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Recruiting NCT07558382

Global Initiative on Takayasu Arteritis (GITA)

Observational Takayasu Arteritis (TAK) Takayasu's Arteritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Takayasu Arteritis (TAK), Takayasu's Arteritis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Takayasu's Arteritis Global Registry

Overview

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.

Primary outcome measures

  • Rate of Clinical Remission at 12 Months [Time frame: 120th month from the start of the study]
Secondary outcome measures (4)
  • Incidence of Disease Relapse During Follow-up [Time frame: From baseline through study completion (up to 120 months)]
  • Frequency of Long-term Complications During Follow-up [Time frame: 120 months]
  • Change in damage during follow-up [Time frame: From baseline through study completion (up to 120 months)]
  • Rate of radiographic progression [Time frame: From baseline through study completion (up to 120 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 2 centers
  • Marmara University School of Medicine — Istanbul
  • Marmara University School of Medicine — Istanbul

Identifiers

NCT: NCT07558382 · 09.2025.25-0420

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