Global Initiative on Takayasu Arteritis (GITA)

NCT07558382 | Recruiting DMC

• 1 other identifier: 09.2025.25-0420
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Takayasu's Arteritis; Takayasu Arteritis (TAK)

Keywords

Takayasu's arteritis; prognosis; Registry; follow-up

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of Disease Relapse During Follow-up

  From baseline through study completion (up to 120 months)

• Frequency of Long-term Complications During Follow-up

  120 months

• Change in damage during follow-up

  From baseline through study completion (up to 120 months)

• Rate of radiographic progression

  From baseline through study completion (up to 120 months)

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (2)

Marmara University School of Medicine

Istanbul, Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Marmara University School of Medicine

Istanbul, Istanbul, 34899, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Takayasu Arteritis

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Fatma Alibaz-Oner, Professor, MD

CONTACT

+902166574545; falibaz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 30, 2026
• Study Start: August 5, 2025
• Primary Completion (Estimated): August 1, 2035
• Study Completion (Estimated): August 1, 2035
• Last Updated: April 30, 2026

Record last verified: 2025-08

Locations

TU (2)