UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021245 |
|---|---|
| Receipt number | R000024469 |
| Scientific Title | A prospective cohort study of Spondyloarthritis in Japan. |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2016/02/26 18:38:49 |
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Basic information
Public title
A prospective cohort study of Spondyloarthritis in Japan.
Acronym
A prospective cohort study of Spondyloarhritis in Japan.
Scientific Title
A prospective cohort study of Spondyloarthritis in Japan.
Scientific Title:Acronym
A prospective cohort study of Spondyloarhritis in Japan.
Region
| Japan |
Condition
Condition
spondyloarthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the proportion of spondyloarthritis patients in Japan.
Basic objectives2
Others
Basic objectives -Others
Prospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
proportion and status of spondyloarthritis in each patient.
Key secondary outcomes
1. Patient profile
2. Outcome of SpA patient
3. Activity of SpA
4. Seviarity of SpA
5. Treatment of SpA
6. Complication
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 Aged 18 years or older
2 Doctor definitive diagnosis of SpA using ASAS
criteria for axial or peripheral SpA.
3 Possible to answer the quetionnaire.
4 Providing the consent
Key exclusion criteria
SpA patients not to provide the consent.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Sano |
Organization
The Japan Spondyloarthritis Society
Hyogo College of Medicine
Division name
Div.of Rheumatology, Dept. of Internal medicine
Zip code
Address
1-1Mukogawa-cho,Nishinomiya-shi
TEL
0798-45-6591
hsano@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Matsui |
Organization
Hyogo College of Medicine
Division name
Div of Rheumatology, Dept of Internal Medicine
Zip code
Address
1-1Mukogawa-cho, Nishinomiya-shi
TEL
0798-45-6591
Homepage URL
k-matsui@hyo-med.ac.jp
Sponsor or person
Institute
The Japan Spondyloarthritis Society
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan Spondyloarthritis Society
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
Address
Tel
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
北海道大学、山形大学、順天堂大学順天堂越谷病院、聖路加国際病院、東邦大学大橋病院、慶應義塾大学
桑名市総合医療センター、松野リウマチ整形外科、行岡病院、大阪大学、倉敷成人病センター、長崎大学
近藤リウマチ整形外科クリニック
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2016 | Year | 02 | Month | 29 | Day |
Last modified on
| 2016 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024469
