Long-term Safety of treatment with tocilizumab in the refractory patients with Takayasu Arteritis

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000025943
• Date of registration: 07/02/2017
• Prospective Registration: No
• Primary sponsor: Osaka Unversity
• Public title: Long-term Safety of treatment with tocilizumab in the refractory patients with Takayasu Arteritis
• Scientific title: Long-term Safety of treatment with tocilizumab in the refractory patients with Takayasu Arteritis - Long-term ACTemra Investigation for remissION introduction in TAKayasu Arteritits (LACTION-TAK)
• Date of first enrolment: 2014/08/07
• Target sample size: 9
• Recruitment status: Complete: follow-up continuing
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029824
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Yoshikazu Nakaoka or Tomohito Ohtani
• Affiliation: Osaka University Graduate School of Medicine Department of Cardiovascular Medicine

• Name: Yasushi Sakata
• Affiliation: Osaka University Hospital Department of Cardiovascular Medicine

Key inclusion & exclusion criteria

Inclusion 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

Age minimum: 16years-old
Age maximum: 60years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Takayasu arteritis

Intervention(s)

Intravenous administration of tocilizumab (8mg/kg/month) will be performed until December 31st, 2017.

Primary Outcome(s)

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(s)

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

Source(s) of Monetary Support

The Ministry of Health, Labour, and Welfare of Japan

Secondary Sponsor(s)

National Cerebral and Cardiovascular Center

Ethics review

Status: YES
Approval date: 07/08/2014
Contact:

Results

• Results available: Yes
• Date Completed: 25/08/2017