UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000020046
Receipt number	R000023151
Scientific Title	A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of abatacept (ABT) in patients with rheumatoid arthritis (RA)
Date of disclosure of the study information	2015/12/03
Last modified on	2016/12/20 17:19:59

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Basic information

Public title

A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of abatacept (ABT) in patients with rheumatoid arthritis (RA)

Acronym

A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of ABT in patients with RA

Scientific Title

A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of abatacept (ABT) in patients with rheumatoid arthritis (RA)

Scientific Title:Acronym

A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of ABT in patients with RA

Region

Japan

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

YES

Objectives

Narrative objectives1

To investigate the efficacy and safety of ABT in patients with rheumatoid arthritis (RA) stratified by the presence or absence of anti-cyclic citrullinated peptide antibody (ACPA) and shared epitope (SE), a common amino acid sequence associated with RA susceptibility, prospectively.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Rate of the patients whose DAS28-ESR score was <2.6 at week 24

Key secondary outcomes

Clinical improvement
1) Rate of the patients whose DAS28-CRP score achieved <2.3 at week 24
2) Clinical remission rate defined by SDAI at week 52

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

ABT should be administered intravenously for all patients at a dose of 250 mg until week 8. Thereafter, it is permitted to continue intravenous infusion or switch to 125 mg/ml solution for subcutaneous injection. Intravenous infusion is performed at the first of the study, week 2 and 4, and subsequently at 4-week intervals.
Subcutaneous administration is performed at a dose of 125 mg after intervenous infusion as a loading dose on the same day. After that it will be administered subcutaneously once a week. A total administration period is 52 weeks.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients whose written informed consent can be obtained and are >=20, =<75 years of age at the time of informed consent acquisition (regardless of sex, hospitalization or outpatient).
2) Patients with a diagnosis of RA according to the 2010 ACR-EULAR classification criteria for
RA and whose duration of disease from diagnosis is >= 3 months and < 10 years before the day of first administration
3) CRP is >= 0.6 mg/dL, or ESR is >= 28 mm/hr and DAS28-ESR score is >= 3.2 before the day of first administration.
4) ACPA-positive patients whose ACPA is >4.5 U/mL and ACPA-negative patients whose ACPA is <= 4.5 U/mL before the day of first administration.

Key exclusion criteria

1) Patients with serious infections including active tuberculosis
2) Patients with a history of hypersensitivity to ABT or any other excipient of ABT
3) Patients with a history of treatment with anti-rheumatic biological agents
4) Patients administered >= 10 mg/day of systemic corticosteroid preparation as prednisolone equivalent within 28 days before registration day
5) Patients with confirmed hepatitis B (except for HBs/HBc antibody-positive and HBs antigen-negative patients) or hepatitis C at the time of resistration
6) Patients with complications of chronic obstructive pulmonary disease
7) Patients with a history of tuberculosis
8) Patients with complications of extra-articular manifestations such as interstitial pneumonitis
9) Patients whose antinuclear antibody is >160-fold
10) Patients with positive for specific autoantibody against connective tissue disease
11) Patients with the following complications: serious renal disease, liver disease, hematologic disease, digestive system disease, diabetes, malignancy (including a history of malignancy) , thyroid disease, autoimmune disease except RA (chronic thyroiditis and Sjogren's syndrome are eliminated), lung disease, cardiovascular disease, neurological disease, eye disease and brain disease
12) Patients who had undergone surgical therapy for RA such as synovectomy, arthroplasty within 6 months (180 days) before first administration
13) Patients who are pregnant, nursing, possibly pregnant or plan to become pregnant during the research period
14) Patients who are drug or alcohol dependence, or those suspected
15) Patients deemed inappropriate to participate in the research by the investigator

Target sample size

130

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Kensuke Oryoji

Organization

Matsuyama Red Cross Hospital

Division name

Division of rheumatoid arthritis

Zip code

Address

1, Bunkyo-cho, Matsuyama City, Ehime

TEL

089-924-1111

Email

oryoji76@yahoo.co.jp

Public contact

Name of contact person

1st name

Middle name

Last name Kensuke Oryoji

Organization

Matsuyama Red Cross Hospital

Division name

Division of rheumatoid arthritis

Zip code

Address

1, Bunkyo-cho, Matsuyama City, Ehime

TEL

089-924-1111

Homepage URL

Email

oryoji76@yahoo.co.jp

Sponsor or person

Institute

Matsuyama Red Cross Hospital

Institute

Department

Personal name

Funding Source

Organization

ONO PHARMACEUTICAL CO., LTD/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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 03 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

2015 Year 09 Month 04 Day

Date of IRB

Anticipated trial start date

2015 Year 12 Month 07 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2015 Year 12 Month 03 Day

Last modified on

2016 Year 12 Month 20 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023151

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name