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

February 27, 2014 updated by: AstraZeneca

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

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients in Asia with rheumatoid arthritis (RA).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

115

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Entry in extension to study termination (variable duration; maximum 52 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every 12 weeks for one year then every 24 weeks until study end
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
Every 12 weeks for one year then every 24 weeks until study end
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
Every 12 weeks for one year then every 24 weeks until study end
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
Every 12 weeks for one year then yearly until study end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Neil - MacKillop, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 2, 2012

First Submitted That Met QC Criteria

July 12, 2012

First Posted (Estimate)

July 13, 2012

Study Record Updates

Last Update Posted (Estimate)

March 28, 2014

Last Update Submitted That Met QC Criteria

February 27, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4300C00029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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