A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis
NCT ID: NCT01640054
Last Updated: 2014-03-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
115 participants
INTERVENTIONAL
2012-07-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dosing regimen
Open label Oral treatment 100mg once daily
Fostamatinib
Fostamatinib 100mg once daily
Interventions
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Fostamatinib
Fostamatinib 100mg once daily
Eligibility Criteria
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Inclusion Criteria
* Patients who have successfully completed study D4300C00008 and whose disease is adequately controlled, in the opinion of the Investigator.
Exclusion Criteria
* Development of any of the withdrawal criteria from study D4300C00008
* Females who are pregnant or breast feeding
* Any other clinically significant disease or disorder, which in the opinion of the Investigator might put the patient at risk due to participation in the study, or may influence the results of the study
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Neil - MacKillop, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Hong Kong, Shatin, Hong Kong
Research Site
Hong Kong, , Hong Kong
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Kitakyushu-shi, Fukuoka, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Kato-shi, Hyōgo, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Nagasaki, Nagasaki, Japan
Research Site
Omura-shi, Nagasaki, Japan
Research Site
Sasebo-shi, Nagasaki, Japan
Research Site
Okayama, Okayama-ken, Japan
Research Site
Tomigusuku-shi, Okinawa, Japan
Research Site
Hamamatsu, Shizuoka, Japan
Research Site
Itabashi-ku, Tokyo, Japan
Research Site
Shinjuku-ku, Tokyo, Japan
Research Site
Anyang-si, Gyeonggi-do, South Korea
Research Site
Gwangju, , South Korea
Research Site
Incheon, , South Korea
Research Site
Seoul, , South Korea
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Singapore, Singapore, Thailand
Research Site
Bangkok, , Thailand
Research Site
Hanoi, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Countries
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References
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Tanaka Y, Millson D, Iwata S, Nakayamada S. Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study. Rheumatology (Oxford). 2021 Jun 18;60(6):2884-2895. doi: 10.1093/rheumatology/keaa732.
Other Identifiers
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D4300C00029
Identifier Type: -
Identifier Source: org_study_id
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