UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042329 |
|---|---|
| Receipt number | 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 | 2023/05/06 09:53:36 |
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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
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
s-nakaya@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
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
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
111
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
No longer recruiting
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
| 2023 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048322
