Psoriasis VulgarisNCT06563635
Frequency of Tuberculosis in Psoriasis Patients
An observational study of Psoriasis Vulgaris and Tuberculosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Psoriasis Vulgaris, Tuberculosis
- How many people
- 719 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 31 Jul 2023
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: psoriasis patients receiving TNF inhibitor therapy in a single center in 15 years
Who may be able to join
- psoriasis patients receiving TNF inhibitor therapy
Who cannot join
- patients without TNF inhibitor therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency of Tuberculosis in Psoriasis Patients Using Anti-TNF Therapy During 15 Years of Follow-up.
Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center.
Read the detailed description
Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center. TNF inhibitor therapy may increase the risk for tuberculosis infection. According to medical data in our hospital in last 15 years, tuberculosis rate of psoriasis patients receiving etanercept, adalimumab and infliximab will be compared.
- Conditions
- Psoriasis Vulgaris, Tuberculosis
- Keywords
- psoriasis, tnf inhibitor, tuberculosis
- Medical subject headings
- Tuberculosis, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| etanercept | psoriasis patients receiving etanercept therapy | |
| infliximab | psoriasis patients receiving infliximab therapy | |
| adalimumab | psoriasis patients receiving adalimumab therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
tuberculosis rate
number of patients with tuberculosis infection after receiving TNF inhibitor therapy
Measured: patients from June 2007 to January 2023, up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 May 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Retrospective
- Enrolment
- 719 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563635
- Sponsor's protocol ID
- E-54022451-050.05.04-116589
- Status last verified
- Aug 2024
- First submitted
- 31 Aug 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Tuberculosis in Psoriasis Patients Using Anti-TNF Therapy During 15 Years of Follow-up.
- ClinicalTrials.gov ID
- NCT06563635
- Acronym / sponsor ID
- E-54022451-050.05.04-116589
- Conditions
- Psoriasis Vulgaris, Tuberculosis
- Keywords
- psoriasis, tnf inhibitor, tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 719 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 21 Aug 2024 (actual)
- 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.
Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center.
Detailed description
Aim of this study is evaluation of patients receiving TNF inhibitor therapy in terms of tuberculosis at the end of 15 years in a single center. TNF inhibitor therapy may increase the risk for tuberculosis infection. According to medical data in our hospital in last 15 years, tuberculosis rate of psoriasis patients receiving etanercept, adalimumab and infliximab will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| etanercept | – | –psoriasis patients receiving etanercept therapy |
| infliximab | – | –psoriasis patients receiving infliximab therapy |
| adalimumab | – | –psoriasis patients receiving adalimumab therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- psoriasis patients receiving TNF inhibitor therapy in a single center in 15 years
Key inclusion criteria (1 listed)
- psoriasis patients receiving TNF inhibitor therapy
Key exclusion criteria (1 listed)
- patients without TNF inhibitor therapy
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
tuberculosis rate
Time frame: patients from June 2007 to January 2023, up to 15 years
number of patients with tuberculosis infection after receiving TNF inhibitor therapy
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 21 Aug 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris and Tuberculosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 1 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 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
tuberculosis rate (time frame: patients from June 2007 to January 2023, up to 15 years). 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 21 Aug 2024.