UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis
Title of the study (Brief title)	efficacy of aterosclerosis of tofacitinib in rheumatoid arthritis
Region	Japan

Condition
Condition	atherosclerosis efficacy of tofacitinib in RA
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	safety and efficacy of tofacitinib in RA
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	AS values in 54 weeks
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	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	RA patients with moderate to severe active disease despite MTX treatment (disease activity score: DAS28>3.2)
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	RA patients with moderate to severe active disease despite MTX treatment (disease activity score: DAS28>3.2)
Key exclusion criteria	NP
Target sample size	50

Research contact person
Name of lead principal investigator	kensuke kume
Organization	hiroshima clinic
Division name	rheumatology
Address	Higashi kannon 20-16, Hiroshima, Japan
TEL	082-232-0707
Email	kumekensuke@live.jp

Public contact
Name of contact person	kensuke kume
Organization	hiroshima clinic
Division name	rheumatology
Address	Higashi kannon 20-16, Hiroshima, Japan
TEL	082-232-0707
Homepage URL
Email	kumekensuke@live.jp

Sponsor
Institute	hiroshima clinic
Institute
Department

Funding Source
Organization	hiroshima clinic
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	2016 Year 09 Month 23 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 05 Month 01 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 09 Month 23 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	under submitting to journal
Other related information

Management information
Registered date	2016 Year 09 Month 23 Day
Last modified on	2017 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027801