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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000785
Receipt No. R000000928
Scientific Title Survival analysis of prospective and retrospective systematic cohort in newly diagnosed rheumatoid arthritis patients
Date of disclosure of the study information 2007/08/01
Last modified on 2021/09/03

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Basic information
Public title Survival analysis of prospective and retrospective systematic cohort in newly diagnosed rheumatoid arthritis patients
Acronym Systematic cohort Analysis in Keio University - Rheumatoid Arthritis (SAKURA study)
Scientific Title Survival analysis of prospective and retrospective systematic cohort in newly diagnosed rheumatoid arthritis patients
Scientific Title:Acronym Systematic cohort Analysis in Keio University - Rheumatoid Arthritis (SAKURA study)
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Rheumatoid arthritis is a chronic inflammatory disease affecting joints, but often causes multiple organ damages, such as interstitial lung disease and secondary amyloidosis. It has been reported that patients with rheumatoid arthritis have decreased survival rates compared with general population. In addition increased events of ischemic heart disease are also reported in patients with rheumatoid arthritis. Recent progress in diagnostic methods and therapeutic strategies has changed clinical surroundings around rheumatoid arthritis remarkably. However, there are few reports describing prognosis and clinical course in patients with rheumatoid arthritis. Aim of this cohort is to clarify the long-term outcomes and to identify factors that influence the prognosis.
Basic objectives2 Others
Basic objectives -Others survival analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Kaplan-Meier survival curve
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Untreated patients who are diagnosed to have rheumatoid arthritis according to the criteria proposed by American College of Rheumatology in 1987 or the criteria proposed by Japan College of Rheumatology in 1994.
Key exclusion criteria Patients already treated with glucocorticosteroids, disease modifying antirheumatic drugs, or immunosuppressive therapy.
Target sample size 900

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Takeuchi
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Division of Rheumatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL 03-3353-1211
Email tsutake@z5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Kaneko
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Division of Rheumatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email med-rinri-jimu@adst.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization RA cohort study group
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Keio University
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
2007 Year 08 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 Completed
Date of protocol fixation
2007 Year 07 Month 11 Day
Date of IRB
2007 Year 08 Month 27 Day
Anticipated trial start date
2007 Year 09 Month 01 Day
Last follow-up date
2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Objective:To clarify the long-term outcomes and to identify factors that influence the prognosis in patients with rheumatoid arthritis
Design:prospective and retrospective cohort study
Sampling:consecutive patients with newly diagnosed rheumatoid arthritis in Keio Universtiy Hospital

Management information
Registered date
2007 Year 07 Month 31 Day
Last modified on
2021 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000928

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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