UMIN-CTR Clinical Trial

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 Tatsuya Middle name Last name Koike
Organization	Osaka City University Medical School
Division name	Center for Senile Degenerative Disorders (CSDD)
Zip code	545-8585
Address	Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL	06-6645-3984
Email	tatsuya@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Koike
Organization	Osaka City University Medical School
Division name	Center for Senile Degenerative Disorders (CSDD)
Zip code	545-8585
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	Ethical Committee of Osaka City University Graduate School of Medicine
Address	Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
Tel	06-6645-2711
Email	ethics@med.osaka-cu.ac.jp

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	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	413
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	2009 Year 11 Month 26 Day
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date	2020 Year 05 Month 31 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	2020 Year 02 Month 02 Day

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