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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020799
Receipt No. R000024012
Scientific Title Efficacy of Infliximab as a second Bio in patients with refractory rheumatoid arthritis
Date of disclosure of the study information 2016/02/01
Last modified on 2019/01/30

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Basic information
Public title Efficacy of Infliximab as a second Bio in patients with refractory rheumatoid arthritis
Acronym Infliximab as a second Bio
Scientific Title Efficacy of Infliximab as a second Bio in patients with refractory rheumatoid arthritis
Scientific Title:Acronym Infliximab as a second Bio
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of Infliximab as a second Bio
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes DAS28
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with rheumatoid arthritis treated with only one bio except for infliximab
more than 3.2 in DAS28-ESR
patients with
Key exclusion criteria contraindication of infliximab and methotorexate
pregnant women
nursing women
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Atsumi
Organization Hokkaido University Hospital
Division name Medicine II
Zip code
Address N14W5 Kita-ku Sapporo
TEL 011-706-5915
Email at3tat@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Bohgaki
Organization Hokkaido University Hospital
Division name Medicine II
Zip code
Address N14W5 Kita-ku Sapporo
TEL 011-706-5915
Homepage URL
Email tbohgaki@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital, Medicine II
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma Corporation
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 02 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 Completed
Date of protocol fixation
2015 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information patients with rheumatoid arthritis fulfilled with inclusion and exclusion criteria

Management information
Registered date
2016 Year 01 Month 29 Day
Last modified on
2019 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024012

Research Plan
Registered date File name
2019/01/30 [No.014-0275]研究計画書【150119承認】 -改訂170729.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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