UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014913
Receipt number R000017317
Scientific Title Investigation of the Effects of Abatacept on Rheumatoid Arthritis: Analysis of Efficacy on Arthritis and Atherosclerosis
Date of disclosure of the study information 2014/09/24
Last modified on 2016/01/26 16:16:04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

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

Condition

Rheumatoid Arthritis

Classification by specialty

Clinical immunology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

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.


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


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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Department of Internal Medicine,
Toho University

Institute

Department

Personal name



Funding Source

Organization

Bristol-Myers Squibb

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

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)


Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 24 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

Open public recruiting

Date of protocol fixation

2014 Year 08 Month 09 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

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.


Management information

Registered date

2014 Year 08 Month 21 Day

Last modified on

2016 Year 01 Month 26 Day



Link to view the page

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name