Etanercept (Enbrel®) in Psoriasis - Pediatrics

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00078819
• Collaborator: (none)
• Enrollment: 211
• Arms: 2
• Actual Duration (Months): 32.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: Etanercept; Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 211 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Placebo-controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS)
• Actual Study Start Date: Sep 8, 2004
• Actual Primary Completion Date: Feb 1, 2006
• Actual Study Completion Date: Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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).	Drug: Placebo; Placebo matching to etanercept administered by subcutaneous injection once a week
Experimental: 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).	Drug: Etanercept; Etanercept 0.8 mg/kg (up to an intended dose of 50 mg) by subcutaneous injection once a week; Other Names: Enbrel®

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Percentage of Participants Achieving a ≥ 50% Improvement in PASI Score (PASI 50) at Week 12 [Baseline and 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.

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

3. Percent Improvement From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 12 [Baseline and 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.

4. Percentage of Participants Achieving a ≥ 90% Improvement in PASI Score (PASI 90) at Week 12 [Baseline and 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.

5. Number of Participants With Adverse Events During the Double-blind Treatment Period [12 weeks]

   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.

6. Etanercept Serum Concentration [Day 1 (predose), week 12, week 24, and week 48]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• Patients with plaque psoriasis

• Patient may not receive certain psoriasis medications during the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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

Publications

• 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, 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.
• 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.
• 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.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT00078819
• Other Study ID Numbers: 20030211
• First Posted: Mar 9, 2004
• Last Update Posted: Jul 29, 2019
• Last Verified: May 1, 2019

• Keywords provided by Amgen: Pediatric Psoriasis
• Additional relevant MeSH terms: Psoriasis; Etanercept

Study Results

Participant Flow

Recruitment Details	This 48-week study was conducted at 42 sites in the United States and Canada. The first participant was enrolled on September 8, 2004, and the last participant on November 29, 2005.
Pre-assignment Detail	On enrollment, participants underwent randomization at a 1:1 ratio by an interactive voice-response system.

Arm/Group Title	Placebo	Etanercept	Withdrawal/Re-treatment Period: Placebo	Withdrawal/Re-treatment Period: Etanercept
Arm/Group Description	Participants randomized to receive 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 with 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 (including those who escaped to etanercept) received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36). Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 (incomplete response) could discontinue the study or continue to receive open-label etanercept with a topical standard-of-care until week 48.	Participants randomized to receive 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 more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with 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 (including those who escaped to etanercept) received open-label etanercept 0.8 mg/kg once a week during the 24-week, open-label treatment period (weeks 13 to 36). Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 (incomplete response) could discontinue the study or continue to receive open-label etanercept with a topical standard-of-care until week 48.	At week 36, participants with a PASI 75 response were re-randomized to receive placebo once a week for 12-weeks in the double-blind withdrawal period (weeks 37 to 48). Participants who relapsed (defined as a loss of PASI 75 response) were to resume open-label treatment with 0.8 mg/kg etanercept once a week until week 48 (re-treatment period).	At week 36, participants with a PASI 75 response were re-randomized to receive 0.8 mg/kg etanercept once a week for 12-weeks in the double-blind, withdrawal period (weeks 37 to 48). Participants who relapsed (defined as a loss of PASI 75 response) were to resume open-label treatment with 0.8 mg/kg etanercept once a week until week 48 (re-treatment period).
Period Title: Double-blind Treatment Period: Week 1-12
STARTED	105	106	0	0
Entered Escape	27	5	0	0
COMPLETED	104	105	0	0
NOT COMPLETED	1	1	0	0
Period Title: Double-blind Treatment Period: Week 1-12
STARTED	103	105	0	0
COMPLETED	63	75	0	0
NOT COMPLETED	40	30	0	0
Period Title: Double-blind Treatment Period: Week 1-12
STARTED	0	0	69	69
Received Study Drug	0	0	69	68
COMPLETED	0	0	40	55
NOT COMPLETED	0	0	29	14
Period Title: Double-blind Treatment Period: Week 1-12
STARTED	0	0	29	13
Received Study Drug	0	0	30	12
COMPLETED	0	0	29	13
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Etanercept	Total
Arm/Group Description	Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12).	Participants randomized to receive 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).	Total of all reporting groups
Overall Participants	105	106	211
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	13.00	14.00	13.00
Age, Customized (Count of Participants)
4 to 11 years	38 36.2%	38 35.8%	76 36%
12 to 17 years	67 63.8%	68 64.2%	135 64%
Sex: Female, Male (Count of Participants)
Female	52 49.5%	51 48.1%	103 48.8%
Male	53 50.5%	55 51.9%	108 51.2%
Race/Ethnicity, Customized (Count of Participants)
White	75 71.4%	83 78.3%	158 74.9%
Black or African American	8 7.6%	3 2.8%	11 5.2%
Hispanic or Latino	14 13.3%	8 7.5%	22 10.4%
Asian	6 5.7%	9 8.5%	15 7.1%
Native Hawaiian or Other Pacific Islander	0 0%	1 0.9%	1 0.5%
Other	2 1.9%	2 1.9%	4 1.9%
Duration of Psoriasis (years) [Median (Full Range) ]
Median (Full Range) [years]	5.80	6.80	5.90
Psoriasis Area and Severity Index (PASI) (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	16.40	16.70	16.40

