Efficacy and Safety of treatment with tocilizumab in refractory patients with Takayasu Arteritis
- Conditions
- Takayasu arteritis
- Registration Number
- JPRN-UMIN000007845
- Lead Sponsor
- Department of Cardiovascular Medicine Graduate School of Medicine Osaka University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 15
Not provided
1)Patients who have a labeled contraindication or a careful administration to tocilizumab 2)Patients who are currently participating in clinical trial studies of other investigational new drugs or devices 3)Patients who are currently participating in other clinical studies 4)Patients who are pregnant, breast-feeding or have possibilities for pregnancy 5)Patients within 6 months of onset of acute myocardial infaraction or cerebrovascular disease 6)Patients who undergoes dialysis treatment 7)Patients with advanced hepatic dysfunction (AST more than 100 IU/l or ALT more than 100 IU/l) 8)Patients who are hepatitis B virus carriers 9)Patients expected to live less than 12 months due to a complicating disease 10)Patients that researchers (cardiologists) evaluated unsuitable for participating in this clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Evaluation of frequency and magnitude of adverse events 2)Evaluation of the effect of tocilizmab on cardiac function (ejection fraction (EF), occurrence of valvular heart diseases such as AR, TR-PG, serum levels of BNP)
- Secondary Outcome Measures
Name Time Method 1)Reduction ratio of glucocorticoids 2)Improvement in disease activities including subjective symptoms 3)Improvement in thickened vessels evaluated by imaging tests 4)Improvement in the serum surrogate markers 5)Abnormalities in blood pressure and pulsation