Study Stopped
AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.
A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis
OSKIRA-Asia-1X
(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia
1 other identifier
interventional
115
6 countries
26
Brief Summary
The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients in Asia with rheumatoid arthritis (RA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started Jul 2012
Shorter than P25 for phase_2 rheumatoid-arthritis
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 2, 2012
CompletedFirst Posted
Study publicly available on registry
July 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
January 9, 2014
CompletedMarch 28, 2014
February 1, 2014
1 year
July 2, 2012
November 21, 2013
February 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event
Entry in extension to study termination (variable duration; maximum 52 weeks)
Secondary Outcomes (4)
Components of ACR Response Criteria Over Time
Every 12 weeks for one year then every 24 weeks until study end
DAS28-CRP Score Over Time
Every 12 weeks for one year then every 24 weeks until study end
HAQ-DI Score Over Time
Every 12 weeks for one year then every 24 weeks until study end
SF-36 Score Over Time
Every 12 weeks for one year then yearly until study end
Study Arms (1)
Dosing regimen
EXPERIMENTALOpen label Oral treatment 100mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study-specific procedures.
- Patients who have successfully completed study D4300C00008 and whose disease is adequately controlled, in the opinion of the Investigator.
You may not qualify if:
- Premature withdrawal from study D4300C00008 or in the opinion of the Investigator the patient's disease is not adequately controlled on current treatment.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (26)
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
Related Publications (1)
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.
PMID: 33254235DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Insufficient efficacy data was available for analysis due to sparse data collection and the early termination of the study.
Results Point of Contact
- Title
- Dave Goldstraw
- Organization
- AstraZeneca Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Neil - MacKillop, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2012
First Posted
July 13, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
March 28, 2014
Results First Posted
January 9, 2014
Record last verified: 2014-02