A Pilot Study in Severe Patients With Takayasu Arteritis.

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Mar 6, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how well two different medications, tocilizumab and adalimumab, can help people with severe Takayasu arteritis (TAK), a rare condition that causes inflammation of the blood vessels. The study aims to find out which of these treatments might work better for patients who are experiencing severe symptoms, like very high blood pressure or significant issues with organ function. Researchers are currently recruiting participants aged 14 and older who have active and severe TAK, meaning they have a high score on a specific health assessment and meet certain medical criteria.

If you or someone you know is eligible to participate, you can expect to receive one of the two medications in a random assignment, meaning you won't know which one you’ll receive. This study is important because it could lead to better treatment options for patients with severe TAK, helping doctors understand how to manage this challenging condition more effectively. However, individuals with certain health issues, like severe organ problems or active infections, won't be able to join the study to ensure the safety of all participants.

Gender

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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)