UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Identification of Antibodies Involved in Atherosclerosis Progression and Evaluation of Orencia`s Efficacy on Antibodies, Atherosclerosis Biomarkers and Structural Markers in Orencia-Treated Patients with Rheumatoid Arthritis Complicated by Atherosclerosis
Title of the study (Brief title)	Orencia Atherosclerosis And Rheumatoid Arthritis Study (ORACLE Arthritis Study)
Region	Japan

Condition
Condition	RA patients aged 20 years or older and have never been treated with biological products or molecular targeted drug therapy.
Classification by specialty	Medicine in general Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is aimed at demonstrating that Abatacept (Orencia), a CTLA4-Ig preparation, can reduce the activities of rheumatoid arthritis (RA) and atherosclerosis and improve biomarkers safely and effectively in patients with atherosclerosis which accompanies rheumatoid arthritis and at identifying disease-specific autoantibody markers by our novel high-sensitive high-throughput autoantibody screening systems using cell free protein synthesis technologies through analysis of changes in autoantibody profile following treatment with this drug.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in RA activity (DASCRP28) and bilateral mean IMT
Key secondary outcomes	Changes in the following endpoints during the treatment and from baseline to post-infusion (i) Serum markers of arteriosclerosis (ii) Arteriosclerosis structural markers (iii) Serum autoantibody profile (vi) Blood biochemistry data and serological data associated with RA (v) Changes in x-ray findings based on the Sharp score (vi) SDAI, CDAI and Boolean remission rates, and clinical improvement based on the HAQ-DI.

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	Abatacept
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	Inclusion criteria (i) Patients aged 20 years or older at the time of informed consent (ii) Patients with RA that is poorly controlled with the use of the existing antirheumatic drugs at the usual dosage for 3 months or more without history of biologics. (iii)Subjects who can undergo Carotid ultrasonography examination during study period. (iv) Patients who personally provided their voluntary written consent upon full understanding of the study after receiving an adequate explanation prior to participation in the study.
Key exclusion criteria	Exclusion criteria are as follows: 1. Patients in whom Orencia is contraindicated such as patients with a history of hypersensitivity to any ingredient of Orencia 2. Patients with active infection or malignancies 3. Patients who have been treated with other biological products or molecular targeted drug therapy 4. Pregnant women, lactating women, and patients who wish to become pregnant 5. Patients who have not provided consent to participate in the study 6. Patients who doctor considered inappropriate for study enrollment.
Target sample size	40

Research contact person
Name of lead principal investigator	Tomoaki Ishigami
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Medical Science and Cardiorenal Medicine,
Address	3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa 236-0004
TEL	0457872635
Email	tommmish@yokohama-cu.ac.jp

Public contact
Name of contact person	Tomoaki Ishigami
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Medical Science and Cardiorenal Medicine,
Address	3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa 236-0004
TEL	0457872635
Homepage URL
Email	tommmish@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Bristol Meyers Squib Co.Ltd.
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	公立大学法人横浜市立大学（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 09 Month 09 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 21 Day
Last modified on	2018 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017540