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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014856
Receipt No. R000016852
Scientific Title Research for establishment and validation of therapeutic guideline aiming at "treatment holiday" in rheumatoid arthritis
Date of disclosure of the study information 2014/09/01
Last modified on 2019/08/20

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Basic information
Public title Research for establishment and validation of therapeutic guideline aiming at "treatment holiday" in rheumatoid arthritis
Acronym FREE-J study
Scientific Title Research for establishment and validation of therapeutic guideline aiming at "treatment holiday" in rheumatoid arthritis
Scientific Title:Acronym FREE-J study
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To construct evidences for establishing a therapeutic guideline aiming at "drug holiday" in rheumatoid arthritis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes DAS28(ESR) remission rate at 1 year after discontinuing biological DMARD
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patient diagnosed as having rheumatoid arthritis according to ACR 1987 revised classification criteria for rheumatoid arthritis or ACR/EULAR 2010 revised classification criteria for rheumatoid arthritis.
(2) Patient maintained stable DAS28(ESR) remission at least 2 consecutive visits under treatment with biological DMARD and concomitant MTX (8mg/week).
(3) Patient;18 year-old with written informed consent for participating in the study.
Key exclusion criteria (1) Patient with contraindication to MTX.
(2) Patient with contraindication to biological DMARD.
(3) Patient with any other reasons for inadequate to participate in this study, judege by attending rheumatologist.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yoshiya
Middle name
Last name Tanaka
Organization University of Occupational and Environmental Health, Japan
Division name The First Department of Internal Medicine
Zip code 807-8555
Address 1-1 Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan
TEL +81-93-603-1611
Email tanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name Ayako
Middle name
Last name Yamaguchi
Organization University of Occupational and Environmental Health, Japan
Division name The First Department of Internal Medicine
Zip code 807-8555
Address 1-1 Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan
TEL +81-93-603-1611
Homepage URL
Email ayasuzu@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization self funding
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 The First Department of Internal Medicine
Address 1-1 Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan
Tel +81-93-603-1611
Email ayasuzu@med.uoeh-u.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
2014 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 436
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 No longer recruiting
Date of protocol fixation
2014 Year 06 Month 21 Day
Date of IRB
2015 Year 06 Month 09 Day
Anticipated trial start date
2014 Year 12 Month 01 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information If a patient with rheumatoid arthritis achieve DAS28 remission at two consequent visit, one can choose one out of five treatments below, then will be observed for two years.
1) Continue both MTX and bDMARD withouot reduction
2) Reduce MTX to a half dose
3) Withdraw MTX
4) Reduce bDMARD to a half dose
5) Withdraw bDMARD

Management information
Registered date
2014 Year 08 Month 13 Day
Last modified on
2019 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016852

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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