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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000028376 |
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Date of registration:
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01/08/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis
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Scientific title:
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Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis - Study of ultrasound detected residual synovitis in rheumatoid arthritis |
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Date of first enrolment:
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2017/07/26 |
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Target sample size:
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30 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032475 |
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Study type:
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Interventional |
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Study design:
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Parallel Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Jun
Fukae |
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Address:
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1-45, 3-chome, Kotoni-1jo, Nishi-ku, Sapporo, Hokkaido
063-0811
Japan |
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Telephone:
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011-611-1371 |
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Email:
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jun.fukae@ryumachi-jp.com |
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Affiliation:
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Hokkaido Medical Center for Rheumatic Diseases Center for Rheumatic Diseases |
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Name:
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Jun
Fukae |
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Address:
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1-45, 3-chome, Kotoni-1jo, Nishi-ku, Sapporo, Hokkaido
Japan |
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Telephone:
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011-611-1371 |
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Email:
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jun.fukae@ryumachi-jp.com |
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Affiliation:
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Hokkaido Medical Center for Rheumatic Diseases Center for Rheumatic Diseases |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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rheumatoid arthritis
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Intervention(s)
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Combination of anti-rheumatic therapy and denosumab
Anti-rheumatic therapy alone
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Primary Outcome(s)
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Joint ultrasonography and clinical assessments are examined at the baseline, 8th, 16th, 24 and 52nd week. Magnetic resonance imaging of finger joints and X-ray are performed at the baseline, 24th and 52nd week.
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Source(s) of Monetary Support
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Hokkaido Medical Center for Rheumatic Diseases
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Ethics review
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Status: YES
Approval date: 01/07/2017
Contact:
jun.fukae@ryumachi-jp.com
Ethics committees of Hokkaido Medical Center for Rheumatic Diseases
011-611-1371
jun.fukae@ryumachi-jp.com
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2020 |
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URL:
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