UMIN-CTR Clinical Trial

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 Atsushi Middle name Last name Kawakami
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Immunology and Rheumatology
Zip code	8528501
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 Shin-ya Middle name Last name Kawashiri
Organization	Nagasaki University Graduate School of Biomedical Sciences
Division name	Department of Community Medicine
Zip code	8528501
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	Nagasaki University Hospital
Address	Sakamoto 1-7-1, Nagasaki
Tel	095-819-7726
Email	none

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	Completed
Date of protocol fixation	2017 Year 08 Month 23 Day
Date of IRB	2017 Year 08 Month 22 Day
Anticipated trial start date	2017 Year 08 Month 31 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 06 Month 30 Day

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	2022 Year 03 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032960