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CompletedNCT02503059Updated Jul 20, 2015

Etanercept Survival in Elderly Population

An observational study in Psoriasis, sponsored by Fundación Pública Andaluza Progreso y Salud. Completed at 5 sites in Spain. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2015-07-20.

Sponsored by Fundación Pública Andaluza Progreso y Salud · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
70
Ages
60 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 70 is below the median of 200 across 396 observational studies indexed under Psoriasis.

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Lead sponsor

Fundación Pública Andaluza Progreso y Salud is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Patients with insufficient clinical data in the medical record
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
70 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. primary ineffectiveness in patients with etanercept treatment

    Number of participants not achieve PASI 50 response at 12 weeks

    Time frame: 24 weeks

  2. Secondary ineffectiveness in patients with etanercept treatment

    Number of participants with Poor adherence to treatment with etanercept",

    Time frame: 24 weeks (duration of treatment with etanercept)

  3. Ineffectiveness of treatment in localized lesions in patients with etanercept treatment

    Despite having achieved a good response PASI no improvement in critical injuries

    Time frame: 24 weeks(duration of treatment with etanercept)

  4. primary ineffectiveness in patients with etanercept treatment

    Number of participants not achieve PASI 75 response at 24 weeks

    Time frame: 24 weeks

Secondary outcomes

  1. Number of participants with adverse events during treatment with etanercept

    Time frame: 24 weeks

  2. Number of participants with disease remission

    Time frame: 24 weeks

  3. number of participants with Poor adherence to treatment with etanercept

    Time frame: 24 weeks

  4. number of participants with Conditions requiring hospitalization and / or surgery

    Time frame: 24 weeks

07

Study locations

5 sites
  • Hospital Clinic
    Barcelona, Spain
  • H.U. Reina Sofía
    Córdoba, Spain
  • Hospital de Andújar
    Jaén, Spain
  • Hospital la Paz
    Madrid, Spain
  • H.U. Virgen de la Victoria
    Málaga, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02503059
Lead sponsor
Fundación Pública Andaluza Progreso y Salud
Responsible party
Sponsor
First posted
Jul 20, 2015
Start date
Nov 2014
Primary completion
Jan 2015
Completion
Feb 2015
Last update
Jul 20, 2015

Study contacts

Enrique Herrera Ceballos, MD
study director · H.U. Virgen de la Victoria

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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