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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033797
Receipt No. R000037945
Scientific Title Correlation analysis between synovitis/enthesitis and peripheral blood innate lymphoid cell subpopulations
Date of disclosure of the study information 2018/08/18
Last modified on 2020/02/10

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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
Middle name
Last name Kei Ikeda
Organization Chiba University Graduate School of Medicine
Division name Department of Allergy and Clinical Immunology
Zip code
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
Middle name
Last name Manami Kato
Organization Chiba University Graduate School of Medicine
Division name Department of Allergy and Clinical Immunology
Zip code
Address 1-8-1 Inohoana, Chuo-ku, Chiba, Chiba 260-8670
TEL 043-226-2198
Homepage URL
Email z7m1029@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
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
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
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 No longer recruiting
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
2020 Year 02 Month 10 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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