UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000785 |
|---|---|
| Receipt number | 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 15:41:28 |
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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
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
med-rinri-jimu@adst.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000928
