Actively Recruiting

Phase 4
Age: 14Years - 100Years
All Genders
NCT04300686

A Pilot Study in Severe Patients With Takayasu Arteritis.

Led by Shanghai Zhongshan Hospital · Updated on 2021-08-10

40

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. We classify TAK patients into 3 levels, including mild, moderate, and severe. And the biological agents tocilizumab and adalimumab are randomly prescribed in severe patients, to find out the relatively better treatment strategy, facilitating better intervention strategy in severe TAK patients.

CONDITIONS

Official Title

A Pilot Study in Severe Patients With Takayasu Arteritis.

Who Can Participate

Age: 14Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 years or older
  • Active disease with Kerr score of 2 or more
  • Severe disease defined by at least one of the following: blood pressure over 180/110 mmHg; involvement of three or more artery branches with stenosis over 70%; significant organ insufficiency including NYHA class III-IV heart failure or eGFR 15-60 ml/min
Not Eligible

You will not qualify if you...

  • Severe organ insufficiency
  • Active infections including tuberculosis and hepatitis
  • Other autoimmune diseases such as systemic lupus erythematosus, Behcet disease, or IgG4-related disease
  • Malignant tumors
  • History of severe drug allergy
  • Two successive relapses despite intervention adjustments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Rheumatology in Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

R

Rongyi Chen, PhD

CONTACT

L

Lili Ma, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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