UMIN-CTR Clinical Trial

Public title

Analysis of Effectiveness and Safety of Abatacept in Japanese patients with Rheumatoid Arthritis.

Acronym

Effectiveness and Safety of Abatacept in Japan

Scientific Title

Analysis of Effectiveness and Safety of Abatacept in Japanese patients with Rheumatoid Arthritis.

Scientific Title:Acronym

Effectiveness and Safety of Abatacept in Japan

Region

Japan

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

Abatacept, which suppresses T cells by binding with CD80/CD86 of antigen-presenting cells, was newly developed and approved in Japan for treatment of rheumatoid arthritis (RA) in September 2010. Some clinical trials implemented in Western countries and Japan suggested that the efficacy and safety of abatacept were equivalent to other existing biologic agents and the incidence of serious adverse events was relatively low. However, evidence of effectiveness and safety of abatacept in Japanese patients in the real world has not sufficiently proved yet and remains to be established. Therefore, we planned this study to clarify effectiveness and safety of abatacept in Japanese patients with RA and to find predictive factors for effectiveness. In addition, we also analyze comprehensive gene expression information from blood samples obtained at the initiation of and 6 months after the therapy with clinical information to find candidate genes associated with the effectiveness and safety of abatacept.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Effectiveness of abatacept: EULAR response rate at month 6; ACR/EULAR remission rate at month 6
Safety of abatacept: incidence of serious adverse drug reactions; incidence of serious infection during 1 year

Key secondary outcomes

Effectiveness of abatacept: changes of joint scores, acute inflammatory response, and visual analogue scales over time; changes of Total Sharp Score at year 1; percentages of patients with delta Total Sharp Score <0.5; changes of physical function over time (HAQ, EQ-5D).
Safety of abatacept: incidence of adverse events and adverse drug reactions during 1 year; incidence of infection during 1 year
Other outcomes: analysis of mRNA expression with clinical information

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

A Patient of rheumatoid arthritis(RA) who meets all of the following will be eligible to the study.

1.A patient who is older than 20 years old
2.A patient who fulfills the 2010 ACR/EULAR classification criteria of RA
3.A patient whose disease activity remains moderate or high despite treatment with disease modifying anti-rheumatic drugs such as methotrexate more than 3 months.
4.A Patient who starts to use abatacept for the first time
5.A Patient who provides a written informed consent to join this study

Key exclusion criteria

A patient who has any of the following will be excluded from the study.

1.When a patient withdraws his or her consent.
2.When a doctor judges a patient not appropriate to join the study.
3.When a patient is pregnant or has possibility to be pregnant.
4.When a patient is under breast-feeding.
5.When a patient is under contraindication of abatacept.

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Masayoshi Harigai

Organization

Tokyo Medical and Dental university

Division name

Department of Pharmacovigilance, Department of Medicine and Rheumatology

Zip code

Address

5-45,Yushima 1-chome, Bunkyo-ku, Tokyo

TEL

03-5803-4677

Email

mharigai.phv@tmd.ac.jp

Name of contact person

1st name
Middle name
Last name	Hayato Yamazaki

Organization

Tokyo Medical and Dental university

Division name

Department of Pharmacovigilance, Department of Medicine and Rheumatology

Zip code

Address

1-5-45, Yushima, Bunkyoku

TEL

03-5803-4677

Homepage URL

https://iipsg.thurch.org/procgi10/procgi.exe?P=AS_ABA&writesheet=Login

Email

yamazaki.rheu@tmd.ac.jp

Institute

Tokyo Medical and Dental university

Institute

Department

Personal name

Organization

Department of Pharmacovigilance, Tokyo Medical and Dental university

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

02

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2010

Year

10

Month

19

Day

Date of IRB

Anticipated trial start date

2010

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Primary outcome:
Effectiveness of abatacept: EULAR response rate at month 6; ACR/EULAR remission rate at month 6
Safety of abatacept: incidence of serious adverse drug reactions; incidence of serious infection during 1 year

Key secondary outcomes:
Effectiveness of abatacept: changes of joint scores, acute inflammatory response, and visual analogue scales over time; changes of Total Sharp Score at year 1; percentages of patients with delta Total Sharp Score <0.5; changes of physical function over time (HAQ, EQ-5D).
Safety of abatacept: incidence of adverse events and adverse drug reactions during 1 year; incidence of infection during 1 year
Other outcomes: analysis of mRNA expression with clinical information

Registered date

2011

Year

02

Month

25

Day

Last modified on

2014

Year

03

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006109