UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003876 |
|---|---|
| Receipt number | 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 | 2020/02/02 12:34:21 |
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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 | 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
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
tatsuya@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004667
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
