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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015217 |
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Date of registration:
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01/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 - Orencia Atherosclerosis And Rheumatoid Arthritis Study (ORACLE Arthritis Study) |
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Date of first enrolment:
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2014/10/01 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017540 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Tomoaki Ishigami |
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Address:
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3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa 236-0004
Japan |
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Telephone:
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0457872635 |
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Email:
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tommmish@yokohama-cu.ac.jp |
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Affiliation:
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Yokohama City University Graduate School of Medicine Department of Medical Science and Cardiorenal Medicine, |
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Name:
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Tomoaki Ishigami |
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Address:
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3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa 236-0004
Japan |
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Telephone:
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0457872635 |
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Email:
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tommmish@yokohama-cu.ac.jp |
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Affiliation:
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Yokohama City University Graduate School of Medicine Department of Medical Science and Cardiorenal Medicine, |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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RA patients aged 20 years or older and have never been treated with biological products or molecular targeted drug therapy.
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Intervention(s)
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Abatacept
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Primary Outcome(s)
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Changes in RA activity (DASCRP28) and bilateral mean IMT
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Bristol Meyers Squib Co.Ltd.
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/08/2018 |
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URL:
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