RECRUITINGPhase 4INTERVENTIONAL

A Pilot Study in Severe Patients With Takayasu Arteritis.

A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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; Who Should NOT Join This Trial: 1. Severe organ insufficiency; 2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.; 3. Other autoimmune conditions (where your immune system attacks your own body)s 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)

Treatments Being Tested

BIOLOGICAL

Tocilizumab

The tocilizumab group is prescribed with tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of tocilizumab is maintained for another 24 weeks, otherwise (resistant), patients would be given adalimumab (40mg.bim.IH.) for 24 weeks instead.

BIOLOGICAL

Adalimumab

The adalimumab group is prescribed with adalimumab (40mg.bim.IH) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of adalimumab would be maintained for another 24 weeks, otherwise (resistant), patients would be given tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks instead.

Locations (1)

Department of Rheumatology in Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, China