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

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)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015217

Enrollment

Registered

2014-10-01

Start date

2014-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RA patients aged 20 years or older and have never been treated with biological products or molecular targeted drug therapy.

Interventions

Abatacept

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Changes in RA activity (DASCRP28) and bilateral mean IMT	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactTomoaki Ishigami

Yokohama City University Graduate School of Medicine Department of Medical Science and Cardiorenal Medicine,

tommmish@yokohama-cu.ac.jp0457872635

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026