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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044434
Receipt No. R000050725
Scientific Title Study on prediction of relapse of rheumatoid arthritis after discontinuation of bDMARD
Date of disclosure of the study information 2021/06/04
Last modified on 2021/06/04

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Basic information
Public title Study on prediction of relapse of rheumatoid arthritis after discontinuation of bDMARD
Acronym Justice Study
Scientific Title Study on prediction of relapse of rheumatoid arthritis after discontinuation of bDMARD
Scientific Title:Acronym Study on prediction of relapse of rheumatoid arthritis after discontinuation of bDMARD
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to identify biomarkers that predict relapse by observing which cytokine changes occur during the recurrence process of rheumatoid arthritis.
Basic objectives2 Others
Basic objectives -Others Identification of biomarkers that predict relapse of rheumatoid arthritis after discontinuation of bDMARD
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage of low disease activity or higher within a 2-year observation period after discontinuation of bDMARD
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

Not applicable
Gender Male and Female
Key inclusion criteria Rheumatoid arthritis patients who have agreed to discontinue bDMARD with DAS28-CRP maintained below 2.3 for more than 1 year
Key exclusion criteria Patients who do not agree to discontinue bDMARD
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Katsuya
Middle name
Last name Nagatani
Organization Jichi Medical University
Division name Division of Rheumatology and Clinical Immunology, Department of Medicine
Zip code 329-0498
Address Yakushiji 3311-1, Shimotsuke, Tochigi, Japan
TEL 0285-58-7358
Email knagatani@jichi.ac.jp

Public contact
Name of contact person
1st name Katsuya
Middle name
Last name Nagatani
Organization Jichi Medical University
Division name Division of Rheumatology and Clinical Immunology, Department of Medicine
Zip code 329-0498
Address Yakushiji 3311-1, Shimotsuke, Tochigi, Japan
TEL 0285-58-7358
Homepage URL
Email knagatani@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Division of Rheumatology and Clinical Immunology, Department of Medicine
Institute
Department

Funding Source
Organization Jichi Medical University
Division of Rheumatology and Clinical Immunology, Department of Medicine
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 Jichi Medical University
Address Yakushiji 3311-1, Shimotsuke, Tochigi, Japan
Tel 0285-58-7358
Email knagatani@jichi.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 自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications unpublished
Number of participants that the trial has enrolled 40
Results unpublished
Results date posted
2021 Year 06 Month 04 Day
Results Delayed
Delay expected
Results Delay Reason unpublished
Date of the first journal publication of results
Baseline Characteristics unpublished
Participant flow unpublished
Adverse events unpublished
Outcome measures unpublished
Plan to share IPD unpublished
IPD sharing Plan description unpublished

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2010 Year 02 Month 04 Day
Date of IRB
2010 Year 02 Month 04 Day
Anticipated trial start date
2010 Year 02 Month 04 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information not applicable

Management information
Registered date
2021 Year 06 Month 04 Day
Last modified on
2021 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050725

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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