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The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.
This study was a multicenter, open-label extension study for pediatric patients who participated in Study 20030211 (NCT00078819).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etanercept | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etanercept | Drug | Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | A serious adverse events is any AE that
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. | 264 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Injection Site Reactions | 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. | 264 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20605256 | Background | Paller AS, Siegfried EC, Eichenfield LF, Pariser D, Langley RG, Creamer K, Kricorian G. Long-term etanercept in pediatric patients with plaque psoriasis. J Am Acad Dermatol. 2010 Nov;63(5):762-8. doi: 10.1016/j.jaad.2010.04.004. Epub 2010 Jun 3. | |
| 26775775 | Background | Paller AS, Siegfried EC, Pariser DM, Rice KC, Trivedi M, Iles J, Collier DH, Kricorian G, Langley RG. Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis. J Am Acad Dermatol. 2016 Feb;74(2):280-7.e1-3. doi: 10.1016/j.jaad.2015.09.056. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Results reported below are from the main analysis performed at year 5 (264 weeks).
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 (NCT00078819).
The study was conducted at 38 sites in the United States and Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | A serious adverse events is any AE that
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. | Participants who received at least one dose of investigational product. | Posted | Number | participants | 264 Weeks |
|
264 weeks
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thyroid cyst | Endocrine disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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| Exposure-adjusted Adverse Event Rates |
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. |
| 264 weeks |
| Number of Participants With Clinically Significant Changes in Vital Signs | 264 weeks |
| Number of Participants With Grade 3 and 4 Laboratory Toxicities | 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. | 264 weeks |
| Number of Participants Who Developed Anti-etanercept Antibodies | 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. | 264 weeks |
| Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) | 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. | Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 |
| Percentage of Participants With a PASI 75 Response | 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. | Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 |
| Percentage of Participants With a PASI 90 Response | 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. | Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 |
| Percent Improvement From Study 20030211 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. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100. | Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264 |
| Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) | 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). | Weeks 12, 48, 96, 144, 192, 240 and 264 |
| Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | 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. | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
| Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | 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. | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
| Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | 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. | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
| Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | 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. | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
| Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | 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. | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
| Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | 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. | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
| Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | 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. | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
| Improvement From Study 20030211 Baseline in Joint Pain | 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). | 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 |
| Noncompliance |
|
| Disease Progression |
|
| Protocol Deviation |
|
| Adverse Event |
|
| Administrative Decision |
|
| Pregnancy |
|
| Ineligibility Determined |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG000 |
| Etanercept |
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. |
|
|
| Secondary | Number of Participants With Injection Site Reactions | 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. | Participants who received at least one dose of investigational product. | Posted | Number | participants | 264 weeks |
|
|
|
| Secondary | Exposure-adjusted Adverse Event Rates | 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. | Participants who received at least one dose of investigational product. | Posted | Number | events per 100 patient years | 264 weeks |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs | Participants who received at least one dose of investigational product. | Posted | Number | participants | 264 weeks |
|
|
|
| Secondary | Number of Participants With Grade 3 and 4 Laboratory Toxicities | 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. | Participants who received at least one dose of investigational product. | Posted | Number | participants | 264 weeks |
|
|
|
| Secondary | Number of Participants Who Developed Anti-etanercept Antibodies | 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. | Participants who received at least one dose of investigational product and had a post-baseline antibody result. | Posted | Number | participants | 264 weeks |
|
|
|
| Secondary | Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) | 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. | Participants who received at least one dose of investigational product and with available data at each time point. | Posted | Number | percentage of participants | Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 |
|
|
|
| Secondary | Percentage of Participants With a PASI 75 Response | 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. | Participants who received at least one dose of investigational product with available data at each time point. | Posted | Number | percentage of participants | Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 |
|
|
|
| Secondary | Percentage of Participants With a PASI 90 Response | 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. | Participants who received at least one dose of investigational product with available data at each time point. | Posted | Number | percentage of participants | Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 |
|
|
|
| Secondary | Percent Improvement From Study 20030211 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. Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline Value * 100. | Participants who received at least one dose of investigational product with available data at each time point. | Posted | Mean | Standard Deviation | percent improvement | Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264 |
|
|
|
| Secondary | Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) | 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). | Participants who received at least one dose of investigational product with available data at each time point. | Posted | Number | percentage of participants | Weeks 12, 48, 96, 144, 192, 240 and 264 |
|
|
|
| Secondary | Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score | 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 received at least one dose of investigational product with baseline data, and with available data at each time point. | Posted | Mean | Standard Deviation | percent improvement | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
|
|
|
| Secondary | Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score | 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. | Participants who received at least one dose of investigational product with baseline data and with available data at each time point. | Posted | Mean | Standard Deviation | percent improvement | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
|
|
|
| Secondary | Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score | 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. | Participants who received at least one dose of investigational product with baseline data and with available data at each time point. | Posted | Mean | Standard Deviation | percent improvement | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
|
|
|
| Secondary | Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score | 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. | Participants who received at least one dose of investigational product with baseline data and with available data at each time point. | Posted | Mean | Standard Deviation | percent improvement | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
|
|
|
| Secondary | Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score | 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. | Participants who received at least one dose of investigational product with baseline data and with available data at each time point. | Posted | Mean | Standard Deviation | percent improvement | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
|
|
|
| Secondary | Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score | 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. | Participants who received at least one dose of investigational product with baseline data and with available data at each time point. | Posted | Mean | Standard Deviation | percent improvement | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
|
|
|
| Secondary | Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score | 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. | Participants who received at least one dose of investigational product with baseline data and with available data at each time point. | Posted | Mean | Standard Deviation | percent improvement | Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 |
|
|
|
| Secondary | Improvement From Study 20030211 Baseline in Joint Pain | 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). | Participants who received at least one dose of investigational product and who completed the joint pain assessment at Study 20030211 baseline, and with available data at each time point. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
|
|
| 7 |
| 181 |
| 148 |
| 181 |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
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.
