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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004476 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Rheumatoid arthritis | |
Classification by specialty |
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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 | |
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Eligibility | ||||
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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 |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
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Public contact | |||||||
Name of contact person |
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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 | |
Institute | Hokkaido Medical Center for Rheumatic Diseases |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 |
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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. |
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Results Delayed | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005347 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |