UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002127 |
|---|---|
| Receipt number | R000002598 |
| Scientific Title | Clinical study to investigate the optimal management of rheumatoid arthritis from the mortality perspective |
| Date of disclosure of the study information | 2009/06/26 |
| Last modified on | 2010/12/27 16:29:41 |
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Basic information
Public title
Clinical study to investigate the optimal management of rheumatoid arthritis from the mortality perspective
Acronym
Study for the optimal management of rheumatoid arthritis from the mortality perspective
Scientific Title
Clinical study to investigate the optimal management of rheumatoid arthritis from the mortality perspective
Scientific Title:Acronym
Study for the optimal management of rheumatoid arthritis from the mortality perspective
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the optimal treatment strategy for rheumatoid arthritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
mortality
Key secondary outcomes
comorbidity
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
Patients with rheumatoid arthritis treated with biologics
Key exclusion criteria
Patients who had been treated with biologics for other than rheumatoid arthritis
Patients regarded as inappropriate to join the study based on medical reason or other rational reasons
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Yamanaka |
Organization
Tokyo Women's Medical University
Division name
Institute of Rheumatology
Zip code
Address
10-22 Kawada-cho, Shinjuku-ku, Tokyo, 162-0054, Japan
TEL
03-5269-1711
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Nakajima |
Organization
Tokyo Women's Medical University
Division name
Institute of Rheumatology
Zip code
Address
10-22 Kawada-cho, Shinjuku-ku, Tokyo, 162-0054, Japan
TEL
02-5269-1711
Homepage URL
ayakonkj@ior.twmu.ac.jp
Sponsor or person
Institute
Institute of Rheumatology, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2009 | Year | 06 | Month | 26 | 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
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
| 2009 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Incidence of comorbidity and serious adverse events will be analyzed
Management information
Registered date
| 2009 | Year | 06 | Month | 26 | Day |
Last modified on
| 2010 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002598
