UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037514 |
|---|---|
| Receipt number | 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 15:25:07 |
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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
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
seikei@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka city university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042770
