 2004
• Primary Completion: February 1, 2006
• Study Completion: June 1, 2007
• Last Updated: July 29, 2019
• Results First Posted: July 29, 2019

Record last verified: 2019-05