UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Research on the Safety of anti-interleukin-6 antibody (Tocilizumab) treatment for the refractory patients with Takayasu Arteritis
Acronym	TOCIlizumab treatment for TAKayasu arteritis (TOCI-TAK)
Scientific Title	Clinical Research on the Safety of anti-interleukin-6 antibody (Tocilizumab) treatment for the refractory patients with Takayasu Arteritis
Scientific Title:Acronym	TOCIlizumab treatment for TAKayasu arteritis (TOCI-TAK)
Region	Japan

Condition
Condition	Takayasu arteritis
Classification by specialty	Cardiology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of tocilizumab treatment in the patients with Takayasu arteritis refractory to glucocorticoid therapy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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)
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous administration of tocilizumab (8mg/kg/month) for up to 12 months
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	2

Research contact person
Name of lead principal investigator	1st name Sakata Middle name Last name Yasushi
Organization	Osaka University Hospital
Division name	Department of Cardiovascular Medicine
Zip code	565-0871
Address	2-2, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL	06-6879-3631
Email	yasushisk@cardiology.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Yoshikazu Middle name Last name Nakaoka
Organization	Osaka University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	565-0871
Address	2-2, Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL	06-6879-3637
Homepage URL
Email	ohtani@cardiology.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Others
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Cerebral and Cardiovascular Center
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Osaka University
Address	2-2, Yamadaoka, Suita, Osaka
Tel	06-6210-8296
Email	rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	大阪大学医学部附属病院（大阪府）、国立循環器病研究センター（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	Two patients with refractory Takayasu arteritis were successfully treated with intravenous tocilizumab(TCZ) 8mg/kg/4weeks. The dosages of glucocorticoid (GC) were reduced from 22.5mg/day to 16.25mg/day and methotrexate was quitted in both cases. There were no severe adverse events during the TCZ treatment.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 02 Month 02 Day
Date of IRB	2017 Year 02 Month 03 Day
Anticipated trial start date	2017 Year 02 Month 07 Day
Last follow-up date	2017 Year 11 Month 13 Day
Date of closure to data entry	2017 Year 11 Month 13 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2020 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 02 Month 01 Day
Last modified on	2022 Year 08 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029817