NCT02503059

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

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

November 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
Last Updated

July 20, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

July 8, 2015

Last Update Submit

July 16, 2015

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (4)

  • primary ineffectiveness in patients with etanercept treatment

    Number of participants not achieve PASI 50 response at 12 weeks

    24 weeks

  • Secondary ineffectiveness in patients with etanercept treatment

    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

    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

    Number of participants not achieve PASI 75 response at 24 weeks

    24 weeks

Secondary Outcomes (4)

  • Number of participants with adverse events during treatment with etanercept

    24 weeks

  • Number of participants with disease remission

    24 weeks

  • number of participants with Poor adherence to treatment with etanercept

    24 weeks

  • number of participants with Conditions requiring hospitalization and / or surgery

    24 weeks

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with insufficient clinical data in the medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Clinic

Barcelona, Barcelona, Spain

Location

H.U. Reina Sofía

Córdoba, Córdoba, Spain

Location

Hospital de Andújar

Jaén, Jaén, Spain

Location

Hospital la Paz

Madrid, Madrid, Spain

Location

H.U. Virgen de la Victoria

Málaga, Málaga, Spain

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Enrique Herrera Ceballos, MD

    H.U. Virgen de la Victoria

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 20, 2015

Study Start

November 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

July 20, 2015

Record last verified: 2015-07

Locations

ES(5)