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

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 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

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

Value
https://center6.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