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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025940
Receipt No. R000029817
Scientific Title Clinical Research on the Safety of anti-interleukin-6 antibody (Tocilizumab) treatment for the refractory patients with Takayasu Arteritis
Date of disclosure of the study information 2017/02/07
Last modified on 2018/08/20

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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
Middle name
Last name Yasushi Sakata
Organization Osaka University Hospital
Division name Department of Cardiovascular Medicine
Zip code
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
Middle name
Last name Tomohito Ohtani or Yoshikazu Nakaoka
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
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
Address
Tel
Email

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
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
2017 Year 12 Month 31 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 01 Day
Last modified on
2018 Year 08 Month 20 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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