Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis
NCT ID: NCT00690573
Last Updated: 2012-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
25 participants
INTERVENTIONAL
2008-05-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adalimumab
Adalimumab
Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
Interventions
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Adalimumab
Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease activity inadequately controlled by nonsteroidal anti-inflammatory drugs (NSAIDs) or methotrexate (MTX)
* Presence at screening of at least 5 swollen joints (not due to deformity) and at least 3 joints with limitation of passive motion with pain by passive motion or/and pain by pressure (tenderness)
* Stable dosage of MTX for at least 12 weeks prior to the screening visit or discontinuation of MTX at least 14 days prior to baseline visit (Day 1)
* Discontinuation of disease-modifying antirheumatic drugs (DMARDs) other than MTX at least 28 days before screening visit
Exclusion Criteria
* Functional class IV JRA by ACR criteria
* Clinically significant cardiac disease or laboratory abnormalities
* Any subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
4 Years
17 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Shigeki Hashimoto, PhD
Role: STUDY_DIRECTOR
Abbott Japan Co.,Ltd
Locations
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Site Reference ID/Investigator# 47248
Aichi, , Japan
Site Reference ID/Investigator# 47253
Fukuoka, , Japan
Site Reference ID/Investigator# 47251
Hyōgo, , Japan
Site Reference ID/Investigator# 47254
Kagoshima, , Japan
Site Reference ID/Investigator# 47250
Kobe, , Japan
Site Reference ID/Investigator# 47255
Okinawa, , Japan
Site Reference ID/Investigator# 7153
Sendai, , Japan
Site Reference ID/Investigator# 47249
Takatsuki, , Japan
Site Reference ID/Investigator# 47243
Tokyo, , Japan
Site Reference ID/Investigator# 47244
Tokyo, , Japan
Site Reference ID/Investigator# 47245
Tokyo, , Japan
Site Reference ID/Investigator# 47246
Yokohama, , Japan
Countries
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References
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Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25.
Imagawa T, Takei S, Umebayashi H, Yamaguchi K, Itoh Y, Kawai T, Iwata N, Murata T, Okafuji I, Miyoshi M, Onoe Y, Kawano Y, Kinjo N, Mori M, Mozaffarian N, Kupper H, Santra S, Patel G, Kawai S, Yokota S. Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan. Clin Rheumatol. 2012 Dec;31(12):1713-21. doi: 10.1007/s10067-012-2082-5. Epub 2012 Oct 2.
Other Identifiers
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M10-240
Identifier Type: -
Identifier Source: org_study_id