UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033797 |
|---|---|
| Receipt number | 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 | 2021/03/25 14:07:23 |
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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 | 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
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
07m1029@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037945
