Clinical Trial Results:
An Open-label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis
Summary
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EudraCT number |
2012-001186-33 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
16 Aug 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Mar 2018
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First version publication date |
02 Mar 2018
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
20050111
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00141921 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Amgen, Inc.
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Sponsor organisation address |
One Amgen Center Drive, Thousand Oaks, CA, United States, 91320
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Public contact |
IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
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Scientific contact |
IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000299-PIP01-08 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Dec 2011
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Aug 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.
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Protection of trial subjects |
This study was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/ guidelines.
Written informed consent and verbal/written assent, if applicable, had to be obtained from each subject (if he or she has attained the legal age for consent) or the subject’s parents or legal guardian before performing any procedures, including screening.
The study protocol, amendments, and the informed consent form (ICF) were reviewed by the Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Aug 2005
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Canada: 56
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Country: Number of subjects enrolled |
United States: 126
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Worldwide total number of subjects |
182
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
63
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Adolescents (12-17 years) |
119
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This study was designed to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe plaque psoriasis who participated in Study 20030211 (2012-001186-33). The study was conducted at 38 sites in the United States and Canada. | ||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Results reported below are from the main analysis performed at year 5 (264 weeks). After the final analysis data cutoff date (22 February 2012), 28 subjects continued protocol specified treatment until they reached 18 years of age. | ||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||
Arms
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Arm title
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Etanercept | ||||||||||||||||||||||||||||||||
Arm description |
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks. | ||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Etanercept
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Investigational medicinal product code |
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Other name |
Enbrel®
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Pharmaceutical forms |
Powder for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection
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Baseline characteristics reporting groups
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Reporting group title |
Etanercept
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Reporting group description |
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Etanercept
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Reporting group description |
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks. |
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End point title |
Number of Participants With Adverse Events [1] | ||||||||||||||||||||||||||||
End point description |
A serious adverse events is any AE that
• is fatal
• is life threatening
• requires in-patient hospitalization or prolongation of existing hospitalization
• results in persistent or significant disability/incapacity
• is a congenital anomaly/birth defect
• other significant medical hazard. The severity assessment for adverse events and infections (except injection site reactions) was done using the Common Toxicity Criteria (CTC) Version 2.0, where Grade 3 indicates a severe toxicity (incapacitating with inability to work or do usual activity).
An infectious event is an event that was considered by the investigator to be an infectious episode. An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
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End point type |
Primary
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End point timeframe |
264 Weeks
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: A formal hypothesis was not tested in this study, no formal statistical testing was done. |
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Notes [2] - Participants who received at least one dose of investigational product. |
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No statistical analyses for this end point |
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End point title |
Number of Participants With Injection Site Reactions | ||||||||||||||||||||||||
End point description |
An injection site reaction is a reaction at the site of the subcutaneous injection, commonly characterized, but not limited to symptoms of erythema (redness, usually raised), pruritis (itching), swelling, or pain that is persistent for 4 hours or longer.
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End point type |
Secondary
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End point timeframe |
264 weeks
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Notes [3] - Participants who received at least one dose of investigational product. |
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No statistical analyses for this end point |
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End point title |
Exposure-adjusted Adverse Event Rates | ||||||||||||||||
End point description |
The exposure adjusted event rate for a given event in a given time period is defined as the number of events reported in the given time period divided by total patient-years on investigational product during the period.
Exposure-adjusted event rate per 100 patient years = total number of events / patient years * 100.
Multiple occurrences of the same event for a participant were counted as multiple events.
