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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014791
Receipt No. 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 2016/07/05

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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
Email 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
Email atsushik@nagasaki-u.ac.jp

Sponsor
Institute Department of Immunology and Rheumatology Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

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
Email

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 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 No longer recruiting
Date of protocol fixation
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
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
2016 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017194

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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