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI 75) at Week 12
Description	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.
Time Frame	Baseline and week 12

Outcome Measure Data

Analysis Population Description

The intent-to-treat population included all randomized participants.

Arm/Group Title	Placebo	Etanercept
Arm/Group Description	Participants randomized to receive 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 with 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 randomized to receive 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 more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with 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.
Measure Participants	105	106
Number [percentage of participants]	11.0 10.5%	57.0 53.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Etanercept
	Comments
	Type of Statistical Test	Superiority
	Comments	The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Two-sided Cochran-Mantel-Haenszel test stratified by age group

2. Secondary Outcome

Title	Percentage of Participants Achieving a ≥ 50% Improvement in PASI Score (PASI 50) at Week 12
Description	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.
Time Frame	Baseline and week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Placebo	Etanercept
Arm/Group Description	Participants randomized to receive 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 with 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 randomized to receive 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 more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with 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.
Measure Participants	105	106
Number [percentage of participants]	23 21.9%	75 70.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Etanercept
	Comments
	Type of Statistical Test	Superiority
	Comments	The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Two-sided Cochran-Mantel-Haenszel test stratified by age group

3. Secondary Outcome

Title	Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) at Week 12
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Placebo	Etanercept
Arm/Group Description	Participants randomized to receive 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 with 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 randomized to receive 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 more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with 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.
Measure Participants	105	106
Number [percentage of participants]	13 12.4%	53 50%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Etanercept
	Comments
	Type of Statistical Test	Superiority
	Comments	The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Two-sided Cochran-Mantel-Haenszel test stratified by age group

4. Secondary Outcome

Title	Percent Improvement From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 12
Description	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.
Time Frame	Baseline and week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with available CDLQI data at baseline

Arm/Group Title	Placebo	Etanercept
Arm/Group Description	Participants randomized to receive 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 with 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 randomized to receive 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 more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with 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.
Measure Participants	102	100
Mean (Standard Error) [percent improvement]	17.5 (8.3)	52.3 (6.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Etanercept
	Comments
	Type of Statistical Test	Superiority
	Comments	The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Van Elteren test
	Comments	Two-sided van Elteren's test stratified by age group

5. Secondary Outcome

Title	Percentage of Participants Achieving a ≥ 90% Improvement in PASI Score (PASI 90) at Week 12
Description	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.
Time Frame	Baseline and week 12

Outcome Measure Data

Analysis Population Description

Intent-to-treat population

Arm/Group Title	Placebo	Etanercept
Arm/Group Description	Participants randomized to receive 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 with 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 randomized to receive 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 more than 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with 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.
Measure Participants	105	106
Number [percentage of participants]	7 6.7%	27 25.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Etanercept
	Comments
	Type of Statistical Test	Superiority
	Comments	The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician's global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Two-sided Cochran-Mantel-Haenszel test stratified by age group

6. Secondary Outcome

Title	Number of Participants With Adverse Events During the Double-blind Treatment Period
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The safety population included all participants who received at least 1 dose of study drug.

Arm/Group Title	Placebo	Etanercept	Escape: Etanercept
Arm/Group Description	Participants randomized to receive placebo administered by subcutaneous injection once a week during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12). Adverse events are reported up until escape for participants who escaped to etanercept.	Participants randomized to receive 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). Adverse events are reported up until escape for participants who escaped to etanercept.	Participants with a > 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped to etanercept 0.8 mg/kg once a week up to week 12.
Measure Participants	105	106	32
Any adverse event	62 59%	68 64.2%	16 7.6%
Non-infectious adverse event	46 43.8%	42 39.6%	9 4.3%
Infection	33 31.4%	50 47.2%	9 4.3%
Serious non-infectious adverse event	0 0%	0 0%	0 0%
Serious infection	0 0%	0 0%	0 0%
Death	0 0%	0 0%	0 0%
Grade 3 non-infectious adverse event	3 2.9%	0 0%	0 0%
Grade 3 infection	0 0%	0 0%	0 0%
Non-infectious AE leading to withdrawal from Study	0 0%	1 0.9%	0 0%
Infection leading to withdrawal from Study	0 0%	0 0%	0 0%
Injection site reaction	5 4.8%	7 6.6%	1 0.5%

