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Etanercept Survival in Elderly Population

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ClinicalTrials.gov Identifier: NCT02503059
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : July 20, 2015
Sponsor:
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )

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.


Condition or disease
Psoriasis

Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Etanercept Survival in Elderly Population
Study Start Date : November 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept




Primary Outcome Measures :
  1. primary ineffectiveness in patients with etanercept treatment [ Time Frame: 24 weeks ]
    Number of participants not achieve PASI 50 response at 12 weeks

  2. 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",

  3. 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

  4. primary ineffectiveness in patients with etanercept treatment [ Time Frame: 24 weeks ]
    Number of participants not achieve PASI 75 response at 24 weeks


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02503059


Locations
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, Spain
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
Study Director: Enrique Herrera Ceballos, MD H.U. Virgen de la Victoria

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02503059     History of Changes
Other Study ID Numbers: FPA-ETA-2014-01
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors