The Registry Study of Takayasu Arteritis in East China

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2021
• Main ID: NCT03893136
• Date of registration: 12/03/2019
• Prospective Registration: No
• Primary sponsor: Shanghai Zhongshan Hospital
• Public title: The Registry Study of Takayasu Arteritis in East China
• Scientific title: The Cohort Study of East Chinese Takayasu's Arteritis (ECTA-cohort Study)
• Date of first enrolment: November 1, 2016
• Target sample size: 1000
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03893136
• Study type: Observational

Countries of recruitment

China

Contacts

• Name: Lindi Jiang, PhD

• Name: Lindi Jiang, PhD

• Name: Lindi Jiang, PhD
• Affiliation: Fudan University

Key inclusion & exclusion 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;



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Takayasu Arteritis

Mechanisms, Defense

Pregnancy Related

Outcome

Treatment Refusal

Intervention(s)

Biological: Tocilizumab

Drug: Leflunomide

Primary Outcome(s)

The change of vascular imaging. [Time Frame: Through study completion, an average of 2 months.]

The change of manifestations of systemic symptom - fatigue [Time Frame: Through study completion, an average of 2 months.]

The change of the emerging signs or symptoms of ischemia [Time Frame: Through study completion, an average of 2 months.]

The change of laboratory tests. [Time Frame: Through study completion, an average of 2 months.]

The change of the signs or symptoms of ischemia [Time Frame: Through study completion, an average of 2 months.]

The change of IL-6 in plasma [Time Frame: Through study completion, an average of 2 months.]

The change of the blood pressure [Time Frame: Through study completion, an average of 2 months.]

The change of quality of life(QOF): SF-36 questionnaire [Time Frame: Through study completion, an average of 2 months.]

The change of manifestations of systemic symptoms - chest congestion [Time Frame: Through study completion, an average of 2 months.]

The change of manifestations of systemic symptom - fever [Time Frame: Through study completion, an average of 2 months.]

Secondary Outcome(s)

The change of obstetric related examinations in childbearing women. [Time Frame: From the initiation of pregnancy, 1 year.]

Secondary ID(s)

ECTA-cohort study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors