The Registry Study of Takayasu Arteritis in East China

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Brief Title

The Registry Study of Takayasu Arteritis in East China

Official Title

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

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.
    

Detailed Description

      1. Overview of Takayasu's arteritis.

           Takayasu arteritis (TA) is a chronic inflammatory blood vessel that seriously endangers
           human health, which affects a large variety of blood vessels, characterized by vascular
           stenosis and occlusion. The clinical manifestations of TA are hypertension, renal
           failure caused by renal artery stenosis; pulseless, syncope and cerebral infarction
           caused by carotid vessels stenosis; pulmonary infarction induced by thoracic aorta
           involvement, etc. The TA usually accompanies high morbidity, high mortality, and poor
           prognosis. TA is a rare disease which is prone to occur in Asian women, especially in
           young women (20-40 years old) in the growth period. Currently, the etiology and
           pathogenesis of TA remain unclear, and the state of the disease is often repeatedly
           active and continuously progressive. Moreover, non-effective therapy exists for the
           moment.

        2. The diagnosis and activity evaluation of TA

           At present, TA is diagnosed according to the American Society of Rheumatology (ACR)
           classification criteria for Takayasu's arteritis: ① onset at age ≤40 years; ②
           claudication of an extremity; ③ decreased brachial artery pulse; ④ >10 mm Hg difference
           in systolic blood pressure between arms; ⑤ a bruit over the subclavian arteries or the
           aorta; ⑥ and arteriographic evidence of narrowing or occlusion of the entire aorta, its
           primary branches, or large arteries in the proximal upper or lower extremities.
           Participants who meet 3 or more criteria could be diagnosed with this disease posterior
           to excluding atherosclerosis, congenital muscle fiber dysplasia, etc.

           The course of TA is often manifested as chronic, repetitive activity and continuous
           progression. The evaluation standard proposed by Kerr et al. to monitor TA activity is
           widely used clinically. Two more new emerging or aggravating clinical manifestations
           indicates disease Activity: ① systemic symptom, such as fever, bones, muscle symptoms; ②
           increased erythrocyte sedimentation rate (ESR); ③characteristics of vascular ischemia or
           inflammation: such as intermittent claudication, pulse weakening or pulseless, vascular
           bruit, vascular pain, asymmetry blood pressure, etc.; ④ abnormalities in angiography.
           Although acute phase response protein such as ESR and C-reactive protein (CRP) are
           non-specific indicators for inflammation, they are still important markers to evaluate
           the disease activity. Imaging follow-up, primarily based on magnetic resonance imaging
           (MRI) and color Doppler ultrasound, is critical in assessing TA disease activity. With
           the help of Pro. Jiang Lin and Dr. Lu Peng, investigators have established an imaging
           diagnostic team in recent years and proposed the systemic MRI scoring standard in the
           international firstly. The standard has been applied to quantitatively assess the
           vascular inflammation prior and posterior to the treatment in participants with TA.
           Recently, investigators co-operated with the Department of Nuclear Medicine and
           Radiology to employ the 18F-FDG-PET/CT to evaluate the systemic vascular inflammation
           and disease activity in participants. Moreover, investigators attempted to use
           contrast-enhanced ultrasound microbubble imaging to assess the carotid artery
           inflammation and stenosis. At present, these two technologies are still being explored.
           Therefore, it is necessary to combine the clinical manifestations, acute phase response
           proteins (ESR and CRP) and imaging to judge the TA disease activity comprehensively.

        3. Treatment of arteritis

           The treatment of TA is divided into two phases: remission induction period and
           maintenance period. The drugs are divided into three categories including
           glucocorticoids, cytotoxic drugs, and biological agents targeting inflammatory
           cytokines.

