UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014037 |
|---|---|
| Receipt number | R000016349 |
| Scientific Title | Findings of Rheumascan in patients with rheumatoid arthritis and other arthritis-related diseases |
| Date of disclosure of the study information | 2014/05/28 |
| Last modified on | 2019/03/30 20:51:10 |
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Basic information
Public title
Findings of Rheumascan in patients with rheumatoid arthritis and other arthritis-related diseases
Acronym
Findings of Rheumascan in patients with rheumatoid arthritis and other arthritis-related diseases
Scientific Title
Findings of Rheumascan in patients with rheumatoid arthritis and other arthritis-related diseases
Scientific Title:Acronym
Findings of Rheumascan in patients with rheumatoid arthritis and other arthritis-related diseases
Region
| Japan |
Condition
Condition
rheumatoid arthritis and other diseases which can cause wrist or finger joint symptoms
Classification by specialty
| Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore findings specific to rheumatoid arthritis and other diseases by intra- and inter-disease (including healthy subjects) comparison of Rheumascan findings and to investigate usefulness of Rheumascan in differential diagnosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. signal intensity (semi-quantitative evaluation of the signal area in each joint region) and distribution of each joint
2. signal intensity and distribution outside the joint regions
Key secondary outcomes
1. Intra- and inter-disease comparison of Rheumascan findings at the enrollement and 3-6 months later.
2. relationship between rheumascan finidings and the diagnosis 3-6 months later in cases of undetermined diagnosis at the enrollment
3. relationship between Rheumascan findings and radiographic and ultrasonographic findings
4. safety of ICG administration in all cases
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
1. rheumascan examination at the enrollment
2. rheumascan examination 3-6 months after the enrollment (if a patient can be followed up 3-6 months later and written consent is obtained)
3. radiography and ultrasonography of hands at the enrollement and 3-6 months later if clinically indicated
4. clinical examination of both hands (skin and joint findings)
Interventions/Control_2
for healthy volunteers, only rheumascan examination and clinical examination are required
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 who can give written consent and fulfill either of the followings
1. 2010 ACR/EULAR RA classification criteria
2. connecitve tissue diseases other than rheumatoid arthritis
3. osteoarthritis, crystal-induced arthritis, complex regional pain syndrome
4. a patient suspected of having any of the above-mentioned diseases
5. healthy volunteers
Key exclusion criteria
1. contraindication of ICG (history of hypersensitive reaction to ICG or iodines)
2. pregnant or breastfeeding
3. a patient considered to be inappropriate for the study by the attending physician
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Mori |
Organization
Tokyo Medical and Dental University
Division name
Department of Lifetime Clinical Immunology
Zip code
Address
5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
TEL
03-5903-4677
mori.phv@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumio Hirano |
Organization
Tokyo Medical and Dental University
Division name
Department of Lifetime Clinical Immunology
Zip code
Address
5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
TEL
03-5803-4677
Homepage URL
hirano.rheu@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Department of Lifetime Clinical Immunology
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 05 | Month | 28 | 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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 22 | Day |
Last modified on
| 2019 | 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=R000016349
