UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy.
Title of the study (Brief title)	Effect of tapering MTX in RA patinents after add-on IGU theraoy.
Region	Japan

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

Objectives
Narrative objectives1	This study aimed to examine the effect of tapering MTX in RA patients after add-on iguratimod therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	rate of sustaining remission after 36 weeks
Key secondary outcomes	ultrasound findings (power Doppler score, Grey scale score) SF-36, HAQ, dose of MTX

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	add-on iguratimod tapering MTX
Interventions/Control_2	continuing the treatment
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	sustaining DAS28ESR remission more than 6 months
Key exclusion criteria	add-on another csDMARDs or bDMARDs within 8 weeks.
Target sample size	100

Research contact person
Name of lead principal investigator	Shuzo Yoshida
Organization	Osama medical college
Division name	Department of Internal Medicine (4)
Address	2-7 Daigakumachi, Takatsuki city, Osaka 569-8686, Japan
TEL	+81-72-683-1221
Email	in1307@osaka-med.ac.jp

Public contact
Name of contact person	Shuzo Yoshida
Organization	Osaka Medical College
Division name	Department of Internal Medicine (4)
Address	2-7 Daigakumachi, Takatsuki city, Osaka 569-8686, Japan
TEL	+81-72-683-1221
Homepage URL
Email	in1307@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Other
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	2017 Year 06 Month 12 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 06 Month 11 Day
Anticipated trial start date	2017 Year 06 Month 12 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	2017 Year 06 Month 11 Day
Last modified on	2017 Year 06 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031756