UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041754 |
|---|---|
| Receipt number | R000047614 |
| Scientific Title | Predictors of abatacept efficacy in immunomics |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2022/09/13 14:51:36 |
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Basic information
Public title
Predictors of abatacept efficacy in immunomics
Acronym
PREDICTABA study
Scientific Title
Predictors of abatacept efficacy in immunomics
Scientific Title:Acronym
PREDICTABA study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine abatacept(ABA) is similarly efficacious in disease activity improvement for the study patients as shown in previous reports.
Basic objectives2
Others
Basic objectives -Others
To extract genomic, transcriptomic and immunophenotypic factors which reflect ABA's efficacy in disease activity improvement.
To classify, experimentally, the patients into sub-groups with the factors and investigate ABA efficacy in the sub-groups.
To identify characters of patients in sub-groups for which ABA is more efficacious, and clarify the predictive factors of ABA efficacy from the patient characters.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Achievement of remission (DAS28-ESR<2.6) or improvement of disease activity (delta-DAS28-ESR>1.2) at Month 6
Key secondary outcomes
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
Patients with RA meeting the 2010 ACR/EULAR Classification Criteria for RA
Patients with an inadequate response to at least one csDMARD previously
Patients aged 20 years or older at the informed consent for study participation
Patients aged 65 years or older or those with a concurrent condition that can increase the risk of infection
Patients starting abatacept therapy at the discretion of their primary physician
Key exclusion criteria
Patients treated with more than 3 types of biologics previously
Patients with a history of hypersensitivity to any of the ingredients of the abatacept product
Patients with a concurrent condition secondary to malignancy
Patients with active infection
Patients who are pregnant or breastfeeding, or those wishing pregnancy, childbearing, or breastfeeding
Patients ineligible for study participation in the opinion of the investigator or subinvestigator
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Keishi |
| Middle name | |
| Last name | Fujio |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Allergy and Rheumatology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
kfujio-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Nagafuchi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Allergy and Rheumatology and Functional Genomics and Immunological Diseases
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
nagafuchi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Bristol Myers Squibb
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
ONO PHARMACEUTICAL CO., LTD.
IRB Contact (For public release)
Organization
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo Human Genome, Gene Analysis Research Ethics Committee
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-3600
ethics@m.u-tokyo.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 | 01 | 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
105
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 | 01 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of the study is to identify predictors of the effectiveness of abatacept. Integrated analyses of the genetic background of individual patients as well as pre-treatment peripheral-blood transcriptomes and detailed immune cell profiles, as determined by mass cytometry, have the potential to stratify RA patients suitable for abatacept therapy.
Management information
Registered date
| 2020 | Year | 09 | Month | 11 | Day |
Last modified on
| 2022 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047614
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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