A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— OSKIRA-Asia-1X  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01640054
• Other study ID #: D4300C00029
• Status: Terminated
• Phase: Phase 2
• First received: July 2, 2012
• Last updated: February 27, 2014
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencySouth Korea: Korea Food and Drug Administration (KFDA)Hong Kong: Department of HealthTaiwan: Department of HealthVietnam: Ministry of HealthThailand: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 115
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Fostamatinib
Fostamatinib 100mg once daily

Locations

Country	Name	City	State
Hong Kong	Research Site	Hong Kong
Hong Kong	Research Site	Hongkong	Shatin
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Hamamatsu-shi	Shizuoka
Japan	Research Site	Itabashi-ku	Tokyo
Japan	Research Site	Kato-shi	Hyogo
Japan	Research Site	Kitakyushu-shi	Fukuoka
Japan	Research Site	Nagasaki-shi	Nagasaki
Japan	Research Site	Okayama-shi	Okayama
Japan	Research Site	Omura-shi	Nagasaki
Japan	Research Site	Sapporo-shi	Hokkaido
Japan	Research Site	Sasebo-shi	Nagasaki
Japan	Research Site	Sendai-shi	Miyagi
Japan	Research Site	Shinjuku-ku	Tokyo
Japan	Research Site	Tomigusuku-shi	Okinawa
Korea, Republic of	Research Site	Anyang-si	Gyeonggi-do
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Seoul
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taipei
Thailand	Research Site	Bangkok
Thailand	Research Site	Singapore
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Hong Kong,  Japan,  Korea, Republic of,  Taiwan,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Components of ACR Response Criteria Over Time	ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily	Every 12 weeks for one year then every 24 weeks until study end	No
Secondary	DAS28-CRP Score Over Time	CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily	Every 12 weeks for one year then every 24 weeks until study end	No
Secondary	HAQ-DI Score Over Time	HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily	Every 12 weeks for one year then every 24 weeks until study end	No
Secondary	SF-36 Score Over Time	n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey	Every 12 weeks for one year then yearly until study end	No