Etanercept Survival in Elderly Population

July 16, 2015 updated by: Fundación Pública Andaluza Progreso y Salud

Evaluate the 3-year survival of etanercept in patients over 60 years with psoriasis in moderate / severe plaque and the reasons that led to the abandonment. Besides factors that might have had a positive or negative influence on adherence to treatment and analysis of efficacy (PASI 75) and safety will be identified.

All variables were collected through retrospective review of medical records of patients dermatology unit are made.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Clinic
      • Córdoba, Spain
        • H.U. Reina Sofía
      • Jaén, Spain
        • Hospital de Andújar
      • Madrid, Spain
        • Hospital La Paz
      • Málaga, Spain
        • H.U. Virgen de la Victoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients over 60 who received etanercept for the treatment of moderate / severe psoriasis

Description

Inclusion Criteria:

  • Patients with moderate / severe psoriasis (with / without psoriatic arthritis,PAs) defined by: PASI(Psoriasis Area and Severity Index)> 10 and / or BSA(Body Surface Area)> 10% and / or DLQI(Dermatology Life Quality Index)> 10
  • PASI> 10 and / or BSA(Body Surface Area)> 10% and / or DLQI(Dermatology Life Quality Index)> 10
  • Over 60 years of age at the start of treatment
  • Receiving etanercept at any time
  • Available history in the Dermatology

Exclusion Criteria:

  • Patients with insufficient clinical data in the medical record

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary ineffectiveness in patients with etanercept treatment
Time Frame: 24 weeks
Number of participants not achieve PASI 50 response at 12 weeks
24 weeks
Secondary ineffectiveness in patients with etanercept treatment
Time Frame: 24 weeks (duration of treatment with etanercept)
Number of participants with Poor adherence to treatment with etanercept",
24 weeks (duration of treatment with etanercept)
Ineffectiveness of treatment in localized lesions in patients with etanercept treatment
Time Frame: 24 weeks(duration of treatment with etanercept)
Despite having achieved a good response PASI no improvement in critical injuries
24 weeks(duration of treatment with etanercept)
primary ineffectiveness in patients with etanercept treatment
Time Frame: 24 weeks
Number of participants not achieve PASI 75 response at 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events during treatment with etanercept
Time Frame: 24 weeks
24 weeks
Number of participants with disease remission
Time Frame: 24 weeks
24 weeks
number of participants with Poor adherence to treatment with etanercept
Time Frame: 24 weeks
24 weeks
number of participants with Conditions requiring hospitalization and / or surgery
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza Progreso y Salud

Investigators

  • Study Director: Enrique Herrera Ceballos, MD, H.U. Virgen de la Victoria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Estimate)

July 20, 2015

Last Update Submitted That Met QC Criteria

July 16, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPA-ETA-2014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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