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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011587
Receipt No. 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

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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
Email 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
Email yossii@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Rheumatology and Clinical Immunology
Graduate School of Medicine, Kyoto University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013417

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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