Status:
RECRUITING
A Pilot Study in Severe Patients With Takayasu Arteritis.
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Takayasu Arteritis
Tocilizumab
Eligibility:
All Genders
14-100 years
Phase:
PHASE4
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 s...
Detailed Description
The Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. Previous studies have revealed that methotrexate, tofacitinib, adal...
Eligibility Criteria
Inclusion
- age≥14 years old;
- active: Kerr score≥ 2;
- severe:
- Blood pressure \> 180/110mmHg;
- ≥ 3 branches with the stenotic rate \> 70% involved;
- high degree of organ insufficiency: NYHF III\~IV; eGFR (MRDR) 15\~ 60ml/min;
Exclusion
- Severe organ insufficiency;
- Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;
- Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease;
- malignant tumors;
- history of severe drug allergy;
- successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients)
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04300686
Start Date
March 1 2020
End Date
December 31 2023
Last Update
August 10 2021
Active Locations (1)
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1
Department of Rheumatology in Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032