The Registry Study of Takayasu Arteritis in East China
The Cohort Study of East Chinese Takayasu's Arteritis (ECTA-cohort Study)
Shanghai Zhongshan Hospital
1,000 participants
Nov 1, 2016
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
Inclusion Criteria8
- onset at age ≤40 years;
- claudication of an extremity;
- decreased brachial artery pulse;
- \>10 mm Hg difference in systolic blood pressure between arms;
- a bruit over the subclavian arteries or the aorta;
- angiographic evidence of narrowing or occlusion of the entire aorta, its primary branches, or large arteries in the proximal upper or lower extremities.
- Patients should meet at least 3 of the above 6 articles.
- Sign the informed consent
Exclusion Criteria12
- autoimmune diseases, such as ANCA-associated vasculitis, systemic lupus erythematosus, Behcet's disease, rheumatoid arthritis, ankylosing spondylitis, etc.;
- complicated medical abnormal conditions, un-related with TA but engendering the unpredictable risks, such as severe, progressive, or uncontrollable kidney, liver, blood, gastrointestinal, pulmonary, heart, neuron or others
- malignant tumors;
- serious acute or chronic infections;
- high risk of tuberculosis infection such as clinical, radiological or laboratory evidence of active or occult tuberculosis, or the history of active tuberculosis;
- Having received or plan to receive plasma exchange or lymphocyte replacement or immunoabsorption therapy within 1 year.
- Preparing to receive an attenuated vaccine during the trial;
- Having received or plan to receive an organ transplant;
- Exit criteria
- participants require to withdraw during the study;
- participants who believe that they need to withdraw due to clinical adverse events;
- Participants can not or does not comply with the requirements of the research protocol;
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Interventions
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03893136