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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

July 2, 2012
May 15, 2013
July 2012
December 2018   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01640054 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis
(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).

(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: Fostamatinib
Fostamatinib 100mg once daily
Experimental: Dosing regimen
Open label Oral treatment 100mg once daily
Intervention: Drug: Fostamatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2018
December 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com
Hong Kong,   Japan,   Korea, Republic of,   Taiwan,   Thailand,   Vietnam
 
NCT01640054
D4300C00029
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Chris - O'Brien, MD AstraZeneca
AstraZeneca
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP