UMIN-CTR Clinical Trial

Basic information
Public title	Correlation analysis between synovitis/enthesitis and peripheral blood innate lymphoid cell subpopulations
Acronym	Synovitis/Enthesitis/ILC
Scientific Title	Correlation analysis between synovitis/enthesitis and peripheral blood innate lymphoid cell subpopulations
Scientific Title:Acronym	Synovitis/Enthesitis/ILC
Region	Japan

Condition
Condition	Rheumatoid arthritis (RA) and peripheral spondyloarthritis (SpA)
Classification by specialty	Clinical immunology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the relationship between synovitis/enthesitis and innate lymphoid cell(ILC) subpopulations in RA and peripheral SpA
Basic objectives2	Others
Basic objectives -Others	Pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between ultrasound score for synovitis/enthesitis and ILC subpopulations
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who are referred to Department of Allergy and Clinical Immunology, Chiba University Hospital and fulfill 2010 ACR/EULAR RA Criteria, CASPAR Criteria, or Assessment of Spondyloarthritis International Society (ASAS) Criteria for peripheral SpA 2) 18 years or older 3) Disease dulation of 10 years or shorter
Key exclusion criteria	1) Concomitant autoimmune-diseases other than Sjogren's syndrome 2) Patients with joints which are difficult to be assessed for synovitis/enthesitis due to severe deformity, surgery, trauma, or other reasons 3) Patients with conditions which are considered inappropriate for this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Ikeda
Organization	Chiba University Graduate School of Medicine
Division name	Department of Allergy and Clinical Immunology
Zip code	2608670
Address	1-8-1 Inohoana, Chuo-ku, Chiba, Chiba 260-8670
TEL	043-226-2198
Email	K.Ikeda@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Manami Middle name Last name Kato
Organization	Chiba University Graduate School of Medicine
Division name	Department of Allergy and Clinical Immunology
Zip code	2608670
Address	1-8-1 Inohoana, Chuo-ku, Chiba, Chiba 260-8670
TEL	043-226-2198
Homepage URL
Email	07m1029@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Ministray of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chiba University
Address	1-8-1 Inohoana, Chuo-ku, Chiba, Chiba 260-8670
Tel	043-226-2501
Email	inohana-rinri@chiba-u.jp

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	2018 Year 08 Month 18 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	100
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	2018 Year 08 Month 17 Day
Date of IRB	2018 Year 08 Month 17 Day
Anticipated trial start date	2018 Year 08 Month 17 Day
Last follow-up date	2020 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Ultrasound score for synovitis/enthesitis and ILC subpopulations

Management information
Registered date	2018 Year 08 Month 18 Day
Last modified on	2021 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037945