Study evaluating safety in children with childhood plaque psoriasis
- Conditions
- Pediatric plaque psoriasisMedDRA version: 14.1Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-001186-33-Outside-EU/EEA
- Lead Sponsor
- Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 182
•Subjects must have met one of the following conditions on the original study 20030211
oComplete the week 48 visit on the original study 20030211
oComplete at least the week 12 visit on the original study 20030211 and have received benefit from the investigational product therapy as demonstrated by achieving =PASI 50 on or after week 12.
•Heterosexual active male and female subjects must practice a method of birth control (considered effective and medically acceptable by the investigator) during the study, including screening.
•An adult must be available to assist with administering SC injections of etanercept and/or subjects must be capable of performing self-injection technique, in the judgement of the investigator.
•Before any study-specific procedure, the appropriate written informed consent and asset must be obtained
•Subjects entering the study following an interruption of investigational product administration > 4 weeks between the last dose on the original study 20030211 and the first dose on this exension study 20050111, must meet the following additional criteria
o No active guttate, erythrodermic, or pustular psoriasis during the screening period
oNo presence of a grade 3 or 4 infection= 30 days before the first screening visit or during the screening period
oALT or AST = 2.0 times the upper limit of normal for the age range
oCreatinine = 1.5 times the upper limit of normal for the age range
oWhite blood cell count =2.0 x 109/L.
oHemoglobin = 8.5 g/dL
oPlatelet count= 150 x 109/L.
oFemale subjects of childbearing potential must have negative serum pregnancy test at screening and a urine pregnancy test at day 1. A female subject of childbearing potential is defined as a female who has had at least one menstrual period, regardless of age.
Are the trial subjects under 18? yes
Number of subjects for this age range: 152
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Any serous adverse event reported during the original study 20030211 and considered to be related to investigational product
•Any grade 3 or 4 adverse event reported during the original study 20030211 and considered related to study drug must be discussed between Amgen and the investigator
•Receipt of PUVA, UVB, UVA, systemic psoriasis therapy other than etanercept (eg: methotrexate, cyclosporine), parenteral corticosteroids, oral corticosteroids, or potent topical steroids = 14 days before the first dose on this extension study 20050111. Poteent topical steroids are defined as greater than moderate strength according to the package insert.
•Receipt of systemic biologics or investigational product(s) other than etanercept (eg: Raptiva, Amevive) = 30 days before the first dose on this extension study 20050111.
•Receipt of live attenuated vaccines =12 weeks prior to the first dose on this extension study 20050111 (eg: MMR, Varicella, or intranasal influenza vaccine [Flumist®]).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective was to evaluate the safety of long-term administration of etanercept in pediatric subjects with moderate to severe plaque psoriasis. ;Secondary Objective: <br>The secondary objective was to evaluate the long-term efficacy of etanercept administration in pediatric subjects with moderate to severe plaque psoriasis;Primary end point(s): The primary endpoint was the occurrence of adverse events, including infectious episodes, serious adverse events, and serious infectious episodes. ;Timepoint(s) of evaluation of this end point: Every three months
- Secondary Outcome Measures
Name Time Method