NCT00141921

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2005

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2011

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

February 10, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
Last Updated

October 5, 2017

Status Verified

September 1, 2017

Enrollment Period

6.4 years

First QC Date

August 31, 2005

Results QC Date

November 29, 2016

Last Update Submit

September 7, 2017

Conditions

Pediatric Plaque Psoriasis

Keywords

ImmunexAmgenPediatric,plaque psoriasisclinical trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (18)

  • 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

  • +13 more secondary outcomes

Study Arms (1)

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.

Drug: Etanercept

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

Also known as: Enbrel®
Etanercept

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Enrollment on previous Amgen study 20030211 (NCT00078819)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 20605256BACKGROUND

  • 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.

    PMID: 26775775BACKGROUND

Related Links

MeSH Terms

Interventions

Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

August 11, 2005

Primary Completion

December 19, 2011

Study Completion

August 16, 2017

Last Updated

October 5, 2017

Results First Posted

February 10, 2017

Record last verified: 2017-09