UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017026 |
|---|---|
| Receipt number | R000019745 |
| Scientific Title | Effects of therapeutic medication for rheumatoid arthritis on cachexia in patients with rheumatoid arthritis. |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2016/03/03 22:17:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of therapeutic medication for rheumatoid arthritis on cachexia in patients with rheumatoid arthritis.
Acronym
Effects of rheumatoid arthritis on cachexia
Scientific Title
Effects of therapeutic medication for rheumatoid arthritis on cachexia in patients with rheumatoid arthritis.
Scientific Title:Acronym
Effects of rheumatoid arthritis on cachexia
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the effects of therapeutic medication for rheumatoid arthritis on cachexia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
biological data: MMP-1, CRP,
nutritional status:body composition, energy expenditure
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with rheumatoid arthritis
Key exclusion criteria
pregnant patients
patients with pacemaker
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sakaue |
Organization
University of Tokushima
Division name
Biomedical science
Zip code
Address
3-18-15 Kuramoto, Tokushima
TEL
0886337091
hsakaue@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rie Tsutsumi |
Organization
Tokushima University
Division name
Biomedical science
Zip code
Address
3-18-15 Kuramoto, Tokushima
TEL
0886339214
Homepage URL
rtsutsumi@tokushima-ua.c.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Sciences, Tokyo JSPS Kakenhi
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kinoshita hospital
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
| 2015 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nutritional assessment
Biological data
Management information
Registered date
| 2015 | Year | 04 | Month | 02 | Day |
Last modified on
| 2016 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019745
