UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042934 |
|---|---|
| Receipt number | R000049009 |
| Scientific Title | Inhibitory Effect of Abatacept against Joint Inflammation Shown by Ultrasound Power Doppler Scoring in Japanese Bio-Naive Patients with Rheumatoid Arthritis |
| Date of disclosure of the study information | 2021/01/07 |
| Last modified on | 2023/07/11 13:25:57 |
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Basic information
Public title
Inhibitory Effect of Abatacept against Joint Inflammation Shown by Ultrasound Power Doppler Scoring in Japanese Bio-Naive Patients with Rheumatoid Arthritis
Acronym
Inhibitory Effect of Abatacept against Joint Inflammation Shown by Ultrasound Power Doppler Scoring in Japanese Bio-Naive Patients with Rheumatoid Arthritis
Scientific Title
Inhibitory Effect of Abatacept against Joint Inflammation Shown by Ultrasound Power Doppler Scoring in Japanese Bio-Naive Patients with Rheumatoid Arthritis
Scientific Title:Acronym
SAKURA STUDY
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of the study is to reveal the relevance to effect of improving PDUS score and pain score, autoantibody, cytokine, intracellular signal with Abatacept subcutaneous injection in the early term, targeting at Japanese patients with rheumatoid arthritis of the biological disease-modifying antirheumatic drug (bDMARDs) -naive.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
-Improvement rate of PDUS score in Abatacept dose 8 weeks later
Key secondary outcomes
-Improvement rate of PDUS score in Abatacept dose 24 and 48 weeks later
-Relevance between the improvement rate of pain score and PDUS score in Abatacept dose 0, 2, 4, 8, 24, 48 weeks later
-Transition of disease activity in Abatacept dose 0, 2, 4, 8, 24, 48 weeks later
-Relevance between ACPA, RF, Cytokine expression levels and improvement rate of PDUS score, pain score, disease activity
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients between 20 and 75 years of age who have been diagnosed with rheumatoid arthritis, according to the 2010 ACR/EULAR classification criteria.
2.Patients have no effects or not enough effects from one csDMARDs or more and who bDMARDs-naiive (DAS 28>3.2 or SDAI>11 or CDAI>10 at registration).
3.Patients were started Abatacept dose by a decision from physicians.
4.Patients who provide written consent form to participate in this study after full explanation of the study.
Key exclusion criteria
1.Patients who are suffering from severe infectious disease.
2.Patients with lymphocytes less than 500/microL and high levels of beta-D glucan
3.Patients who are infected EB virus or HBV
4.Patients who are unsuitable to participate in this study by attending physicians.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hirotake |
| Middle name | |
| Last name | Sakuraba |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Gastroenterology and Hematology
Zip code
036-8216
Address
Zaifu-Cho 5, Hirosaki-Shi, Aomori Prefecture, Japan
TEL
0172-39-5053
hirotake@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotake |
| Middle name | |
| Last name | Sakuraba |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Gastroenterology and Hematology
Zip code
036-8216
Address
Zaifu-Cho 5, Hirosaki-Shi, Aomori Prefecture, Japan
TEL
0172-39-5053
Homepage URL
hirotake@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers K.K./ONO Pharmaceutical Co.,ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committees of Hirosaki University Graduate School of Medicine
Address
Zaifu-Cho 5, Hirosaki-Shi, Aomori Prefecture, Japan
Tel
0172-33-5111
rinri@hirosaki-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
| 2021 | Year | 01 | Month | 07 | 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
21
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Statistical analysis is difficult due to No of registered cases.
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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study observes Japanese patients with rheumatoid arthritis of the biological disease-modifying antirheumatic drug (bDMARDs) -naiive after the start of Abatacept subcutaneous injection for 48 weeks.
The study subjects are observed at before the start of the Abatacept administration, the day of the start of the Abatacept administration (week 0), and week 2, 4, 8, 12, 24, 36, and 48 after the start of the Abatacept administration (total 9 points).
Management information
Registered date
| 2021 | Year | 01 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049009
| Research Plan | |
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| 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 |