7. Secondary Outcome

Title	Etanercept Serum Concentration
Description	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.
Time Frame	Day 1 (predose), week 12, week 24, and week 48

Outcome Measure Data

Analysis Population Description

Participants assigned to etanercept at any time during the study, with available data. Week 12 excludes participants assigned to placebo who escaped to etanercept. Week 48 includes participants randomized to etanercept at week 36 and remaining on etanercept to week 48. Participants randomized to placebo and retreated with etanercept are excluded.

Arm/Group Title	Etanercept
Arm/Group Description	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).
Measure Participants	208
Day 1	1.50 (3.13)
Week 12	1614 (828)
Week 24	2104 (1255)
Week 48	1650 (1126)

Adverse Events

Time Frame	Double-blind treatment period: 12 weeks Escape to etanercept: from time of escape to week 12 (maximum of 8 weeks) Open-label treatment period: 24 weeks Incomplete response: From date of incomplete response to week 48 (maximum of 24 weeks) Withdrawal Period: 12 weeks Re-treatment Period: From date of re-treatment to week 48 (maximum of 8 weeks)
Adverse Event Reporting Description	Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Arm/Group Title	Double-blind Period: Placebo		Double-blind Period: Etanercept 0.8 mg/kg QW		Double-blind Period: Escape to Etanercept 0.8 mg/kg QW		Open-label Period: Etanercept 0.8 mg/kg QW		Open-label Period Incomplete Response: Etanercept 0.8 mg/kg QW		Withdrawal Period: Placebo		Withdrawal Period: Etanercept 0.8 mg/kg QW		Re-treatment Period: Placebo/Etanercept 0.8 mg/kg QW		Re-treatment Period: Etanercept / Etanercept 0.8 mg/kg QW
Arm/Group Description	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 received 0.8 mg/kg etanercept administered by subcutaneous injection once a week (QW) during the 12-week, double-blind, placebo-controlled treatment period (day 1 to week 12).		Participants with a > 50% worsening (ie, increase) in PASI score at or after week 4 compared with baseline and an increase of at least 4 points at 1 visit, or with an increase of more than 25% and by a minimum of 4 points at each of two consecutive visits, escaped 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).		Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 continued to receive open-label etanercept 0.8 mg/kg QW plus optional topical standard-of-care therapy (low-to-moderate-potency topical corticosteroids) until week 48.		At week 36, participants with a PASI 75 response were re-randomized to receive placebo once a week for 12 weeks in the double-blind, withdrawal period (weeks 37 to 48) or until relapse (loss of PASI 75 response).		At week 36, participants with a PASI 75 response were re-randomized to receive 0.8 mg/kg etanercept once a week for 12-weeks in the double-blind, withdrawal period (weeks 37 to 48) or until relapse (loss of PASI 75 response).		Participants randomized to placebo at week 36 who relapsed (loss of PASI 75 response) resumed open-label treatment with 0.8 mg/kg etanercept once a week until week 48.		Participants randomized to etanercept at week 36 who relapsed (loss of PASI 75 response) resumed open-label treatment with 0.8 mg/kg etanercept once a week until week 48.
All Cause Mortality
