NCT06266247

Brief Summary

Our primary aim in our study is to evaluate the relationship between the activity, which will be evaluated by clinical and standard phase reactants, and the IL-6 and TNF-α levels, which will be measured in serum, in Behçet\'s patients. Our secondary aim was to evaluate Sirtuin-1 in Behcet\'s patients and compare it with the normal population. Our third aim is to find out whether there is a relationship between these values and organ involvement.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

January 25, 2024

Last Update Submit

February 12, 2024

Conditions

Keywords

Behçetinflammation

Outcome Measures

Primary Outcomes (1)

  • Our primary aim is to evaluate the relationship between the activity to be evaluated with clinical and standard acute phase reactants and the IL-6 and TNF-α levels to be measured in serum in Behçet's patients.

    Since Behçet's disease is an inflammatory disease, immediate blood samples will be taken from patients presenting to the outpatient clinic. Acute phase reactants, tnf-alpha levels and interleukin-6 levels will be measured. Behçet's disease current activity form 2006 (BDCAF-2006) will be filled and disease activity levels will be evaluated. BDCAF-2006 and acute phase reactants, tnf-alpha levels and interleukin-6 levels will be compared. The same comparison will be made with acute phase reactants, tnf-alpha levels and interleukin-6 levels in the blood obtained from the control group. The difference between both groups will be evaluated

    From enrollment to the end of treatment at 6 months"

Study Arms (1)

patients

OTHER

1. Group: Behcet patients 2. Group: Healty people

Diagnostic Test: Take blood samples

Interventions

Take blood samplesDIAGNOSTIC_TEST

Tnf alpha, sirtuin and il-6 levels will be examined in patients with Behcet\'s disease using biological drugs and not using biological drugs

patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with Behçet's disease between the ages of 18-65 who come to the Rheumatology Polyclinic for their normal routine check-up.

You may not qualify if:

  • Suffer from other arthritis or joint diseases;
  • Combined with severe liver and kidney function damage or metabolic diseases (such as thyroid and parathyroid diseases), affecting bone metabolism;
  • Combined with serious cardiovascular and cerebrovascular diseases or chronic kidney diseases;
  • Combined with tumour and bone metastasis;
  • Taking anticancer drugs or other drugs that affect bone metabolism;
  • Pregnant or lactating women;
  • Exclude other autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karamanoğlu Mehmetbey University

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Behcet SyndromeInflammationVasculitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical profesor

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 20, 2024

Study Start

January 15, 2024

Primary Completion

June 30, 2024

Study Completion

October 30, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations