UMIN-CTR Clinical Trial

Public title

Orencia Responsiveness Investigation by Japanese inter-hospital network Study (ORIJIN Study)

Acronym

ORIJIN Study

Scientific Title

Orencia Responsiveness Investigation by Japanese inter-hospital network Study (ORIJIN Study)

Scientific Title:Acronym

ORIJIN Study

Region

Japan

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

In this study, the clinical efficacy of abatacept will be evaluated in patients with rheumatoid arthritis who have not been treated with biological disease-modifying anti-rheumatic drugs (bDMARDs) and who are positive or negative for anti-citrullinated protein antibodies (ACPA).
In addition, we will measure ACPA as differentiated by each citrullinated antigen to determine differences in individual patient characteristics, HLA genotype, changes in antibody titer and its relationship to therapeutic response.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Simplified disease activity index (SDAI) remission rate at 12 months with subcutaneous administration of abatacept

Key secondary outcomes

1)Evaluate the achievement rate of low disease activity of SDAI at 12 months after administration
2)Determine patient HLA genotype
3)The following items before administration, 6 months, 12 months, 24 months
a)Changes in the proportion of disease activity categories by SDAI, CDAI, DAS28-ESR, DAS28-CRP
b)Transition of SDAI, CDAI, DAS28-ESR and DAS28-CRP
c)Evaluation of therapeutic responsiveness by DAS28-ESR and DAS28-CRP
d)Transition of Japanese version health evaluation questionnaire (J-HAQ) score
e)Transition of mTSS joint destruction score
f)Changes in anti-CCP antibody titer and ACPA by antigen
g)Transition of rheumatoid factor (RF)

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

(1) Research subjects
Patients with rheumatoid arthritis who are attending or hospitalized at the institutions participating in the study will be included in the study.
(2) Selection criteria
Patients who meet all of the following criteria (items 1-7) will be included in this study.
1)Patients with RA who meet the 2010 ACR/EULAR classification criteria (Aletaha D, et al:2010 Rheumatoid arthritis classification criteria)
2)RA patients with disease activity
3)bDMARD-naive patients who have had an inadequate response to one or more conventional synthetic anti-rheumatic drugs (csDMARDs) on previous treatment
4)Patients who meet the following criteria for blood tests:
a)Peripheral blood white blood cell count: 4,000/mm3 or higher
b)Peripheral blood lymphocyte count: more than 1,000/mm3
c)Blood beta-D-glucan negative
5)Patients who are 20 years of age or older at the time of obtaining consent to participate in this study
6)Patients who understand the principal investigator or sub-researcher's explanation of the research procedure and who can obtain written consent to participate in the research of their own volition
7)Patients who began subcutaneous administration of abatacept by the decision of their doctor

Key exclusion criteria

Patients who violate the following criteria (items 1-5) at the time of eligibility determination before obtaining consent shall be excluded.
1) Patients with a history of hypersensitivity to the ingredients of abatacept preparations
2) Patients with malignant tumor
3) Patients with active infections
4) Hepatitis B and hepatitis B virus carriers (HBsAg positive)
5) Pregnant or lactating patients, or potentially pregnant or lactating patients
6) Patients who are judged by the investigator or investigator to be ineligible for participation in this study

Target sample size

100

Name of lead principal investigator

1st name	Naoto
Middle name
Last name	Tamura

Organization

Juntendo University School of Medicine

Division name

Department of Internal Medicine and Rheumatology

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo, Tokyo, Japan

TEL

03-3813-3111

Email

tnaoto@juntendo.ac.jp

Name of contact person

1st name	Makio
Middle name
Last name	Kusaoi

Organization

Juntendo University School of Medicine

Division name

Department of Internal Medicine and Rheumatology

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo, Tokyo, Japan

TEL

03-3813-3111

Homepage URL

Email

makio.k@juntendo.ac.jp

Institute

Juntendo University School of Medicine, Department of Internal Medicine and Rheumatology

Institute

Department

Personal name

Organization

Bristol-Myers Squibb Company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

ONO PHARMACEUTICAL CO., LTD.

Organization

Ethical review board of Juntendo university, faculty of medicine

Address

3-1-3 Hongo, Bunkyo, Tokyo, Japan

Tel

03-3813-3111

Email

hongo-rinri@juntendo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

順天堂大学医学部附属順天堂医院（東京）
順天堂大学医学部附属浦安病院（千葉）
順天堂大学医学部附属静岡病院（静岡）
順天堂大学医学部附属練馬病院（東京）
順天堂大学医学部附属順天堂越谷病院（埼玉）
順天堂大学医学部附属順天堂東京江東高齢者医療センター（東京）
広島大学病院（広島）
名古屋医学部附属病院（愛知）
あずまリウマチ・内科クリニック（埼玉）
独立行政法人 国立病院機構 災害医療センター（東京）

Date of disclosure of the study information

2020

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

92

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

No longer recruiting

Date of protocol fixation

2017

Year

01

Month

04

Day

Date of IRB

2017

Year

01

Month

04

Day

Anticipated trial start date

2017

Year

11

Month

29

Day

Last follow-up date

2022

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The results of the physician's evaluation and clinical laboratory data will be collected at regular intervals as follows
1) Physical examination and interview for the past 6 months of history and surgery
2) Patient background (at the time of screening)
3) Pre-treatment
4) Prescribed abatacept dosage/administration method
5) Concomitant medications/treatment
6) csDMARDs: drug name, dosage, duration of administration, reason for discontinuation/change
7) Oral steroids
8) Number of tender and swollen joints: at the start of abatacept, at 6 months, at 12 months, at 24 months, and at discontinuation.
9) Physician Activity Assessment (VAS)
10) Progression of joint destruction (mTSS)
11) Hematology
12) Blood biochemical tests (AST, ALT, serum creatinine, CRP): at the start of abatacept, at 6 months, at 12 months, at 24 months, and at discontinuation.
13) Adverse events
14) Anti-CCP antibodies, RF: Abatacept at start, 6 months, 12 months, 24 months, and at discontinuation.
15) ACPA by antigen (outsourced to Brightpath Biotechnology, Inc.): at the start of abatacept, 6 months, 12 months, 24 months, and at discontinuation
16) HLA genotyping
Patient Reported Outcomes (PRO)
1) Japanese Health Assessment Questionnaire (J-HAQ)
2) Pain assessment (VAS)
3) Overall Assessment (VAS)

Registered date

2020

Year

11

Month

26

Day

Last modified on

2022

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048584