UMIN-CTR Clinical Trial

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