           Glucocorticoids are the basic drug for TA treatment. Most TA participants receiving high
           doses of glucocorticoids treatment could be induced remission quickly, but about 17%-29%
           of refractory participants treated with standard glucocorticoids strategy could not be
           alleviated. And the recurrence rate is up to 90% with the single glucocorticoid. About
           more than 2/3 of participants would be glucocorticoid-dependent, and more than half of
           the participants need other drugs to maintain remission. Moreover, long-term high-dose
           glucocorticoids also have many adverse effects.

           Recently, targeted biological agents have been attempted to treat refractory, recurrent
           TA and glucocorticoid-dependent remission induction TA participants. Compared with
           conventional drugs, targeted biological agents work faster and could bring disease
           remissions for 70%-90% of refractory participants. However, the long-term use of
           biological agents would threaten the low-immunity participants with the risk of
           infections and cancer. Moreover, the effect on the reproductive system is unclear for
           the moment; in addition, these drugs are expensive and mainly used in refractory and
           critically ill participants.

           The combination of glucocorticoids combining with immunosuppressive agents such as
           cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil, etc. are the
           commonly used remission induction strategy clinically. However, large amounts of
           clinical evidence demonstrate that TA participants receiving glucocorticoids with the
           immunosuppressive agents would also face the histopathological activities lesions in the
           future. In the long-term follow-up, the relapse rate is much higher, and the mortality
           rate is significantly higher than that of healthy people.

           In summary, the current commonly used drugs for TA treatment could not meet the needs of
           the clinical setting, and TA participants lack a universally effective treatment
           strategy.

        4. Pregnancy of TA participants

      TA often occurs in women of childbearing age, so reducing the risk of maternal pregnancy
      caused by pregnancy in TA participants is one of the investigators' focuses in recent years.
      At present, there are no relevant guidelines for the pregnancy of TA participants, and
      doctors instruct them to take pills and monitor disease activity mainly basing on the
      doctor's clinical experience. Usually, investigators do not recommend the TA participants in
      active phase to conceive, not only because that the use of hormones and cytotoxic drugs could
      influence the development of the fetus, but also because that the stenosis or occlusion of
      the distal artery would increase the cardiac load so as to cause congestive heart failure,
      pre-eclampsia as well as fetal growth restriction and stillbirth. A case-control study in
      Brazil recruiting 89 TA and 89 healthy pregnant women discovered that the risk of gestational
      hypertension and low birth weight was much higher in TA than that in healthy controls.
      Moreover, the perinatal mortality rate is much higher in TA pregnant participants as well. A
      retrospective study in France including 96 TA pregnant women, 240 cases of pregnancy events,
      revealed that TA did not affect the pregnancy outcomes, but increased the risk of
      complications such as pregnancy hypertension with the elevating of the disease activity.
      Therefore, there is a lack of large-scale evidence-based medical proof uncovering the
      relationship between the pregnancy outcome and maternal risk in participants of TA. Here, the
      present follow-up registration also extends to the service of pregnant TA participants, which
      is designed to guide the treatment of pregnant participants and monitor maternal safety.

      This objective of this study is to record the related materials of the follow-up of TA
      participants and the pregnancy course, to direct the standardized medication, to monitor the
      changes of disease conditions, and to provide the better prognosis and pregnancy outcome for
      TA participants.
    


Study Type

Observational


Primary Outcome

The change of manifestations of systemic symptom - fever

Secondary Outcome

 The change of obstetric related examinations in childbearing women.

Condition

Takayasu Arteritis

Intervention

Tocilizumab

Study Arms / Comparison Groups

 Control group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

1000

Start Date

November 1, 2016

Completion Date

May 31, 2026

Primary Completion Date

May 31, 2026

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;
      

Gender

All

Ages

18 Years - 65 Years


Contacts

Lindi Jiang, PhD, +86-021-64041990, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT03893136

Organization ID

ECTA-cohort study


Responsible Party

Sponsor

Study Sponsor

Shanghai Zhongshan Hospital


Study Sponsor

Lindi Jiang, PhD, Study Chair, Fudan University


Verification Date

August 2021