Takayasu arteritis
Conditions
Interventions
Intravenous administration of tocilizumab (8mg/kg/month) for up to 12 months
Sponsors
Osaka University
National Cerebral and Cardiovascular Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with Takayasu arteritis whose dosage of predonisolone could not be reduced below 15 mg/day 2)Patients who agreed to join this clinical study and signed a consent form approved by the director of Osaka university hospital or patients whose acceptance to join this clinical study were obtained by the authorized delegates alternatively
Exclusion criteria
Exclusion criteria: 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 11)Patients who have the history of gastrointestinal bleeding due to the inflammatory bowel diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Evaluation of frequency and magnitude of 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYoshikazu Nakaoka
Osaka University Graduate School of Medicine Department of Cardiovascular Medicine
Outcome results
None listed