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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034567
Receipt No. R000039401
Scientific Title Clinical study on Efficay of Biological Disease-Modifying Rheumatic Drug spacing -multicenter cohort-
Date of disclosure of the study information 2018/10/19
Last modified on 2019/10/21

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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/ctr_e/ctr_view.cgi?recptno=R000039401

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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