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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000024945
Receipt No. R000028667
Scientific Title Analysis of time to and factors for clinical remission (especially, drug-free remission) in adult Still's disease and systemic juvenile idiopathic arthritis (multicenter study)
Date of disclosure of the study information 2016/11/23
Last modified on 2019/06/06

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Basic information
Public title Analysis of time to and factors for clinical remission (especially, drug-free remission) in adult Still's disease and systemic juvenile idiopathic arthritis (multicenter study)
Acronym Analysis of time to and factors for clinical remission (especially, drug-free remission) in adult Still's disease and systemic juvenile idiopathic arthritis (multicenter study)
Scientific Title Analysis of time to and factors for clinical remission (especially, drug-free remission) in adult Still's disease and systemic juvenile idiopathic arthritis (multicenter study)
Scientific Title:Acronym Analysis of time to and factors for clinical remission (especially, drug-free remission) in adult Still's disease and systemic juvenile idiopathic arthritis (multicenter study)
Region
Japan

Condition
Condition adult Still's disease and systemic juvenile idiopathic arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify time to and factors for clinical remission (especially, drug-free remission) in adult Still's disease and systemic juvenile idiopathic arthritis.
Basic objectives2 Others
Basic objectives -Others To clarify time to and factors for clinical remission (especially, drug-free remission) in adult Still's disease and systemic juvenile idiopathic arthritis.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Time to clinical remission in adult Still's disease and systemic juvenile idiopathic arthritis.
Key secondary outcomes Time to drug-free remission and factors for clinical remission in adult Still's disease and systemic juvenile idiopathic arthritis.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients of adult Still's disease and systemic idiopathic arthritis
Key exclusion criteria Patients less than 8 g/dl of hemoglobin in the prospective observation study.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Yoshifumi
Middle name
Last name Tada
Organization Saga University
Division name Department of Rheumatology, Faculty of Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga, Japan
TEL 0952-31-6511
Email taday@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Yoshifumi
Middle name
Last name Tada
Organization Saga University
Division name Department of Rheumatology, Faculty of Medicine
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga, Japan
TEL 0952-31-6511
Homepage URL
Email taday@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committe Saga University Hospital
Address 5-1-1 Nabeshima, Saga, Japan
Tel 0952-34-3400
Email kenkyu-shinsei@ml.cc.saga-u.ac.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
2016 Year 11 Month 23 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 Suspended
Date of protocol fixation
2016 Year 10 Month 27 Day
Date of IRB
2016 Year 10 Month 27 Day
Anticipated trial start date
2016 Year 11 Month 24 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients diagnosed before November 23 2016 is enrolled the retrospective study.
Patients diagnosed after November 24 2016 is enrolled the prospective study.

Management information
Registered date
2016 Year 11 Month 22 Day
Last modified on
2019 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028667

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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