UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028804
Receipt number 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 2022/03/04 14:53:39

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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 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 or person

Institute

Nagasaki University Graduate School of Biomedical Sciences

Institute

Department

Personal name



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

Value
https://center6.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