Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01242514
• Date of registration: 10/11/2010
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) OSKIRA-X
• Scientific title: (OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis
• Date of first enrolment: January 2011
• Target sample size: 1917
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01242514
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: Chris O'Brien, MD PhD
• Affiliation: AstraZeneca

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002,
D4300C00003 or D4300C00004) with fostamatinib

- Patients who have participated in a qualifying study and who have been classified as
non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001,
D4300C00002, D4300C00003).

Exclusion Criteria:

- Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003
and D4300C00004)

- Females who are pregnant or breast feeding

- Poorly controlled hypertension

- Significant liver function test abnormalities or physical symptoms of hepatotoxicity

- Significant infection

- Gastrointestinal intolerance

- Cancer



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Fostamatinib

Primary Outcome(s)

Percentage of Patients Who Had at Least 1 Adverse Event in Any Category [Time Frame: Entry in extension to end of study (variable duration; maximum 109 weeks)]

Secondary Outcome(s)

Mean DAS28-CRP Score [Time Frame: Weeks 0, 12, 24, 36 and 52]

Mean HAQ-DI Score [Time Frame: Weeks 0, 12, 24, 36 and 52]

Mean mTSS Score [Time Frame: Weeks 0 and 52]

Secondary ID(s)

2010-020892-22

D4300C00005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/04/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01242514