ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01640054
Recruitment Status : Terminated (AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.)
First Posted : July 13, 2012
Results First Posted : January 9, 2014
Last Update Posted : March 28, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
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 : July 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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) ]
    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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01640054     History of Changes
Other Study ID Numbers: D4300C00029
First Posted: July 13, 2012    Key Record Dates
Results First Posted: January 9, 2014
Last Update Posted: March 28, 2014
Last Verified: February 2014

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