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A Pilot Study in Severe Patients With Takayasu Arteritis.

RecruitingPhase 4Ages 14 Years - 100 YearsAllShanghai Zhongshan Hospital
NCT04300686 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. age≥14 years old; 2. active: Kerr score≥ 2; 3. severe: 1. Blood pressure \> 180/110mmHg; 2. ≥ 3 branches with the stenotic rate \> 70% involved; 3. high degree of organ insufficiency: NYHF III\~IV; eGFR (MRDR) 15\~ 60ml/min; Exclusion Criteria: 1. Severe organ insufficiency; 2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.; 3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease; 4. malignant tumors; 5. history of severe drug allergy; 6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients)
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What it tests

  • Tocilizumab
  • Adalimumab
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Where

1 site
Department of Rheumatology in Zhongshan hospital, Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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