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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042329
Receipt No. R000048322
Scientific Title Effect of combined abnormalities in both genome sequences and immune-phenotypes in the efficacy of abatacept on patients with rheumatoid arthritis
Date of disclosure of the study information 2020/11/02
Last modified on 2021/05/20

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Basic information
Public title Study of factors predicting the efficacy of abatacept in patients with rheumatoid arthritis
Acronym Study on predictors of abatacept efficacy
Scientific Title Effect of combined abnormalities in both genome sequences and immune-phenotypes in the efficacy of abatacept on patients with rheumatoid arthritis
Scientific Title:Acronym Effect of genome and immune-phenotypes in the efficacy of abatacept
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To identify a subpopulation of RA patients with high efficacy of abatacept by combining genomic information and immune-phenotypes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Achievement rate of DAS28-CRP> 1.2 improvement 12 months after abatacept administration
Key secondary outcomes 1) Identification of subgroups the patients according to their abnormality patterns in both SNP existence and baseline immune-phenotype profiles
2) Identification of patient subgroups for which abatacept is more efficacious

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) RA patients satisfying the ACR/EULAR RA Classification Criteria 2010
2) Patients with RA poorly responding to treatment with one or more csDMARDs and having received no biopharmaceutical before
3) Patients aged 20 and over at the time of issuing consent to this study
4) Patients having begun to receive subcutaneous injection of abatacept on the basis of the attending physician's decision
Key exclusion criteria 1) Patients with a history of allergy to any component of abatacept
2) Patients with complication by malignant tumor
3) Patients with active infection or hepatitis B and HB carrier
4) Pregnant women, lactating women or women desiring pregnancy, child delivery or breast-feeding
5) Patients judged as inappropriate for this study by Principal Investigator or Sub-investigator
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Yoshiya
Middle name
Last name Tanaka
Organization University of Occupational and Environmental Health, Japan
Division name First Department of Internal Medicine
Zip code 807-8555
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka
TEL 093-603-1611
Email tanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name Shingo
Middle name
Last name Nakayamada
Organization University of Occupational and Environmental Health, Japan
Division name First Department of Internal Medicine
Zip code 807-8555
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka
TEL 093-603-1611
Homepage URL
Email s-nakaya@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization Bristol-Myers Squibb
Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Statistical Genetics, Osaka University Graduate School of Medicine, Osaka, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Occupational and Environmental Health, Japan
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka
Tel 093-603-1611
Email daigakukanri@mbox.pub.uoeh-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

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 02 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
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 Enrolling by invitation
Date of protocol fixation
2019 Year 05 Month 22 Day
Date of IRB
2019 Year 05 Month 22 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2023 Year 05 Month 31 Day
Date of closure to data entry
2023 Year 05 Month 31 Day
Date trial data considered complete
2023 Year 05 Month 31 Day
Date analysis concluded
2023 Year 12 Month 31 Day

Other
Other related information If statistical analyses (cluster analysis, pathway analysis, etc.) are conducted on the region of disease sensitivity genes identified by GWAS of RA patients and the immunological phenotype of RA patients, it will be possible to elucidate the pathophysiological mechanism based on the association of potential immune disorders and immunological phenotype and to identify an immunological subgroup of RA patients. Furthermore, groups of patients characterized by different responses to treatment will be identified through analysis of improvement in disease activity (delta DAS28) and changes in immunological phenotype after abatacept treatment as compared to them before treatment.


Management information
Registered date
2020 Year 11 Month 02 Day
Last modified on
2021 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048322

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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