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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-UMIN000011891 |
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Date of registration:
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01/10/2013 |
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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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Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis.
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Scientific title:
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Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis. - GLORIA study |
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Date of first enrolment:
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2013/10/01 |
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Target sample size:
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50 |
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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=R000013897 |
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Study type:
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Interventional |
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Study design:
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Single arm 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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Mamiko Shimizu |
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Address:
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1-16-2Sugao,Miyamae-ku,Kawasaki-shi,Kanagawa-ken,japan
Japan |
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Telephone:
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042-977-8111 |
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Email:
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mamiko.shimizu@marianna-u.ac.jp |
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Affiliation:
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St.Marianna University School of Medicine Division of Rheumatology, Department of Internal Medicine |
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Name:
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Hidehiro Yamada |
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Address:
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1-16-2Sugao,Miyamae-ku,Kawasaki-shi,Kanagawa-ken,japan
Japan |
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Telephone:
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042-977-8111 |
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Email:
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soramameyamada@marianna-u.ac.jp |
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Affiliation:
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St.Marianna University School of Medicine Division of Rheumatology, Department of Internal Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1.progressive interstitial lung disease 2.HBV and/or HCV carier 3.History of any biologic DMARDs use 4.Seriou infection, active tuberculosis, demyelinating disease, or congestive heart failure
Age minimum:
20years-old
Age maximum:
70years-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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Golimumab
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Primary Outcome(s)
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1.Remission induction rate 2.Health assessment questionare 3. Rate of no radiological progression 4. Bio-free remission maintenance rate and duration 5.Maintenance rate of low disease activity after cessation of golimumab 6.Remission induction rate after re-introduction of golimumab in patients with relapse.
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Source(s) of Monetary Support
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St.Marianna University School of Medicine
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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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Date Posted:
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Date Completed:
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URL:
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