UMIN-CTR Clinical Trial

Public title

Investigation of the Effects of Abatacept on Rheumatoid Arthritis: Analysis of Efficacy on Arthritis and Atherosclerosis

Acronym

ABT-ATS study

Scientific Title

Investigation of the Effects of Abatacept on Rheumatoid Arthritis: Analysis of Efficacy on Arthritis and Atherosclerosis

Scientific Title:Acronym

ABT-ATS study

Region

Japan

Condition

Rheumatoid Arthritis

Classification by specialty

Clinical immunology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To analyze and compare the efficacy of ABT on arthritis and atherosclerosis in young RA patients and in elderly RA patients.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

EULAR good response rate at 6 months will be compared between the ABT and csDMARD groups in young patients and in elderly patients.
Changes in intima-media thickness by carotid duplex at 3 years will be compared between the ABT and csDMARD groups in young patients and in elderly patients.

Key secondary outcomes

1)EULAR moderate response rate, changing in DAS28 score, remission, low-disease activity and moderate-disease activity rates in DAS28, changing in SDAI and CDAI score, remission rate in SDAI and CDAI, and Boolean remission rate at 6 months will be compared between the ABT and csDMARD groups in young patients and in elderly patients.
2)EULAR good and moderate response rates, changing in DAS28 score, remission, low-disease activity and moderate-disease activity rates in DAS28, changing in SDAI and CDAI score, remission rate in SDAI and CDAI, Boolean remission rate, changing in Total Sharp Score, and HAQ score at 1, 2 and 3 years will be compared between the ABT and csDMARD groups in young patients and in elderly patients.
3)Changes in intima-media thickness by carotid duplex, PWV and ABI at 1, 2 and 3 years will be compared between the ABT and csDMARD groups in young patients and in elderly patients. The relationship between RA disease activity (efficacy of ABT on RA) and atherosclerosis will be analyzed.
4)The ABT continuation rate will be compared between young and elderly patients up to 3 years.
5)The frequency of serious infection will be compared between the ABT and csDMARD groups. The risk factors of onset will be analyzed and compared between young and elderly patients. The type, etc. of infection will also be analyzed in detail.

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

Patients diagnosed with RA based on the 2010 RA diagnostic criteria of the ACR/EULAR,and from whom written consent for participation in the study can be obtained.Among RA patients who are refractory to nonbiological conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and have no history of treatment with biological drugs.
RA patients in whom abatacept (ABT) is newly started and young (20 to 64 years old) and elderly (65 years or older), and RA patients in whom a new csDMARD is started (addition or change of csDMARDs).

Key exclusion criteria

1)Patients who correspond to the contraindications of abatacept
2)Patients with active infection and malignant tumor
3)Patients aged less than 20 years
4)Pregnant and lactating women and women who are willing to become pregnant
5)Patients from whom consent for participation in the study cannot be obtained
6)Patients who are judged inappropriate for participation in the study by the investigator

Target sample size

280

Name of lead principal investigator

1st name
Middle name
Last name	Toshihiro Nanki

Organization

Toho University

Division name

Department of Internal Medicine

Zip code

Address

6-11-1 Omor-inishi, Ota-ku, Tokyo

TEL

03-3762-4151

Email

toshihiro.nanki@med.toho-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Megumi Nagasaki

Organization

Teikyo University

Division name

Teikyo Academic Research Center

Zip code

Address

2-11-1 Kaga, Itabashi-ku, Tokyo

TEL

03-3964-1211

Homepage URL

Email

mnagasaki@med.teikyo-u.ac.jp

Institute

Department of Internal Medicine,
Toho University

Institute

Department

Personal name

Organization

Bristol-Myers Squibb

Organization

Division

Category of Funding Organization

Profit 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

帝京大学（東京）、国家公務員共済組合連合会横浜南共済病院（神奈川）、東邦大学医療センター大橋病院（東京）、ひろせクリニック（埼玉）、熊本大学（熊本）、東京都健康長寿医療センター（東京）、香川大学（香川）、北里大学（神奈川）、帝京大学ちば総合医療センター（千葉）、東京慈恵会医科大学（東京）、東京医科大学（東京）、北海道大学（北海道）、宇多津病院（香川）、兵庫医科大学（兵庫）、医療法人慈誠会上板橋病院（東京）、大阪市立大学（大阪）、横浜市立みなと赤十字病院（神奈川）、JA静岡厚生連静岡厚生病院（静岡）、JA北海道厚生連帯広厚生病院（北海道）、ゆうファミリークリニック（宮城）、徳島大学（徳島）、愛媛大学（愛媛）、横浜市立大学（神奈川）、埼玉医科大学総合医療センター（埼玉）、産業医科大学（福岡）、善仁会市民の森病院（宮崎）、つがる西北五広域連合つがる総合病院（青森）、京都大学（京都）、東邦大学医療センター大森病院（東京）

Date of disclosure of the study information

2014

Year

09

Month

24

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

Main results already published

Date of protocol fixation

2014

Year

08

Month

09

Day

Date of IRB

2014

Year

08

Month

09

Day

Anticipated trial start date

2014

Year

09

Month

22

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a multicenter, open, prospective study with an observation period of 3 years.
Study subjects will be young (20 to 64 years old) and elderly (65 years or older) patients in whom ABT is newly started (ABT young group and ABT elderly group, respectively) and young (20 to 64 years old) and elderly (65 years or older) patients in whom a new csDMARD is started (addition or change of csDMARDs) (control young group and control elderly group, respectively) who are diagnosed with RA based on the 2010 RA diagnostic criteria of the ACR/EULAR and who are refractory to csDMARDs and have no history of treatment with biological drugs.
Target sample size will be 70 patients in each group for a total of 280 patients.
As for the primary endpoint of efficacy of ABT on arthritis, EULAR good response rate will be compared after 6 month-treatment between the ABT and control groups in young patients aged 20 to 64 years and in elderly patients aged 65 years or older. Regarding atherosclerosis, changes in intima-media thickness by carotid duplex after 3 year-treatment will be compared between the ABT and control groups in young patients and in elderly patients.

Registered date

2014

Year

08

Month

21

Day

Last modified on

2024

Year

07

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017317