Registration Study of Takayasu's Arteritis in China

Status Recruiting

Clinical Trial Summary

Takayasu arteritis(TA) is a chronic progressive vasculitis predominantly affecting the aorta and its major branches. The demographic, clinical and prognostic features of Takayasu arteritis in China remains in uncertainties. Investigators aim to setup a national registration study for Takayasu arteritis, to observe the prevalence, clinical manifestations, natural history, survival, progression, diagnostic and therapeutic methods of the disease in China.

Clinical Trial Description

Objective: The study aims to investigate the demographic, clinical and prognostic features and to draw the diagnostic and therapeutic algorithm of Takayasu arteritis in China.

Study Type: A national, multicenter, observational, ambispective cohort study.

Study Design: The cardinal contents of this registry study are as follows:

1. Select representative clinical centers through typical sampling methods and train the local investigators in basic knowledge of Takayasu arteritis. Introduce the Electronic Data Capture System and train in completing case report forms.

2. Collect demographic, clinical, imaging, laboratory, diagnostic and therapeutic information of Takayasu arteritis patients hospitalized from Jan 1st 2002 to now. Build a baseline database of Takayasu arteritis patients.

3. Recruit new diagnosed Takayasu arteritis patients in future 2 years from 2017 or till reaching a total of 1067 registered patients.

4. Gather the 3-month, 6-month, 1-year follow up information including general, clinical, therapeutic, prognostic data of all recruits and build up the follow-up database.

5. Establish bio-bank for serum/plasma, urine, stool, tissues or cells.

Data management, quality control and statistic analysis: Electronic Data Capture System has been built and the investigators will manage and analyze data in align with key indicators. The investigators have invited professional statistic analysts to assist analyzing data and a third party to supervise data quality.

Ethics: The Ethics Committee of Fuwai Hospital approved this study and following ethical supports from participating centers are required. Informed consents before patient enrollment are required. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03199183
Study type	Observational [Patient Registry]
Source	China National Center for Cardiovascular Diseases
Contact	Luyun Fan, MD.
Phone	01088398249
Email	katevan@163.com
Status	Recruiting
Phase
Start date	January 1, 2017
Completion date	July 1, 2020

View Details

See also
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Terminated	`NCT04882072` - A Study of Ustekinumab in Participants With Takayasu Arteritis (TAK)	Phase 3
Completed	`NCT03750929` - Aerobic Capacity and Strength Exercise in Takayasu's Arteritis	N/A
Recruiting	`NCT04137614` - Drug-coated Balloon for Takayasu Arteritis Associated Renal Artery Stenosis	N/A
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Recruiting	`NCT05102448` - Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis	Phase 4
Recruiting	`NCT03893136` - The Registry Study of Takayasu Arteritis in East China
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Recruiting	`NCT04299971` - Efficiency of Methotrexate and Tofacitinib in Mild and Moderate Patients	Phase 4
Recruiting	`NCT04300686` - A Pilot Study in Severe Patients With Takayasu Arteritis.	Phase 4
Recruiting	`NCT03192878` - Infliximab Biosimilar in Takayasu's Arteritis	N/A
Active, not recruiting	`NCT04071691` - PET Imaging of Giant Cell and Takayasu Arteritis
Recruiting	`NCT05904301` - Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases
Completed	`NCT02101333` - Efficacy and Tolerance of Tocilizumab In Takayasu Arteritis	Phase 3
Not yet recruiting	`NCT03550781` - Anti-inflammatory Treatment for Inactive Takayasu Arteritis	Phase 2/Phase 3
Active, not recruiting	`NCT05168475` - Biologics in Refractory Vasculitis	Phase 2
Completed	`NCT03956394` - Takayasu Arteritis Activity Evaluation by Ultrafast Ultrasound Imaging	N/A
Recruiting	`NCT05151848` - Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis	Phase 4
Completed	`NCT03430388` - Yellow Fever Vaccine in Patients With Rheumatic Diseases	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Registration Study of Takayasu's Arteritis in China — TA-China

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms