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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037514
Receipt No. R000042770
Scientific Title Baricinitib reduction after achieving remission may keep remission in RA patients
Date of disclosure of the study information 2019/08/01
Last modified on 2019/11/20

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Basic information
Public title Baricinitib reduction after achieving remission may keep remission in RA patients
Acronym BREAK study
Scientific Title Baricinitib reduction after achieving remission may keep remission in RA patients
Scientific Title:Acronym BREAK study
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is aimed to investigate the effect of reducing baricitinib to 2mg/day among patients with rheumatoid arthritis treated with 4mg/day baricitinib and achieved low disease activity
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes risk factors for flare after baricitinib reduction
Key secondary outcomes

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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with rheumatoid arthritis over 20 years old who fulfills ACR/EULAR criteria and treated by 4mg/day baricitinib
Key exclusion criteria Those who were considered not suitable for the study by researchers
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Tadashi
Middle name
Last name Okano
Organization Osaka city university
Division name Orthopedics
Zip code 545-8585
Address 3-4-1, Asahimachi, Abeno-ku, Osaka-city
TEL 0666453851
Email seikei@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Tadashi
Middle name
Last name Okano
Organization Osaka city university
Division name Orthopedics
Zip code 545-8585
Address 3-4-1, Asahimachi, Abeno-ku, Osaka-city
TEL 0666453851
Homepage URL
Email seikei@med.osaka-cu.ac.jp

Sponsor
Institute Osaka city university
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka City University Hospital Certified Review Board
Address 3-4-1, Asahimachi, Abeno-ku, Osaka-city
Tel 06-6645-3456
Email irb@med.osaka-cu.ac.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

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2019 Year 08 Month 01 Day
Date of IRB
2019 Year 09 Month 01 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The patients continuing baricitinib 4mg with subclinical inflammation, those who maintained low disease activity after reducing baricitinib and those who flared after reducing baricitinib will be compared.

Management information
Registered date
2019 Year 07 Month 28 Day
Last modified on
2019 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042770

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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