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Global Initiative on Takayasu Arteritis (GITA) (GITA)

23 april 2026 bijgewerkt door: Fatma Alibaz Oner, Marmara University

Takayasu's Arteritis Global Registry

Takayasu's Arteritis Global Registry aims to bring a large group of patients from different parts of the world to analyse and compare the patients' demographic, clinical, laboratory, radiological and prognostic features with outcomes, approaches to diagnosis, assessment, management and therapeutic interventions in different centers. The present project provides for both a retrospective and a prospective longitudinal study. The study is designed as retrospective for patients already diagnosed with TAK and treated with available treatments. Also, the study is designed as prospective for patients diagnosed with TAK after the initiation of the Registry or the adhesion to the project. This is thought as a multicentre, international study addressed to all Centers that will want to contribute to the present project. The study is non-interventional: demographic, clinical and therapeutic data required over time are collected with the routine diagnostic, clinical and therapeutic procedures usually carried out for the optimal management of patients and according with good clinical practice.

Studie Overzicht

Toestand

Werving

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

1000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Fatma Alibaz-Oner, Professor, MD
Telefoonnummer: +902166574545
E-mail: falibaz@gmail.com

Studie Locaties

Turkije (Türkiye)
- Istanbul
  - Istanbul, Istanbul, Turkije (Türkiye), 34899
    - Werving
    - Marmara University School of medicine
    - Contact:
      
      Fatma Alibaz Oner, Professor, MD
      
      Telefoonnummer: +902166574545
      
      E-mail: falibaz@gmail.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind
Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients aged >18 years diagnosed with Takayasu arteritis according to ACR 1990 or ACR/EULAR 2021 criteria will be included

Beschrijving

Inclusion Criteria:

Each patient must fullfill the ACR 1990 or ACR/EULAR 2021 criteria for Takayasu arteritis.
Patients (or legally acceptable representatives of subjects enrolled) have to
provide informed and free agreement to participate in the study and to disclose any medical event to the investigator. The parents or legally acceptable representative and the adolescent subject must be willing and able to comply with the study protocol requirements for the duration of the study
freely sign written and dated informed consent after being duly informed of the nature, significance, and implications of the study;
be informed that the patient enrolled may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

Patients must be excluded from the study when the following criteria are observed:

The patient does not full-fill the ACR 1990 or ACR/EULAR 2021 criteria for Takayasu arteritis
informed consent/assent is not provided and signed

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Takayasu's arteritis This prospective observational, multi-centre, multi-national cohort study aims to comprehensively collect and analyse the demographic, clinical, laboratory, and radiological data of patients with TAK. By doing so, the TAK Registry will enable the investigation of key outcomes, including disease activity, relapse and mortality and associated factors, ultimately contributing to a better understanding and management of TAK.

Groep / Cohort

Takayasu's arteritis

This prospective observational, multi-centre, multi-national cohort study aims to comprehensively collect and analyse the demographic, clinical, laboratory, and radiological data of patients with TAK. By doing so, the TAK Registry will enable the investigation of key outcomes, including disease activity, relapse and mortality and associated factors, ultimately contributing to a better understanding and management of TAK.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Rate of Clinical Remission at 12 Months Tijdsspanne: 120th month from the start of the study	Clinical remission will be defined according to the absence of clinical signs and symptoms of active disease and normalization of inflammatory markers	120th month from the start of the study

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Incidence of Disease Relapse During Follow-up Tijdsspanne: From baseline through study completion (up to 120 months)	Number of events per patient-year	From baseline through study completion (up to 120 months)
Frequency of Long-term Complications During Follow-up Tijdsspanne: 120 months	Percentage of patients who experience complications	120 months
Change in damage during follow-up Tijdsspanne: From baseline through study completion (up to 120 months)	Change in damage assessed with LVVID and TADS scores	From baseline through study completion (up to 120 months)
Rate of radiographic progression Tijdsspanne: From baseline through study completion (up to 120 months)	New lesion or progression of existing vascular lesion in BTA, MRA or new or increased active vasculitic uptake in vascular territory with PET/CT	From baseline through study completion (up to 120 months)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Marmara University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 augustus 2025

Primaire voltooiing (Geschat)

1 augustus 2035

Studie voltooiing (Geschat)

1 augustus 2035

Studieregistratiedata

Eerst ingediend

9 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 april 2026

Eerst geplaatst (Werkelijk)

30 april 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)