UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014791 |
|---|---|
| Receipt number | R000017194 |
| Scientific Title | Prospective longitudinal cohort study among the Japanese patients with rapid radiographic progression due to rheumatoid arthritis. |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2023/02/17 16:07:02 |
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Basic information
Public title
Prospective longitudinal cohort study among the Japanese patients with rapid radiographic progression due to rheumatoid arthritis.
Acronym
Prospective cohort study of radiographic progression in patients with rheumatoid arthritis.
Scientific Title
Prospective longitudinal cohort study among the Japanese patients with rapid radiographic progression due to rheumatoid arthritis.
Scientific Title:Acronym
Prospective cohort study of radiographic progression in patients with rheumatoid arthritis.
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To build a practical therapeutic strategies for prevention of rheumatoid arthritis by image evaluation by X-ray imaging of arthritis patients.
Basic objectives2
Others
Basic objectives -Others
Construction of a therapeutic strategy
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency and the progression of joint involvement.
Key secondary outcomes
a. Correlation between therapeutic effect and the progression of joint involvement
b. Stratified analysis in the patient background.
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
1. Patients of outpatient.
2. 20 years of age or older, the age of consent at the time of acquisition of male and female patients.
3. During treatment, or there is a history of treatment using DMARDs, but patients who have not been confirmed sufficiently therapeutic effect of the current situation
4. Patients who signed the consent form.
Key exclusion criteria
1. Patients with the possibility of pregnancy or during pregnancy.
2. Currently, persons participating in the clinical trials of the same species and effect.(Phase1-3)
3. Person as an object of study, the attending physician is determined to be undesirable.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Kawakami |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology Nagasaki University Graduate School of Biomedical Sciences
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7262
atsushik@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Kawakami |
Organization
Nagasaki University Hospital
Division name
Department of Immunology and Rheumatology Nagasaki University Graduate School of Biomedical Sciences
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7262
Homepage URL
atsushik@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Immunology and Rheumatology Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4998707/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4998707/
Number of participants that the trial has enrolled
113
Results
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4998707/
Results date posted
| 2023 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4998707/
Participant flow
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4998707/
Adverse events
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4998707/
Outcome measures
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4998707/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Apple Survey
Management information
Registered date
| 2014 | Year | 08 | Month | 07 | Day |
Last modified on
| 2023 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017194
| 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 |