	Double-blind Period: Placebo		Double-blind Period: Etanercept 0.8 mg/kg QW		Double-blind Period: Escape to Etanercept 0.8 mg/kg QW		Open-label Period: Etanercept 0.8 mg/kg QW		Open-label Period Incomplete Response: Etanercept 0.8 mg/kg QW		Withdrawal Period: Placebo		Withdrawal Period: Etanercept 0.8 mg/kg QW		Re-treatment Period: Placebo/Etanercept 0.8 mg/kg QW		Re-treatment Period: Etanercept / Etanercept 0.8 mg/kg QW
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Double-blind Period: Placebo		Double-blind Period: Etanercept 0.8 mg/kg QW		Double-blind Period: Escape to Etanercept 0.8 mg/kg QW		Open-label Period: Etanercept 0.8 mg/kg QW		Open-label Period Incomplete Response: Etanercept 0.8 mg/kg QW		Withdrawal Period: Placebo		Withdrawal Period: Etanercept 0.8 mg/kg QW		Re-treatment Period: Placebo/Etanercept 0.8 mg/kg QW		Re-treatment Period: Etanercept / Etanercept 0.8 mg/kg QW
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/105 (0%)		0/106 (0%)		0/32 (0%)		0/208 (0%)		0/59 (0%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Double-blind Period: Placebo		Double-blind Period: Etanercept 0.8 mg/kg QW		Double-blind Period: Escape to Etanercept 0.8 mg/kg QW		Open-label Period: Etanercept 0.8 mg/kg QW		Open-label Period Incomplete Response: Etanercept 0.8 mg/kg QW		Withdrawal Period: Placebo		Withdrawal Period: Etanercept 0.8 mg/kg QW		Re-treatment Period: Placebo/Etanercept 0.8 mg/kg QW		Re-treatment Period: Etanercept / Etanercept 0.8 mg/kg QW
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	44/105 (41.9%)		59/106 (55.7%)		10/32 (31.3%)		174/208 (83.7%)		54/59 (91.5%)		23/69 (33.3%)		26/68 (38.2%)		9/30 (30%)		8/12 (66.7%)
Gastrointestinal disorders
Abdominal Pain	0/105 (0%)		0/106 (0%)		0/32 (0%)		6/208 (2.9%)		0/59 (0%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		1/12 (8.3%)
Abdominal Pain Upper	2/105 (1.9%)		3/106 (2.8%)		0/32 (0%)		11/208 (5.3%)		2/59 (3.4%)		2/69 (2.9%)		0/68 (0%)		0/30 (0%)		0/12 (0%)
Diarrhoea	4/105 (3.8%)		1/106 (0.9%)		0/32 (0%)		9/208 (4.3%)		4/59 (6.8%)		1/69 (1.4%)		0/68 (0%)		0/30 (0%)		1/12 (8.3%)
Nausea	3/105 (2.9%)		3/106 (2.8%)		0/32 (0%)		13/208 (6.3%)		3/59 (5.1%)		1/69 (1.4%)		1/68 (1.5%)		0/30 (0%)		1/12 (8.3%)
Vomiting	2/105 (1.9%)		4/106 (3.8%)		0/32 (0%)		15/208 (7.2%)		6/59 (10.2%)		1/69 (1.4%)		2/68 (2.9%)		0/30 (0%)		1/12 (8.3%)
General disorders
Injection Site Bruising	4/105 (3.8%)		1/106 (0.9%)		0/32 (0%)		12/208 (5.8%)		3/59 (5.1%)		0/69 (0%)		1/68 (1.5%)		0/30 (0%)		0/12 (0%)
Injection Site Pain	0/105 (0%)		2/106 (1.9%)		0/32 (0%)		6/208 (2.9%)		3/59 (5.1%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		1/12 (8.3%)
Injection Site Reaction	0/105 (0%)		2/106 (1.9%)		0/32 (0%)		7/208 (3.4%)		3/59 (5.1%)		1/69 (1.4%)		0/68 (0%)		0/30 (0%)		0/12 (0%)
Pyrexia	1/105 (1%)		2/106 (1.9%)		0/32 (0%)		12/208 (5.8%)		1/59 (1.7%)		2/69 (2.9%)		2/68 (2.9%)		0/30 (0%)		0/12 (0%)
Immune system disorders
Seasonal Allergy	1/105 (1%)		1/106 (0.9%)		0/32 (0%)		4/208 (1.9%)		1/59 (1.7%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		1/12 (8.3%)
Infections and infestations
Body Tinea	0/105 (0%)		0/106 (0%)		0/32 (0%)		3/208 (1.4%)		0/59 (0%)		1/69 (1.4%)		0/68 (0%)		0/30 (0%)		1/12 (8.3%)
Conjunctivitis Viral	0/105 (0%)		0/106 (0%)		0/32 (0%)		1/208 (0.5%)		0/59 (0%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		1/12 (8.3%)
