UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004476 |
|---|---|
| Receipt number | R000005347 |
| Scientific Title | Observational study for assessing disease activity with quantitative joint power Doppler ultrasonography in patient with rheumatoid arthritis |
| Date of disclosure of the study information | 2010/10/29 |
| Last modified on | 2012/11/29 09:47:28 |
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Basic information
Public title
Observational study for assessing disease activity with quantitative joint power Doppler ultrasonography in patient with rheumatoid arthritis
Acronym
Assessment of disease activity with quantitative joint power Doppler ultrasonography in patient with rheumatoid arthritis
Scientific Title
Observational study for assessing disease activity with quantitative joint power Doppler ultrasonography in patient with rheumatoid arthritis
Scientific Title:Acronym
Assessment of disease activity with quantitative joint power Doppler ultrasonography in patient with rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate response of synovial vascularity to biological agents, determined by power Doppler ultrasonography, and progression of structural joint damage in rheumatoid arthritis
Basic objectives2
Others
Basic objectives -Others
Examine a relation between synovial vascularity and radiographic joint damage
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical and laboratory assessments are examined through study. Radiography of hands and feet are performed at baseline, 20th and the 50th week. Power Doppler ultrasonography is performed at baseline, 8th, 20th and 40th week.
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
Patient who are satisfied the criteria below:
1) Patients who are satisfied American College of Rheumatology 1987 RA diagnostic criteria
2) Patients diagnosed as active state of RA according to DAS28-ESR (>3.2)
3) Patients who are started to be treated with biologics
4) Patients are informed of this protocol and consented to participated
Key exclusion criteria
Patients who fulfill one of the following criteria must be excluded:
1) Patients who have apparent infection
2) Female patients who are during pregnancy or lactation
3) Patients who are judged to be inappropriate by investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhide Tanimura |
Organization
Hokkaido Medical Center for Rheumatic Diseases
Division name
Center for Rheumatic Diseases
Zip code
Address
1-45, 3-chome, Kotoni-1jo, Nishi-ku, Sapporo, Hokkaido
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Fukae |
Organization
Hokkaido Medical Center for Rheumatic Diseases
Division name
Center for Rheumatic Diseases
Zip code
Address
1-45, 3-chome, Kotoni-1jo, Nishi-ku, Sapporo, Hokkaido
TEL
011-611-1371
Homepage URL
jun.fukae@ryumachi-jp.com
Sponsor or person
Institute
Hokkaido Medical Center for Rheumatic Diseases
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Result: Clinical composite scores for rheumatoid activity were significantly decreased from baseline to 8th week, being sustained at a low level by biologic agents during the observational period. MCP and PIP joints with positive synovial vascularity after 8th week showed more subsequent joint damage progression than joints without synovial vascularity throughout the follow-up.
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
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Objective: To investigate the relation between synovial vascularity, assessed by quantitative power Doppler ultrasonography, and progression of structural damage in individual finger joint in patients with RA Design: prospective observational study Sampling: Patients were examined by joint imaging assessments through study
Management information
Registered date
| 2010 | Year | 10 | Month | 29 | Day |
Last modified on
| 2012 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005347
