Global Initiative on Takayasu Arteritis (GITA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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
Trial population
Patients aged \>18 years diagnosed with Takayasu arteritis according to ACR 1990 or ACR/EULAR 2021 criteria will be included
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Takayasu's arteritis
Trial outcomes
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
Time frame
120th month from the start of the studySecondary outcomes
1
Incidence of Disease Relapse During Follow-up
Number of events per patient-year
Time frame
From baseline through study completion (up to 120 months)2
Frequency of Long-term Complications During Follow-up
Percentage of patients who experience complications
Time frame
120 months3
Change in damage during follow-up
Change in damage assessed with LVVID and TADS scores
Time frame
From baseline through study completion (up to 120 months)4
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
Time frame
From baseline through study completion (up to 120 months)Sponsors and contacts
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Source ClinicalTrials.gov