Pediatric Open-Label Extension Study of Etanercept in Patients With Plaque Psoriasis

Phase 3CompletedNCT00141921

Amgen182 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

182

Conditions

Pediatric Plaque Psoriasis

Interventions

EtanerceptDRUG

Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Enrollment on previous Amgen study 20030211 (NCT00078819) Exclusion Criteria: * Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

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.

Time frame: 264 Weeks

Secondary Outcomes

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.

Time frame: 264 weeks

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.

Time frame: 264 weeks

Number of Participants With Clinically Significant Changes in Vital Signs

Time frame: 264 weeks

Number of Participants With Grade 3 and 4 Laboratory Toxicities

Data from ClinicalTrials.gov

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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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.