NCT00581165

Brief Summary

Evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in Spain; (ii) the incidence of adverse events reported in these patients, and (iii) the role that age and concomitant therapy might play in the development of adverse reactions.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2006

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

February 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
Last Updated

December 27, 2007

Status Verified

December 1, 2007

Enrollment Period

1.5 years

First QC Date

December 21, 2007

Last Update Submit

December 26, 2007

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment

    18 months

Secondary Outcomes (1)

  • Reduction and/or withdrawal of systemic therapies, Proportion of patients with plaque psoriasis achieving PASI 50, 75 and 90 at each evaluation and BSA at each evaluation

    18 months

Interventions

EtanerceptDRUG

recommended dose of enbrel is 25mg administered twice weekly.

Eligibility Criteria

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

You may qualify if:

  • Informed consent signed by patients prior to study entry
  • years of age or older at screening visit
  • Patients with moderate to severe psoriasis
  • Patients who have failed conventional systemic treatment
  • Patients who have a contraindication to conventional systemic therapy
  • Patients who are intolerant to conventional systemic therapy
  • A negative serum pregnancy test at screening in women of childbearing potential
  • Able to self-inject study drug or have a designee who can do so
  • In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin 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

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 27, 2007

Study Start

February 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

December 27, 2007

Record last verified: 2007-12