UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028260 |
|---|---|
| Receipt number | R000032338 |
| Scientific Title | The remaining of power Doppler signal predicts effectiveness of biological DMARDs on radiographic yearly progression |
| Date of disclosure of the study information | 2017/07/17 |
| Last modified on | 2017/07/17 01:52:03 |
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Basic information
Public title
The remaining of power Doppler signal predicts effectiveness of biological DMARDs on radiographic yearly progression
Acronym
SPEEDY study
Scientific Title
The remaining of power Doppler signal predicts effectiveness of biological DMARDs on radiographic yearly progression
Scientific Title:Acronym
SPEEDY study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we would like to clarify the predictive factor for the effectiveness of biological DMARDs in patients with rheumatoid arthritis by using ultrasonography.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is to clarify the relationship between the reaction of power Doppler signal at one month and joint destruction after one year in patients with rheumatoid arthritis.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
RA patients fulling the American Rheumatology Association criteria 1987 and ACR/EULAR classification cliteria 2010.
The patients started biological DMARDs or tofacitinib.
Key exclusion criteria
Patients with other diseases that can affect the infllamation state.
Patients who was deemed inappropriate by test doctor to participate in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Okano |
Organization
Osaka City University Medical School
Division name
Orthopedic Surgery
Zip code
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
0666453851
ma1sa3ru@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Okano |
Organization
Osaka City University Medical School
Division name
Orthopedic Surgery
Zip code
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
0666453851
Homepage URL
ma1sa3ru@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Medical School
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary outcome is to clarify the relationship between the reaction of power Doppler signal at one month and joint destruction after one year in patients with rheumatoid arthritis.
Management information
Registered date
| 2017 | Year | 07 | Month | 17 | Day |
Last modified on
| 2017 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032338
