UMIN-CTR Clinical Trial

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
Last 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
Email	mori.phv@tmd.ac.jp

Public contact
1st 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
Email	hirano.rheu@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016349