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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019262
Receipt No. 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

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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
Email 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
Email college@katzenauge.sakura.ne.jp

Sponsor
Institute Takarazuka city hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022271

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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