UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018822 |
|---|---|
| Receipt number | R000021772 |
| Scientific Title | Joint imaging for Rheumatoid Arthritis based on differential phase contrast by X-ray Talbot-Lau interferometry |
| Date of disclosure of the study information | 2015/08/27 |
| Last modified on | 2017/03/30 09:20:57 |
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Basic information
Public title
Joint imaging for Rheumatoid Arthritis based on differential
phase contrast by X-ray Talbot-Lau interferometry
Acronym
Detection of cartilage damage in RA with X-ray Talbot-Lau interferometry
Scientific Title
Joint imaging for Rheumatoid Arthritis based on differential
phase contrast by X-ray Talbot-Lau interferometry
Scientific Title:Acronym
Detection of cartilage damage in RA with X-ray Talbot-Lau interferometry
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Medicine in general | Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect a cartilage damage in rheumatoid arthritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Change of maximam cartilao thickness in joint of finger with RA after treatment
Key secondary outcomes
Comparison between obtained image by MRI and X-ray Talbot-Lau interferometry etc
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) age of 20y/o to 75 y/o
2) RA diagnosed with ACR criteria
3) With active disease and need change in therapy
4) Written informed consent to participate.
Key exclusion criteria
1) The pregnant and lactating female , female who has possibility of the pregnancy.
2) Patients with Steinbrocker classIV
3) Patients who were judged inappropriate to entry this study by physician
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Ishii |
Organization
Tohoku university hospital
Division name
Hematology and Rheumatology
Zip code
Address
1-1, Seiryocho, Aobaku, Sendai, Miyagi
TEL
022-717-7165
tishii@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Ishii |
Organization
Tohoku university hospital
Division name
Hematology and Rheumatology
Zip code
Address
1-1, Seiryocho, Aobaku, Sendai, Miyagi
TEL
022-717-7165
Homepage URL
tishii@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
Konica Minolta
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Konica Minolta
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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 27 | 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
Date of protocol fixation
| 2015 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
X-ray of joint will take at 0 week and 24 week after DMARD treatment start
Management information
Registered date
| 2015 | Year | 08 | Month | 27 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021772
