Takayasu Arteritis (TAK)GITANCT07558382
Global Initiative on Takayasu Arteritis (GITA)
An observational study of Takayasu Arteritis (TAK) and Takayasu's Arteritis, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Takayasu Arteritis (TAK), Takayasu's Arteritis
- How many people
- 1,000 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Aug 2025to Aug 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged >18 years diagnosed with Takayasu arteritis according to ACR 1990 or ACR/EULAR 2021 criteria will be included
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Marmara University School of Medicine
Istanbul, Istanbul, 34899
Sema Fatmaz Alibaz Oner, Professor, MD, +902166574545, falibaz@gmail.com
- Recruiting
Marmara University School of Medicine
Istanbul, Istanbul, 34899
Fatma Alibaz Oner, Professor, MD, +902166574545, falibaz@gmail.com
About this study
Official title: 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.
- Conditions
- Takayasu Arteritis (TAK), Takayasu's Arteritis
- Keywords
- Takayasu's arteritis, prognosis, Registry, follow-up
- Medical subject headings
- Takayasu Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 120th month from the start of the study
Secondary outcomes (4)
Incidence of Disease Relapse During Follow-up
Number of events per patient-year
Measured: From baseline through study completion (up to 120 months)
Frequency of Long-term Complications During Follow-up
Percentage of patients who experience complications
Measured: 120 months
Change in damage during follow-up
Change in damage assessed with LVVID and TADS scores
Measured: 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
Measured: From baseline through study completion (up to 120 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start5 Aug 2025
- Primary completionAug 2035 (estimated)
- Study completionAug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takayasu Arteritis (TAK)Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Alibaz Oner, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558382
- Sponsor's protocol ID
- 09.2025.25-0420
- Acronym
- GITA
- Status last verified
- Aug 2025
- First submitted
- 9 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Takayasu's Arteritis Global Registry
- ClinicalTrials.gov ID
- NCT07558382
- Acronym / sponsor ID
- GITA / 09.2025.25-0420
- Conditions
- Takayasu Arteritis (TAK), Takayasu's Arteritis
- Keywords
- Takayasu's arteritis, prognosis, Registry, follow-up
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- Aug 2035 (estimated)
- Study completion
- Aug 2035 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged >18 years diagnosed with Takayasu arteritis according to ACR 1990 or ACR/EULAR 2021 criteria will be included
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Clinical Remission at 12 Months
Time frame: 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
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Takayasu Arteritis (TAK)
Not yet recruitingObservational study
Monitoring Disease Activity in Patients With Takayasu Arteritis With the OMERACT Takayasu Ultrasound Score (OTUS)
Takayasu Arteritis (TAK)
Not yet recruitingPhase 4
Efficacy and Safety of Vunakizumab and Ivarmacitinib in the Treatment of Active Takayasu's Arteritis
Takayasu Arteritis (TAK)
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)
Takayasu Arteritis (TAK)
RecruitingObservational study
Vasculitis Pregnancy Registry
Vasculitis, Behcet's Disease
RecruitingObservational study
VCRC Tissue Repository
Aortitis, Cutaneous Vasculitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takayasu Arteritis (TAK) and Takayasu's Arteritis, run by Marmara University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Alibaz-Oner, Professor, MD (+902166574545, falibaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Clinical Remission at 12 Months (time frame: 120th month from the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.