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

• ClinicalTrials.gov Identifier: NCT00141921
• Recruitment Status: Completed
• First Posted: September 2, 2005
• Results First Posted: February 10, 2017
• Last Update Posted: October 5, 2017
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Study Description

Brief Summary:

The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.

Condition or disease	Intervention/treatment	Phase
Pediatric Plaque Psoriasis	Drug: Etanercept	Phase 3

Detailed Description:

This study was a multicenter, open-label extension study for pediatric patients who participated in Study 20030211 (NCT00078819).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 182 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis
• Actual Study Start Date: August 11, 2005
• Actual Primary Completion Date: December 19, 2011
• Actual Study Completion Date: August 16, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Etanercept; Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection; Other Name: Enbrel®

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adverse Events [ Time Frame: 264 Weeks ]

   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.

Secondary Outcome Measures :

1. Number of Participants With Injection Site Reactions [ Time Frame: 264 weeks ]
   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.
2. Exposure-adjusted Adverse Event Rates [ Time Frame: 264 weeks ]

   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.

3. Number of Participants With Clinically Significant Changes in Vital Signs [ Time Frame: 264 weeks ]
4. Number of Participants With Grade 3 and 4 Laboratory Toxicities [ Time Frame: 264 weeks ]
   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.
5. Number of Participants Who Developed Anti-etanercept Antibodies [ Time Frame: 264 weeks ]

   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.

6. Percentage of Participants With a Psoriasis Area and Severity Index 50 Response (PASI 50) [ Time Frame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 ]

   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.

7. Percentage of Participants With a PASI 75 Response [ Time Frame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 ]

   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.

8. Percentage of Participants With a PASI 90 Response [ Time Frame: Baseline and weeks 12, 48, 96, 144, 192, 240 and 264 ]

   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.

9. Percent Improvement From Study 20030211 Baseline in PASI Score [ Time Frame: Study 20030211 baseline, Study 20050111 baseline and weeks 12, 48, 96, 144, 192, 240 and 264 ]

   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.

10. Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) [ Time Frame: Weeks 12, 48, 96, 144, 192, 240 and 264 ]
    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).
11. Percent Improvement From Study 20030211 Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score [ Time Frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 ]

    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.

12. Percent Improvement From Study 20030211 Baseline in CDLQI Symptoms and Feelings Score [ Time Frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 ]

    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.

13. Percent Improvement From Study 20030211 Baseline in CDLQI Leisure Score [ Time Frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 ]

    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.

14. Percent Improvement From Study 20030211 Baseline in CDLQI School or Holidays Score [ Time Frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 ]

    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.

15. Percent Improvement From Study 20030211 Baseline in CDLQI Personal Relationships Score [ Time Frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 ]

    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.

16. Percent Improvement From Study 20030211 Baseline in CDLQI Sleep Score [ Time Frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 ]

    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.

17. Percent Improvement From Study 20030211 Baseline in CDLQI Treatment Satisfaction Score [ Time Frame: Study 20030211 baseline, Study 20050111 baseline and weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 and 264 ]

    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.

18. Improvement From Study 20030211 Baseline in Joint Pain [ Time Frame: 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 ]

    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).

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Enrollment on previous Amgen study 20030211 (NCT00078819)

Exclusion Criteria:

• Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept

Contacts and Locations

Sponsors and Collaborators

Amgen

Investigators

• Study Director: MD; Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 

Publications:

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.

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.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT00141921 History of Changes
• Other Study ID Numbers: 20050111
• First Posted: September 2, 2005
• Results First Posted: February 10, 2017
• Last Update Posted: October 5, 2017
• Last Verified: September 2017

Keywords provided by Amgen:

Immunex; Amgen; Pediatric,; plaque psoriasis; clinical trial

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Etanercept; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gastrointestinal Agents; Immunosuppressive Agents; Immunologic Factors