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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042934
Receipt No. 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 2021/01/07

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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
Email 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
Email hirotake@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University Hospital
Institute
Department

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
Email 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
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 Open public recruiting
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
2021 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049009

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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