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| Title | Measurements |
|---|---|
|
| Injection site pruritus |
|
| Injection site haematoma |
|
| Injection site swelling |
|
| Injection site discolouration |
|
| Injection site irritation |
|
| Injection site pain |
|
| Title | Measurements |
|---|---|
|
| Injection Site Reactions |
|
| Title | Measurements |
|---|---|
|
| Grade 3 high alanine aminotransferase |
|
| Grade 3 high white blood cells |
|
| Any grade 4 toxicity |
|
| Title | Measurements |
|---|---|
|
| Week 144 (N = 114) |
|
| Week 192 (n = 92) |
|
| Week 240 (N = 74) |
|
| Week 264 (N = 66) |
|
| Title | Measurements |
|---|---|
|
| Week 144 (N = 114) |
|
| Week 192 (n = 92) |
|
| Week 240 (N = 74) |
|
| Week 264 (N = 66) |
|
| Title | Measurements |
|---|---|
|
| Week 144 (N = 114) |
|
| Week 192 (n = 92) |
|
| Week 240 (N = 74) |
|
| Week 264 (N = 66) |
|
| Title | Measurements |
|---|---|
|
| Week 96 (N = 138) |
|
| Week 144 (N = 114) |
|
| Week 192 (n = 92) |
|
| Week 240 (N = 74) |
|
| Week 264 (N = 66) |
|
| Title | Measurements |
|---|---|
|
| Week 144 (N = 114) |
|
| Week 192 (n = 92) |
|
| Week 240 (N = 74) |
|
| Week 264 (N = 66) |
|
| Title | Measurements |
|---|---|
|
| Week 72 (N = 136) |
|
| Week 96 (N = 127) |
|
| Week 120 (N = 105) |
|
| Week 144 (N = 103) |
|
| Week 168 (N = 93) |
|
| Week 192 (N = 81) |
|
| Week 216 (N = 70) |
|
| Week 240 (N = 64) |
|
| Week 264 (N = 56) |
|
| Title | Measurements |
|---|---|
|
| Week 72 (N = 136) |
|
| Week 96 (N = 128) |
|
| Week 120 (N = 105) |
|
| Week 144 (N = 104) |
|
| Week 168 (N = 94) |
|
| Week 192 (N = 81) |
|
| Week 216 (N = 71) |
|
| Week 240 (N = 65) |
|
| Week 264 (N = 57) |
|
| Title | Measurements |
|---|---|
|
| Week 72 (N = 136) |
|
| Week 96 (N = 129) |
|
| Week 120 (N = 105) |
|
| Week 144 (N = 104) |
|
| Week 168 (N = 94) |
|
| Week 192 (N = 81) |
|
| Week 216 (N = 71) |
|
| Week 240 (N = 64) |
|
| Week 264 (N = 56) |
|
| Title | Measurements |
|---|---|
|
| Week 72 (N = 133) |
|
| Week 96 (N = 129) |
|
| Week 120 (N = 105) |
|
| Week 144 (N = 105) |
|
| Week 168 (N = 94) |
|
| Week 192 (N = 81) |
|
| Week 216 (N = 71) |
|
| Week 240 (N = 65) |
|
| Week 264 (N = 57) |
|
| Title | Measurements |
|---|---|
|
| Week 72 (N = 136) |
|
| Week 96 (N = 129) |
|
| Week 120 (N = 105) |
|
| Week 144 (N = 105) |
|
| Week 168 (N = 94) |
|
| Week 192 (N = 81) |
|
| Week 216 (N = 71) |
|
| Week 240 (N = 65) |
|
| Week 264 (N = 57) |
|
| Title | Measurements |
|---|---|
|
| Week 72 (N = 132) |
|
| Week 96 (N = 127) |
|
| Week 120 (N = 101) |
|
| Week 144 (N = 102) |
|
| Week 168 (N = 93) |
|
| Week 192 (N = 81) |
|
| Week 216 (N = 71) |
|
| Week 240 (N = 65) |
|
| Week 264 (N = 56) |
|
| Title | Measurements |
|---|---|
|
| Week 72 (N = 134) |
|
| Week 96 (N = 128) |
|
| Week 120 (N = 105) |
|
| Week 144 (N = 104) |
|
| Week 168 (N = 93) |
|
| Week 192 (N = 81) |
|
| Week 216 (N = 71) |
|
| Week 240 (N = 65) |
|
| Week 264 (N = 56) |
|
| Title | Measurements |
|---|---|
|
| Week 36 (N = 22) |
|
| Week 48 (N = 24) |
|
| Week 60 (N = 14) |
|
| Week 72 (N = 16) |
|
| Week 84 (N = 14) |
|
| Week 96 (N = 16) |
|
| Week 108 (N = 14) |
|
| Week 120 (N = 12) |
|
| Week 132 (N = 15) |
|
| Week 144 (N = 12) |
|
| Week 156 (N = 12) |
|
| Week 168 (N = 10) |
|
| Week 180 (N = 11) |
|
| Week 192 (N = 11) |
|
| Week 204 (N = 11) |
|
| Week 216 (N = 9) |
|
| Week 228 (N = 10) |
|
| Week 240 (N = 9) |
|
| Week 252 (N = 8) |
|
| Week 264 (N = 8) |
|