Frequency of Tuberculosis in Psoriasis Patients | NCT06563635

Studies
Frequency of Tuberculosis in Psoriasis Patients

NCT06563635

Sponsor

Bezmialem Vakif University

Status

Completed

Last Update Posted

Aug 21, 2024Actual

Enrollment

719Actual

Phase

Not provided

Conditions

Psoriasis Vulgaris
Tuberculosis

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Jul 31, 2023Actual

Completion Date

Jul 31, 2023Actual

First Submitted Date

Aug 31, 2023

First Submission Date that Met QC Criteria

Aug 19, 2024

First Posted Date

Aug 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2024

Last Update Posted Date

Aug 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

719Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
etanercept		psoriasis patients receiving etanercept therapy
infliximab		psoriasis patients receiving infliximab therapy
adalimumab		psoriasis patients receiving adalimumab therapy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
tuberculosis rate	number of patients with tuberculosis infection after receiving TNF inhibitor therapy	patients from June 2007 to January 2023, up to 15 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

psoriasis patients receiving TNF inhibitor therapy

Exclusion Criteria:

patients without TNF inhibitor therapy

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

psoriasis patients receiving TNF inhibitor therapy in a single center in 15 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bezmialem Vakif University Hospital		Istanbul			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis
D011565	Psoriasis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided