UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025940 |
|---|---|
| Receipt number | 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 | 2022/08/08 19:32:38 |
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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 | 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
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
ohtani@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029817
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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