Sponsor study identifier
interventional
182
0 countries
N/A
Study Start
August 11, 2005
Actual (reported)Primary Completion
December 19, 2011
Actual (reported)Study Completion
August 16, 2017
Actual (reported)The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 16, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 11, 2005
Actual (reported)August 31, 2005
Actual (reported)September 2, 2005
Actual (reported)December 19, 2011
Actual (reported)February 10, 2017
Actual (reported)August 16, 2017
Actual (reported)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.
264 Weeks
Number of Participants With Injection Site Reactions
264 weeks
Exposure-adjusted Adverse Event Rates
264 weeks
Number of Participants With Clinically Significant Changes in Vital Signs
264 weeks
Number of Participants With Grade 3 and 4 Laboratory Toxicities
264 weeks
Number of Participants Who Developed Anti-etanercept Antibodies
264 weeks
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.
Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
MD
Amgen
182 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
August 11, 2005
Actual (reported)Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
Contact the study team to confirm eligibility.
Primary Completion
December 19, 2011
Actual (reported)Study Completion
August 16, 2017
Actual (reported)Last Updated
October 5, 2017
Results First Posted
February 10, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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