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End point type |
Secondary
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End point timeframe |
264 weeks
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Notes [4] - Participants who received at least one dose of investigational product. |
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No statistical analyses for this end point |
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End point title |
Number of Participants With Clinically Significant Changes in Vital Signs | ||||||
End point description |
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End point type |
Secondary
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End point timeframe |
264 weeks
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Notes [5] - Participants who received at least one dose of investigational product. |
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No statistical analyses for this end point |
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End point title |
Number of Participants With Grade 3 and 4 Laboratory Toxicities | ||||||||||||||||||
End point description |
The severity assessment for adverse events and infections (not including injection site reaction) used the Common Toxicity Criteria (CTC) Version 2.0, where Grade 1= Mild - aware of sign or symptom, but easily tolerated; Grade 2= Moderate - discomfort enough to cause interference with usual activity; Grade 3 = Severe - incapacitating with inability to work or do usual activity; Grade 4= Life-threatening - refers to an event in which the patient was, in the view of the investigator, at risk of immediate death at the time of event; Grade 5 = Fatal.
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End point type |
Secondary
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End point timeframe |
264 weeks
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Notes [6] - Participants who received at least one dose of investigational product. |
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No statistical analyses for this end point |
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End point title |
Number of Participants Who Developed Anti-etanercept Antibodies | ||||||||||
End point description |
Binding antibodies to etanercept were detected using an anti-etanercept immunoassay. The positive samples in the immunoassay were further analyzed for the presence of neutralizing antibodies using a bioassay.
Participants who developed anti-etanercept antibodies are those who were antibody positive post-baseline with a negative or no result at baseline.
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End point type |
Secondary
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End point timeframe |
264 weeks
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Notes [7] - Subjects who received at least 1 dose of investigational product with post-baseline antibody data. |
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No statistical analyses for this end point |
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End point title |
Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) | ||||||||||||||||||||||
End point description |
A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
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End point type |
Secondary
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End point timeframe |
Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
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Notes [8] - Participants who received at least one dose of investigational product. |
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No statistical analyses for this end point |
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End point title |
Percentage of Participants With a PASI 75 Response | ||||||||||||||||||||||
End point description |
A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
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End point type |
Secondary
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End point timeframe |
Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
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Notes [9] - Participants who received at least one dose of investigational product. |
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No statistical analyses for this end point |
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End point title |
Percentage of Participants With a PASI 90 Response | ||||||||||||||||||||||
End point description |
A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
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End point type |
Secondary
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End point timeframe |
Baseline and weeks 12, 48, 96, 144, 192, 240 and 264
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Notes [10] - Participants who received at least one dose of investigational product. |
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No statistical analyses for this end point |
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End point title |
Percent Improvement From Study 20030211 Baseline in PASI Score | ||||||||||||||||||||||||
End point description |
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
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End point type |
Secondary
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End point timeframe |
Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264
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Notes [11] - Participants who received at least one dose of investigational product. |
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No statistical analyses for this end point |
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End point title |
Percentage of Participants With a Static Physician’s Global Assessment (sPGA) of Clear (0) or Almost Clear (1) | ||||||||||||||||||||||
End point description |
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
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End point type |
Secondary
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End point timeframe |
Weeks 12, 48, 96, 144, 192, 240 and 264
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Notes [12] - Participants who received at least one dose of investigational product. |
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No statistical analyses for this end point |
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End point title |
Percent Improvement From Study 20030211 Baseline in Children’s Dermatology Life Quality Index (CDLQI) Total Score | ||||||||||||||||||||||||||||||||
End point 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.
