RecruitingNCT03893136

The Registry Study of Takayasu Arteritis in East China

The Cohort Study of East Chinese Takayasu's Arteritis (ECTA-cohort Study)


Sponsor

Shanghai Zhongshan Hospital

Enrollment

1,000 participants

Start Date

Nov 1, 2016

Study Type

OBSERVATIONAL

Conditions

Summary

The Takayasu arteritis (TA) is a rare inflammatory large vessel arteritis which often occurs women in Aisa, one of which is China. The rare cases restricted the development of intervention strategy, especially in female patients who plan to be pregnant. So investigators try to recruit as many TA participants as possible to build a TA cohort so that investigators could manage patients much more professionally and standardized and explore the better interventional strategy for a better outcome as well, with full use of blood and vascular tissues.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This registry study tracks patients with Takayasu Arteritis in East China. Takayasu Arteritis is a rare inflammatory disease that affects the large arteries — especially the aorta and its major branches. The inflammation causes the arteries to narrow or become blocked, reducing blood flow to vital organs and limbs. It primarily affects young women and can cause symptoms like arm weakness, blood pressure differences between arms, and arterial bruits (whooshing sounds a doctor can hear with a stethoscope). The registry collects long-term data on diagnosis, treatment, and outcomes to improve understanding and management of this rare disease in the East Asian population, where it is more prevalent than in Western countries. Patients must meet at least 3 of 6 defined clinical criteria for diagnosis and sign informed consent. You may be eligible if: - You have been diagnosed with Takayasu Arteritis (meeting at least 3 of 6 clinical criteria) - You are between 18 and 65 years old (with onset at or before age 40) - You are located in East China - You are willing to sign informed consent You may NOT be eligible if: - You have another autoimmune disease (lupus, ANCA vasculitis, Behcet's, etc.) - You have serious uncontrolled organ disease unrelated to Takayasu - You have active tuberculosis or are at high risk for TB - You have a malignant tumor - You have had an organ transplant or are planning one Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTocilizumab

The scramble TA group is given bioagents such as IL-6R antibody, CD20-antibody, TNF-alpha antibody, and other bioagents which are safe to use in human to treat other refractory diseases. The sham group is given cyclophosphamide. And the prednisone is the basic drugs to be used in TA.

DRUGLeflunomide

The scramble TA group is given new molecules such as Leflunomide, Iguratimod, and other molecules which are safe to use in human to treat other refractory diseases. The sham group is also given cyclophosphamide. And the prednisone is the basic drugs to be used in TA.


Locations(1)

Department of Rheumatology in Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT03893136


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