UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019262 |
|---|---|
| Receipt number | R000022271 |
| Scientific Title | Examination about the efficacy and safety of abatacept iv in rheumatoid arthritis |
| Date of disclosure of the study information | 2015/10/07 |
| Last modified on | 2015/10/08 13:50:29 |
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Basic information
Public title
Examination about the efficacy and safety of abatacept iv in rheumatoid arthritis
Acronym
Examination for effectiveness with the intervention time of abatacept therapy in rheumatoid arthritis.(ORIB study)
Scientific Title
Examination about the efficacy and safety of abatacept iv in rheumatoid arthritis
Scientific Title:Acronym
Examination for effectiveness with the intervention time of abatacept therapy in rheumatoid arthritis.(ORIB study)
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination about efficacy and safety of abatacept in rheumatoid arthritis patients with MTX-inadequate response and bio-naive.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical Remission Rate at week 48
Treatment reactivity by disease activity at week 48.
Safety in this study period.
Key secondary outcomes
modified total sharp score at week48
J-HAQ at week 48
Disease activity score
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
Rheumatoid arthritis with MTX-inadequate response and bio-naive
Key exclusion criteria
patients with no MTX treatment
past biological agents' user
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Hagiwara |
Organization
Takarazuka city hospital
Division name
division of rheumatology
Zip code
Address
Kohama4-5-1, Takarazuka city
TEL
0797871161
college@katzenauge.sakura.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Hagiwara |
Organization
Takarazuka city hospital
Division name
Division of rheumatology
Zip code
Address
Kohama4-5-1, Takarazuka city
TEL
0797871161
Homepage URL
college@katzenauge.sakura.ne.jp
Sponsor or person
Institute
Takarazuka city hospital
Institute
Department
Personal name
Funding Source
Organization
Takarazuka city hospital
Organization
Division
Category of Funding Organization
Self funding
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
宝塚市立病院（兵庫県）、独立行政法人地域機能推進機構大阪病院（大阪府）、兵庫県立リハビリテーション中央病院（兵庫県）、独立行政法人国立病院機構姫路医療センター（兵庫県）、松原メイフラワー病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Rammission Rate at week 48 (as follow)
DAS28ESR 34.5%
SDAI 34.5%
High disease activity patients got more efficacy response by abatacept therapy than others.
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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 31 | Day |
Other
Other related information
Study design :Cohort study
Recruitment:
Research targeted at rheumatoid arthritis patient who consulted this study entry facilities, and who took abatacept therapy as a 1st biologics from Mar 2011 to Mar 2014.
Research period: 48 weeks
Management information
Registered date
| 2015 | Year | 10 | Month | 07 | Day |
Last modified on
| 2015 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022271
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
