Etanercept Survival in Elderly Population

Psoriasis Clinical Trial

Official title:

Etanercept Survival in Elderly Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503059
• Other study ID #: FPA-ETA-2014-01
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: July 16, 2015
• Start date: November 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Spain	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

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary ineffectiveness in patients with etanercept treatment	Number of participants not achieve PASI 50 response at 12 weeks	24 weeks	No
Primary	Secondary ineffectiveness in patients with etanercept treatment	Number of participants with Poor adherence to treatment with etanercept",	24 weeks (duration of treatment with etanercept)	No
Primary	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)	No
Primary	primary ineffectiveness in patients with etanercept treatment	Number of participants not achieve PASI 75 response at 24 weeks	24 weeks	No
Secondary	Number of participants with adverse events during treatment with etanercept		24 weeks	Yes
Secondary	Number of participants with disease remission		24 weeks	No
Secondary	number of participants with Poor adherence to treatment with etanercept		24 weeks	No
Secondary	number of participants with Conditions requiring hospitalization and / or surgery		24 weeks	No