UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044434 |
|---|---|
| Receipt number | 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 17:04:10 |
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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
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
knagatani@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Division of Rheumatology and Clinical Immunology, Department of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050725
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
