The Registry Study of Takayasu Arteritis in East China

NCT03893136 | Recruiting FDA Drug

• 1 other identifier: ECTA-cohort study
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Takayasu Arteritis; Mechanisms, Defense; Pregnancy Related; Treatment Refusal; Outcome

Keywords

Takayasu arteritis; follow-up; treatment; outcome; pregnancy; cohort

Outcome Measures

Primary Outcomes (10)

• The change of manifestations of systemic symptom - fever

  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.

  Through study completion, an average of 2 months.

• The change of manifestations of systemic symptom - fatigue

  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".

  Through study completion, an average of 2 months.

• The change of manifestations of systemic symptoms - chest congestion

  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".

  Through study completion, an average of 2 months.

• The change of the emerging signs or symptoms of ischemia

  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.

  Through study completion, an average of 2 months.

• The change of the signs or symptoms of ischemia

  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".

  Through study completion, an average of 2 months.

• The change of the blood pressure

  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.

  Through study completion, an average of 2 months.

• The change of laboratory tests.

  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.

  Through study completion, an average of 2 months.

• The change of IL-6 in plasma

  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.

  Through study completion, an average of 2 months.

• The change of vascular imaging.

  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.

  Through study completion, an average of 2 months.

• The change of quality of life(QOF): SF-36 questionnaire

  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).

  Through study completion, an average of 2 months.

Secondary Outcomes (1)

• The change of obstetric related examinations in childbearing women.

  From the initiation of pregnancy, 1 year.

Study Arms (3)

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; Drug: Leflunomide

Interventions

Tocilizumab BIOLOGICAL

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.

Also known as: IL-6R antibody

scramble TA group

Leflunomide DRUG

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.

Also known as: Arava

scramble TA group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Department of Rheumatology in Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (14)

• Direskeneli H, Aydin SZ, Merkel PA. Disease assessment in Takayasu's arteritis. Rheumatology (Oxford). 2013 Oct;52(10):1735-6. doi: 10.1093/rheumatology/ket274. Epub 2013 Aug 16. No abstract available.

  PMID: 23955648 BACKGROUND

• Arnaud L, Haroche J, Mathian A, Gorochov G, Amoura Z. Pathogenesis of Takayasu's arteritis: a 2011 update. Autoimmun Rev. 2011 Nov;11(1):61-7. doi: 10.1016/j.autrev.2011.08.001. Epub 2011 Aug 9.

  PMID: 21855656 BACKGROUND

• Wen D, Du X, Ma CS. Takayasu arteritis: diagnosis, treatment and prognosis. Int Rev Immunol. 2012 Dec;31(6):462-73. doi: 10.3109/08830185.2012.740105.

  PMID: 23215768 BACKGROUND

• Fillaus JA, Oliveto J, Cutinha A, Cannella A, Plumb TJ. Takayasu arteritis presenting as new-onset hypertension. J Clin Rheumatol. 2014 Oct;20(7):389-90. doi: 10.1097/RHU.0000000000000177. No abstract available.

  PMID: 25275769 BACKGROUND

• Arend WP, Michel BA, Bloch DA, Hunder GG, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of Takayasu arteritis. Arthritis Rheum. 1990 Aug;33(8):1129-34. doi: 10.1002/art.1780330811.

  PMID: 1975175 BACKGROUND

• Kerr GS, Hallahan CW, Giordano J, Leavitt RY, Fauci AS, Rottem M, Hoffman GS. Takayasu arteritis. Ann Intern Med. 1994 Jun 1;120(11):919-29. doi: 10.7326/0003-4819-120-11-199406010-00004.

  PMID: 7909656 BACKGROUND

• Jiang L, Li D, Yan F, Dai X, Li Y, Ma L. Evaluation of Takayasu arteritis activity by delayed contrast-enhanced magnetic resonance imaging. Int J Cardiol. 2012 Mar 8;155(2):262-7. doi: 10.1016/j.ijcard.2010.10.002. Epub 2010 Nov 6.

