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

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fostamatinib
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dosing regimen

Arm Description

Open label Oral treatment 100mg once daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Components of ACR Response Criteria Over Time
ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily
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
HAQ-DI Score Over Time
HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily
SF-36 Score Over Time
n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey

Full Information

First Posted
July 2, 2012
Last Updated
February 27, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01640054
Brief Title
A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. 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).
Detailed Description
(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dosing regimen
Arm Type
Experimental
Arm Description
Open label Oral treatment 100mg once daily
Intervention Type
Drug
Intervention Name(s)
Fostamatinib
Intervention Description
Fostamatinib 100mg once daily
Primary Outcome Measure Information:
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)
Secondary Outcome Measure Information:
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil - MacKillop, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Hongkong
State/Province
Shatin
Country
Hong Kong
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Facility Name
Research Site
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Kato-shi
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Sendai-shi
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Nagasaki-shi
State/Province
Nagasaki
Country
Japan
Facility Name
Research Site
City
Omura-shi
State/Province
Nagasaki
Country
Japan
Facility Name
Research Site
City
Sasebo-shi
State/Province
Nagasaki
Country
Japan
Facility Name
Research Site
City
Okayama-shi
State/Province
Okayama
Country
Japan
Facility Name
Research Site
City
Tomigusuku-shi
State/Province
Okinawa
Country
Japan
Facility Name
Research Site
City
Hamamatsu-shi
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Itabashi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Anyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research Site
City
Gwangju
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Singapore
Country
Thailand
Facility Name
Research Site
City
Hanoi
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
33254235
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.
Results Reference
derived

Learn more about this trial

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

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