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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003876
Receipt No. R000004667
Scientific Title Total Management of Risk Factors in Rheumatoid Arthritis Patients to Lower Morbidity and Mortality (TOMORROW study)
Date of disclosure of the study information 2010/08/07
Last modified on 2011/10/25

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Basic information
Public title Total Management of Risk Factors in Rheumatoid Arthritis Patients to Lower Morbidity and Mortality (TOMORROW study)
Acronym TOMORROW study
Scientific Title Total Management of Risk Factors in Rheumatoid Arthritis Patients to Lower Morbidity and Mortality (TOMORROW study)
Scientific Title:Acronym TOMORROW study
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effects of disease activity, disease period and therapies on fat metabolism under the comparison with the healthy subject to determine an association between fat metabolism and inflammation in patients with rheumatoid arthritis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Osteoporotic fracture, fall, cardiovascular event, DAS28
Key secondary outcomes Bone mineral density

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 patients with rheumatoid arthritis who are treated with or without biologics and healthy subjects
Key exclusion criteria The person who cannot come for testing regularly, patients with undifferentiated arthritis
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Koike
Organization Osaka City University Medical School
Division name Rheumatosurgery
Zip code
Address Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL 06-6645-3984
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Koike
Organization Osaka City University Medical School
Division name Rheumatosurgery
Zip code
Address Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL 06-6645-3984
Homepage URL
Email tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Medical School
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka City University Hospital, Center for Drug & Food Clinical Evaluation
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 大阪市立大学大学院医学研究科

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 07 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 01 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2020 Year 03 Month 01 Day
Date of closure to data entry
2020 Year 09 Month 01 Day
Date trial data considered complete
2020 Year 11 Month 01 Day
Date analysis concluded
2021 Year 05 Month 01 Day

Other
Other related information Prospective cohort study, relationship between baseline characteristics and fracture/fall/cardiovascular event

Management information
Registered date
2010 Year 07 Month 06 Day
Last modified on
2011 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004667

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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