Global Initiative on Takayasu Arteritis (GITA) (GITA)

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.

Study Overview

• Status: Recruiting
• Conditions: Takayasu's Arteritis; Takayasu Arteritis (TAK)

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Fatma Alibaz-Oner, Professor, MD; Phone Number: +902166574545; Email: falibaz@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34899
      • Recruiting
      • Marmara University School of Medicine
      • Contact: Fatma Alibaz Oner, Professor, MD; Phone Number: +902166574545; Email: falibaz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Clinical Remission at 12 Months	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Disease Relapse During Follow-up	Number of events per patient-year	From baseline through study completion (up to 120 months)
Frequency of Long-term Complications During Follow-up	Percentage of patients who experience complications	120 months
Change in damage during follow-up	Change in damage assessed with LVVID and TADS scores	From baseline through study completion (up to 120 months)
Rate of radiographic progression	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)

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2025
• Primary Completion (Estimated): August 1, 2035
• Study Completion (Estimated): August 1, 2035

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: prognosis; follow-up; Registry; Takayasu's arteritis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Diseases, Vascular; Aortic Diseases; Vasculitis; Arteritis; Skin and Connective Tissue Diseases; Aortic Arch Syndromes; Takayasu Arteritis
• Other Study ID Numbers: 09.2025.25-0420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No