UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of abatacept (ABT) in patients with rheumatoid arthritis (RA)
Title of the study (Brief title)	A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of ABT in patients with RA
Region	Japan

Condition
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	1
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	Kensuke Oryoji
Organization	Matsuyama Red Cross Hospital
Division name	Division of rheumatoid arthritis
Address	1, Bunkyo-cho, Matsuyama City, Ehime
TEL	089-924-1111
Email	oryoji76@yahoo.co.jp

Public contact
Name of contact person	Kensuke Oryoji
Organization	Matsuyama Red Cross Hospital
Division name	Division of rheumatoid arthritis
Address	1, Bunkyo-cho, Matsuyama City, Ehime
TEL	089-924-1111
Homepage URL
Email	oryoji76@yahoo.co.jp

Sponsor
Institute	Matsuyama Red Cross Hospital
Institute
Department

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)

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

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 03 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 09 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023151