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Main
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Note: This record shows only the 20 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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27 May 2013 |
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Main ID: |
JPRN-JapicCTI-080587 |
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Date of registration:
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25/10/2011 |
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Primary sponsor: |
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Public title:
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Safety, Efficacy and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis
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Scientific title:
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A Multicenter, Open-label Study of Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis |
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Date of first enrolment:
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01/06/2008 |
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Target sample size:
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25 |
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Recruitment status: |
Complete |
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URL:
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http://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-080587 |
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Study type:
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INTERVENTIONAL |
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Study design:
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A Multi-Center, Open-label Study
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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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Email:
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Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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E-mail: ABTJ-CTR@abbott.com |
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Affiliation:
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Abbott Japan Co., Ltd. Abbott Japan Clinical Trials Registration Desk |
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Key inclusion & exclusion criteria
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Inclusion criteria: Subjects who have a diagnosis of Polyarticular JRA by the ACR criteria.
Exclusion criteria: Subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Age minimum:
4
Age maximum:
17
Gender:
BOTH
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Health Condition(s) or Problem(s) studied
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Juvenile Rheumatoid Arthritis (JRA)
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Primary Outcome(s)
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ACR Pediatric 30 response rate
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Secondary Outcome(s)
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ACR Pediatric 50 response rate, ACR Pediatric 70 response rate, adverse event including vital signs and clinical laboratory test, serum adalimumab and anti-adallimumab antibody level
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Secondary ID(s)
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NCT00690573
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Source(s) of Monetary Support
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