  PMID: 21059475 BACKGROUND

• O'Connor TE, Carpenter HE, Bidari S, Waters MF, Hedna VS. Role of inflammatory markers in Takayasu arteritis disease monitoring. BMC Neurol. 2014 Mar 28;14:62. doi: 10.1186/1471-2377-14-62.

  PMID: 24678735 BACKGROUND

• Kotter I, Henes JC, Wagner AD, Loock J, Gross WL. Does glucocorticosteroid-resistant large-vessel vasculitis (giant cell arteritis and Takayasu arteritis) exist and how can remission be achieved? A critical review of the literature. Clin Exp Rheumatol. 2012 Jan-Feb;30(1 Suppl 70):S114-29. Epub 2012 May 11.

  PMID: 22640655 BACKGROUND

• Nakaoka Y, Higuchi K, Arita Y, Otsuki M, Yamamoto K, Hashimoto-Kataoka T, Yasui T, Ikeoka K, Ohtani T, Sakata Y, Shima Y, Kumanogoh A, Yamauchi-Takihara K, Tanaka T, Kishimoto T, Komuro I. Tocilizumab for the treatment of patients with refractory Takayasu arteritis. Int Heart J. 2013;54(6):405-11. doi: 10.1536/ihj.54.405.

  PMID: 24309452 BACKGROUND

• Youngstein T, Peters JE, Hamdulay SS, Mewar D, Price-Forbes A, Lloyd M, Jeffery R, Kinderlerer AR, Mason JC. Serial analysis of clinical and imaging indices reveals prolonged efficacy of TNF-alpha and IL-6 receptor targeted therapies in refractory Takayasu arteritis. Clin Exp Rheumatol. 2014 May-Jun;32(3 Suppl 82):S11-8. Epub 2013 Sep 30.

  PMID: 24093733 BACKGROUND

• Mekinian A, Comarmond C, Resche-Rigon M, Mirault T, Kahn JE, Lambert M, Sibilia J, Neel A, Cohen P, Hie M, Berthier S, Marie I, Lavigne C, Anne Vandenhende M, Muller G, Amoura Z, Devilliers H, Abad S, Hamidou M, Guillevin L, Dhote R, Godeau B, Messas E, Cacoub P, Fain O, Saadoun D; French Takayasu Network. Efficacy of Biological-Targeted Treatments in Takayasu Arteritis: Multicenter, Retrospective Study of 49 Patients. Circulation. 2015 Nov 3;132(18):1693-700. doi: 10.1161/CIRCULATIONAHA.114.014321. Epub 2015 Sep 9.

  PMID: 26354797 BACKGROUND

• Assad AP, da Silva TF, Bonfa E, Pereira RM. Maternal and Neonatal Outcomes in 89 Patients with Takayasu Arteritis (TA): Comparison Before and After the TA Diagnosis. J Rheumatol. 2015 Oct;42(10):1861-4. doi: 10.3899/jrheum.150030. Epub 2015 Sep 1.

  PMID: 26329335 BACKGROUND

• Comarmond C, Mirault T, Biard L, Nizard J, Lambert M, Wechsler B, Hachulla E, Chiche L, Koskas F, Gaudric J, Cluzel P, Messas E, Resche-Rigon M, Piette JC, Cacoub P, Saadoun D; French Takayasu Network. Takayasu Arteritis and Pregnancy. Arthritis Rheumatol. 2015 Dec;67(12):3262-9. doi: 10.1002/art.39335.

  PMID: 26315109 BACKGROUND

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.

MeSH Terms

Conditions

Takayasu Arteritis; Treatment Refusal

Interventions

tocilizumab; Leflunomide

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lindi Jiang, PhD

  Fudan University

  STUDY CHAIR

Central Study Contacts

Lindi Jiang, PhD

CONTACT

+86-021-64041990; zsh-rheum@hotmail.com

Rongyi Chen, MD

CONTACT

+8615221160538; chenry825@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 28, 2019
• Study Start: November 1, 2016
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

CN (1)