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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028804
Receipt No. R000032960
Scientific Title An exploratory study analyzing the effect of abatacept therapy on serostatus in Japanese real world as well as the relationship between efficacy evaluation with clinical parameters and changes in serostatus
Date of disclosure of the study information 2017/09/01
Last modified on 2018/08/27

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Basic information
Public title An exploratory study analyzing the effect of abatacept therapy on serostatus in Japanese real world as well as the relationship between efficacy evaluation with clinical parameters and changes in serostatus
Acronym An exploratory study analyzing the effect of abatacept therapy on serostatus
Scientific Title An exploratory study analyzing the effect of abatacept therapy on serostatus in Japanese real world as well as the relationship between efficacy evaluation with clinical parameters and changes in serostatus
Scientific Title:Acronym An exploratory study analyzing the effect of abatacept therapy on serostatus
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We planned an exploratory study, in which retrospectively analyzing the effect of abatacept therapy on serostatus in Japanese real world as well as the relationship between efficacy evaluation with clinical parameters and changes in serostatus using the preceding cohort study(Kyushu multicenter rheumatoid arthritis ultrasound prospective cohort study).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The seroconversion rate of IgM-ACPA at 12 months after treatment
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
100 years-old >=
Gender Male and Female
Key inclusion criteria RA patients who meet 2010 ACR/EULAR Classification Criteria for RA
Patients who consulted at Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences and research cooperation institutions between June 2013 and June 2017
>Abatacept arm
Patients who meet Japan College of Rheumatology guidelines for the use of abatacept against RA and started abatacept treatment
Patients who were able to be follow-upped for 12 months after introduction of the therapy
Patients who had no history of biological agents
>MTX arm (Control arm)
Patients who were able to be follow-upped for 12 months after introduction of the therapy
Patients who were matched with age and disease duration with abatacept arm
Key exclusion criteria Patients who are judges as inappropriate for enrollment to the study by the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Kawakami
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Immunology and Rheumatology
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL 095-819-7260
Email atsushik@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin-ya Kawashiri
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Community Medicine
Zip code
Address 1-12-4 Sakamoto, Nagasaki 852-8523, Japan
TEL 095-819-7189
Homepage URL
Email shin-ya@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Bristol-Myers Squibb 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
Address
Tel
Email

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
2017 Year 09 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
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
2017 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation for 12 months after initiation of treatment

Management information
Registered date
2017 Year 08 Month 24 Day
Last modified on
2018 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032960

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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