UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040279 |
|---|---|
| Receipt number | R000045952 |
| Scientific Title | Exploratory research to analyze the effects of disease susceptibility genes on therapeutic response and autoantibodies in rheumatoid arthritis |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2020/04/30 22:39:44 |
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Basic information
Public title
Exploratory research to analyze the effects of disease susceptibility genes on therapeutic response and autoantibodies in rheumatoid arthritis
Acronym
Research to analyze the effects of disease susceptibility genes on therapeutic response and autoantibodies in rheumatoid arthritis
Scientific Title
Exploratory research to analyze the effects of disease susceptibility genes on therapeutic response and autoantibodies in rheumatoid arthritis
Scientific Title:Acronym
Research to analyze the effects of disease susceptibility genes on therapeutic response and autoantibodies in rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to analyze the therapeutic response after treatment in targeted synthetic, biological, and conventional synthetic disease modifying antirheumatic drugs (DMARDs) according to the presence or absence of human leukocyte antigen(HLA) and shared epitope (SE).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of clinical disease activity at 3, 6, and 12 months after the treatment between treatments with targeted synthetic/biological DMARDs and conventional synthetic DMARDs according to the presence or absence of human leukocyte antigen(HLA) and shared epitope (SE).
Key secondary outcomes
Comparison of ultrasound activity at 6 and 12 months after the treatment between treatments with targeted synthetic/biological DMARDs and conventional synthetic DMARDs according to the presence or absence of human leukocyte antigen(HLA) and shared epitope (SE).
Comparison of autoantibody titers at 3 and 12 months after the treatment between treatments with targeted synthetic/biological DMARDs and conventional synthetic DMARDs according to the presence or absence of HLA and SE.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have already participated in previous studies associated with rheumatoid arthritis at our institution and who have obtained consent for this study.
Key exclusion criteria
Not applicable
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawakami |
Organization
Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Medical Sciences
Division name
Department of Immunology and Rheumatology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7260
atsushik@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yushiro |
| Middle name | |
| Last name | Endo |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
095-819-7260
Homepage URL
yushiro19861105@hotmail.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
Tel
095-819-7726
toshimasashimizu2000@yahoo.co.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
| 2020 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2020 | Year | 04 | Month | 30 | Day |
Last modified on
| 2020 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045952
| Research Plan | |
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| 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 |