Ear Infection	1/105 (1%)		2/106 (1.9%)		0/32 (0%)		9/208 (4.3%)		2/59 (3.4%)		1/69 (1.4%)		1/68 (1.5%)		0/30 (0%)		1/12 (8.3%)
Folliculitis	0/105 (0%)		0/106 (0%)		0/32 (0%)		6/208 (2.9%)		3/59 (5.1%)		0/69 (0%)		1/68 (1.5%)		0/30 (0%)		0/12 (0%)
Gastroenteritis	0/105 (0%)		6/106 (5.7%)		1/32 (3.1%)		13/208 (6.3%)		4/59 (6.8%)		0/69 (0%)		0/68 (0%)		1/30 (3.3%)		0/12 (0%)
Gastroenteritis Viral	3/105 (2.9%)		2/106 (1.9%)		0/32 (0%)		13/208 (6.3%)		5/59 (8.5%)		1/69 (1.4%)		0/68 (0%)		0/30 (0%)		1/12 (8.3%)
Influenza	2/105 (1.9%)		8/106 (7.5%)		0/32 (0%)		23/208 (11.1%)		2/59 (3.4%)		2/69 (2.9%)		1/68 (1.5%)		1/30 (3.3%)		0/12 (0%)
Nasopharyngitis	9/105 (8.6%)		8/106 (7.5%)		0/32 (0%)		39/208 (18.8%)		12/59 (20.3%)		2/69 (2.9%)		7/68 (10.3%)		0/30 (0%)		0/12 (0%)
Otitis Media	2/105 (1.9%)		0/106 (0%)		0/32 (0%)		10/208 (4.8%)		5/59 (8.5%)		0/69 (0%)		2/68 (2.9%)		1/30 (3.3%)		0/12 (0%)
Pharyngitis	4/105 (3.8%)		2/106 (1.9%)		0/32 (0%)		13/208 (6.3%)		5/59 (8.5%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		0/12 (0%)
Pharyngitis Streptococcal	1/105 (1%)		3/106 (2.8%)		1/32 (3.1%)		17/208 (8.2%)		6/59 (10.2%)		0/69 (0%)		2/68 (2.9%)		0/30 (0%)		0/12 (0%)
Sinusitis	1/105 (1%)		1/106 (0.9%)		1/32 (3.1%)		12/208 (5.8%)		3/59 (5.1%)		0/69 (0%)		2/68 (2.9%)		2/30 (6.7%)		1/12 (8.3%)
Skin Infection	1/105 (1%)		1/106 (0.9%)		1/32 (3.1%)		8/208 (3.8%)		4/59 (6.8%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		0/12 (0%)
Upper Respiratory Tract Infection	12/105 (11.4%)		18/106 (17%)		4/32 (12.5%)		64/208 (30.8%)		25/59 (42.4%)		7/69 (10.1%)		2/68 (2.9%)		3/30 (10%)		3/12 (25%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/105 (0%)		5/106 (4.7%)		0/32 (0%)		10/208 (4.8%)		4/59 (6.8%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		0/12 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma	0/105 (0%)		2/106 (1.9%)		2/32 (6.3%)		13/208 (6.3%)		3/59 (5.1%)		1/69 (1.4%)		1/68 (1.5%)		0/30 (0%)		0/12 (0%)
Nervous system disorders
Dizziness	1/105 (1%)		5/106 (4.7%)		0/32 (0%)		8/208 (3.8%)		3/59 (5.1%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		0/12 (0%)
Headache	13/105 (12.4%)		14/106 (13.2%)		1/32 (3.1%)		42/208 (20.2%)		12/59 (20.3%)		2/69 (2.9%)		6/68 (8.8%)		0/30 (0%)		0/12 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	2/105 (1.9%)		4/106 (3.8%)		0/32 (0%)		19/208 (9.1%)		4/59 (6.8%)		5/69 (7.2%)		1/68 (1.5%)		0/30 (0%)		0/12 (0%)
Nasal Congestion	3/105 (2.9%)		3/106 (2.8%)		1/32 (3.1%)		17/208 (8.2%)		3/59 (5.1%)		2/69 (2.9%)		0/68 (0%)		2/30 (6.7%)		0/12 (0%)
Pharyngolaryngeal Pain	6/105 (5.7%)		1/106 (0.9%)		1/32 (3.1%)		20/208 (9.6%)		9/59 (15.3%)		3/69 (4.3%)		1/68 (1.5%)		0/30 (0%)		0/12 (0%)
Rhinorrhoea	2/105 (1.9%)		3/106 (2.8%)		1/32 (3.1%)		9/208 (4.3%)		5/59 (8.5%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		0/12 (0%)
Skin and subcutaneous tissue disorders
Acne	0/105 (0%)		0/106 (0%)		1/32 (3.1%)		10/208 (4.8%)		4/59 (6.8%)		0/69 (0%)		2/68 (2.9%)		0/30 (0%)		0/12 (0%)
Guttate Psoriasis	1/105 (1%)		1/106 (0.9%)		0/32 (0%)		4/208 (1.9%)		3/59 (5.1%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		0/12 (0%)
Psoriasis	0/105 (0%)		1/106 (0.9%)		0/32 (0%)		5/208 (2.4%)		3/59 (5.1%)		0/69 (0%)		0/68 (0%)		0/30 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.