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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021492
Receipt No. R000024788
Scientific Title To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients.
Date of disclosure of the study information 2016/03/20
Last modified on 2018/09/10

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Basic information
Public title To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients.
Acronym Switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.
Scientific Title To investigate the safety of switch from infliximab biosimilar 1 in rheumatoid arthritis patients.
Scientific Title:Acronym Switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.
Region
Japan

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

Objectives
Narrative objectives1 To investigate the safety and efficacy of switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in safety and efficacy before and after switch prescripution.
Key secondary outcomes

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 switch from infliximab to infliximab biosimilar 1 in rheumatoid arthritis patients.
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 rheumatoid arthritis treated infliximab
Key exclusion criteria 1.Patients who corresponds to a contraindication of infliximab of infliximab biosimilar 1

2.Patients their doctors find not appropriate for this study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Inoue
Organization Inoue Hospital
Division name Dpepartment of Rheumatology
Zip code
Address 55 Tohrimachi,Takasaki city, Gunma 370-0053,Japan
TEL 027-322-3660
Email m2inoue@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Inoue
Organization Inoue Hospital
Division name Dpepartment of Rheumatology
Zip code
Address 55 Tohrimachi,Takasaki city, Gunma 370-0053,Japan
TEL 027-322-3660
Homepage URL
Email m2inoue@marianna-u.ac.jp

Sponsor
Institute Inoue Hospital
Institute
Department

Funding Source
Organization Inoue 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

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 20 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
2016 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
2017 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 16 Day
Last modified on
2018 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024788

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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