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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-UMIN000002421 |
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Date of registration:
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04/09/2009 |
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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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Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis
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Scientific title:
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Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis - Comparative study of tocilizumab therapy versus conventional therapy for the treatment of rheumatoid arthritis complicating AA amyloidosis |
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Date of first enrolment:
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2008/07/01 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002954 |
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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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Kazuyuki Yoshizaki |
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Address:
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Office for University-Industry Collaboration, Osaka Univ. Bid. Incubation A-407, 2-1, Yamadaoka,
Japan |
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Telephone:
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06-6879-4738 |
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Email:
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kyoshi@chem.eng.osaka-u.ac.jp |
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Affiliation:
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Osaka University Immuno-Medical Science Division of Applied Chemistry, Graduate School of Engineering |
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Name:
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Kazuyuki Yoshizaki |
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Address:
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Office for University-Industry Collaboration, Osaka Univ. Bid. Incubation A-407, 2-1, Yamadaoka, Suita City, Osaka
Japan |
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Telephone:
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06-6879-4738 |
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Email:
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kyoshi@chem.eng.osaka-u.ac.jp |
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Affiliation:
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Osaka University Immuno-Medical Science Division of Applied Chemistry, Graduate School of Engineering |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Pregnancy, lactation or planning pregnancy 2. Complicating severe infection 3. History of hypersensitivity to the treatment drug 4. Patients who are judged to be inappropriate by investigator
Age minimum:
20years-old
Age maximum:
Not applicable
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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tocilizumab
Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab
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Primary Outcome(s)
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Change of the amyloid deposition in the gastric biopsy specimen
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Secondary Outcome(s)
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Change of renal function Serum creatinine, urinary protein, urinary creatinine, estimated creatinine clearance, cystatin C Change of serum SAA Change of diarrhea frequency Change of DAS28-ESR
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date:
Contact:
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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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01/09/2012 |
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URL:
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