PsoriasisDERMNCT02322580
An Observational Monocentric Study Investigating the Association Between Trough Serum Levels of Etanercept, Antibodies Towards Etanercept and Its Effectiveness in Psoriasis Patients
An observational study of Psoriasis, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
The purpose of this study is to investigate the association between trough serum levels of etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- etanercept
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Psoriasis patients who receive Enbrel® therapy according to the current EU Summary of Product Characteristics (SmPC)
Who may be able to join
- Age from 18 years on, male or female
- Established diagnosis of psoriasis
- Etanercept either on monotherapy or in combination with acitretin (Neotigason®), given according to the current EU SmPC including the safety measures.
- Patients who give informed consent for this study
Who cannot join
None listed.
About this study
Official title: Intermittent Versus Continuous Treatment: an Observational Monocentric Study Investigating the Association Between Trough Levels of Enbrel and Therapy Regimen
The purpose of this study is to investigate the association between trough serum levels of etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients.
- Conditions
- Psoriasis
- Being tested
- etanercept
- Keywords
- anti-TNF, therapeutic drug monitoring, immunogenicity
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
Also called Enbrel®
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis patients who receive Enbrel® therapy | Not described Receives: Drug: etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
trough serum etanercept concentration
Measured: one year
anti-etanercept serum concentration
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionSep 2016
- Study completionNov 2016
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322580
- Sponsor's protocol ID
- S56818
- Acronym
- DERM
- Status last verified
- May 2016
- First submitted
- 11 Dec 2014
- Last updated
- 2 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Versus Continuous Treatment: an Observational Monocentric Study Investigating the Association Between Trough Levels of Enbrel and Therapy Regimen
- ClinicalTrials.gov ID
- NCT02322580
- Acronym / sponsor ID
- DERM / S56818
- Conditions
- Psoriasis
- Keywords
- anti-TNF, therapeutic drug monitoring, immunogenicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Dec 2014 (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.
The purpose of this study is to investigate the association between trough serum levels of etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis patients who receive Enbrel® therapy | – | Drug: etanercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psoriasis patients who receive Enbrel® therapy according to the current EU Summary of Product Characteristics (SmPC)
Key inclusion criteria (4 listed)
- Age from 18 years on, male or female
- Established diagnosis of psoriasis
- Etanercept either on monotherapy or in combination with acitretin (Neotigason®), given according to the current EU SmPC including the safety measures.
- Patients who give informed consent for this study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etanerceptAlso: Enbrel® | Drug | Psoriasis patients who receive Enbrel® therapy |
Primary outcome
trough serum etanercept concentration
Time frame: one year
anti-etanercept serum concentration
Time frame: one year
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 2 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Universitaire Ziekenhuizen KU Leuven.
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 4 inclusion and 0 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 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
trough serum etanercept concentration (time frame: one year). The study lists 2 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 2 Dec 2016.