Efficacy and Safety of treatment with tocilizumab in refractory patients with Takayasu Arteritis

Efficacy and Safety of treatment with tocilizumab in refractory patients with Takayasu Arteritis - ACTemra Investigation for remissiON introduction in Takayasu Arteritits (ACTION-TA)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007845

Enrollment

Registered

2012-05-01

Start date

2012-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takayasu arteritis

Interventions

Intravenous administration of tocilizumab (8mg/kg/month) for 24 months

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 Institutional Review Board 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

Design outcomes

Primary

Measure	Time frame
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

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

ynakaoka@cardiology.med.osaka-u.ac.jp06-6879-3636

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026