UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept
Title of the study (Brief title)	Clinical outcome in patients with RA switched to TNF blocker after tocilizumab or abatacept
Region	Japan

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

Objectives
Narrative objectives1	To investigate clinical outcome in patients with rheumatoid arthritis switched to tumor necrosis factor blockers after tocilizumab or abatacept failure
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical remission rate in 48w (DAS28ESR<2.6)
Key secondary outcomes	Power Dopper signal

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	Infliximab or adalimumab or golimumab
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	active rheumatoid arthritis patients (disease activity score-ESR >2.6) after 1st BIO (tocilizumab or abatacept) failure
Key exclusion criteria	none
Target sample size	50

Research contact person
Name of lead principal investigator	Shuzo Yoshida
Organization	Osaka Medical College
Division name	Department of Internal Medicine (I)
Address	2-7 Daigakumachi, Takatsuki city, Osaka 569-8686, Japan
TEL	072-683-1221
Email	in1307@poh.osaka-med.ac.jp

Public contact
Name of contact person	Shuzo Yoshida
Organization	Osaka Medical College
Division name	Department of Internal Medicine (I)
Address	2-7 Daigakumachi, Takatsuki city, Osaka 569-8686, Japan
TEL	072-683-1221
Homepage URL
Email	in1307@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 04 Month 03 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 27 Day
Anticipated trial start date	2015 Year 03 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 27 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019675