Registry of Takayasu Arteritis in East China

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

This study is trying to gather information from women with Takayasu arteritis in East China to understand the disease better and find the best ways to treat it.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Drugs / interventions: methotrexate, cyclophosphamide
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT03893136 on ClinicalTrials.gov

What this trial studies

This observational study aims to create a comprehensive cohort of patients with Takayasu arteritis (TA) in East China, focusing on the disease's mechanisms, treatment responses, and outcomes, particularly in women of childbearing age. By recruiting a significant number of participants, the study seeks to standardize patient management and explore effective intervention strategies. The study will utilize blood and vascular tissue samples to better understand the disease and its progression.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 20-40 who meet specific diagnostic criteria for Takayasu arteritis.

Not a fit: Patients with other autoimmune diseases or severe unrelated medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and treatment strategies for patients with Takayasu arteritis, particularly in women planning for pregnancy.

How similar studies have performed: While Takayasu arteritis is a rare condition, previous studies have shown the potential for improved outcomes through standardized management approaches, making this study a valuable addition to existing research.

Eligibility criteria

Inclusion Criteria

* 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 Criteria

* 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;

Where this trial is running

Shanghai, Shanghai Municipality

• Department of Rheumatology in Zhongshan hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lindi Jiang, PhD

Conditions Takayasu Arteritis; Mechanisms, Defense; Pregnancy Related; Treatment Refusal; Outcome; Takayasu arteritis; follow-up; treatment