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End point type |
Secondary
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End point timeframe |
Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
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Notes [13] - Participants who received at least one dose of investigational product with baseline data. |
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No statistical analyses for this end point |
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End point title |
Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | ||||||||||||||||||||||||||||||||
End point 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 CDLQI Symptoms and Feelings Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
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End point type |
Secondary
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End point timeframe |
Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
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Notes [14] - Participants who received at least one dose of investigational product with baseline data. |
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No statistical analyses for this end point |
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End point title |
Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | ||||||||||||||||||||||||||||||||
End point 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 CDLQI Leisure Score includes 3 questions and ranges from 0 to 9, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
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End point type |
Secondary
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End point timeframe |
Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
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Notes [15] - Participants who received at least one dose of investigational product with baseline data. |
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No statistical analyses for this end point |
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End point title |
Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | ||||||||||||||||||||||||||||||||
End point 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 CDLQI School or Holidays Score includes 1 question (How much did your skin problem effect your school work/holiday plans over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
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End point type |
Secondary
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End point timeframe |
Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
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Notes [16] - Participants who received at least one dose of investigational product with baseline data. |
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No statistical analyses for this end point |
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End point title |
Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | ||||||||||||||||||||||||||||||||
End point 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 CDLQI Personal Relationships Score includes 2 questions and ranges from 0 to 6, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
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End point type |
Secondary
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End point timeframe |
Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
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Notes [17] - Participants who received at least one dose of investigational product with baseline data. |
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No statistical analyses for this end point |
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End point title |
Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | ||||||||||||||||||||||||||||||||
End point 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 CDLQI Sleep Score includes 1 question (How much has your sleep been affected by your skin problems over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
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End point type |
Secondary
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End point timeframe |
Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
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Notes [18] - Participants who received at least one dose of investigational product with baseline data. |
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No statistical analyses for this end point |
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End point title |
Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | ||||||||||||||||||||||||||||||||
End point 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 CDLQI Treatment Satisfaction Score includes 1 question (How much of a problem has the treatment for your skin been over the last week?) and ranges from 0 to 3, with lower scores indicating better quality of life.
Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline Value * 100.
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End point type |
Secondary
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End point timeframe |
Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264
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Notes [19] - Participants who received at least one dose of investigational product with baseline data. |
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No statistical analyses for this end point |
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End point title |
Improvement From Study 20030211 Baseline in Joint Pain | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Participants were asked to indicate how much joint pain they had experienced in the last 7 days on a visual analog scale (VAS) from no pain on the left end of the line (score = 0) to severe pain on the right side of the line (score = 10).
Improvement from baseline = (Baseline Value – Post-baseline Value).
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End point type |
Secondary
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End point timeframe |
Study 20030211 baseline, Study 20050111 baseline and weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252 and 264
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Notes [20] - Participants who received at least one dose of investigational product with baseline data |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Through the End of Treatment (Week 264 or the first quarterly visit after the subject's 18th birthday, whichever comes last) or Early Termination Visit.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
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Reporting groups
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Reporting group title |
Etanercept
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Reporting group description |
Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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19 Jul 2005 |
• Per US Food and Drug Administration request, the discontinuation and dose adjustment criteria were amended to require that subjects with a systemic infection that required intravenous antibiotic use or hospitalization be removed from the study.
• Etanercept dose wording was changed to correctly reflect that an exact 0.8 mg/kg dose is not always possible using 2 vials of lyophilized investigational product as the subject’s body weight approaches 62 kg. |
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19 Oct 2006 |
• Extended length of study for an additional 18 months
• Included the option for investigators to stop treatment with investigational product for subjects with a Static Physician Global Assessment score of clear (0) or almost clear (1) at week 96, 108, 120, 132, 144, or 156 |
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10 Sep 2008 |
• Extended length of the study to 5 years
• Subjects were no longer required to permanently discontinue treatment if therapy was temporarily withheld more than once because of clearing of psoriasis or if more than 3 consecutive doses were withheld because of an adverse event or surgical procedure
• Removed 30 day follow-up visit
• Removed collection of Harter’s Self-Perception Profile in Children and Adolescents |
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26 Jul 2010 |
• Allowed for the collection of additional safety data (assessments of adverse events and concomitant medication use) on subjects who were under the age of 18. After week 264, only serious adverse events were to be collected.
• Subjects were allowed to continue on this study until they reached 18 years of age.
• Added a second planned interim analysis (a “week 264 analysis”) after all subjects remaining in the study completed the week 264 assessments. This comprises the main comprehensive, integrated analysis of Study 20050111 data. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |