NCT00121615

Brief Summary

The objective of the study is to describe the safety, tolerability, and efficacy of the long-term administration of etanercept in adults with psoriasis who have completed etanercept psoriasis study 20030115 or 20030117, in Canada, and are continuing in a long-term extension. Subjects from the 20030115 study will be followed for 24 months which began in Oct. 2004. Subjects in the 20030117 study will be followed for 12 months which began in mid 2005.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
391

participants targeted

Target at P50-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

October 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
Last Updated

March 6, 2009

Status Verified

March 1, 2009

First QC Date

June 30, 2005

Last Update Submit

March 5, 2009

Conditions

InflammationPsoriasis

Keywords

Clinical Trials

Outcome Measures

Primary Outcomes (1)

  • Subject incidence of serious adverse events, including serious infections, non-melanoma skin cancer, and all malignancies, and all adverse events.

Secondary Outcomes (1)

  • Longitudinal changes from baseline for the Physician and Patient Global Assessments and DLQI

Interventions

etanerceptDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Papp KA, Poulin Y, Bissonnette R, Bourcier M, Toth D, Rosoph L, Poulin-Costello M, Setterfield M, Syrotuik J. Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population. J Am Acad Dermatol. 2012 Feb;66(2):e33-45. doi: 10.1016/j.jaad.2010.07.026. Epub 2010 Sep 17.

    PMID: 20850895DERIVED

Related Links

MeSH Terms

Conditions

InflammationPsoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 21, 2005

Study Start

October 1, 2004

Last Updated

March 6, 2009

Record last verified: 2009-03