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

This study has been terminated.
(AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01640054
First received: July 2, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: Fostamatinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage of Patients Who Had at Least 1 Adverse Event in Any Category [ Time Frame: Entry in extension to study termination (variable duration; maximum 52 weeks) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Every 12 weeks for one year then every 24 weeks until study end ] [ Designated as safety issue: No ]
    ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily

  • DAS28-CRP Score Over Time [ Time Frame: Every 12 weeks for one year then every 24 weeks until study end ] [ Designated as safety issue: No ]
    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 [ Time Frame: Every 12 weeks for one year then every 24 weeks until study end ] [ Designated as safety issue: No ]
    HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily

  • SF-36 Score Over Time [ Time Frame: Every 12 weeks for one year then yearly until study end ] [ Designated as safety issue: No ]
    n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey


Enrollment: 115
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing regimen
Open label Oral treatment 100mg once daily
Drug: Fostamatinib
Fostamatinib 100mg once daily

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640054

Locations
Hong Kong
Research Site
Hongkong, Shatin, Hong Kong
Research Site
Hong Kong, Hong Kong
Japan
Research Site
Fukuoka-shi, Fukuoka, Japan
Research Site
Kitakyushu-shi, Fukuoka, Japan
Research Site
Sapporo-shi, Hokkaido, Japan
Research Site
Kato-shi, Hyogo, Japan
Research Site
Sendai-shi, Miyagi, Japan
Research Site
Nagasaki-shi, Nagasaki, Japan
Research Site
Omura-shi, Nagasaki, Japan
Research Site
Sasebo-shi, Nagasaki, Japan
Research Site
Okayama-shi, Okayama, Japan
Research Site
Tomigusuku-shi, Okinawa, Japan
Research Site
Hamamatsu-shi, Shizuoka, Japan
Research Site
Itabashi-ku, Tokyo, Japan
Research Site
Shinjuku-ku, Tokyo, Japan
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, Korea, Republic of
Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Thailand
Research Site
Bangkok, Thailand
Research Site
Singapore, Thailand
Vietnam
Research Site
Hanoi, Vietnam
Research Site
Ho Chi Minh, Vietnam
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Neil - MacKillop, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01640054     History of Changes
Other Study ID Numbers: D4300C00029
Study First Received: July 2, 2012
Results First Received: November 21, 2013
Last Updated: February 27, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
South Korea: Korea Food and Drug Administration (KFDA)
Hong Kong: Department of Health
Taiwan: Department of Health
Vietnam: Ministry of Health
Thailand: Food and Drug Administration
China: Food and Drug Administration

Keywords provided by AstraZeneca:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014