UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015217 |
|---|---|
| Receipt number | R000017540 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2018/04/19 18:35:34 |
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Basic information
Public title
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
Acronym
Orencia Atherosclerosis And Rheumatoid Arthritis Study
(ORACLE Arthritis Study)
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tomoaki Ishigami |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine,
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa 236-0004
TEL
0457872635
tommmish@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Ishigami |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine,
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa 236-0004
TEL
0457872635
Homepage URL
tommmish@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 09 | Month | 09 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017540
