OSKIRA-Asia-1X: A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis

• Sponsor: AstraZeneca (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01640054
• Collaborator: (none)
• Enrollment: 115
• Locations: 26
• Arm: 1
• Duration (Months): 12
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Fostamatinib	Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: (OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dosing regimen Open label Oral treatment 100mg once daily	Drug: Fostamatinib; Fostamatinib 100mg once daily

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Who Had at Least 1 Adverse Event in Any Category [Entry in extension to study termination (variable duration; maximum 52 weeks)]

   AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event

Secondary Outcome Measures

1. Components of ACR Response Criteria Over Time [Every 12 weeks for one year then every 24 weeks until study end]

   ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily

2. DAS28-CRP Score Over Time [Every 12 weeks for one year then every 24 weeks until study end]

   CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily

3. HAQ-DI Score Over Time [Every 12 weeks for one year then every 24 weeks until study end]

   HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily

4. SF-36 Score Over Time [Every 12 weeks for one year then yearly until study end]

   n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Hongkong	Shatin	Hong Kong
2	Research Site	Hong Kong		Hong Kong
3	Research Site	Fukuoka-shi	Fukuoka	Japan
4	Research Site	Kitakyushu-shi	Fukuoka	Japan
5	Research Site	Sapporo-shi	Hokkaido	Japan
6	Research Site	Kato-shi	Hyogo	Japan
7	Research Site	Sendai-shi	Miyagi	Japan
8	Research Site	Nagasaki-shi	Nagasaki	Japan
9	Research Site	Omura-shi	Nagasaki	Japan
10	Research Site	Sasebo-shi	Nagasaki	Japan
11	Research Site	Okayama-shi	Okayama	Japan
12	Research Site	Tomigusuku-shi	Okinawa	Japan
13	Research Site	Hamamatsu-shi	Shizuoka	Japan
14	Research Site	Itabashi-ku	Tokyo	Japan
15	Research Site	Shinjuku-ku	Tokyo	Japan
16	Research Site	Anyang-si	Gyeonggi-do	Korea, Republic of
17	Research Site	Gwangju		Korea, Republic of
18	Research Site	Incheon		Korea, Republic of
19	Research Site	Seoul		Korea, Republic of
20	Research Site	Kaohsiung		Taiwan
21	Research Site	Taichung		Taiwan
22	Research Site	Taipei		Taiwan
23	Research Site	Bangkok		Thailand
24	Research Site	Singapore		Thailand
25	Research Site	Hanoi		Vietnam
26	Research Site	Ho Chi Minh		Vietnam

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Neil - MacKillop, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01640054
• Other Study ID Numbers: D4300C00029
• First Posted: Jul 13, 2012
• Last Update Posted: Mar 28, 2014
• Last Verified: Feb 1, 2014

• Keywords provided by AstraZeneca: Rheumatoid Arthritis
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

Participant Flow

Recruitment Details	A total of 115 patients were enrolled; all received at least 1 dose of investigational product. This was an open-label study.
Pre-assignment Detail	No patients failed screening.

Arm/Group Title	FOSTA 100 MG QD PO
Arm/Group Description	Fostamatinib 100 mg qd
Period Title: Overall Study
STARTED	115
Did Not Receive Treatment	0
COMPLETED	109
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	FOSTA 100 MG QD PO
Arm/Group Description	Fostamatinib 100 mg qd
Overall Participants	115
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53 (11.3)
Sex: Female, Male (Count of Participants)
Female	101 87.8%
Male	14 12.2%
Race/Ethnicity, Customized (Number) [Number]
White	0 0%
Black or African American	0 0%
Asian	115 100%
American Indian or Alaska Native	0 0%
Indian or Pakistani	0 0%
Native Hawaiian or other Pacific Islander	0 0%

Outcome Measures

1. Secondary Outcome

Title	Components of ACR Response Criteria Over Time
Description	ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily
Time Frame	Every 12 weeks for one year then every 24 weeks until study end

Outcome Measure Data

Analysis Population Description

Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

Arm/Group Title	FOSTA 100 MG QD PO
Arm/Group Description	Fostamatinib 100 mg qd
Measure Participants	0

2. Secondary Outcome

Title	DAS28-CRP Score Over Time
Description	CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily
Time Frame	Every 12 weeks for one year then every 24 weeks until study end

Outcome Measure Data

Analysis Population Description

Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

Arm/Group Title	FOSTA 100 MG QD PO
Arm/Group Description	Fostamatinib 100 mg qd
Measure Participants	0

3. Secondary Outcome

Title	HAQ-DI Score Over Time
Description	HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily
Time Frame	Every 12 weeks for one year then every 24 weeks until study end

Outcome Measure Data

Analysis Population Description

Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

Arm/Group Title	FOSTA 100 MG QD PO
Arm/Group Description	Fostamatinib 100 mg qd
Measure Participants	0

4. Secondary Outcome

Title	SF-36 Score Over Time
Description	n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey
Time Frame	Every 12 weeks for one year then yearly until study end

Outcome Measure Data

Analysis Population Description

Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

Arm/Group Title	FOSTA 100 MG QD PO
Arm/Group Description	Fostamatinib 100 mg qd
Measure Participants	0

5. Primary Outcome

Title	Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
Description	AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event
Time Frame	Entry in extension to study termination (variable duration; maximum 52 weeks)

Outcome Measure Data

Analysis Population Description

The full analysis set was the primary population for reporting efficacy and safety data, and comprised all patients who received at least 1 dose of investigational product.

Arm/Group Title	FOSTA 100 MG QD PO
Arm/Group Description	Fostamatinib 100 mg qd
Measure Participants	115
Any AE	62.6
Any AE with outcome of death	0
Any SAE (including events with outcome of death)	3.5
Any AE leading to discontinuation of IP	2.6

Adverse Events

Arm/Group Title	FOSTA 100 MG QD PO
Arm/Group Description	Fostamatinib 100 mg qd
All Cause Mortality
	FOSTA 100 MG QD PO
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	FOSTA 100 MG QD PO
	Affected / at Risk (%)	# Events
Total	4/115 (3.5%)
Gastrointestinal disorders
PANCREATITIS ACUTE	1/115 (0.9%)	1
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT	1/115 (0.9%)	1
Musculoskeletal and connective tissue disorders
OSTEONECROSIS	1/115 (0.9%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBORRHOEIC KERATOSIS	1/115 (0.9%)	1
Other (Not Including Serious) Adverse Events
	FOSTA 100 MG QD PO
	Affected / at Risk (%)	# Events
Total	29/115 (25.2%)
Blood and lymphatic system disorders
NEUTROPENIA	6/115 (5.2%)	7
Infections and infestations
NASOPHARYNGITIS	14/115 (12.2%)	18
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS	7/115 (6.1%)	8
Vascular disorders
HYPERTENSION	7/115 (6.1%)	7

Limitations/Caveats

Insufficient efficacy data was available for analysis due to sparse data collection and the early termination of the study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.