Etanercept (Enbrel®) in Psoriasis - Pediatrics

Psoriasis Clinical Trial

Official title:

Placebo-controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078819
• Other study ID #: 20030211
• Status: Completed
• Phase: Phase 3
• Start date: September 8, 2004
• Est. completion date: June 1, 2007

Study information

• Verified date: May 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: June 1, 2007
• Est. primary completion date: February 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

• Patients with plaque psoriasis

• Patient may not receive certain psoriasis medications during the study

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Achieving a = 50% Improvement in PASI Score (PASI 50) at Week 12	The percentage of participants who achieved 50% or greater improvement from baseline in PASI score after 12 weeks of treatment. PASI 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	Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) at Week 12	The sPGA is a static measurement based on induration, erythema, and scaling. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling); = almost clear (minimal plaque elevation, erythema or scaling); = mild (mild plaque elevation or scaling, light red coloration); = moderate (moderate plaque elevation, scaling, light red coloration); = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration); = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).; Participants who entered the escape arm or had missing data at week 12 were considered non-responders.	Week 12
Secondary	Percent Improvement From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 12	The Children's Dermatology Life Quality Index (CDLQI) was used to assess the impact of psoriasis on subject health-related quality of life. The CDLQI has 10 items assessing health-related quality of life (HRQOL) in patients with skin disease each measured on a scale from 0 (Not at all) to 3 (Very much). The total score ranges from 0 to 30, with lower scores indicating better quality of life. If participants were = 13 years old, the text instrument was completed by the participants themselves. Participants = 8 but < 13 years old used the cartoon version of the instrument and participants = 7 years old used the cartoon version of the instrument completed with help from the parents or caregivers.; Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100.; Participants who entered the escape arm or who had missing data at week 12 were considered to have 0% improvement from baseline.	Baseline and week 12
Secondary	Percentage of Participants Achieving a = 90% Improvement in PASI Score (PASI 90) at Week 12	The percentage of participants who achieved 90% or greater improvement 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	Number of Participants With Adverse Events During the Double-blind Treatment Period	The severity assessment for adverse events and infections was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 0 = no toxicity, Grade 1 = mild toxicity, Grade 2 = moderate toxicity, Grade 3 = severe toxicity, Grade 4 = life-threatening toxicity.; Serious adverse events were any events that suggested a significant hazard or side effect, regardless of the investigator's or sponsor's opinion on the relationship to study medication. These included, but were not limited to, events at any dose that were fatal, life threatening, required in-patient hospitalization or prolonged hospitalization, were a persistent or significant disability/incapacity, or were a congenital abnormality/birth defect. Medical events that jeopardized a participant, required intervention to prevent one of the above outcomes, or resulted in urgent investigation could be considered serious.	12 weeks
Secondary	Etanercept Serum Concentration	Serum concentrations for etanercept were measured by using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.627 ng/mL.	Day 1 (predose), week 12, week 24, and week 48

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling
•   Notice regarding posted summaries of trial results
•   To access clinical trial results information click on this link