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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-C000000452 |
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Date of registration:
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01/08/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanercept
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Scientific title:
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Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanercept - RIVERAME |
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Date of first enrolment:
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2006/08/01 |
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Target sample size:
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50 |
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Recruitment status: |
Pending |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000550 |
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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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Phase IV
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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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Shunsei Hirohata |
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Address:
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Japan |
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Telephone:
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Email:
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shun-tei@umin.ac.jp |
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Affiliation:
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Teikyo University School of Medicine Department of Internal Medicine |
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Name:
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Shunsei Hirohata |
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Address:
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2-11-1 Kaga, Itabashiku, Tokyo
Japan |
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Telephone:
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03-3964-1211 |
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Email:
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Affiliation:
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Teikyo University School of Medicine Department of Internal Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: patients who are contra indicated for methotrexate or etanercept
Age minimum:
Not applicable
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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methotrexate 8mg/week
methotrexate 8mg/week and etanercept(25mg x1-2/week) for 3 months
methotrexate 8mg/week and etanercept(25mgx1-2/week) for 6 months
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Primary Outcome(s)
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Inhibitiion of joint destruction as shown by Sharp score, Knee joint X-ray, and serum MMP3 levels, and remission rates evaluated by DAS28
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Source(s) of Monetary Support
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Takeda Pharmaceutical Co.
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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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01/08/2013 |
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URL:
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