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The Registry Study of Takayasu Arteritis in East China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893136
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : August 10, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief 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.

Condition or disease Intervention/treatment
Takayasu Arteritis Mechanisms, Defense Pregnancy Related Treatment Refusal Outcome Biological: Tocilizumab Drug: Leflunomide

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Cohort Study of East Chinese Takayasu's Arteritis (ECTA-cohort Study)
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : May 31, 2026
Estimated Study Completion Date : May 31, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Leflunomide

Group/Cohort Intervention/treatment
Control group
The control group mainly consists of healthy volunteers. The whole blood is obtained and frozen to detect the corresponding biochemical markers in the futures. The vascular tissues are obtained from the deserted and free abdominal aorta conjugated to the renal artery in the kidney transplantation.
sham TA group
In the TA cohort, patients are divided into two groups mainly, sham TA group and scramble TA group. The sham TA group is the TA group who is given the traditional and classical intervention or treatment and so on.
scramble TA group
Compared to sham TA group in the cohort, scramble TA group refers to TA patients who are given novel drugs or new drugs which are safe to treat other autoimmune diseases but have not been used to treat TA yet, or some new interventions and so on.
Biological: Tocilizumab
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.
Other Name: IL-6R antibody

Drug: Leflunomide
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.
Other Name: Arava




Primary Outcome Measures :
  1. The change of manifestations of systemic symptom - fever [ Time Frame: Through study completion, an average of 2 months. ]
    The change of manifestations of systemic symptoms could effectively reflect the disease status of patients. The systemic symptoms associated with Takayasu arteritis mainly consist of fever, fatigue and chest congestion. Fever is examined by thermometer with the axillary's temperature, and the T>37.5 degree is considered to be fever. After investigators excluding the fever caused by infection through CT or laboratory examinations, the occurrence of fever usually indicates the disease activity.

  2. The change of manifestations of systemic symptom - fatigue [ Time Frame: Through study completion, an average of 2 months. ]
    The occurrence of fatigue indicates that the disease might be in the active phase. Self reported fatigue is obtained through inquiry, recorded by investigators and classified as "WITH" and "WITHOUT".

  3. The change of manifestations of systemic symptoms - chest congestion [ Time Frame: Through study completion, an average of 2 months. ]
    The occurrence of chest congestion indicates that the heart and pulmonary might be involved and the disease might be in the active phase. Self reported chest congestion is obtained through inquiry, recorded by investigators and classified as "WITH" and "WITHOUT".

  4. The change of the emerging signs or symptoms of ischemia [ Time Frame: Through study completion, an average of 2 months. ]
    Multiple emerging signs or symptoms could sensitively reflect the extent of ischemia of artery or organs. Self-reported emerging signs or symptoms of ischemia including vascular pain, dizziness, headache, amaurosis, vision loss, blurred vision, palpitations, chest pain, abdominal pain, claudication and other symptom through inquiry are recorded by investigators and classified as "WITH" and "WITHOUT". Participants with emerging signs or symptoms of ischemia usually face aggravating TA disease.

  5. The change of the signs or symptoms of ischemia [ Time Frame: Through study completion, an average of 2 months. ]
    The vascular bruits and pulse strength are evaluated and scored from 0 to 2 (0=without bruits and pulse; 1=bruits and decreased pulse; 2= normal) by a special well-trained investigator. If the score decreases, the ischemia is exacerbated and classified as "WITH".

  6. The change of the blood pressure [ Time Frame: Through study completion, an average of 2 months. ]
    The blood pressure change is measured with sphygmomanometer by the investigators. The measure is performed three times in each visit, and the mean systolic blood pressure (SBP) and mean diastolic blood pressure (DBP) are recorded. If the pressure fluctuates over 20mmHg, the stenosis of artery may exacerbate and the disease might be in the active phase.

  7. The change of laboratory tests. [ Time Frame: Through study completion, an average of 2 months. ]
    The laboratory inflammatory markers such as erythrocyte sedimentation rate (ESR) are concise and efficient methods to monitor the change of disease status, and are examined by clinical laboratory in Zhongshan Hospital of Fudan University. Investigators record and summarize the results and evaluate the change of ESR under different treatment options.

  8. The change of IL-6 in plasma [ Time Frame: Through study completion, an average of 2 months. ]
    IL-6 plays an important role in the progression of Takayasu arteritis. The level of plasma IL-6 is detected by clinical laboratory in Zhongshan Hospital of Fudan University. Investigators record and summarize the results and evaluate the change of IL-6 under different interventions, and analyze the relationship between IL-6 and disease status.

  9. The change of vascular imaging. [ Time Frame: Through study completion, an average of 2 months. ]
    MRA and contrast-enhanced carotid ultrasound imaging are important methods to evaluate TA vascular inflammation and structural change. In the initial interview and every 3 times of follow-up, the imaging examination are carried out and the images are stored at the hospital. Two radiologists perform the independent reading and evaluation. Vascular imaging is employed to monitor the improvement of the vascular wall inflammation and vascular structures (including vessel wall thickness and vascular stenosis) during treatment. For patients with stent or other metallic foreign things in the body, PET-CT and CT are also used to examine the shape and lumen of the vessels.

  10. The change of quality of life(QOF): SF-36 questionnaire [ Time Frame: Through study completion, an average of 2 months. ]
    The change of Quality of Life (QOF) with the SF-36 questionnaire Self reported the change of quality of life. Patients complete the SF-36 quality of life assessment questionnaire. Investigators provide the guidance and training on how to complete the questionnaire but must not interfere with the patients' own choice. Investigators evaluate the change of overall quality of life of patients and score the change from 0 to 2 (0= alleviated, 1=similar, 2= worsen).


Secondary Outcome Measures :
  1. The change of obstetric related examinations in childbearing women. [ Time Frame: From the initiation of pregnancy, 1 year. ]
    For childbearing women who are preparing to be pregnant and being pregnant, investigators pay special attention to these participants and provide proper guidance and assistance promptly. To evaluate the change of obstetric related examinations, investigators record the results of obstetric related examinations such as height of uterus, abdominal perimeter, and collaborate with ultrasound specialist to perform the obstetric ultrasound to monitor the status of fetus. At last, investigators assess the process and scores from 0 to 4 with the help of doctors from gynecologist and obstetrician. (0= much better than normal women, 1= similar to normal women, 2= worse than normal women but without obstetrics and gynecology complications, 3= worse than normal women with obstetrics and gynecology complications, 4= abortion, death of fetus or mother.)


Biospecimen Retention:   Samples With DNA
The whole blood was drawn and centrifuged to get serum, plasma, and cell pellet. The vascular specimens were also obtained with permission.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The population of the present investigation is TA patients mainly deriving from east China. The subjects are mainly female at the pregnancy age, who have the necessity to be pregnant. But there is not any drug or other intervention to cure them thoroughly.
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893136


Contacts
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Contact: Lindi Jiang, PhD +86-021-64041990 zsh-rheum@hotmail.com
Contact: Rongyi Chen, MD +8615221160538 chenry825@hotmail.com

Locations
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China, Shanghai
Department of Rheumatology in Zhongshan hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Lindi Jiang, PhD    +86-021-64041990    zsh-rheum@hotmail.com   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Lindi Jiang, PhD Fudan University
Publications:

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03893136    
Other Study ID Numbers: ECTA-cohort study
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Shanghai Zhongshan Hospital:
Takayasu arteritis
follow-up
treatment
outcome
pregnancy
cohort
Additional relevant MeSH terms:
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Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases
Leflunomide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs