UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016613 |
|---|---|
| Receipt number | R000019281 |
| Scientific Title | MRI-efficacy of Abatacept in patients with rheumatoid arthritis [MIYAKO study] |
| Date of disclosure of the study information | 2015/02/25 |
| Last modified on | 2017/03/01 20:36:55 |
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Basic information
Public title
MRI-efficacy of Abatacept in patients with rheumatoid arthritis [MIYAKO study]
Acronym
MRI-efficacy of Abatacept in patients with rheumatoid arthritis [MIYAKO study]
Scientific Title
MRI-efficacy of Abatacept in patients with rheumatoid arthritis [MIYAKO study]
Scientific Title:Acronym
MRI-efficacy of Abatacept in patients with rheumatoid arthritis [MIYAKO study]
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate MRI-efficacy of abatacept in patients with rheumatoid arthritis in daily clinical use
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of efficacy of abatacept : 48 weeks follow-up with MRI
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Patients with written informed consent for participating in the study
2. Patients diagnosed as having rheumatoid arthritis according to ACR 1987 revised classification criteria for rheumatoid arthritis or ACR/EULAR 2010 revised classification criteria for rheumatoid arthritis
3. Glucocorticoid use should be under 10 mg/day
Key exclusion criteria
Patients with the reasons for inadequate to participate in this study, judeged by attending rheumatologist
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Kawahito |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Inflammation and Immunology
Zip code
Address
465 Kajiicho, Kamigyouku, Kyoto-city, Japan
TEL
075-251-5505
kawahity@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Kukida |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Inflammation and Immunology
Zip code
Address
465 Kajiicho, Kamigyouku, Kyoto-city, Japan
TEL
075-251-5505
Homepage URL
y-kukida@koto.kpu-m.ac.jp
Sponsor or person
Institute
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb
Ono Pharmaceutical 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 25 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Clinical assessments:
MRI of hands, Radiographs of hands and feet, Tender joints count(TJC), Swollen joints count(SJC), Patient global assessments, Doctor global assessments, CRP, MMP-3, RF, Anti-CCP antibody, Blood lipid level, DAS-CRP, HAQ-DI, serious adverse events
Management information
Registered date
| 2015 | Year | 02 | Month | 23 | Day |
Last modified on
| 2017 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019281
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
