UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on Efficay of Biological Disease-Modifying Rheumatic Drug spacing -multicenter cohort-
Acronym	Stuy on efficay of bDMARD spacing
Scientific Title	Clinical study on Efficay of Biological Disease-Modifying Rheumatic Drug spacing -multicenter cohort-
Scientific Title:Acronym	Stuy on efficay of bDMARD spacing
Region	Japan

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

Objectives
Narrative objectives1	To determine which bDMARD is most appropriate for spacing in RA patients with persistent stable symptoms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Period of low disease activity by CDAI
Key secondary outcomes	Back ground factor for maintained low disease activity

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Rheuamtoid arthritis on EULAR2010 criteria 2. RA activity maintained low disease activity or remission over 3 months treated with golimumab or tocilizumab or abatacept 3. Dose inteval period extended by 1.5 times on golimumab, tocilizumab or abatacept 4. be able to follow up over 60 weeks
Key exclusion criteria	Patients discontinuing therapy for adverse reactions and those withdrawing for reasons unrelated to the drugs
Target sample size	190

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Matsuno
Organization	Matsuno Clinic for Rheumatic diseases
Division name	Rheumatology
Zip code	930-0138
Address	7182-2, Kurehacho, Toyama city, Japan, 930-0138
TEL	076-436-1757
Email	info@toyama-ra.com

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Matsuno
Organization	Matsuno Clinic for Rheumatic diseases
Division name	Rheumatology
Zip code	930-0138
Address	7182-2, Kurehacho, Toyama city, Japan,930-0138
TEL	076-436-1757
Homepage URL
Email	info@toyama-ra.com

Sponsor
Institute	Matsuno Clinic for Rheumatic diseases
Institute
Department

Funding Source
Organization	Matsuno Clinic for Rheumatic diseases
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	Matsubara Mayflower Hospital ethics committee
Address	944-25, Fujita, Kato, Hyogo
Tel	0795-42-8851
Email	tiken@mayflower-hp.jp

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	松野リウマチ科整形外科、片山整形外科リウマチ科クリニック、松原メイフラワー病院

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 19 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	2017 Year 03 Month 08 Day
Date of IRB	2017 Year 03 Month 09 Day
Anticipated trial start date	2017 Year 03 Month 09 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 05 Month 31 Day
Date trial data considered complete	2018 Year 08 Month 31 Day
Date analysis concluded	2018 Year 09 Month 30 Day

Other
Other related information	analysis for continuation rates treated with each biologics with Kaplan-Meier

Management information
Registered date	2018 Year 10 Month 19 Day
Last modified on	2019 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039401