Clinical trial NCT01640054: A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis
Official title: (OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: (OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
timeFrame: Entry in extension to study termination (variable duration; maximum 52 weeks)
Secondary outcomes:
measure: Components of ACR Response Criteria Over Time
timeFrame: Every 12 weeks for one year then every 24 weeks until study end
measure: DAS28-CRP Score Over Time
timeFrame: Every 12 weeks for one year then every 24 weeks until study end
measure: HAQ-DI Score Over Time
timeFrame: Every 12 weeks for one year then every 24 weeks until study end
measure: SF-36 Score Over Time
timeFrame: Every 12 weeks for one year then yearly until study end
Other outcomes:
Locations:
city: Hongkong
country: Hong Kong
facility: Research Site
state: Shatin
city: Hong Kong
country: Hong Kong
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Kato-shi
country: Japan
facility: Research Site
state: Hyogo
city: Sendai-shi
country: Japan
facility: Research Site
state: Miyagi
city: Nagasaki-shi
country: Japan
facility: Research Site
state: Nagasaki
city: Omura-shi
country: Japan
facility: Research Site
state: Nagasaki
city: Sasebo-shi
country: Japan
facility: Research Site
state: Nagasaki
city: Okayama-shi
country: Japan
facility: Research Site
state: Okayama
city: Tomigusuku-shi
country: Japan
facility: Research Site
state: Okinawa
city: Hamamatsu-shi
country: Japan
facility: Research Site
state: Shizuoka
city: Itabashi-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Research Site
state: Tokyo
city: Anyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Singapore
country: Thailand
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Neil - MacKillop, MD
role: STUDY_DIRECTOR
References:
citation: 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.