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Recruiting Phase 4 NCT04300686

A Pilot Study in Severe Patients With Takayasu Arteritis.

Trial Parameters

Condition Takayasu Arteritis
Sponsor Shanghai Zhongshan Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 40
Sex ALL
Min Age 14 Years
Max Age 100 Years
Start Date 2020-03-01
Completion 2022-05-01
Interventions
TocilizumabAdalimumab

Brief Summary

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.

Eligibility Criteria

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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