PsoriasisNCT02503059
Etanercept Survival in Elderly Population
An observational study of Psoriasis, run by Fundación Pública Andaluza Progreso y Salud at 5 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 70 participants
- Where
- 5 sitesSpain
- Study dates
- Nov 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients over 60 who received etanercept for the treatment of moderate / severe psoriasis
Who may be able to join
- 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
Who cannot join
- Patients with insufficient clinical data in the medical record
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Clinic
Barcelona, Barcelona
H.U. Reina Sofía
Córdoba, Córdoba
Hospital de Andújar
Jaén, Jaén
Hospital la Paz
Madrid, Madrid
H.U. Virgen de la Victoria
Málaga, Málaga
About this study
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.
- Conditions
- Psoriasis
- Medical subject headings
- Psoriasis
What is being measured
The primary outcome is the main question the study is designed to answer.
primary ineffectiveness in patients with etanercept treatment
Number of participants not achieve PASI 50 response at 12 weeks
Measured: 24 weeks
Secondary ineffectiveness in patients with etanercept treatment
Number of participants with Poor adherence to treatment with etanercept",
Measured: 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
Measured: 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
Measured: 24 weeks
Secondary outcomes (4)
Number of participants with adverse events during treatment with etanercept
Measured: 24 weeks
Number of participants with disease remission
Measured: 24 weeks
number of participants with Poor adherence to treatment with etanercept
Measured: 24 weeks
number of participants with Conditions requiring hospitalization and / or surgery
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startNov 2014
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique Herrera Ceballos, MD, Study director, H.U. Virgen de la Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503059
- Sponsor's protocol ID
- FPA-ETA-2014-01
- Status last verified
- Jul 2015
- First submitted
- 8 Jul 2015
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etanercept Survival in Elderly Population
- ClinicalTrials.gov ID
- NCT02503059
- Acronym / sponsor ID
- FPA-ETA-2014-01
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over 60 who received etanercept for the treatment of moderate / severe psoriasis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with insufficient clinical data in the medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
primary ineffectiveness in patients with etanercept treatment
Time frame: 24 weeks
Number of participants not achieve PASI 50 response at 12 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",
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
primary ineffectiveness in patients with etanercept treatment
Time frame: 24 weeks
Number of participants not achieve PASI 75 response at 24 weeks
4 secondary outcomes
Number of participants with adverse events during treatment with etanercept
Time frame: 24 weeks
Number of participants with disease remission
Time frame: 24 weeks
number of participants with Poor adherence to treatment with etanercept
Time frame: 24 weeks
number of participants with Conditions requiring hospitalization and / or surgery
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Herrera Ceballos, MD study director
H.U. Virgen de la Victoria
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Fundación Pública Andaluza Progreso y Salud at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary ineffectiveness in patients with etanercept treatment (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2015.