UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024945 |
|---|---|
| Receipt number | 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 11:30:15 |
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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
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
taday@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028667
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
