UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011587 |
|---|---|
| Receipt number | R000013417 |
| Scientific Title | A pilot evaluation of safety and efficacy of usutekinumab in Takayasu arteritis |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2015/08/28 20:54:27 |
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Basic information
Public title
A pilot evaluation of safety and efficacy of usutekinumab in Takayasu arteritis
Acronym
TAKUS-Free Pilot Study
Scientific Title
A pilot evaluation of safety and efficacy of usutekinumab in Takayasu arteritis
Scientific Title:Acronym
TAKUS-Free Pilot Study
Region
| Japan |
Condition
Condition
Takayasu arteritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether usutekinumab, monoclonal antibodies against IL-12/23 p40 that are practically used to treat psoriasis vulgaris, are safe and effective in Takayasu arteritis cases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
1. Safety
a) Serious adverse events (anaphylaxis, hypotension, angioedema and serious viral/bacterial/fungal infections such as tuberculosis, cellulitis, diverticulitis, osteomyelitis, gastroenteritis, pneumonia and urinary tract infection)
b) Symptoms related with adverse events (skin rash, sore throat, cough, sputum, dyspnea on efforts, chest pain, chest tightness, nausea, abdominal pain, diarrhea and frequent urination)
c) Abnormal data in general laboratory tests (Complete blood count, biochemical examination)
2. Efficacy
a) Improved visual analogue scales (headache, neck pain, easy fatigability of arms, easy fatigability of body, muscle pain)
b) Improved biomarkers (CRP, ESR, matrix metalloproteinase-9)
c) Improved findings in images (MR angiography, carotid artery US)
Key secondary outcomes
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
Subcutaneous injection of usutekinumab (45 mg/body, 0 and 4th week)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A case who was diagnosed as having Takayasu arteritis using the classification criteria (2006-2007) of Ministry of Health, Labour and Welfare, Japan and who is attending to Department of Rheumatology and Clinical Immunology, Kyoto University Hospital
2) A case who has either an HLA-B*52:01 allele or a risk allele of IL-12B SNPs
3) A case with uncontrolled or recurrent symptoms such as fever, neck pain, headache and easy fatigability even after use of glucocorticoids and immunosuppressive agents
Key exclusion criteria
1) A case who is suspected of having active or latent tuberculosis or of type B hepatitis by the results of a tuberculin test, chest X-ray or laboratory tests
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Yoshifuji |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Rheumatology and Clinical Immunology
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507 JAPAN
TEL
075-751-3793
yossii@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Yoshifuji |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Rheumatology and Clinical Immunology
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507 JAPAN
TEL
075-751-3793
Homepage URL
yossii@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Rheumatology and Clinical Immunology
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Rheumatism Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学大学院医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Main results already published
Date of protocol fixation
| 2013 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 26 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 27 | Day |
Last modified on
| 2015 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013417
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
