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

This study is currently recruiting participants.
Verified May 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01640054
First received: July 2, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety and tolerability of fostamatinib [ Time Frame: Until study end (up to 6 years) ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed by adverse event reports, laboratory safety data, vital signs, electrocardiograms and physical examination at various intervals


Secondary Outcome Measures:
  • Components of ACR response criteria and DAS28 score over time (ACR= American College of Rheumatology response criteria (DAS28 = Disease Activity Score based on a 28 joint count) [ Time Frame: Every 12 weeks for one year then every 24 weeks until study end (up to 6 years) ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire - Disability Index (HAQ-DI). [ Time Frame: Every 12 weeks for one year then every 24 weeks until study end (up to 6 years) ] [ Designated as safety issue: No ]
  • 36-item Short Form Health Survey (SF-36) questionnaire [ Time Frame: Every 12 weeks for one year then yearly until study end (up to 6 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640054

Contacts
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

Locations
Hong Kong
Research Site Recruiting
Hongkong, Shatin, Hong Kong
Research Site Recruiting
Hong Kong, Hong Kong
Japan
Research Site Not yet recruiting
Matsuyama-shi, Ehime, Japan
Research Site Recruiting
Fukuoka-shi, Fukuoka, Japan
Research Site Recruiting
Kitakyushu-shi, Fukuoka, Japan
Research Site Not yet recruiting
Kurume-shi, Fukuoka, Japan
Research Site Recruiting
Sapporo-shi, Hokkaido, Japan
Research Site Recruiting
Kato-shi, Hyogo, Japan
Research Site Not yet recruiting
Kanazawa-shi, Ishikawa, Japan
Research Site Recruiting
Sendai-shi, Miyagi, Japan
Research Site Not yet recruiting
Isahaya, Nagasaki, Japan
Research Site Recruiting
Nagasaki-shi, Nagasaki, Japan
Research Site Recruiting
Omura-shi, Nagasaki, Japan
Research Site Recruiting
Sasebo-shi, Nagasaki, Japan
Research Site Not yet recruiting
Shibata-shi, Niigata, Japan
Research Site Recruiting
Okayama-shi, Okayama, Japan
Research Site Recruiting
Tomigusuku-shi, Okinawa, Japan
Research Site Recruiting
Hamamatsu-shi, Shizuoka, Japan
Research Site Recruiting
Itabashi-ku, Tokyo, Japan
Research Site Recruiting
Shinjuku-ku, Tokyo, Japan
Korea, Republic of
Research Site Recruiting
Anyang-si, Gyeonggi-do, Korea, Republic of
Research Site Recruiting
Gwangju, Korea, Republic of
Research Site Recruiting
Incheon, Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of
Taiwan
Research Site Not yet recruiting
Chiayi, Taiwan
Research Site Not yet recruiting
Hualien City, Taiwan
Research Site Recruiting
Kaohsiung, Taiwan
Research Site Recruiting
Taichung, Taiwan
Research Site Recruiting
Taipei, Taiwan
Research Site Not yet recruiting
Taoyuan, Taiwan
Thailand
Research Site Recruiting
Bangkok, Thailand
Research Site Recruiting
Singapore, Thailand
Vietnam
Research Site Recruiting
Hanoi, Vietnam
Research Site Recruiting
Ho Chi Minh, Vietnam
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Chris - O'Brien, 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
Last Updated: May 15, 2013
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 May 16, 2013