None listed
Conditions
Interventions
Group 1 Type of group
Fostamatinib 100mg twice daily
Group name:Group 3 Type of group
Fostamatinib 100mg once daily
Sponsors
AstraZeneca AB,
Eligibility
Age
18 Years to 85 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event Measure:Percentage of Patients Who Had at Least 1 Adverse Event in Any Category Timepoints:Entry in extension to end of study (variable duration; maximum 109 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patients own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily Measure:Mean DAS28-CRP Score Timepoints:Weeks 0, 12, 24, 36 and 52 ; Outcome name:mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily Measure:Mean mTSS Score Timepoints:Weeks 0 and 52 ; Outcome name:HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily Measure:Mean HAQ-DI Score Timepoints:Weeks 0, 12, 24, 36 and 52 | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Estonia, France, Germany, Hungaria, India, Israel, Italy, Latovia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kindgdom, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed