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
Not Applicable
Recruiting
- Conditions
- RA patients aged 20 years or older and have never been treated with biological products or molecular targeted drug therapy.
- Registration Number
- JPRN-UMIN000015217
- Lead Sponsor
- Yokohama City University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in RA activity (DASCRP28) and bilateral mean IMT
- Secondary Outcome Measures
Name Time Method 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.